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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Remarks:
- As per OECD Guideline No. 421, “Reproduction/Developmental Toxicity Sc reening Test”, adopted on 29 July 2016
- Adequacy of study:
- key study
- Study period:
- From : 19 March 2022 to 18 November 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline No. 421, “Reproduction/Developmental Toxicity Screening Te st”, adopted on 29 July 2016
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- Adopted on 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS [please address all points below]:
- Premating exposure duration for parental (P0) animals: 2 weeks
- Basis for dose level selection: The doses of 150, 300 and 600 mg/kg body weight were selected as low (G2), mid (G3) and high dose (G4) levels, respectively for the present “Reproduction/ Developmental Toxicity Screening Test by Oral Gavage in Sprague Dawley rats” in consultation with sponsor based on the below mentioned toxicity information of the test item Cyclic Glucamide C12-C14.
- A dose range finding study (Bioneeds Study No. BIO-CTX 279) was conducted initially with the dose levels of 120, 300 and 750 mg/kg body weight/day by Oral Gavage in Sprague Dawley rats. The results of this study reveals that, the test item was non-toxic up to the dose level of 300 mg/kg body weight/day when administered for a period of 14 consecutive days repeatedly. An increase in creatinine and decrease in absolute and relative kidney weight were noted in males at the dose level of 750 mg/kg body weight/day. Thickened mucosa with uneven surface was observed in non-glandular part of the stomach in both males and females at the dose level of 750 mg/kg body weight/day during gross pathological examinations.
- Based on the results obtained from the above dose range finding study, another dose range finding study in lines with OECD TG 421, “Reproduction/Developmental Toxicity Screening Test” with the doses of 100, 250 and 500 mg/kg body weight was conducted (Bioneeds Study No. BIO-DTX 051). The oral administration of test item did not produce any indication of systemic, reproduction and developmental toxicity in either sex of both adults and pups at the tested dose levels of 100 and 250 mg/kg body weight/day. At dose level 500 mg/kg body weight/day, the test item did not produce any indication of reproduction and developmental toxicity in either sex of both adults and pups. However, systemic toxicity effects such as, clinical signs (wetness around mouth immediately after administration in both the sexes), reduced body weight and percent change in body weight gain in males and gross pathological changes (red discoloration of gastric and intestinal contents in 3 out of 6 males, thickened mucosa with uneven surface in non-glandular part of the stomach in 2 out 6 females) were noted at this dose level (500 mg/kg body weight/day).
- Route of administration: oral (gavage) route
- on choice of species, strain: Rat is one of the standard laboratory rodent species used for toxicity
assessment and also recommended by various regulatory authorities.
- vehicle : distilled water was used for the preparation of test item formulations, and it is one of the commonly used vehicle for toxicity studies.
- number of animals: 96 (48 Males + 48 Females) as per guideline
Test material
- Reference substance name:
- D-Glucitol, anhydro-1-deoxy-1-(methylamino)-, N-[C12-14(even numbered) acyl] derivs.
- Molecular formula:
- C19H37NO5 C21H41NO5
- IUPAC Name:
- D-Glucitol, anhydro-1-deoxy-1-(methylamino)-, N-[C12-14(even numbered) acyl] derivs.
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source : manufacturer or supplier
- batch number of test material: S148866
- Purity : 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (21 to 29°C)
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: dose concentration was stable up to
48 hours at room temperature.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid : . Required quantity of test item was weighed into a clean glass beaker, approximately 80-90% of the vehicle was added to the beaker containing test item, mixed well with clean glass rod under sonication until the test item dissolves completely and then transferred to a measuring cylinder. Finally, the volume was adjusted to required mark in measuring cylinder with vehicle to get a desired concentration
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Rat is one of the standard laboratory rodent species used for toxicity assessment and also recommended by various regulatory authorities.
- Details on species / strain selection:
- Rat is one of the standard laboratory rodent species used for toxicity assessment and also
recommended by various regulatory authorities. - Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hylasco Biotechnology India Pvt. Ltd,
Charles River Technology Licensee,
CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals)
Registration No.: 1808/PO/RcBt/S/15/CPCSEA
- Females(nulliparous and non-pregnan)t: yes
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: Males: 210.23 to 264.08 g Females: 200.03 to 232.26 g
- Housing: During acclimatization - two animals, Pre-mating - two animals, Mating - two animals, Postmating : Males were housed two, while females were housed individually
- Diet : Altromin maintenance diet for rats and mice (manufactured by Altromin Spezialfutter GmbH &
Co. KG) was provided ad libitum
- Water : Deep bore-well water passed through reverse osmosis unit and was provided ad libitum
- Acclimation period: seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.1 to 23.8
- Humidity (%): 42 to 65
- Air changes (per hr):12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 20 April 2022 To: 24 June 2022
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Required quantity of test item was weighed into a clean glass beaker, approximately 80-90% of the vehicle was added to the beaker containing test item, mixed well with clean glass rod under sonication until the test item dissolves completely and then transferred to a measuring cylinder. Finally, the volume was adjusted to required mark in measuring cylinder with vehicle to get a desired concentration
VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10mL/Kg
- batch no. : M017, M0324 - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 19 days
- Proof of pregnancy: sperm in vaginal smear referred to as gestation day 0 of pregnancy
- After 14 days of unsuccessful pairing replacement of first male by another male with proven fertility. Yes
- After successful mating each pregnant female was caged (how): individually
- Any other deviations from standard protocol: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- dose formulation analysis for dose concentration verification was performed during week 1 and 5 of the treatment. The results of dose concentration verifications for the prepared test item formulations and the mean results of analysis were within the rang
- Duration of treatment / exposure:
- Males: The males were treated for two weeks pre-mating, during mating period and up to the day before sacrifice (total of 35 days of administration).
Females:
-The pregnant animals were treated for a two-week pre-mating period (14-days), during mating until confirmed as mated, pregnancy (gestation) and up to lactation day 13 (ranging from a total period of 49 to 65 days).
-The non-pregnant animals were treated during two-week pre-mating period, during mating until confirmed as mated and further 24 days from the day of confirmation of mating - Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 600 mg/kg bw/day
- Remarks:
- high dose
- Dose / conc.:
- 300 mg/kg bw/day
- Remarks:
- mid dose
- Dose / conc.:
- 150 mg/kg bw/day
- Remarks:
- low dose
- No. of animals per sex per dose:
- 12 animals per sex per dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale:
The doses of 150, 300 and 600 mg/kg body weight were selected as low (G2), mid (G3) and high dose (G4) levels, respectively for the present “Reproduction/ Developmental Toxicity Screening Test by Oral Gavage in Sprague Dawley rats” in consultation with sponsor based on the below mentioned toxicity information of the test item Cyclic Glucamide C12-C14.
- A dose range finding study (Bioneeds Study No. BIO-CTX 279) was conducted initially with the dose levels of 120, 300 and 750 mg/kg body weight/day by Oral Gavage in Sprague Dawley rats. The results of this study reveals that, the test item was non-toxic up to the dose level of 300 mg/kg body weight/day when administered for a period of 14 consecutive days repeatedly. An increase in creatinine and decrease in absolute and relative kidney weight were noted in males at the dose level of 750 mg/kg body weight/day. Thickened mucosa with uneven surface was observed in non-glandular part of the stomach in both males and females at the dose level of 750 mg/kg body weight/day during gross pathological examinations.
- Based on the results obtained from the above dose range finding study, another dose range finding study in lines with OECD TG 421, “Reproduction/Developmental Toxicity Screening Test” with the doses of 100, 250 and 500 mg/kg body weight was conducted (Bioneeds Study No. BIO-DTX 051). The oral administration of test item did not produce any indication of systemic, reproduction and developmental toxicity in either sex of both adults and pups at the tested dose levels of 100 and 250 mg/kg body weight/day. At dose level 500 mg/kg body weight/day, the test item did not produce any indication of reproduction and developmental toxicity in either sex of both adults and pups. However, systemic toxicity effects such as, clinical signs (wetness around mouth immediately after administration in both the sexes), reduced body weight and percent change in body weight gain in males and gross pathological changes (red discoloration of gastric and intestinal contents in 3 out of 6 males, thickened mucosa with uneven surface in non-glandular part of the stomach in 2 out 6 females) were noted at this dose level (500 mg/kg body weight/day).
- Rationale for animal assignment:
The animals were weighed and arranged in ascending order of their body weights. These body weight stratified animals were distributed to all the groups using Microsoft Excel Spreadsheet, such that body weight variation of animals selected for the study does not exceed ±20% (Males: -17.20 to 8.28%; Females: -6.03 to 5.64%) of the mean body weight of each sex. The grouping was done one day prior to initiation of treatment.
- Fasting period before blood sampling: 14 or 16 hours
- Other:
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once daily
CLINICAL OBSERVATIONS: Yes
- Time schedule: These observations were made approximately at the same time on each day after dose administration for first three days of treatment and observed during pre and post dose administration from day 4 until termination.
BODY WEIGHT: Yes
- Time schedule for examinations:
Males: The males were weighed
- at the receipt
- on the day of randomization and grouping
- on the first day of dosing, weekly thereafter
- and at termination.
Females:
- The females were weighed
- at receipt
- on the day of randomization and grouping
- on the first day of dosing, weekly thereafter during pre-mating and until confirmation of mating.
- All the pregnant animals were weighed on gestation day (GD) 0, 7, 14, and 20 and on lactation day
(LD) 1, 4, 7, 13 and 14 (fasting/terminal body weight).
- The non-pregnant animals were weighed weekly once until termination and the fasting/terminal body
weights were also recorded before scheduled sacrifice.
FOOD CONSUMPTION : Males: Cage wise feed consumption was measured for all males once in a week during pre-mating
period coinciding with body weight recording.
Females:
- Cage wise feed consumption was measured for all females once in a week during premating period
coinciding with body weight recording.
- Cage wise feed consumption was measured for all pregnant animals during GD 0 to 7, 7 to 14 and
14 to 20, during LD 1 to 4, 4 to 7 and 7 to 13.
- Cage wise feed consumption was measured for all non-pregnant animals once in a week coinciding
with body weight recording.
- Oestrous cyclicity (parental animals):
- Oestrus cyclicity was monitored during
- two weeks after five days of acclimatization to screen the females for regular oestrus cyclicity
- two week pre-mating treatment period
- during mating treatment period until confirmation of mating
- at termination - Sperm parameters (parental animals):
- Parameters examined in adult male (parents)generations:testis weight, epididymis weight
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no, however one/ two pups were eliminated if more than 10 pups/
litter for measurement of serum total T4 levels
PARAMETERS EXAMINED
The following parameters were examined in [F1] offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies,
weight gain, physical or behavioural abnormalities, anogenital distance (AGD), pup weight on the
day of AGD, presence of nipples/areolae in male pups, other. Particular attention paid to the exter
nal reproductive genitals which were examined for signs of altered development; gross evaluation of
external genitalia
GROSS EXAMINATION OF DEAD PUPS: yes, for external and internal abnormalities. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: : The males were sacrificed after completion of 35 days of treatment
- Maternal animals: All the littered females were sacrificed on lactation day 14.
- The non-pregnant females were sacrificed after 26 days from the last day of confirmation of mating.
GROSS NECROPSY
- Gross necropsy consisted of careful examination of the external surface of the body, all orifices, and the cranial, thoracic and abdominal cavities and their contents as well as organs and tissues of each animal with special emphasis on reproductive organs.
HISTOPATHOLOGY / ORGAN WEIGHTS
Epididymides, Kidney, Ovaries, Prostate , Seminal vesicles and coagulating glands, Testes, Uterus with cervix, Thyroid along with parathyroid##(post fixation) were weighed,
Histopathological examination was conducted on all the tissues collected from the vehicle control and high dose group animals (with special emphasis on stages of spermatogenesis in the male gonads and histopathology of interstitial testicular cell structure - stage aware histopathological evaluation) - Postmortem examinations (offspring):
- SACRIFICE
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and
abdominal viscera and with particular attention to the external reproductive genitals and the findings
were recorded.
- Statistics:
- Parametric - One-way ANOVA with Dunnett’s post test
• Body weight (weekly/gestation/lactation)
• Percent Change in body weight (weekly/gestation/lactation)
• Feed consumption (weekly/gestation/lactation)
• Copulatory interval
• Gestation length
• Absolute/relative organ weights
• Mean pup weight per litter
• Mean pup anogenital distance ratio per litter
• Serum T4 values (adults/pups)
Non-Parametric -Kruskal-Wallis
• Implantations/litter
• No. of pups/litter
• Sex ratio/litter
• Litter size
• No. of early resorptions/litter
• No. of late resorptions/litter
• Prenatal loss/litter
• Postnatal loss/litter
Cross Tabs - Chi-square test
• Reproductive performances (frequency occurrences)
- mated/non-mated
- fertile/infertile
- pregnant/non-pregnant
- with/without live pups
- with/without dead pups - Reproductive indices:
- Male and Female reproductive indices
Male mating index (%) = No. of males with confirmed mating / Total no. of males cohabited X 100
Female mating index (%) = No. of sperm-positive females / Total no. of females cohabited X 100
Male fertility index (%) = No. of males impregnating a female / Total no. of males mated X 100
Female fertility index (%) = No. of pregnant females / No. of sperm-positive females X 100
Gestation index (%) = No. of females with live born / No. of females with evidence of pregnancy X 100
Parturition index (%) = No. of females littered / No. of females with evidence of pregnancy X 100
Pregnancy index (%) = No. of pregnant females / No. of females with confirmed mating X 100
Post-implantation loss (%) = No. of implantations - No. of viable pups / No. of implantations X 100
Total postnatal loss (%) = Total no. of pups dead/cannibalized during postnatal period / Total no. of live pups delivered X 100 - Offspring viability indices:
- Live birth index (%) per litter = No. of pups born alive / Total no. of pups born X 100
Pup survival index (%) on LD 4/7/13 = Total No. of live pups on (LD 4/7/13) / No. of pups born/4/7 X 100
Other indices
Anogenital distance (AGD) ratio = Anogenital distance (mm) / Cube root of PND 4 pup weight X 100
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- There were no clinical signs of toxicity noted in any of the animals of both sexes from the tested dose groups, G2 (150 mg/kg body weight/day), G3 (300 mg/kg body weight/day) and vehicle control group G1 (0 mg/kg body weight/day) throughout the experimental period.
In group G4 males, there were no adverse clinical signs of toxicity noted in any of the animals throughout the experimental period. However, 8 out of 12 animals (from treatment day 3), 3 out of 12 animals (from treatment day 4) and 1 out of 12 animals (from treatment day 5) were noted with wetness around mouth after dose administration and continued until termination. These noted observations can be due to surfactant nature of the test item which led to form foam or wetness near to route of administration (mouth).
In group G4 females, there were no adverse clinical signs of toxicity noted in any of the animals except wetness around mouth in 9 out of 12 treated animals (from treatment day 3), 2 out of 12 animals (from treatment day 4) and 1 out of 12 animals (from treatment day 6) after dose administration (post dose) and continued until termination. These noted observations can be due to surfactant nature of the test item which led to form foam or wetness near to route of administration (mouth). Among the other 2 out 12 treated animals, one was noted with lethargy, perinasal staining and rough hair coat along with the post-dose wetness around mouth from treatment day 39 and found dead on treatment day 41. The other female was noted with lethargy between treatment day 39 to 41, with lethargy along with perinasal staining from treatment day 42 to 47.
Later, the animal was recovered from perinasal staining and lethargy but noted with wetness around mouth until termination. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- There were no mortality/morbidity noted in any of the animals of both sexes from the dose groups G1, G2 and G3 throughout the experimental period.
In group G4 females, 1 out of 12 females was found dead after parturition (on treatment day 41). - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Weekly body weights:
In group G2, there were no adverse effects noted in mean body weight and percent change in body weight gain of both sexes when compared with vehicle control group. However, a minimal reduction in both mean body weight and percent change in body weight gain was noted in males throughout the experimental period when compared with vehicle control group. The noted reductions are statistically significant during day 1 to 14, 1 to 21, 1 to 28 and 1 to 35. These changes are considered as treatment related noted due to stress induced by the test item exposure.
In group G3, there were no adverse effects noted in mean body weight and percent change in body weight gain in females when compared with vehicle control group. However, a moderate reduction in both mean body weight and percent change in body weight gain was noted in males throughout the experimental period when compared with vehicle control group. The noted reductions are statistically significant on day
28 and 35 for mean body weight and during day 1 to 21, 1 to 28 and 1 to 35 for percent change in mean body weight gain. These changes are considered as treatment related noted due to stress induced by the test item exposure.
In group G4 males, test item related effects were noted in both mean body weight and percent change in body weight gain when compared with vehicle control group throughout the experimental period. The noted reductions are statistically significant on day 14, 21 28 and 35 for mean body weight and during entire experimental period (1 to 7, 1 to 14, 1 to 21, 1 to 28 and 1 to 35) for percent change in mean body weight gain. These changes are considered as treatment related due to stress induced by the test item exposure and due to noted clinical signs of toxicity.
In group G4 females, there were no test item related effects noted in both mean body weight and percent change in body weight gain when compared with vehicle control group throughout the experimental period.
Gestation body weights:
In groups G2 and G3, there were no changes noted in both mean gestational body weight and percent change in mean gestational body weight gain when compared with the vehicle control group throughout gestation period.
In group G4, a minimal reduction in mean gestational body weight was noted throughout the pregnancy. However, the percent change in mean gestational body weight gain was comparable with vehicle control group. These changes are considered as treatment related due to stress induced by the test item exposure and due to noted clinical signs of toxicity.
Lactation body weight:
In groups G2 and G3, there were no changes noted in both mean lactation body weight and percent change in mean lactation body weight gain when compared with the vehicle control group throughout lactation period.
In group G4, a minimal reduction in both mean lactation body weight and percent change in mean lactation body weight gain was noted throughout the lactation period. These noted reductions are statistically significant for mean body weight on lactation day 13 and during lactation day 1 to 4 for percent change in mean lactation body weight gain when compared with vehicle control group. These changes are considered as treatment related due to stress induced by the test item exposure and due to noted clinical signs of toxicity. - Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- There were no changes noted in mean feed consumption in all the tested dose groups of both sexes when compared with the vehicle control group.
There were no changes noted in mean feed consumption during gestation period in the tested dose groups G2 and G3 when compared with the vehicle control group.
In group G4, a minimal reduction in mean gestational feed consumption was noted throughout the gestational period and the noted reductions are statistically significant during gestation day (GD) 7 to 14 and 14 to 20 when compared with vehicle control group. These changes are considered as treatment related due to stress induced by the test item exposure, due to minimal reduction noted in mean gestational body weight and due to noted clinical signs of toxicity.
There were no changes noted in mean lactation feed consumption in all the tested dose groups when compared with the vehicle control group. - Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test item-related changes noted in obtained mean haematological values in all the tested dose groups of both sexes when compared with the vehicle control group.
However, the following statistically significant differences in mean haematological values were noted in the dose groups when compared with vehicle control group:
- decrease in mean corpuscular hemoglobin in group G2 males.
- decrease in mean neutrophils (absolute and %) in groups G2 and G4 males.
- increase in mean percent lymphocytes in groups G2, G3 and G4 males.
- increase in mean prothrombin time in group G3 males.
These statistically significant changes are considered as incidental and un-related to treatment, as the obtained mean values are within in-house historical control range of same species and strain. - Clinical biochemistry findings:
- not examined
- Endocrine findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test item-related changes in mean serum T4 levels in any of the tested dose group males when compared with the vehicle control group.
However, statistically significant decrease in mean serum T4 levels in group G4 males was noted when compared with vehicle control group. This noted change is considered as incidental and un-related to treatment as the obtained mean value is within in-house historical control range of same species and strain and also no changes noted in thyroid along with parathyroid during gross examinations at this dose level. - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Microscopically, test item-related changes were observed in non-glandular part of stomach:
- G3 males: 12 (out of 12) - Hyperplasia, squamous cell, non-glandular (mild); 2 (out of 12) - Hyperkeratosis, non-glandular (minimal) and 1 (out of 12) - cyst, squamous, non-glandular.
- G3 females: 11 (out of 12) - Hyperplasia, squamous cell, non-glandular (mild).
- G4 males: 2 (out of 12) - Hyperplasia, squamous cell, non-glandular (moderate); 10 (out of 12) - Hyperplasia, squamous cell, non-glandular (marked); 2 (out of 12) - Hyperkeratosis, non-glandular (minimal); 10 (out of 12) - Hyperkeratosis, non-glandular (mild).
- G4 females: 3 (out of 12) - Hyperplasia, squamous cell, non-glandular (mild); 7 (out of 12) - Hyperplasia, squamous cell, non-glandular (marked); 1 (out of 12) - Hyperkeratosis, non-glandular (minimal); 6 (out of 12) - Hyperkeratosis, non-glandular (mild). - Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no test item-related irregularities observed in oestrus cyclicity of females from any of the tested dose groups during treatment period. However, one animal from group G3 and two animals from group G4 were noted with single irregular oestrus cycle during treatment period. These noted irregularities are considered as incidental and unrelated to treatment as the same females were noted with normal preceding and proceeding oestrus cycles and there were no effects noted in reproductive performance of these females.
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- Male Mating Index:
A total of 12 (out of 12), 12 (out of 12), 11 (out of 12) and 10 (out of 12) males were confirmed with mating during cohabitation period with a mating index of 100.00% 100.00, 91.67% and 83.33% from groups G1, G2, G3 and G4, respectively.
There were no statistically significant differences noted for male mating index in any of the tested dose groups when compared with the vehicle control group.
Male Fertility Index:
A total of 12 (out of 12), 11 (out of 12), 10 (out of 11) and 10 (out of 10) mated males were confirmed as fertile by impregnating a female or siring a litter with a fertility index of 100.00%, 91.67%, 90.91% and 100.00% from the tested dose groups G1, G2, G3 and G4 respectively.
There were no statistically significant differences noted for male fertility index in any of the tested dose groups when compared with the vehicle control group.
Female Mating Index:
A total of 12 (out of 12) females were confirmed as sperm positive during vaginal smear examination with a mating index of 100.0% from all the tested dose groups and vehicle control group.
Female Fertility Index:
A total of 12 (out of 12), 11 (out of 12), 10 (out of 12) and 11 (out of 12) mated females were confirmed with presence of implantations / presence of live or dead pups / evidence of parturition with a fertility index of 100.00%, 91.67%, 83.33% and 91.67% from groups G1, G2, G3 and G4 respectively.
There were no statistically significant differences noted for female fertility index in any of the tested dose groups when compared with the vehicle control group.
Pre-coital Interval/Copulatory Interval/Mean time to Mating:
A total of 12 pairs were left for cohabitation from each group. The mean
pre-coital interval was 2.67, 3.08, 4.75 and 6.33 days for groups G1, G2, G3 and G4 respectively.
There were no statistically significant differences noted for mean
pre-coital interval in any of the tested dose groups when compared with the vehicle control group.
Gestation Length/Duration of Pregnancy:
The mean gestation length [day of confirmed as successfully mated to day of parturition] was 22.00, 22.27, 22.20 and 22.18 days for groups G1, G2, G3 and G4 respectively.
There were no statistically significant differences noted for mean gestation length in any of the tested dose groups when compared with the vehicle control group.
Fecundity or Pregnancy Index:
A total of 12 (out of 12), 11 (out of 12), 10 (out of 12) and 11 (out of 12), mated females were confirmed as pregnant / with evidence of implantation sites with a fecundity index of 100.00%, 91.67%, 83.33% and 91.67% from groups G1, G2, G3 and G4 respectively.
There were no statistically significant differences noted for fecundity index in any of the tested dose groups when compared with the vehicle control group.
Gestation Index:
A total of 12 (out of 12), 11 (out of 11), 9 (out of 10) and 10 (out of 11) pregnant females were confirmed with live born pups with a gestation index of 100.00%, 100.00%, 90.00% and 90.91% from groups G1, G2, G3 and G4 respectively.
There were no statistically significant differences noted for gestation index in any of the tested dose groups when compared with the vehicle control group.
Parturition Index:
A total of 12 (out of 12), 11 (out of 11), 10 (out of 10) and 11 (out of 11), pregnant females were confirmed with parturition with a parturition index of 100.0% for all the tested dose groups and vehicle control group.
Implantation sites and Viable pups:
A mean number of 11.50, 10.00, 10.30 and 11.55 implantation sites and mean number of 10.58, 9.55, 9.10 and 9.82 viable pups were noted from groups G1, G2, G3 and G4 respectively.
There were no statistically significant changes noted for both mean implantation sites and viable pups in any of the tested dose groups when compared with the vehicle control group.
Post-implantation loss:
A mean number of 0.92, 0.45, 1.20 and 1.73 post-implantation losses with a percentage of 9.46%, 6.15%, 18.15% and 22.48% were noted from groups G1, G2, G3 and G4 respectively.
In group G3, the increase in mean number of post-implantation losses and its percentage can be due to total implantation loss noted in 1 out of 10 littered dams. The mean number of post-implantation loss is 0.67 with a percentage of 9.06 after excluding the data of the dam with total implantation loss at this dose level which is comparable with vehicle control group. Hence, this noted increase can be considered as incidental.
The increase in post-implantations losses from groups G4 is considered as secondary test item related effects caused due to clinical signs of toxicity and stress induced by the test item exposure. However, there were no statistically significant changes noted as for mean number and percentage of occurred post-implantation losses in any of the tested dose groups when compared with the vehicle control group.
Postnatal Loss:
A mean number of 0.17, 0.00, 0.22 and 1.50 postnatal losses with a percentage of 2.08, 0.00, 1.54 and 22.22 were noted from groups G1, G2, G3 and G4 respectively.
The increase in postnatal loss in group G4 (no. and %) is due to treatment related effects noted in dams, such as clinical signs of toxicity and effects on body weight.
There were no statistically significant changes noted for mean number and percentage of occurred postnatal losses in any of the tested dose groups when compared with the vehicle control group.
In conclusion, there were no adverse effects noted on male and female reproductive performance/indices of adults from the tested dose groups G2 and G3 when compared with vehicle control group.
In group G4, treatment related effects noted on some of the male and female reproductive performance/indices which can be due to stress induce by the test item exposure.
Details on results (P0)
At the dose level of 300 mg/kg body weight/day, animals noted with some effects such as moderately reduced body weights in males, and histopathological findings such as hyperplasia, squamous cell, non-glandular and hyperkeratosis, non-glandular in stomach. There were no test item related effects noted in any of the reproductive and developmental end points at this dose level, except a minimal and not statistically significant increase in post-implantation loss.
At the dose level of 600 mg/kg body weight/day, animals noted with treatment related clinical signs of toxicity, reduced body weights and feed consumption, increased post-implantation loss, increase in postnatal loss and histopathological findings such as hyperplasia, squamous cell, non-glandular and hyperkeratosis, non-glandular in stomach.
In conclusion, there were no adverse effects noted on male and female reproductive performance/indices of adults from the tested dose groups G2 and G3 when compared with vehicle control group.
In group G4, treatment related effects noted on some of the male and female reproductive performance/indices which can be due to stress induce by the test item exposure.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- haematology
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: NOAEL for systemic toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: The effects on reproduction at the dose level of 600 mg/kg body weight/day is considered to be a secondary non-specific consequence of the other toxic effects.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no test item related external abnormalities or behavioural changes noted in any of the pups during daily observation from all the tested dose groups and vehicle control group during postnatal period. All the pups had normal behaviour during daily observations.
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- A total of 2 out of 127 pups were dead/cannibalized from group G1; a total of 4 out of 91 pups were found dead during lactation day 1 to 4 in group G3; a total of 15 out of 108 pups were found dead during lactation day 1 to 4 in group G4. The noted mortalities in group G3 and G4 can be due to test item induced stress on dams and effects on systemic endpoints in group G4.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no changes noted in mean pup [both male and female] weight per litter in all the tested dose groups when compared with the vehicle control group, recorded on postnatal day (PND) 1, 4, 7 and 13.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no changes in mean pup [both male and female] anogenital distance measurement (mm) and its ratio per litter in all the tested dose groups when compared with the vehicle control group, recorded on postnatal day 4. However, statistically significant decrease in mean male pup Anogenital distance and mean Anogenital distance ratio in group G4 was noted when compared with vehicle control group. This noted change is considered as incidental and un-related to treatment as the obtained mean value is within in-house historical control range of same species and strain.
- Nipple retention in male pups:
- no effects observed
- Description (incidence and severity):
- There were no occurrences or evidence of retention of nipples in any of the male pups examined on the postnatal day 13 from all the tested dose groups and vehicle control group litters.
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no gross pathological changes observed during conduct of necropsy in any of the F1 pups of both sexes from all tested dose groups, except a single and incidental finding from group G3, where the pup was found dead and noted with discoloration in head region.
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- There were no changes in mean serum T4 hormone levels of pups at postnatal day 13 in any of the tested dose group litters when compared with vehicle control group litters.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
In group G2, there were no test item related changes observed in birth parameters such as, total litter size, number of live pups born, sex ratio (m/f) and live birth index when compared with the vehicle control group. The pup survival index per litter during lactation period was unaffected by the test item when compared with the vehicle control group.
In group G3, there were no adverse test item related changes observed in birth parameters such as, total litter size, number of live pups born, sex ratio (m/f) and live birth index when compared with the vehicle control group. However, a minimal reduction in live birth index was noted from this dose level. This reduction is due to noted total litter loss in 1 out of 10 littered females. This can be considered as incidental, and the attained mean live birth index is within the in-house historical control range (In-house historical control range: 80 to 100%). The pup survival index per litter during lactation period was unaffected by the test item when compared with the vehicle control group.
In group G4, there were no changes observed in total litter size and number of live pups born. The live birth index was reduced due to increase in number of dead pups at birth. However, the attained mean live birth index is within the in-house historical control range (In-house historical control range: 80 to 100%). The pup survival index per litter during lactation day 1 to 4 was also reduced at this dose level and this reduction was due to total postnatal loss noted in 2 out of 11 littered dams. These effects are considered as treatment related due to noted clinical signs of toxicity and also due to stress induced by test item exposure. The noted statistically significant decrease in sex ratio at birth in group G4 when compared with the vehicle control group is considered as incidental and un-related to treatment.
Pup observations during Postnatal Period
There were no test item related external abnormalities or behavioural changes noted in any of the pups during daily observation from all the tested dose groups and vehicle control group during postnatal period. All the pups had normal behaviour during daily observations.
A total of 2 out of 127 pups were dead/cannibalized from group G1; a total of 4 out of 91 pups were found dead during lactation day 1 to 4 in group G3; a total of 15 out of 108 pups were found dead during lactation day 1 to 4 in group G4. The noted mortalities in group G3 and G4 can be due to test item induced stress on dams and effects on systemic endpoints in group G4.
Mean Pup Weight per Litter during Postnatal Period
There were no changes noted in mean pup [both male and female] weight per litter in all the tested dose groups when compared with the vehicle control group, recorded on postnatal day (PND) 1, 4, 7 and 13.
Mean Pup Anogenital distance and Anogenital distance Ratio per Litter
There were no changes in mean pup [both male and female] anogenital distance measurement (mm) and its ratio per litter in all the tested dose groups when compared with the vehicle control group, recorded on postnatal day 4. However, statistically significant decrease in mean male pup Anogenital distance in group G4 was noted when compared with vehicle control group. This noted change is considered as incidental and un-related to treatment as the obtained mean value is within in-house historical control range of same species and strain.
Nipple Retention in Male Pups per Litter
There were no occurrences or evidence of retention of nipples in any of the male pups examined on the postnatal day 13 from all the tested dose groups and vehicle control group litters.
Serum Thyroid Hormone (T4) Levels - Postnatal Pups
There were no changes in mean serum T4 hormone levels of pups at postnatal day 13 in any of the tested dose group litters when compared with vehicle control group litters.
Refer: Table 22 (Summary Data) and Appendices 22 (Individual Data)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other:
- Remarks on result:
- other: Postnatal loss due to secondary effects (stress induce by the test item exposure)
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 600 mg/kg bw/day
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- not specified
- Relevant for humans:
- no
Any other information on results incl. tables
- SUMMARY RECORD OF MEAN PUP ANOGENITAL DISTANCE (AGD) MEASUREMENT (mm) AND ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4
- INDIVIDUAL ANIMAL TERMINAL BODY WEIGHT (g) AND ORGAN WEIGHT RELATIVE TO
TERMINAL BODY WEIGHT (%) RECORD - INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO
PER LITTER ON POSTNATAL DAY 4 RECORD - OBSERVATION RECORD OF INDIVIDUAL MALE PUP/S FOR RETENTION OF NIPPLE/AREOLAE (No.) PER LITTER ON
POSTNATAL DAY 13
Parameters ↓ | Group, Sex & Dose | ||||
G1 & 0 | G2 & 150 | G3 & 300 | G4 & 600 | ||
Reproductive Indices | |||||
No. of Pairs started | 12 | 12 | 12 | 12 | |
Reproductive Performance / Indices (males) | |||||
Total No. of males cohabited | 12 | 12 | 12 | 12 | |
No. of males with confirmed mating | 12 | 12 | 11 | 10 | |
No. of males impregnating/siring a female | 12 | 11 | 10 | 10 | |
Male Mating Index (%) | 100.00 | 100.00 | 91.67 | 83.33 | |
Male Fertility Index (%) | 100.00 | 91.67 | 90.91 | 100.00 | |
| |||||
Reproductive Performance and Indices (females) | |||||
Mean Oestrus cycle length (days) | Mean | 4.65 | 4.53 | 4.46 | 4.59 |
±SD | 0.30 | 0.17 | 0.25 | 0.19 | |
No. of females with regular oestrus cycle | 12 | 12 | 11 | 10 | |
Total No. of females cohabited | 12 | 12 | 12 | 12 | |
No. of sperm-positive females | 12 | 12 | 12 | 12 | |
No. of females with evidence of pregnancy | 12 | 11 | 10 | 11 | |
No. of females with live born pups | 12 | 11 | 9 | 10 | |
No. of females with conceiving days 1 to 5 | 11 | 11 | 8 | 7 | |
No. of females with conceiving days >5 | 1 | 1 | 4 | 5 | |
Pre-coital Interval (Days) | Mean | 2.67 | 3.08 | 4.75 | 6.33 |
±SD | 2.39 | 3.03 | 5.05 | 6.24 | |
Female Mating Index (%) | 100.00 | 100.00 | 100.00 | 100.00 | |
Female Fertility Index (%) | 100.00 | 91.67 | 83.33 | 91.67 | |
No. of females with Pregnancy≤21 days | 2 | 1 | 2 | 2 | |
No. of females with Pregnancy = 22 days | 8 | 6 | 4 | 5 | |
No. of females with Pregnancy = 23 days | 2 | 4 | 4 | 4 | |
Gestation Length (Days) | Mean | 22.00 | 22.27 | 22.20 | 22.18 |
±SD | 0.60 | 0.65 | 0.79 | 0.75 | |
Female Fecundity or Pregnancy Index (%) | 100.00 | 91.67 | 83.33 | 91.67 | |
Gestation Index (%) | 100.00 | 100.00 | 90.00 | 90.91 | |
Parturition index (%) | 100.00 | 100.00 | 100.00 | 100.00 |
±SD: Standard deviation; %: Percent; No.: Number; >: Greater than; ≤: less than or equal to; =: Equal to.
SUMMARY OF THE STUDY (Contd…).
Parameters ↓ | Group, Sex & Dose | ||||
G1 & 0 | G2 & 150 | G3 & 300 | G4 & 600 | ||
Delivery and Litter Observations | |||||
No. of Dams with live young born | 12 | 11 | 10 | 11 | |
No. of Dams with live young at PND 4 | 12 | 11 | 9 | 8 | |
No. of Dams with live young at PND 7 | 12 | 11 | 9 | 8 | |
No. of Dams with live young at PND 13 | 12 | 11 | 9 | 8 | |
No. of Implants/dam | Mean | 11.50 | 10.00 | 10.30 | 11.55 |
±SD | 2.47 | 3.58 | 3.92 | 4.41 | |
No. of Live pups/dam at birth | Mean | 10.58 | 9.55 | 9.10 | 9.82 |
±SD | 3.23 | 3.88 | 5.20 | 5.44 | |
No. of Live pups/dam at | Mean | 10.42 | 9.55 | 8.90 | 8.45 |
±SD | 3.42 | 3.88 | 4.95 | 6.07 | |
No. of Live pups/dam at | Mean | 9.50 | 9.00 | 9.22 | 10.63 |
±SD | 2.61 | 3.13 | 3.42 | 2.39 | |
No. of Live pups/dam at | Mean | 9.50 | 9.00 | 9.22 | 10.63 |
±SD | 2.61 | 3.13 | 3.42 | 2.39 | |
Live Birth Index/dam (%) | Mean | 100.00 | 97.79 | 85.90 | 81.25 |
±SD | 0.00 | 5.00 | 31.94 | 33.73 | |
Pup Survival Index/dam on PND 4 (%) | Mean | 97.92 | 100.00 | 98.46 | 77.78 |
±SD | 7.22 | 0.00 | 3.14 | 41.33 | |
Pup Survival Index/dam on PND 7 (%) | Mean | 100.00 | 100.00 | 100.00 | 100.00 |
±SD | 0.00 | 0.00 | 0.00 | 0.00 | |
Pup Survival Index/dam on PND 13 (%) | Mean | 100.00 | 100.00 | 100.00 | 100.00 |
±SD | 0.00 | 0.00 | 0.00 | 0.00 | |
Sex ratio (m/f)/dam At Birth | Mean | 1.37 | 1.12 | 1.43 | 0.72 |
±SD | 1.03 | 0.48 | 0.78 | 0.28 | |
Sex ratio (m/f)/dam at PND 4 | Mean | 1.37 | 1.12 | 1.41 | 0.74 |
±SD | 1.03 | 0.48 | 0.75 | 0.27 | |
Sex ratio (m/f)/dam at PND 7 | Mean | 2.02 | 1.22 | 1.60 | 0.90 |
±SD | 2.28 | 0.47 | 0.76 | 0.48 | |
Sex ratio (m/f)/dam at PND 13 | Mean | 2.02 | 1.22 | 1.60 | 0.90 |
±SD | 2.28 | 0.47 | 0.76 | 0.48 |
m/f: male/female; No.: Number; PND: Postnatal Day; ±SD: Standard deviation; %: Percent.
SUMMARY OF THE STUDY (Contd…).
Parameters ↓ | Group, Sex & Dose | |||||
G1 & 0 | G2 & 150 | G3 & 300 | G4 & 600 | |||
Delivery and Litter Observations | ||||||
Mean Male Pup weight (g)/dam | At birth | Mean | 6.78 | 6.79 | 6.79 | 6.34 |
±SD | 0.25 | 0.15 | 0.30 | 0.96 | ||
PND 4 | Mean | 11.43 | 11.25 | 11.35 | 11.07 | |
±SD | 0.49 | 0.49 | 0.53 | 0.57 | ||
PND 7 | Mean | 15.37 | 15.26 | 15.40 | 15.03 | |
±SD | 0.53 | 0.59 | 0.59 | 0.52 | ||
PND 13 | Mean | 28.70 | 28.71 | 28.74 | 28.38 | |
±SD | 0.87 | 0.78 | 0.84 | 0.63 | ||
Mean Female Pup weight (g)/dam | At Birth | Mean | 6.47 | 6.40 | 6.43 | 6.15 |
±SD | 0.32 | 0.28 | 0.28 | 0.82 | ||
PND 4 | Mean | 10.68 | 10.58 | 10.54 | 10.62 | |
±SD | 0.40 | 0.48 | 0.35 | 0.67 | ||
PND 7 | Mean | 14.62 | 14.52 | 14.78 | 14.63 | |
±SD | 0.47 | 0.73 | 0.59 | 0.55 | ||
PND 13 | Mean | 27.66 | 27.80 | 27.89 | 27.43 | |
±SD | 0.83 | 0.72 | 0.66 | 0.29 | ||
Mean Male Pup AGD Measurement/dam (mm) on PND 4 | Mean | 5.20 | 5.15 | 5.10 | 4.99 | |
±SD | 0.20 | 0.15 | 0.21 | 0.10 | ||
Mean Male Pup AGD ratio/dam on PND 4 | Mean | 2.31 | 2.30 | 2.24 | 2.24 | |
±SD | 0.06 | 0.04 | 0.15 | 0.05 | ||
Mean Female Pup AGD Measurement/dam (mm) on PND 4 | Mean | 2.68 | 2.68 | 2.63 | 2.55 | |
±SD | 0.15 | 0.20 | 0.15 | 0.12 | ||
Mean Female Pup AGD ratio/dam on PND 4 | Mean | 1.22 | 1.22 | 1.20 | 1.16 | |
±SD | 0.06 | 0.07 | 0.06 | 0.04 | ||
Male Pup Nipple Retention/dam on PND 13 | Mean | 0.00 | 0.00 | 0.00 | 0.00 | |
±SD | 0.00 | 0.00 | 0.00 | 0.00 |
AGD: Anogenital distance; PND: Postnatal Day; ±SD: Standard deviation.
SUMMARY OF THE STUDY (Contd…).
Parameters ↓ | Group, Sex & Dose | ||||
G1 & 0 | G2 & 150 | G3 & 300 | G4 & 600 | ||
ABNORMAL PUPS DURING AT BIRTH | |||||
No. of Dams with live young born at birth | 12 | 11 | 9 | 10 | |
No. of Dams with 0 abnormal live pups | 11 | 11 | 8 | 10 | |
No. of Dams with ≥1 abnormal live pup | 1 | 0 | 1 | 1 | |
LOSS OF OFFSPRING | |||||
Pre-natal or post-implantation loss (implantations minus live births) | |||||
No. of Females with 0 post-implantation loss | 6 | 6 | 5 | 4 | |
No. of Females with 1 post-implantation loss | 2 | 5 | 2 | 3 | |
No. of Females with 2 post-implantation losses | 3 | 0 | 2 | 0 | |
No. of Females with 3 post-implantation losses | 1 | 0 | 0 | 2 | |
No. of Females with 4 post-implantation losses | 0 | 0 | 0 | 1 | |
No. of Females with 6 post-implantation losses | 0 | 0 | 1 | 1 | |
Post-implantation Loss (No.) | Mean | 0.92 | 0.45 | 1.20 | 1.73 |
±SD | 1.08 | 0.52 | 1.87 | 2.00 | |
Post-implantation Loss (%) | Mean | 9.46 | 6.15 | 18.15 | 22.48 |
±SD | 12.29 | 7.58 | 31.69 | 33.98 | |
Postnatal loss (live births minus alive at PND 13) | |||||
No. of Females with 0 Post-natal Loss | 11 | 11 | 7 | 6 | |
No. of Females with 1 Post-natal Loss | 0 | 0 | 2 | 2 | |
No. of Females with 2 Post-natal Loss | 1 | 0 | 0 | 1 | |
No. of Females with 11 Post-natal Loss | 0 | 0 | 0 | 1 | |
Postnatal loss (No.) | Mean | 0.17 | 0.00 | 0.22 | 1.50 |
±SD | 0.58 | 0.00 | 0.44 | 3.41 | |
Postnatal Loss (%) | Mean | 2.08 | 0.00 | 1.54 | 22.22 |
±SD | 7.22 | 0.00 | 3.14 | 41.33 |
PND: Postnatal Day; ±SD: Standard deviation; ≥: Greater than or equal to; No.: Number; %: Percentage.
Refer Appendix 1
Group, Sex & Dose (mg/kg body weight/day) | Total No. of Animals | Clinical Signs of Toxicitya: Observation | Mortalityb: No. of Mortalities | |
Pre-dose | Post-dose | |||
G1, M & 0 | 12 | N (12) | N (12) | 0 (12) |
G2, M & 150 | 12 | N (12) | N (12) | 0 (12) |
G3, M & 300 | 12 | N (12) | N (12) | 0 (12) |
G4, M & 600 | 12 | N (12) | 6+ (12) | 0 (12) |
M: Male; N: Normal.
a: observed once daily; b: observed twice daily.
6: Wetness around mouth; +: Slight.
TABLE 1 (Contd…). SUMMARY OF CLINICAL SIGNS OF TOXICITY, DETAILED CLINICAL EXAMINATION
AND MORTALITY RECORD
Refer Appendix 1
Group, Sex & Dose (mg/kg body weight/day) | Total No. of Animals | Clinical Signs of Toxicitya: Observation | Mortalityb: No. of Mortalities | |
Pre-dose | Post-dose | |||
G1, F & 0 | 12 | N (12) | N (12) | 0 (12) |
G2, F & 150 | 12 | N (12) | N (12) | 0 (12) |
G3, F & 300 | 12 | N (12) | N (12) | 0 (12) |
G4, F & 600 | 12 | N (10), 1 (2),
| 6+ (12), 1 (2), 82 (2), 116 (1)
| 1 (12) |
F: Female; N: Normal; NAD: No Abnormality Detected.
a: observed once daily; b: observed twice daily.
6: Wetness around mouth; +: Slight; 1: Lethargy; 82: Peri nasal Staining; 116: Rough hair coat.
Refer Appendix 2
Group, Sex & Dose (mg/kg body weight/day) | Body Weight (g) on Day | |||||||
1 | 7 | 14 | 21 | 28 | 35 | |||
G1, M & 0 | Mean | 366.74 | 386.26 | 406.21 | 418.26 | 430.83 | 439.80 | |
±SD | 22.32 | 28.19 | 33.98 | 32.17 | 29.87 | 33.17 | ||
n | 12 | 12 | 12 | 12 | 12 | 12 | ||
G2, M & 150 | Mean | 365.58 | 379.08 | 383.38 | 390.28 | 401.38 | 413.65 | |
±SD | 21.46 | 28.35 | 32.41 | 30.93 | 28.18 | 27.05 | ||
n | 12 | 12 | 12 | 12 | 12 | 12 | ||
G3, M & 300 | Mean | 367.94 | 382.03 | 393.34 | 395.63 | 399.89* | 404.92* | |
±SD | 25.28 | 29.11 | 32.78 | 36.99 | 34.89 | 34.66 | ||
n | 12 | 12 | 12 | 12 | 12 | 12 | ||
G4, M & 600 | Mean | 366.63 | 369.69 | 372.83* | 373.40* | 378.10* | 379.83* | |
±SD | 22.08 | 26.35 | 31.29 | 27.44 | 28.31 | 29.06 | ||
n | 12 | 12 | 12 | 12 | 12 | 12 |
M: Male; SD: Standard Deviation; n: Number of Animals.
* Statistically significant (P<0.05) change than the vehicle control group.
TABLE 2 (Contd…). SUMMARY OF BODY WEIGHT (g) RECORD
Refer Appendix 2
Group, Sex & Dose (mg/kg body weight/day) |
| Body Weight (g) on Day | |||||
1 | 7 | 14 | 21# | 28# | |||
G1, F & 0 | Mean | 258.75 | 265.07 | 271.98 | 290.01 | - | |
±SD | 9.72 | 12.05 | 12.24 | - | - | ||
n | 12 | 12 | 12 | 1 | - | ||
G2, F & 150 | Mean | 258.43 | 265.55 | 273.91 | 291.08 | - | |
±SD | 10.91 | 12.20 | 13.03 | - | - | ||
n | 12 | 12 | 12 | 1 | - | ||
G3, F & 300 | Mean | 259.83 | 264.42 | 269.00 | 285.11 | 279.42 | |
±SD | 10.65 | 14.32 | 14.66 | 3.70 | - | ||
n | 12 | 12 | 12 | 3 | 1 | ||
G4, F & 600 | Mean | 259.58 | 266.45 | 271.14 | 265.77 | 290.14 | |
±SD | 11.57 | 15.72 | 18.19 | 23.88 | 5.47 | ||
n | 12 | 12 | 12 | 3 | 2 |
F: Female; SD: Standard Deviation; n: Number of Animals.
#: The data obtained from females in cohabitation only considered for mean calculations.
The data of day 21 & 28 body weight was not subjected to statistical analysis due to uneven number of variables.
Refer Appendix 3
Group, Sex & Dose (mg/kg body weight/day) | Body Weight (g) on Gestation Day | |||||
0 | 7 | 14 | 20 | |||
G1, F & 0 | Mean | 279.28 | 296.44 | 328.88 | 392.71 | |
±SD | 14.73 | 16.02 | 19.45 | 33.70 | ||
n | 12 | 12 | 12 | 12 | ||
G2, F & 150 | Mean | 277.34 | 294.62 | 324.67 | 371.36 | |
±SD | 12.93 | 12.84 | 17.97 | 29.95 | ||
n | 11 | 11 | 11 | 11 | ||
G3, F & 300 | Mean | 280.03 | 294.55 | 323.78 | 374.48 | |
±SD | 15.03 | 17.80 | 20.86 | 40.80 | ||
n | 10 | 10 | 10 | 10 | ||
G4, F & 600 | Mean | 273.37 | 288.21 | 313.29 | 367.02 | |
±SD | 17.77 | 17.60 | 24.95 | 48.24 | ||
n | 11 | 11 | 11 | 11 |
F: Female; SD: Standard Deviation; n: Number of Dams.
Note: Excluded the data of non-pregnant females for mean calculations and statistical analysis but presented in individual animal data.
Refer Appendix 4
Group, Sex & Dose (mg/kg body weight/day) |
| Body Weight (g) on Lactation Day | ||||
1 | 4 | 7 | 13 | |||
G1, F & 0 | Mean | 303.09 | 308.32 | 316.87 | 331.86 | |
±SD | 13.23 | 13.43 | 13.25 | 11.98 | ||
n | 12 | 12 | 12 | 12 | ||
G2, F & 150 | Mean | 296.63 | 299.90 | 307.99 | 322.06 | |
±SD | 16.55 | 18.85 | 18.76 | 20.51 | ||
n | 11 | 11 | 11 | 11 | ||
G3, F & 300 | Mean | 302.09 | 305.21 | 311.05 | 326.37 | |
±SD | 19.30 | 16.80 | 14.89 | 10.85 | ||
n | 10 | 10 | 10 | 10 | ||
G4, F & 600 | Mean | 292.13 | 290.14 | 299.99 | 312.93* | |
±SD | 16.98 | 21.53 | 21.24 | 25.12 | ||
n | 11 | 11 | 10 | 10 |
F: Female; SD: Standard Deviation; n: Number of Dams.
* Statistically significant (P<0.05) change than the vehicle control group.
Note: One female from group G4 was found dead on lactation day (LD 5).
Refer Appendix 5
Group, Sex & Dose (mg/kg body weight/day) |
| Percent Change in Body Weight (%) during Day | |||||
1 to 7 | 1 to 14 | 1 to 21 | 1 to 28 | 1 to 35 | |||
G1, M & 0 | Mean | 5.28 | 10.67 | 14.01 | 17.50 | 19.92 | |
±SD | 2.72 | 4.29 | 4.20 | 4.51 | 5.00 | ||
n | 12 | 12 | 12 | 12 | 12 | ||
G2, M & 150 | Mean | 3.63 | 4.82* | 6.72* | 9.79* | 13.20* | |
±SD | 3.13 | 5.40 | 5.08 | 4.31 | 5.05 | ||
n | 12 | 12 | 12 | 12 | 12 | ||
G3, M & 300 | Mean | 3.82 | 6.92 | 7.53* | 8.75* | 10.15* | |
±SD | 3.11 | 5.46 | 6.98 | 7.21 | 7.67 | ||
n | 12 | 12 | 12 | 12 | 12 | ||
G4, M & 600 | Mean | 0.80* | 1.64* | 1.87* | 3.16* | 3.65* | |
±SD | 2.95 | 5.16 | 5.03 | 5.58 | 6.14 | ||
n | 12 | 12 | 12 | 12 | 12 |
M: Male; SD: Standard Deviation; n: Number of Animals.
* Statistically significant (P<0.05) change than the vehicle control group.
TABLE 5 (Contd…). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT GAIN (%) WITH RESPECT TO DAY 1 RECORD
Refer Appendix 5
Group, Sex & Dose (mg/kg body weight/day) |
| Percent Change in Body Weight (%) during Day | ||||
1 to 7 | 1 to 14 | 1 to 21# | 1 to 28# | |||
G1, F & 0 | Mean | 2.42 | 5.10 | 9.52 | - | |
±SD | 1.56 | 2.16 | - | - | ||
n | 12 | 12 | 1 | - | ||
G2, F & 150 | Mean | 2.75 | 5.99 | 7.12 | - | |
±SD | 1.66 | 2.04 | - | - | ||
n | 12 | 12 | 1 | - | ||
G3, F & 300 | Mean | 1.73 | 3.49 | 7.94 | 10.01 | |
±SD | 2.30 | 2.21 | 3.47 | - | ||
n | 12 | 12 | 3 | 1 | ||
G4, F & 600 | Mean | 2.60 | 4.38 | 1.82 | 7.89 | |
±SD | 2.56 | 3.31 | 4.91 | 5.41 | ||
n | 12 | 12 | 3 | 2 |
F: Female; SD: Standard Deviation; n: Number of Animals.
#: The data obtained from females in cohabitation only considered for mean calculations. The data of day 1 to 21 body weight was not subjected to statistical analysis due to uneven number of variables.
Refer Appendix 6
Group, Sex & Dose (mg/kg body weight/day) | Percent Change in Body Weight Gain (%) during Gestation Day | ||||
0 to 7 | 7 to 14 | 14 to 20 | |||
G1, F & 0 | Mean | 6.16 | 10.94 | 19.32 | |
±SD | 2.03 | 2.87 | 6.18 | ||
n | 12 | 12 | 12 | ||
G2, F & 150 | Mean | 6.25 | 10.17 | 14.31 | |
±SD | 1.37 | 2.60 | 5.06 | ||
n | 11 | 11 | 11 | ||
G3, F & 300 | Mean | 5.16 | 9.92 | 15.46 | |
±SD | 1.80 | 2.02 | 6.58 | ||
n | 10 | 10 | 10 | ||
G4, F & 600 | Mean | 5.48 | 8.62 | 16.83 | |
±SD | 2.61 | 3.56 | 8.00 | ||
n | 11 | 11 | 11 |
F: Female; SD: Standard Deviation; n: Number of Dams.
Note: Excluded the data of non-pregnant females for mean calculations and statistical analysis but presented in individual animal data.
Refer Appendix 7
Group, Sex & Dose (mg/kg body weight/day) |
| Percent Change in Body Weight Gain (%) during Lactation Day | |||
1 to 4 | 4 to 7 | 7 to 13 | |||
G1, F & 0 | Mean | 1.74 | 2.78 | 4.76 | |
±SD | 1.92 | 0.63 | 1.74 | ||
n | 12 | 12 | 12 | ||
G2, F & 150 | Mean | 1.08 | 2.71 | 4.56 | |
±SD | 1.89 | 0.46 | 1.23 | ||
n | 11 | 11 | 11 | ||
G3, F & 300 | Mean | 1.09 | 1.96 | 5.01 | |
±SD | 1.62 | 1.59 | 2.77 | ||
n | 10 | 10 | 10 | ||
G4, F & 600 | Mean | -0.75* | 1.94 | 4.26 | |
±SD | 2.67 | 1.69 | 1.69 | ||
n | 11 | 10 | 10 |
F: Female; SD: Standard Deviation; n: Number of Dams.
Note: One female from group G4 was found dead on lactation day (LD 5).
* Statistically significant (P<0.05) change than the vehicle control group.
Refer Appendix 8
(mg/kg body weight/day) | Feed Consumption (g/animal/day) during Pre-mating Period | ||
Week 1 | Week 2 | ||
G1, M & 0 | Mean | 21.40 | 24.60 |
±SD | 2.66 | 1.34 | |
n | 12 (6) | 12 (6) | |
G2, M & 150 | Mean | 21.93 | 24.50 |
±SD | 2.19 | 0.86 | |
n | 12 (6) | 12 (6) | |
G3, M & 300 | Mean | 22.68 | 23.37 |
±SD | 1.63 | 1.21 | |
n | 12 (6) | 12 (6) | |
G4, M & 600 | Mean | 21.13 | 23.28 |
±SD | 1.97 | 0.94 | |
n | 12 (6) | 12 (6) |
M: Male; SD: Standard Deviation; n: Number of Animals (Number of Cages).
TABLE 8 (Contd…). SUMMARY OF FEED CONSUMPTION (g/animal/day) RECORD
Refer Appendix 8
(mg/kg body weight/day) | Feed Consumption (g/animal/day) during Pre-mating Period | ||
Week 1 | Week 2 | ||
G1, F & 0 | Mean | 18.07 | 18.30 |
±SD | 0.96 | 1.11 | |
n | 12 (6) | 12 (6) | |
G2, F & 150 | Mean | 18.03 | 18.15 |
±SD | 1.24 | 1.56 | |
n | 12 (6) | 12 (6) | |
G3, F & 300 | Mean | 17.93 | 17.68 |
±SD | 1.30 | 1.53 | |
n | 12 (6) | 12 (6) | |
G4, F & 600 | Mean | 17.36 | 17.07 |
±SD | 1.19 | 1.37 | |
n | 12 (6) | 12 (6) |
F: Female; SD: Standard Deviation; n: Number of Animals (Number of Cages).
Refer Appendix 9
Group, Sex & Dose (mg/kg body weight/day) |
| Feed Consumption (g/animal/day) during Gestation Day (GD) | ||
0 to 7 | 7 to 14 | 14 to 20 | ||
G1, F & 0 | Mean | 19.85 | 21.88 | 26.70 |
±SD | 1.31 | 1.29 | 1.84 | |
n | 12 | 12 | 12 | |
G2, F & 150 | Mean | 19.73 | 21.62 | 25.95 |
±SD | 0.97 | 1.41 | 1.47 | |
n | 11 | 11 | 11 | |
G3, F & 300 | Mean | 19.33 | 21.67 | 26.32 |
±SD | 1.35 | 1.70 | 2.08 | |
n | 10 | 10 | 10 | |
G4, F & 600 | Mean | 18.79 | 20.36* | 24.48* |
±SD | 1.51 | 1.38 | 2.18 | |
n | 11 | 11 | 11 |
F: Female; SD: Standard Deviation; n: Number of Dams.
Note: Excluded the data of non-pregnant females for mean calculations and statistical analysis but presented in individual animal data.
* Statistically significant (P<0.05) change than the vehicle control group.
Refer Appendix 10
Group, Sex & Dose (mg/kg body weight/day) |
| Feed Consumption (g/animal/day) during Lactation Day (LD) | ||
1 to 4 | 4 to 7 | 7 to 13 | ||
G1, F & 0 | Mean | 27.67 | 32.58 | 41.73 |
±SD | 1.82 | 2.16 | 1.86 | |
n | 12 | 12 | 12 | |
G2, F & 150 | Mean | 28.39 | 32.99 | 41.15 |
±SD | 2.20 | 1.83 | 1.27 | |
n | 11 | 11 | 11 | |
G3, F & 300 | Mean | 27.10 | 32.04 | 40.94 |
±SD | 2.54 | 2.57 | 2.18 | |
n | 10 | 10 | 10 | |
G4, F & 600 | Mean | 25.93 | 31.34 | 40.07 |
±SD | 3.83 | 3.77 | 3.26 | |
n | 11 | 10 | 10 |
F: Female; SD: Standard Deviation; n: Number of Dams.
Note: One female from group G4 was found dead on lactation day (LD 5).
Refer Appendix 11
Group, Sex & Dose |
| Total Leucocyte Count | Total Erythrocyte Count | Hemoglobin | Haematocrit | Mean Corpuscular Volume | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin Concentration | Platelet Count |
(WBC) | (RBC) | (HGB) | (HCT) | (MCV) | (MCH) | (MCHC) | (PLT) | ||
(103 cells/µL) | (106 cells/µL) | (g/dL) | (%) | (fL) | (pg) | (g/dL) | (103 cells/µL) | ||
G1, M & 0 | Mean | 14.50 | 8.80 | 16.12 | 48.28 | 54.93 | 18.33 | 33.37 | 940.42 |
±SD | 6.85 | 0.64 | 1.23 | 3.55 | 3.27 | 1.01 | 0.59 | 274.26 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G2, M & 150 | Mean | 12.28 | 8.93 | 15.58 | 47.84 | 53.64 | 17.45* | 32.51 | 1046.58 |
±SD | 5.82 | 0.71 | 1.42 | 3.52 | 1.60 | 0.63 | 0.87 | 175.26 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G3, M & 300 | Mean | 13.12 | 8.83 | 15.83 | 47.93 | 54.37 | 17.97 | 33.04 | 970.42 |
±SD | 3.17 | 0.49 | 0.68 | 1.65 | 2.20 | 0.85 | 1.20 | 272.35 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G4, M & 600 | Mean | 10.85 | 9.15 | 16.21 | 48.92 | 53.57 | 17.76 | 33.16 | 870.75 |
±SD | 2.38 | 0.52 | 0.67 | 2.78 | 2.60 | 0.89 | 1.13 | 303.05 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 |
M: Male; SD: Standard Deviation; n: Number of Animals.
* Statistically significant (P<0.05) change than the vehicle control group.
TABLE 11 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 11
Group, Sex & Dose | Mean Platelet Volume | Reticulocyte Count | Neutrophils | Lymphocytes | Monocytes | Eosinophils | Basophils | Absolute Reticulocyte Count | |
(MPV) | (Retic) | (Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (Retic) | ||
(fL) | (%) | (%) | (%) | (%) | (%) | (%) | (109 cells/L) | ||
G1, M & 0 | Mean | 7.20 | 3.04 | 34.35 | 59.75 | 3.02 | 1.20 | 0.41 | 259.38 |
±SD | 0.24 | 1.84 | 11.35 | 12.04 | 1.13 | 0.52 | 0.12 | 129.15 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G2, M & 150 | Mean | 7.08 | 3.36 | 23.53* | 71.46* | 2.13 | 1.46 | 0.38 | 298.34 |
±SD | 0.42 | 0.62 | 6.29 | 5.61 | 0.76 | 0.84 | 0.09 | 49.66 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G3, M & 300 | Mean | 7.27 | 3.01 | 26.54 | 68.38* | 2.53 | 1.10 | 0.38 | 261.83 |
±SD | 0.51 | 1.27 | 8.16 | 7.65 | 0.99 | 0.59 | 0.11 | 89.76 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G4, M & 600 | Mean | 7.24 | 3.25 | 25.14* | 69.44* | 2.85 | 1.08 | 0.34 | 293.83 |
±SD | 0.53 | 1.61 | 6.23 | 5.41 | 1.22 | 0.42 | 0.12 | 139.07 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 |
M: Male; SD: Standard Deviation; n: Number of Animals.
* Statistically significant (P<0.05) change than the vehicle control group.
TABLE 11 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 11
Group, Sex & Dose (mg/kg body weight/day) | Absolute Neutrophils | Absolute Lymphocytes | Absolute Monocytes | Absolute Eosinophils | Absolute Basophils | Prothrombin Time | Activated Prothrombin Time | |
(Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (PT) | (APTT) | ||
(103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (Seconds) | (Seconds) | ||
G1, M & 0 | Mean | 5.48 | 8.12 | 0.47 | 0.17 | 0.06 | 19.44 | 18.53 |
±SD | 4.77 | 2.48 | 0.40 | 0.08 | 0.03 | 2.55 | 5.29 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G2, M & 150 | Mean | 2.67* | 8.93 | 0.28 | 0.22 | 0.05 | 20.21 | 20.21 |
±SD | 0.61 | 4.97 | 0.23 | 0.30 | 0.04 | 2.63 | 5.46 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G3, M & 300 | Mean | 3.42 | 9.02 | 0.34 | 0.14 | 0.05 | 22.94* | 22.13 |
±SD | 1.08 | 2.65 | 0.17 | 0.06 | 0.03 | 2.71 | 4.63 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G4, M & 600 | Mean | 2.75* | 7.52 | 0.30 | 0.12 | 0.04 | 21.88 | 20.26 |
±SD | 0.93 | 1.73 | 0.11 | 0.06 | 0.02 | 1.99 | 9.25 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 |
M: Male; SD: Standard Deviation; n: Number of Animals.
* Statistically significant (P<0.05) change than the vehicle control group.
TABLE 11 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 11
Group, Sex & Dose | Total Leucocyte Count | Total Erythrocyte Count | Hemoglobin | Haematocrit | Mean Corpuscular Volume | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin Concentration | Platelet Count | |
(WBC) | (RBC) | (HGB) | (HCT) | (MCV) | (MCH) | (MCHC) | (PLT) | ||
(103 cells/µL) | (106 cells/µL) | (g/dL) | (%) | (fL) | (pg) | (g/dL) | (103 cells/µL) | ||
G1, F & 0 | Mean | 10.32 | 7.83 | 14.93 | 45.49 | 58.28 | 19.13 | 32.86 | 1105.50 |
±SD | 3.70 | 0.61 | 1.02 | 2.83 | 3.56 | 1.22 | 0.96 | 204.53 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G2, F & 150 | Mean | 9.66 | 7.70 | 14.88 | 45.42 | 59.35 | 19.43 | 32.76 | 907.83 |
±SD | 4.16 | 0.84 | 1.00 | 2.65 | 4.46 | 1.24 | 0.76 | 288.00 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G3, F & 300 | Mean | 11.81 | 7.22 | 14.15 | 43.81 | 61.29 | 19.73 | 32.28 | 1016.75 |
±SD | 4.20 | 0.96 | 1.26 | 2.57 | 6.24 | 1.60 | 1.21 | 197.49 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G4, F & 600 | Mean | 11.70 | 7.92 | 15.40 | 47.00 | 59.46 | 19.46 | 32.77 | 1118.18 |
±SD | 3.22 | 0.44 | 0.70 | 2.27 | 3.83 | 1.13 | 0.62 | 313.07 | |
n | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 |
F: Female; SD: Standard Deviation; n: Number of Animals.
Note: One female from group G4 was found dead on lactation day (LD 5).
TABLE 11 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 11
Group, Sex & Dose | Mean Platelet Volume | Reticulocyte Count | Neutrophils | Lymphocytes | Monocytes | Eosinophils | Basophils | Absolute Reticulocyte Count | |
(MPV) | (Retic) | (Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (Retic) | ||
(fL) | (%) | (%) | (%) | (%) | (%) | (%) | (109 cells/L) | ||
G1, F & 0 | Mean | 7.49 | 4.23 | 31.80 | 60.46 | 4.18 | 1.67 | 0.27 | 321.19 |
±SD | 0.35 | 2.52 | 7.38 | 8.94 | 2.41 | 1.21 | 0.08 | 169.30 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G2, F & 150 | Mean | 7.78 | 4.16 | 28.93 | 63.97 | 3.58 | 1.89 | 0.27 | 308.49 |
±SD | 0.55 | 2.84 | 7.38 | 8.01 | 1.50 | 1.33 | 0.05 | 179.86 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G3, F & 300 | Mean | 7.77 | 6.67 | 30.85 | 61.76 | 3.46 | 1.18 | 0.29 | 392.06 |
±SD | 0.64 | 3.81 | 9.66 | 10.47 | 1.63 | 0.58 | 0.08 | 188.05 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G4, F & 600 | Mean | 7.67 | 3.49 | 26.70 | 67.96 | 2.55 | 1.36 | 0.30 | 274.01 |
±SD | 0.36 | 1.28 | 9.29 | 10.15 | 1.15 | 1.03 | 0.09 | 98.28 | |
n | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 |
F: Female; SD: Standard Deviation; n: Number of Animals.
Note: One female from group G4 was found dead on lactation day (LD 5).
TABLE 11 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 11
Group, Sex & Dose (mg/kg body weight/day) | Absolute Neutrophils | Absolute Lymphocytes | Absolute Monocytes | Absolute Eosinophils | Absolute Basophils | Prothrombin Time | Activated Prothrombin Time | |
(Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (PT) | (APTT) | ||
(103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (Seconds) | (Seconds) | ||
G1, F & 0 | Mean | 3.23 | 6.39 | 0.36 | 0.17 | 0.03 | 22.38 | 22.36 |
±SD | 1.29 | 2.78 | 0.11 | 0.13 | 0.01 | 3.14 | 3.80 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G2, F & 150 | Mean | 2.96 | 6.08 | 0.32 | 0.16 | 0.03 | 21.63 | 20.81 |
±SD | 1.82 | 2.30 | 0.12 | 0.09 | 0.02 | 3.31 | 6.12 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G3, F & 300 | Mean | 3.66 | 7.29 | 0.42 | 0.13 | 0.04 | 19.93 | 23.01 |
±SD | 1.86 | 2.99 | 0.25 | 0.06 | 0.02 | 2.65 | 6.71 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |
G4, F & 600 | Mean | 3.17 | 7.89 | 0.32 | 0.15 | 0.03 | 20.48 | 20.75 |
±SD | 1.68 | 2.30 | 0.21 | 0.11 | 0.01 | 2.01 | 3.90 | |
n | 11 | 11 | 11 | 11 | 11 | 11 | 11 |
F: Female; SD: Standard Deviation; n: Number of Animals.
Note: One female from group G4 was found dead on lactation day (LD 5).
Refer Appendix 12
F: Female; SD: Standard Deviation; n: Number of Animals; -: Not Applicable.
Refer Appendix 13
Group & Dose | Delivery Record At birth | ||||||||||||||||||
Litter Size (No.) | Live Pups (No.) | Dead Pups (No.) | Cannibalized Pups (No.) | Sex Ratio (m/f) at Birth | Live Birth Index | ||||||||||||||
Male | Female | Total | Male | Female | Total | Undetermined | Male | Female | Total | ||||||||||
G1 & 0 | Mean | 10.58 | 5.83 | 4.75 | 10.58 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.37 | 100.00 | |||||
±SD | 3.23 | 2.48 | 1.42 | 3.23 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.03 | 0.00 | ||||||
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | ||||||
G2 & 150 | Mean | 9.73 | 4.91 | 4.64 | 9.55 | 0.18 | 0.00 | 0.18 | 0.00 | 0.00 | 0.00 | 0.00 | 1.12 | 97.79 | |||||
±SD | 3.80 | 1.64 | 2.84 | 3.88 | 0.40 | 0.00 | 0.40 | 0.00 | 0.00 | 0.00 | 0.00 | 0.48 | 5.00 | ||||||
n | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 10 | 11 | ||||||
G3 & 300 | Mean | 10.00 | 5.00 | 4.10 | 9.10 | 0.60 | 0.30 | 0.90 | 0.00 | 0.00 | 0.00 | 0.00 | 1.43 | 85.90 | |||||
±SD | 4.11 | 2.36 | 3.31 | 5.20 | 1.26 | 0.67 | 1.91 | 0.00 | 0.00 | 0.00 | 0.00 | 0.78 | 31.94 | ||||||
n | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 8 | 10 | ||||||
G4 & 600 | Mean | 11.09 | 4.09 | 5.73 | 9.82 | 0.55 | 0.73 | 1.27 | 0.00 | 0.00 | 0.00 | 0.00 | 0.72* | 81.25 | |||||
±SD | 4.61 | 2.51 | 3.29 | 5.44 | 0.82 | 1.35 | 2.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.28 | 33.73 | ||||||
n | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 9 | 11 |
SD: Standard Deviation; n: Number of Dams; m/f: Male/Female; %: Percentage.
* Statistically significant (P<0.05) change than the vehicle control group.
TABLE 13 (Contd…). SUMMARY RECORD OF DELIVERY AND LITTER OBSERVATIONS
Refer Appendix 13
Group & Dose | LD 1 to 4 | Sex Ratio (m/f) on LD 4 | Pup Survival Index [LD 1 to 4] | |||||||||||||
Live Pups (No.) | Dead Pups (No.) | Cannibalized Pups (No.) | ||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||
G1 & 0 | Mean | 5.75 | 4.67 | 10.42 | 0.00 | 0.08 | 0.08 | 0.08 | 0.00 | 0.08 | 1.37 | 97.92 | ||||
±SD | 2.56 | 1.50 | 3.42 | 0.00 | 0.29 | 0.29 | 0.29 | 0.00 | 0.29 | 1.03 | 7.22 | |||||
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |||||
G2 & 150 | Mean | 4.91 | 4.64 | 9.55 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.12 | 100.00 | ||||
±SD | 1.64 | 2.84 | 3.88 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.48 | 0.00 | |||||
n | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 10 | 11 | |||||
G3 & 300 | Mean | 4.90 | 4.00 | 8.90 | 0.22 | 0.22 | 0.44 | 0.00 | 0.00 | 0.00 | 1.41 | 98.46 | ||||
±SD | 2.23 | 3.09 | 4.95 | 0.44 | 0.44 | 0.73 | 0.00 | 0.00 | 0.00 | 0.75 | 3.14 | |||||
n | 10 | 10 | 10 | 9 | 9 | 9 | 9 | 9 | 9 | 8 | 9 | |||||
G4 & 600 | Mean | 3.55 | 4.91 | 8.45 | 0.60 | 0.90 | 1.50 | 0.00 | 0.00 | 0.00 | 0.74 | 77.78 | ||||
±SD | 2.77 | 3.53 | 6.07 | 0.97 | 2.51 | 3.41 | 0.00 | 0.00 | 0.00 | 0.27 | 41.33 | |||||
n | 11 | 11 | 11 | 10 | 10 | 10 | 10 | 10 | 10 | 8 | 10 |
SD: Standard Deviation; n: Number of Dams; LD: Lactation day m/f: Male/Female; %: Percentage.
TABLE 13 (Contd…). SUMMARY RECORD OF DELIVERY AND LITTER OBSERVATIONS
Group & Dose | Pups Sacrificed for Hormonal analysis (No.) | Live Pups (No.) on LD 4 after sacrifice for | LD 5 to 7 | Sex Ratio (m/f) on LD 7 | Pup Survival Index (%) [LD 5 to 7] | |||||||||||||||||||
Live Pups (No.) | Dead Pups (No.) | Cannibalized (No.) | ||||||||||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||||
G1 & 0 | Mean | 0.00 | 0.92 | 0.92 | 5.75 | 3.75 | 9.50 | 5.75 | 3.75 | 9.50 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 2.02 | 100.00 | ||||||
±SD | 0.00 | 1.00 | 1.00 | 2.56 | 1.14 | 2.61 | 2.56 | 1.14 | 2.61 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 2.28 | 0.00 | |||||||
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |||||||
G2 & 150 | Mean | 0.00 | 0.55 | 0.55 | 4.91 | 4.09 | 9.00 | 4.91 | 4.09 | 9.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.22 | 100.00 | ||||||
±SD | 0.00 | 0.93 | 0.93 | 1.64 | 2.21 | 3.13 | 1.64 | 2.21 | 3.13 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.47 | 0.00 | |||||||
n | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 11 | 10 | 11 | |||||||
G3 & 300 | Mean | 0.00 | 0.67 | 0.67 | 5.33 | 3.67 | 9.00 | 5.44 | 3.78 | 9.22 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.59 | 100.00 | ||||||
±SD | 0.00 | 0.87 | 0.87 | 1.73 | 2.50 | 3.84 | 1.51 | 2.33 | 3.42 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.76 | 0.00 | |||||||
n | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 8 | 9 | |||||||
G4 & 600 | Mean | 0.00 | 1.00 | 1.00 | 4.88 | 5.75 | 10.63 | 4.88 | 5.75 | 10.63 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.90 | 100.00 | ||||||
±SD | 0.00 | 1.07 | 1.07 | 1.89 | 1.39 | 2.39 | 1.89 | 1.39 | 2.39 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.48 | 0.00 | |||||||
n | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 |
SD: Standard Deviation; n: Number of Dams; LD: Lactation Day; m/f: Male/Female; %: Percentage.
TABLE 13 (Contd…). SUMMARY RECORD OF DELIVERY AND LITTER OBSERVATIONS
Group & Dose weight/day) | LD 8 to 13 | Sex Ratio (m/f) on LD 13 | Pup Survival Index (%) [LD 8 to 13] | |||||||||||||
Live Pups (No.) | Dead Pups (No.) | Cannibalized (No.) | ||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||
G1 & 0 | Mean | 5.75 | 3.75 | 9.50 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 2.02 | 100.00 | ||||
±SD | 2.56 | 1.14 | 2.61 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 2.28 | 0.00 | |||||
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | |||||
G2 & 150 | Mean | 4.91 | 4.09 | 9.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.22 | 100.00 | ||||
±SD | 1.64 | 2.21 | 3.13 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.47 | 0.00 | |||||
n | 11 | 11 | 11 | 12 | 12 | 12 | 12 | 12 | 12 | 10 | 11 | |||||
G3 & 300 | Mean | 5.44 | 3.78 | 9.22 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 1.59 | 100.00 | ||||
±SD | 1.51 | 2.33 | 3.42 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.76 | 0.00 | |||||
n | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 9 | 8 | 9 | |||||
G4 & 600 | Mean | 4.88 | 5.75 | 10.63 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.90 | 100.00 | ||||
±SD | 1.89 | 1.39 | 2.39 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.48 | 0.00 | |||||
n | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 |
SD: Standard Deviation; n: Number of Dams; LD: Lactation Day; m/f: Male/Female; %: Percentage.
Refer Appendix 14
Group, Sex & Dose (mg/kg body weight/day) | No. of Males with Evidence of Mating | Male Mating Index (%) | No. of Males Capable of Impregnating a Female | Male Fertility Index (%) | |
G1, M & 0 | 12 (12) | 100.00 | 12 (12) | 100.00 | |
G2, M & 150 | 12 (12) | 100.00 | 11 (12) | 91.67 | |
G3, M & 300 | 11 (12) | 91.67 | 10 (11) | 90.91 | |
G4, M & 600 | 10 (12) | 83.33 | 10 (10) | 100.00 |
M: Male.
TABLE 14 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
Refer Appendix 14
Group, Sex & Dose (mg/kg body weight/day) | Cohabitation Record and Pre-coital Interval (Mean Time of Mating) |
| Gestational Length (duration of pregnancy) | ||||
Pre-coital Interval (Days) | Conceiving Days (1 to 5) | Conceiving Days (More than 5 days) | Gestation Length (Days) | ||||
G1, F & 0 | Mean | 2.67 | N | 11 | 1 | 22.00 | |
±SD | 2.39 | % | 91.67 | 8.33 | 0.60 | ||
n | 12 | 12 | |||||
G2, F & 150 | Mean | 3.08 | N | 11 | 1 | 22.27 | |
±SD | 3.03 | % | 91.67 | 8.33 | 0.65 | ||
n | 12 | 11 | |||||
G3, F & 300 | Mean | 4.75 | N | 8 | 4 | 22.20 | |
±SD | 5.05 | % | 66.67 | 33.33 | 0.79 | ||
n | 12 | 10 | |||||
G4, F & 600 | Mean | 6.33 | N | 7 | 5 | 22.18 | |
±SD | 6.24 | % | 58.33 | 41.67 | 0.75 | ||
n | 12 | 11 |
F: Female; SD: Standard Deviation.
N: Number of females evaluated for pre-coital interval; n: Number of females (for pre-coital interval); n: Number of pregnants (for gestation length).
TABLE 14 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
Refer Appendix 14
Group, Sex & Dose (mg/kg body weight/day) | Female Mating Index (%) | Female Fertility Index (%) | |||
No. of Females with Evidence of Mating (No. of Females used for Mating) | Female Mating Index (%) | No. of Females Confirmed as Fertile | Female Fertility Index (%) | ||
G1, F & 0 | 12 (12) | 100.00 | 12 (12) | 100.00 | |
G2, F & 150 | 12 (12) | 100.00 | 11 (12) | 91.67 | |
G3, F & 300 | 12 (12) | 100.00 | 10 (12) | 83.33 | |
G4, F & 600 | 12 (12) | 100.00 | 11 (12) | 91.67 |
F: Female.
TABLE 14 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
Refer Appendix 14
Group, Sex & Dose (mg/kg body weight/day) | Female Fecundity or Pregnancy Index (%) | Gestation Index (%) | Parturition index (%) | |||
No. of Pregnant Females (No. of Females Confirmed with Mating) | Female Fecundity | Females with Live Born Pups at Parturition with Evidence of | Gestation Index (%) | No. of Females Littered | Parturition index (%) | |
G1, F & 0 | 12 (12) | 100.00 | 12 (12) | 100.00 | 12 (12) | 100.00 |
G2, F & 150 | 11 (12) | 91.67 | 11 (11) | 100.00 | 11 (11) | 100.00 |
G3, F & 300 | 10 (12) | 83.33 | 9 (10) | 90.00 | 10 (10) | 100.00 |
G4, F & 600 | 11 (12) | 91.67 | 10 (11) | 90.91 | 11 (11) | 100.00 |
F: Female.
TABLE 14 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
Refer Appendix 14
Group, Sex & Dose weight/day) |
| Post-implantation Loss |
| Post-natal Loss | ||||
No. of Implantations | No. of Viable (Live) Pups | Post-implantation Loss (No.) | Post-implantation Loss (%) | Total No. of Pups Found Dead/ Cannibalized during lactation period | Post-natal Loss (%) | |||
G1, F & 0 | Mean | 11.50 | 10.58 | 0.92 | 9.46 | 0.17 | 2.08 | |
±SD | 2.47 | 3.23 | 1.08 | 12.29 | 0.58 | 7.22 | ||
n | 12 | 12 | 12 | 12 | 12 | 12 | ||
G2, F & 150 | Mean | 10.00 | 9.55 | 0.45 | 6.15 | 0.00 | 0.00 | |
±SD | 3.58 | 3.88 | 0.52 | 7.58 | 0.00 | 0.00 | ||
n | 11 | 11 | 11 | 11 | 11 | 11 | ||
G3, F & 300 | Mean | 10.30 | 9.10 | 1.20 | 18.15 | 0.22 | 1.54 | |
±SD | 3.92 | 5.20 | 1.87 | 31.69 | 0.44 | 3.14 | ||
n | 10 | 10 | 10 | 10 | 9 | 9 | ||
G4, F & 600 | Mean | 11.55 | 9.82 | 1.73 | 22.48 | 1.50 | 22.22 | |
±SD | 4.41 | 5.44 | 2.00 | 33.98 | 3.41 | 41.33 | ||
n | 11 | 11 | 11 | 11 | 10 | 10 |
F: Female; n: Number of Dams; SD: Standard deviation.
Refer Appendix 15
Group, Sex & Dose (mg/kg body weight/day) |
| Testes | Epididymides | Kidneys | Prostate | Seminal vesicles with coagulating glands | Thyroid along with parathyroidWP |
G1, M & 0 | Mean | 3.5167 | 1.4480 | 2.7957 | 1.3934 | 1.5711 | 0.0278 |
±SD | 0.2711 | 0.1446 | 0.3097 | 0.3304 | 0.4393 | 0.0056 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | |
G2, M & 150 | Mean | 3.2816 | 1.4650 | 2.5982 | 1.2479 | 1.5978 | 0.0270 |
±SD | 0.3615 | 0.1751 | 0.2982 | 0.3783 | 0.5457 | 0.0081 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | |
G3, M & 300 | Mean | 3.4600 | 1.4427 | 2.6737 | 1.3600 | 1.2867 | 0.0278 |
±SD | 0.1846 | 0.1390 | 0.3206 | 0.3427 | 0.5705 | 0.0090 | |
n | 12 | 12 | 12 | 12 | 12 | 12 | |
G4, M & 600 | Mean | 3.3491 | 1.3851 | 2.4600* | 1.1554 | 1.0562* | 0.0276 |
±SD | 0.2924 | 0.1634 | 0.2912 | 0.4617 | 0.3505 | 0.0080 | |
n | 12 | 12 | 12 | 12 | 12 | 12 |
M: Male; SD: Standard Deviation; n: Number of Animals; WP: Weighed post fixation.
* Statistically significant (P<0.05) change than the vehicle control group.
TABLE 15 (Contd…). SUMMARY OF ABSOLUTE ORGAN WEIGHT (g) RECORD
Refer Appendix 15
Group, Sex & Dose |
| Ovaries | Uterus with cervix | Kidneys | Thyroid along with parathyroidWP |
G1, F & 0 | Mean | 0.1376 | 0.5899 | 1.9210 | 0.0328 |
±SD | 0.0206 | 0.1406 | 0.2379 | 0.0050 | |
n | 12 | 12 | 12 | 12 | |
G2, F & 150 | Mean | 0.1408 | 0.5771 | 1.8349 | 0.0222* |
±SD | 0.0185 | 0.1734 | 0.2129 | 0.0047 | |
n | 12 | 12 | 12 | 12 | |
G3, F & 300 | Mean | 0.1301 | 0.5680 | 1.8861 | 0.0231* |
±SD | 0.0147 | 0.0962 | 0.1785 | 0.0047 | |
n | 12 | 12 | 12 | 12 | |
G4, F & 600 | Mean | 0.1407 | 0.5646 | 1.9393 | 0.0204* |
±SD | 0.0227 | 0.1826 | 0.2642 | 0.0065 | |
n | 11 | 11 | 11 | 11 |
F: Female; SD: Standard Deviation; n: Number of Animals; WP: Weighed post fixation.
Note: One female from group G4 was found dead on lactation day (LD 5).
* Statistically significant (P<0.05) change than the vehicle control group.
M: Male; SD: Standard Deviation; n: Number of Animals.
* Statistically significant (P<0.05) change than the vehicle control group.
TABLE 16 (Contd…). SUMMARY OF TERMINAL BODY WEIGHT (g) AND ORGAN WEIGHT RELATIVE TO
TERMINAL BODY WEIGHT (%) RECORD
Refer Appendix 16
Group, Sex & Dose (mg/kg body weight/day) |
| Terminal Body Weight (g) | Ovaries | Uterus with cervix | Kidneys | Thyroid along with parathyroid |
G1, F & 0 | Mean | 315.07 | 0.0437 | 0.1874 | 0.6094 | 0.0104 |
±SD | 11.11 | 0.0064 | 0.0457 | 0.0687 | 0.0016 | |
n | 12 | 12 | 12 | 12 | 12 | |
G2, F & 150 | Mean | 305.52 | 0.0461 | 0.1875 | 0.6011 | 0.0073* |
±SD | 18.23 | 0.0056 | 0.0495 | 0.0654 | 0.0014 | |
n | 12 | 12 | 12 | 12 | 12 | |
G3, F & 300 | Mean | 304.61 | 0.0428 | 0.1882 | 0.6236 | 0.0076* |
±SD | 21.37 | 0.0051 | 0.0401 | 0.0923 | 0.0018 | |
n | 12 | 12 | 12 | 12 | 12 | |
G4, F & 600 | Mean | 299.44 | 0.0473 | 0.1932 | 0.6476 | 0.0068* |
±SD | 25.80 | 0.0087 | 0.0769 | 0.0657 | 0.0021 | |
n | 11 | 11 | 11 | 11 | 11 |
F: Female; SD: Standard Deviation; n: Number of Animals.
Note: One female from group G4 was found dead on lactation day (LD 5).
* Statistically significant (P<0.05) change than the vehicle control group.
Refer Appendix 17
Group, Sex & Dose (mg/kg body weight/day) | Serum T4 Levels (ng/mL) | |
G1, M & 0 | Mean | 75.850 |
±SD | 6.853 | |
n | 12 | |
G2, M & 150 | Mean | 78.693 |
±SD | 8.670 | |
n | 12 | |
G3, M & 300 | Mean | 72.972 |
±SD | 4.821 | |
n | 12 | |
G4, M & 600 | Mean | 68.263* |
±SD | 5.591 | |
n | 12 |
M: Male; SD: Standard Deviation; n: Number of Animals; ng/mL: Nanogram per milliliter.
* Statistically significant (P<0.05) change than the vehicle control group.
Refer Appendix 18
Group & Dose (mg/kg body weight/day) | At Birth (PND 1) | PND 1 to 4 | Pups Sacrificed for Blood Collection on PND 4 (No.) * | PND 5 to 7$ | PND 8 to 13$ | |
G1 & 0 | No. of Dams# | 12 | 12 | 6 | 12 | 12 |
No. of Live Pups | 127 | 125 | 11 | 114 | 114 | |
Pup Observation/ No. of Pups observed | N/126, P/1 | N/125, D/1, C/1, P/1 | - | N/114 | N/114 | |
G2 & 150 | No. of Dams# | 11 | 11 | 3 | 11 | 11 |
No. of Live Pups | 105 | 105 | 6 | 99 | 99 | |
Pup Observation/ No. of Pups observed | N/105 | N/105 | - | N/99 | N/99 | |
G3 & 300 | No. of Dams# | 10 | 10 | 4 | 10 | 10 |
No. of Live Pups | 91 | 87 | 6 | 81 | 81 | |
Pup Observation/ No. of Pups observed | N/91 | N/87, D/4 | - | N/81 | N/81 | |
G4 & 600 | No. of Dams# | 11 | 8 | 4 | 8 | 8 |
No. of Live Pups | 108 | 93 | 8 | 85 | 85 | |
Pup Observation/ No. of Pups observed | N/108 | N/93, D/15 | - | N/85 | N/85 |
N: Normal; PND: Postnatal Day; #: Dams confirmed with littering.
*: Pups selected for blood collection from dams with litter size of more than 10; $: Pups sacrificed on PND 4 were excluded.
D: Dead; C: Cannibalized; P: Pale coloured.
Refer Appendix 19
Group & Dose |
| PND 1 |
| PND 4 |
| PND 7 |
| PND 13 | ||||
Mean Male Pup Weight (g) | Mean Female Pup Weight (g) | Mean Male Pup Weight (g) | Mean Female Pup Weight (g) | Mean Male Pup Weight (g) | Mean Female Pup Weight (g) | Mean Male Pup Weight (g) | Mean Female Pup Weight (g) | |||||
G1 & 0 | Mean | 6.78 | 6.47 | 11.43 | 10.68 | 15.37 | 14.62 | 28.70 | 27.66 | |||
±SD | 0.25 | 0.32 | 0.49 | 0.40 | 0.53 | 0.47 | 0.87 | 0.83 | ||||
n | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 | ||||
G2 & 150 | Mean | 6.79 | 6.40 | 11.25 | 10.58 | 15.26 | 14.52 | 28.71 | 27.80 | |||
±SD | 0.15 | 0.28 | 0.49 | 0.48 | 0.59 | 0.73 | 0.78 | 0.72 | ||||
n | 11 | 10 | 11 | 10 | 11 | 10 | 11 | 10 | ||||
G3 & 300 | Mean | 6.79 | 6.43 | 11.35 | 10.54 | 15.40 | 14.78 | 28.74 | 27.89 | |||
±SD | 0.30 | 0.28 | 0.53 | 0.35 | 0.59 | 0.59 | 0.84 | 0.66 | ||||
n | 9 | 8 | 9 | 8 | 9 | 8 | 9 | 8 | ||||
G4 & 600 | Mean | 6.34 | 6.15 | 11.07 | 10.62 | 15.03 | 14.63 | 28.38 | 27.43 | |||
±SD | 0.96 | 0.82 | 0.57 | 0.67 | 0.52 | 0.55 | 0.63 | 0.29 | ||||
n | 10 | 9 | 8 | 8 | 8 | 8 | 8 | 8 |
SD: Standard Deviation; n: Number of Litters; PND: Postnatal Day.
Refer Appendix 20
Group & Dose |
| AGD Measurement (mm) |
| AGD Ratio | ||
Male | Female | Male | Female | |||
G1 & 0 | Mean | 5.20 | 2.68 | 2.31 | 1.22 | |
±SD | 0.20 | 0.15 | 0.06 | 0.06 | ||
n | 12 | 12 | 12 | 12 | ||
G2 & 150 | Mean | 5.15 | 2.68 | 2.30 | 1.22 | |
±SD | 0.15 | 0.20 | 0.04 | 0.07 | ||
n | 11 | 10 | 11 | 10 | ||
G3 & 300 | Mean | 5.10 | 2.63 | 2.24 | 1.20 | |
±SD | 0.21 | 0.15 | 0.15 | 0.06 | ||
n | 9 | 8 | 9 | 8 | ||
G4 & 600 | Mean | 4.99* | 2.55 | 2.24 | 1.16 | |
±SD | 0.10 | 0.12 | 0.05 | 0.04 | ||
n | 8 | 8 | 8 | 8 |
SD: Standard Deviation; n: Number of Litters; AGD: Anogenital Distance; mm: Millimetre.
* Statistically significant (P<0.05) change than the vehicle control group.
Refer Appendix 21
Group & Dose |
| Mean No. of Pups with Retention of Nipples/ Areolae on Postnatal Day 13 |
G1 & 0 | Mean | 0.00 |
±SD | 0.00 | |
n | 12 (69) | |
G2 & 150 | Mean | 0.00 |
±SD | 0.00 | |
n | 11 (54) | |
G3 & 300 | Mean | 0.00 |
±SD | 0.00 | |
n | 9 (48) | |
G4 & 600 | Mean | 0.00 |
±SD | 0.00 | |
n | 8 (39) |
SD: Standard Deviation; n: Number of Litters (number of male pups).
Refer Appendix 22
Group & Dose (mg/kg body weight/day) | Serum T4 Levels (ng/mL) | |
G1 & 0 | Mean | 70.116 |
±SD | 6.744 | |
n | 12 | |
G2 & 150 | Mean | 70.333 |
±SD | 5.589 | |
n | 11 | |
G3 & 300 | Mean | 68.587 |
±SD | 4.778 | |
n | 9 | |
G4 & 600 | Mean | 67.837 |
±SD | 9.360 | |
n | 8 |
SD: Standard Deviation; n: Number of Litters; PND: Postnatal Day; ng/mL: Nanogram per milliliter
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | ||||||||||||||||
1 | 2 | 3 | 4Pr | 4Po | 5Pr | 5Po | 6Pr | 6Po | 7Pr | 7Po | 8Pr | 8Po | 9Pr | 9Po | 10Pr | 10Po | ||
G1, M & 0 | Rg7881 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7882 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7883 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7884 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7885 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7886 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7887 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7888 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7889 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7890 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7891 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7892 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, M & 150 | Rg7893 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7894 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7895 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7896 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7897 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7898 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7899 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7900 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7901 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7902 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7903 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7904 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
M: Male; N: Normal; Pr: Pre-dose; Po: Post-dose.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
11Pr | 11Po | 12Pr | 12Po | 13Pr | 13Po | 14Pr | 14Po | 15Pr | 15Po | 16Pr | 16Po | 17Pr | 17Po | 18Pr | 18Po | 19Pr | 19Po | 20Pr | 20Po | ||
G1, M & 0 | Rg7881 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7882 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7883 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7884 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7885 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7886 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7887 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7888 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7889 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7890 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7891 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7892 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, M & 150 | Rg7893 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7894 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7895 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7896 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7897 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7898 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7899 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7900 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7901 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7902 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7903 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7904 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
M: Male; N: Normal; Pr: Pre-dose; Po: Post-dose.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||
21Pr | 21Po | 22Pr | 22Po | 23Pr | 23Po | 24Pr | 24Po | 25Pr | 25Po | 26Pr | 26Po | 27Pr | 27Po | 28Pr | 28Po | ||
G1, M & 0 | Rg7881 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7882 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7883 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7884 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7885 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7886 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7887 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7888 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7889 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7890 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7891 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7892 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, M & 150 | Rg7893 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7894 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7895 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7896 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7897 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7898 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7899 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7900 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7901 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7902 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7903 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7904 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
M: Male; N: Normal; Pr: Pre-dose; Po: Post-dose.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | ||||||||||||||
29Pr | 29Po | 30Pr | 30Po | 31Pr | 31Po | 32Pr | 32Po | 33Pr | 33Po | 34Pr | 34Po | 35Pr | 35Po | 36T | ||
G1, M & 0 | Rg7881 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7882 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7883 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7884 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7885 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7886 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7887 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7888 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7889 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7890 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7891 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7892 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, M & 150 | Rg7893 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7894 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7895 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7896 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7897 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7898 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7899 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7900 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7901 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7902 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7903 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7904 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
M: Male; N: Normal; Pr: Pre-dose; Po: Post-dose: T: Day of termination.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | ||||||||||||||||
1 | 2 | 3 | 4Pr | 4Po | 5Pr | 5Po | 6Pr | 6Po | 7Pr | 7Po | 8Pr | 8Po | 9Pr | 9Po | 10Pr | 10Po | ||
G3, M & 300 | Rg7905 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7906 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7907 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7908 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7909 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7910 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7911 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7912 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7913 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7914 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7915 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7916 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, M & 600 | Rg7917 | N | N | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
Rg7918 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7919 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7920 | N | N | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7921 | N | N | N | N | N | N | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7922 | N | N | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7923 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7924 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7925 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7926 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7927 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7928 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
M: Male; N: Normal; Pr: Pre-dose; Po: Post-dose.
6: Wetness around mouth; +: Slight.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
11Pr | 11Po | 12Pr | 12Po | 13Pr | 13Po | 14Pr | 14Po | 15Pr | 15Po | 16Pr | 16Po | 17Pr | 17Po | 18Pr | 18Po | 19Pr | 19Po | 20Pr | 20Po | ||
G3, M & 300 | Rg7905 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7906 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7907 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7908 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7909 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7910 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7911 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7912 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7913 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7914 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7915 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7916 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, M & 600 | Rg7917 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
Rg7918 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7919 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7920 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7921 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7922 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7923 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7924 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7925 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7926 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7927 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7928 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
M: Male; N: Normal; Pr: Pre-dose; Po: Post-dose.
6: Wetness around mouth; +: Slight.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||
21Pr | 21Po | 22Pr | 22Po | 23Pr | 23Po | 24Pr | 24Po | 25Pr | 25Po | 26Pr | 26Po | 27Pr | 27Po | 28Pr | 28Po | ||
G3, M & 300 | Rg7905 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7906 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7907 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7908 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7909 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7910 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7911 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7912 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7913 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7914 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7915 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7916 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, M & 600 | Rg7917 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
Rg7918 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7919 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7920 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7921 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7922 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7923 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7924 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7925 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7926 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7927 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7928 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
M: Male; N: Normal; Pr: Pre-dose; Po: Post-dose.
6: Wetness around mouth; +: Slight.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | ||||||||||||||
29Pr | 29Po | 30Pr | 30Po | 31Pr | 31Po | 32Pr | 32Po | 33Pr | 33Po | 34Pr | 34Po | 35Pr | 35Po | 36T | ||
G3, M & 300 | Rg7905 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7906 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7907 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7908 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7909 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7910 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7911 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7912 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7913 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7914 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7915 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7916 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, M & 600 | Rg7917 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N |
Rg7918 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7919 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7920 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7921 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7922 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7923 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7924 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7925 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7926 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7927 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | |
Rg7928 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N |
M: Male; N: Normal; Pr: Pre-dose; Po: Post-dose; T: Day of termination.
6: Wetness around mouth; +: Slight.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | ||||||||||||||||
1 | 2 | 3 | 4Pr | 4Po | 5Pr | 5Po | 6Pr | 6Po | 7Pr | 7Po | 8Pr | 8Po | 9Pr | 9Po | 10Pr | 10Po | ||
G1, F & 0 | Rg7929 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7930 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7931 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7932 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7933 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7934 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7935 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7936 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7937 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7938 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7939 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7940 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, F & 150 | Rg7941 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7942 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7943 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7944 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7945 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7946 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7947 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7948 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7949NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7950 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7951 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7952 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; NP: Non-pregnant.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
11Pr | 11Po | 12Pr | 12Po | 13Pr | 13Po | 14Pr | 14Po | 15Pr | 15Po | 16Pr | 16Po | 17Pr | 17Po | 18Pr | 18Po | 19Pr | 19Po | 20Pr | 20Po | ||
G1, F & 0 | Rg7929 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7930 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7931 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7932 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7933 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7934 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7935 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7936 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7937 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7938 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7939 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7940 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, F & 150 | Rg7941 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7942 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7943 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7944 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7945 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7946 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7947 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7948 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7949NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7950 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7951 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7952 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; NP: Non-pregnant.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
21Pr | 21Po | 22Pr | 22Po | 23Pr | 23Po | 24Pr | 24Po | 25Pr | 25Po | 26Pr | 26Po | 27Pr | 27Po | 28Pr | 28Po | 29Pr | 29Po | 30Pr | 30Po | ||
G1, F & 0 | Rg7929 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7930 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7931 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7932 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7933 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7934 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7935 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7936 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7937 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7938 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7939 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7940 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, F & 150 | Rg7941 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7942 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7943 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7944 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7945 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7946 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7947 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7948 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7949NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7950 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7951 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7952 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; NP: Non-pregnant.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
31Pr | 31Po | 32Pr | 32Po | 33Pr | 33Po | 34Pr | 34Po | 35Pr | 35Po | 36Pr | 36Po | 37Pr | 37Po | 38Pr | 38Po | 39Pr | 39Po | 40Pr | 40Po | ||
G1, F & 0 | Rg7929 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7930 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7931 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7932 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7933 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7934 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7935 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7936 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7937 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7938 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7939 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7940 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, F & 150 | Rg7941 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7942 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7943 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7944 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7945 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7946 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7947 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7948 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7949NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7950 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7951 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7952 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; NP: Non-pregnant.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
41Pr | 41Po | 42Pr | 42Po | 43Pr | 43Po | 44Pr | 44Po | 45Pr | 45Po | 46Pr | 46Po | 47Pr | 47Po | 48Pr | 48Po | 49Pr | 49Po | 50Pr | 50Po | ||
G1, F & 0 | Rg7929 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - |
Rg7930 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7931 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7932 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - | |
Rg7933 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7934 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7935 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7936 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7937 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7938 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7939 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - | |
Rg7940 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G2, F & 150 | Rg7941 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - |
Rg7942 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7943 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7944 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7945 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7946 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7947 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7948 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - | |
Rg7949NP | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7950 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7951 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7952 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; -: Not applicable.
NP: Non-pregnant (sacrificed after 24 days from the day of confirmation of mating and found as non-pregnant).
Note: All the littered females were observed until termination i.e., up to lactation day 14.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | ||||||||||||||||||||
51Pr | 51Po | 52Pr | 52Po | 53Pr | 53Po | 54Pr | 54Po | 55Pr | 55Po | 56Pr | 56Po | 57Pr | 57Po | 58Pr | 58Po | 59Pr | 59Po | 60Pr | 60Po | 61 | ||
G1, F & 0 | Rg7929 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Rg7930 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7931 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7932 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7933 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7934 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7935 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | |
Rg7936 | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7937 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7938 | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7939 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7940 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
G2, F & 150 | Rg7941 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Rg7942 | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7943 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7944 | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7945 | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7946 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7947 | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7948 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7949NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7950 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7951 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7952 | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; -: Not applicable.
NP: Non-pregnant (sacrificed after 24 days from the day of confirmation of mating and found as non-pregnant).
Note: All the littered females were observed until termination i.e., up to lactation day 14.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | ||||||||||||||||
1 | 2 | 3 | 4Pr | 4Po | 5Pr | 5Po | 6Pr | 6Po | 7Pr | 7Po | 8Pr | 8Po | 9Pr | 9Po | 10Pr | 10Po | ||
G3, F & 300 | Rg7953NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7954 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7955 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7956 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7957NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7958 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7959 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7960 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7961 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7962 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7963TL | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7964 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, F & 600 | Rg7965TL | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
Rg7966 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7967TL | N | N | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7968 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7969 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7970 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7971 | N | N | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7972TL | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7973NP | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7974 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7975 | N | N | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7976 | N | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; NP: Non-pregnant; TL: Total litter loss.
6: Wetness around mouth; +: Slight.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
11Pr | 11Po | 12Pr | 12Po | 13Pr | 13Po | 14Pr | 14Po | 15Pr | 15Po | 16Pr | 16Po | 17Pr | 17Po | 18Pr | 18Po | 19Pr | 19Po | 20Pr | 20Po | ||
G3, F & 300 | Rg7953NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7954 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7955 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7956 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7957NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7958 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7959 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7960 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7961 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7962 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7963TL | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7964 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, F & 600 | Rg7965TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
Rg7966 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7967TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7968 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7969 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7970 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7971 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7972TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7973NP | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7974 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7975 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7976 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; NP: Non-pregnant; TL: Total litter loss.
6: Wetness around mouth; +: Slight.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
21Pr | 21Po | 22Pr | 22Po | 23Pr | 23Po | 24Pr | 24Po | 25Pr | 25Po | 26Pr | 26Po | 27Pr | 27Po | 28Pr | 28Po | 29Pr | 29Po | 30Pr | 30Po | ||
G3, F & 300 | Rg7953NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7954 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7955 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7956 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7957NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7958 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7959 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7960 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7961 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7962 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7963TL | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7964 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, F & 600 | Rg7965TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
Rg7966 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7967TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7968 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7969 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7970 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7971 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7972TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7973NP | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7974 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7975 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7976 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; NP: Non-pregnant; TL: Total litter loss.
6: Wetness around mouth; +: Slight.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
31Pr | 31Po | 32Pr | 32Po | 33Pr | 33Po | 34Pr | 34Po | 35Pr | 35Po | 36Pr | 36Po | 37Pr | 37Po | 38Pr | 38Po | 39Pr | 39Po | 40Pr | 40Po | ||
G3, F & 300 | Rg7953NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg7954 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7955 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7956 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7957NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7958 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7959 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7960 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7961 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7962 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7963TL | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7964 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, F & 600 | Rg7965TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
Rg7966 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7967TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | 1 | 6+ | 1 | 6+ | |
Rg7968 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7969 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7970 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7971 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7972TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | 1, 82, 116 | 6+, 1, 82,116 | 1, 82, 116 | 6+, 1, 82, 116 | |
Rg7973NP | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7974 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7975 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7976 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; NP: Non-pregnant; TL: Total litter loss.
6: Wetness around mouth; +: Slight; 1: Lethargy; 82: Perinasal Staining; 116: Rough hair coat.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||||||
41Pr | 41Po | 42Pr | 42Po | 43Pr | 43Po | 44Pr | 44Po | 45Pr | 45Po | 46Pr | 46Po | 47Pr | 47Po | 48Pr | 48Po | 49Pr | 49Po | 50Pr | 50Po | ||
G3, F & 300 | Rg7953NP | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Rg7954 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7955 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - | |
Rg7956 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7957NP | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - | - | - | - | - | |
Rg7958 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7959 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7960 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - | |
Rg7961 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7962 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7963TL | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7964 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
G4, F & 600 | Rg7965TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
Rg7966 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7967TL | 1 | 6+ | 1, 82 | 6+, 1, 82 | 1, 82 | 6+, 1, 82 | 1, 82 | 6+, 1, 82 | 1, 82 | 6+, 1, 82 | 1, 82 | 6+, 1, 82 | 1, 82 | 6+, 1, 82 | 1 | 6+ | 1 | 6+ | 1 | 6+ | |
Rg7968 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7969 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7970 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7971 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | - | |
Rg7972TL | D | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7973NP | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7974 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7975 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7976 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; -: Not applicable; TL: Total litter loss.
NP: Non-pregnant (sacrificed after 24 days from the day of confirmation of mating and found as non-pregnant).
6: Wetness around mouth; +: Slight; D: Dead; 1: Lethargy; 82: Perinasal Staining.
Note: All the littered females were observed until termination i.e., up to lactation day 14.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | |||||||||||||||
51Pr | 51Po | 52Pr | 52Po | 53Pr | 53Po | 54Pr | 54Po | 55Pr | 55Po | 56Pr | 56Po | 57Pr | 57Po | 58Pr | 58Po | ||
G3, F & 300 | Rg7953NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Rg7954 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7955 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7956 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7957NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7958 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7959 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7960 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7961 | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | |
Rg7962 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7963TL | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | - | |
Rg7964 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
G4, F & 600 | Rg7965TL | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | - |
Rg7966 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | - | - | - | |
Rg7967TL | 1 | 6+ | N | 6+ | N | - | - | - | - | - | - | - | - | - | - | - | |
Rg7968 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7969 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | - | - | - | |
Rg7970 | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7971 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7972TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7973NP | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | |
Rg7974 | N | 6+ | N | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7975 | N | 6+ | N | 6+ | N | - | - | - | - | - | - | - | - | - | - | - | |
Rg7976 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; -: Not applicable; TL: Total litter loss; 6: Wetness around mouth; +: Slight.
NP: Non-pregnant (sacrificed after 24 to 26 days from the day of confirmation of mating and found as non-pregnant).
Note: All the littered females were observed until termination i.e., up to lactation day 14.
APPENDIX 1 (Contd…). INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Clinical Signs of Toxicity and Mortality Record on Day | ||||||||||||||
59Pr | 59Po | 60Pr | 60Po | 61Pr | 61Po | 62Pr | 62Po | 63Pr | 63Po | 64Pr | 64Po | 65Pr | 65Po | 66 | ||
G3, F & 300 | Rg7953NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Rg7954 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7955 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7956 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7957NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7958 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rg7959 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7960 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7961 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7962 | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7963TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7964 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
G4, F & 600 | Rg7965TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Rg7966 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7967TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7968 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7969 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7970 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7971 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7972TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7973NP | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7974 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7975 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
Rg7976 | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N | 6+ | N |
F: Female; N: Normal; Pr: Pre-dose; Po: Post-dose; -: Not applicable; TL: Total litter loss; 6: Wetness around mouth; +: Slight.
NP: Non-pregnant (sacrificed after 24 to 26 days from the day of confirmation of mating and found as non-pregnant).
Note: All the littered females were observed until termination i.e., up to lactation day 14.
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Body Weight (g) on Day | ||||||
1 | 7 | 14 | 21 | 28 | 35 | |||
G1, M & 0 | Rg7881 | 332.74 | 360.61 | 374.71 | 394.34 | 411.20 | 417.89 | |
Rg7882 | 338.31 | 353.49 | 370.33 | 386.90 | 394.76 | 394.99 | ||
Rg7883 | 341.49 | 337.74 | 348.61 | 381.74 | 405.68 | 413.90 | ||
Rg7884 | 351.67 | 373.17 | 398.01 | 396.08 | 417.34 | 428.37 | ||
Rg7885 | 362.41 | 375.02 | 392.01 | 402.12 | 424.88 | 434.89 | ||
Rg7886 | 373.01 | 383.21 | 385.16 | 387.15 | 404.90 | 434.47 | ||
Rg7887 | 367.53 | 384.66 | 405.29 | 409.93 | 406.26 | 404.10 | ||
Rg7888 | 379.05 | 401.87 | 429.20 | 444.84 | 444.78 | 447.81 | ||
Rg7889 | 377.28 | 400.47 | 426.65 | 442.14 | 460.30 | 467.89 | ||
Rg7890 | 382.92 | 415.44 | 440.19 | 449.31 | 465.98 | 482.48 | ||
Rg7891 | 387.16 | 418.15 | 446.64 | 445.19 | 443.52 | 441.68 | ||
Rg7892 | 407.36 | 431.33 | 457.76 | 479.38 | 490.36 | 509.12 | ||
G2, M & 150 | Rg7893 | 334.94 | 341.34 | 346.12 | 347.10 | 361.14 | 374.85 | |
Rg7894 | 343.96 | 338.16 | 349.26 | 346.80 | 354.24 | 365.11 | ||
Rg7895 | 343.44 | 367.83 | 377.74 | 390.11 | 388.63 | 404.21 | ||
Rg7896 | 354.64 | 376.29 | 384.74 | 394.74 | 414.86 | 427.80 | ||
Rg7897 | 356.25 | 370.55 | 379.69 | 382.24 | 389.28 | 412.62 | ||
Rg7898 | 360.13 | 358.24 | 355.42 | 369.05 | 386.08 | 403.15 | ||
Rg7899 | 366.10 | 367.04 | 347.77 | 355.54 | 384.16 | 404.93 | ||
Rg7900 | 371.54 | 380.88 | 366.71 | 400.94 | 433.94 | 452.17 | ||
Rg7901 | 375.24 | 400.06 | 413.40 | 416.72 | 412.71 | 410.76 | ||
Rg7902 | 377.55 | 405.36 | 424.70 | 426.02 | 423.28 | 418.10 | ||
Rg7903 | 395.81 | 411.50 | 419.55 | 416.15 | 428.79 | 455.63 | ||
Rg7904 | 407.36 | 431.73 | 435.46 | 437.90 | 439.46 | 434.48 | ||
G3, M & 300 | Rg7905 | 337.81 | 335.86 | 356.03 | 351.69 | 358.27 | 353.18 | |
Rg7906 | 337.28 | 349.30 | 354.28 | 350.09 | 345.15 | 349.33 | ||
Rg7907 | 339.90 | 360.12 | 382.79 | 386.02 | 401.92 | 405.25 | ||
Rg7908 | 355.30 | 376.11 | 403.88 | 416.62 | 420.32 | 422.40 | ||
Rg7909 | 358.48 | 372.71 | 367.49 | 370.07 | 386.44 | 402.95 | ||
Rg7910 | 363.65 | 355.55 | 348.53 | 339.99 | 348.27 | 363.01 | ||
Rg7911 | 374.06 | 392.11 | 411.60 | 431.29 | 434.58 | 454.33 | ||
Rg7912 | 369.93 | 390.89 | 414.64 | 413.36 | 422.97 | 436.47 | ||
Rg7913 | 384.94 | 415.47 | 435.10 | 441.25 | 436.32 | 428.59 | ||
Rg7914 | 385.76 | 413.73 | 399.64 | 397.54 | 401.76 | 396.80 | ||
Rg7915 | 383.28 | 391.30 | 394.16 | 398.46 | 394.88 | 405.56 | ||
Rg7916 | 424.91 | 431.26 | 451.92 | 451.18 | 447.84 | 441.19 | ||
G4, M & 600 | Rg7917 | 340.98 | 334.17 | 329.74 | 338.70 | 358.51 | 362.21 | |
Rg7918 | 338.31 | 337.67 | 331.32 | 325.25 | 320.55 | 330.75 | ||
Rg7919 | 342.73 | 335.77 | 327.79 | 340.03 | 348.72 | 340.38 | ||
Rg7920 | 351.10 | 361.03 | 376.12 | 385.68 | 379.66 | 372.53 | ||
Rg7921 | 358.81 | 365.05 | 368.05 | 361.59 | 356.56 | 358.90 | ||
Rg7922 | 362.18 | 350.19 | 348.13 | 364.44 | 383.60 | 413.88 | ||
Rg7923 | 365.00 | 380.56 | 400.21 | 400.33 | 416.14 | 417.46 | ||
Rg7924 | 373.30 | 374.73 | 385.91 | 379.26 | 372.38 | 368.37 | ||
Rg7925 | 382.72 | 396.05 | 408.64 | 401.16 | 414.48 | 396.89 | ||
Rg7926 | 384.83 | 400.08 | 410.02 | 404.38 | 400.24 | 391.18 | ||
Rg7927 | 390.68 | 406.11 | 398.22 | 400.92 | 396.04 | 415.90 | ||
Rg7928 | 408.96 | 394.86 | 389.79 | 379.02 | 390.26 | 389.55 |
M: Male.
APPENDIX 2 (Contd…). INDIVIDUAL ANIMAL BODY WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Body Weight (g) on Day | |||||
1 | 7 | 14 | 21# | 28# | |||
G1, F & 0 | Rg7929 | 248.22 | 247.36 | 255.45 | - | - | |
Rg7930 | 245.21 | 253.07 | 258.31 | - | - | ||
Rg7931 | 251.50 | 256.72 | 267.01 | - | - | ||
Rg7932 | 251.34 | 258.40 | 265.08 | - | - | ||
Rg7933 | 247.85 | 252.31 | 264.51 | - | - | ||
Rg7934 | 258.86 | 260.39 | 261.94 | - | - | ||
Rg7935 | 264.81 | 268.64 | 272.44 | 290.01 | - | ||
Rg7936 | 259.29 | 270.29 | 276.21 | - | - | ||
Rg7937 | 268.76 | 282.75 | 292.75 | - | - | ||
Rg7938 | 267.33 | 274.71 | 276.39 | - | - | ||
Rg7939 | 268.45 | 272.71 | 281.79 | - | - | ||
Rg7940 | 273.34 | 283.43 | 291.83 | - | - | ||
G2, F & 150 | Rg7941 | 241.75 | 248.06 | 262.99 | - | - | |
Rg7942 | 244.27 | 251.76 | 260.26 | - | - | ||
Rg7943 | 250.97 | 253.76 | 259.10 | - | - | ||
Rg7944 | 254.05 | 255.56 | 259.01 | - | - | ||
Rg7945 | 254.64 | 263.39 | 269.91 | - | - | ||
Rg7946 | 250.58 | 259.98 | 264.49 | - | - | ||
Rg7947 | 259.73 | 268.97 | 280.24 | - | - | ||
Rg7948 | 263.06 | 265.08 | 283.42 | - | - | ||
Rg7949NP | 266.79 | 283.19 | 281.36 | - | - | ||
Rg7950 | 266.57 | 277.18 | 278.08 | - | - | ||
Rg7951 | 271.74 | 280.32 | 293.06 | 291.08 | - | ||
Rg7952 | 276.95 | 279.34 | 295.04 | - | - | ||
G3, F & 300 | Rg7953NP | 246.88 | 249.47 | 244.84 | - | - | |
Rg7954 | 251.20 | 252.10 | 260.73 | - | - | ||
Rg7955 | 253.76 | 249.27 | 258.72 | - | - | ||
Rg7956 | 247.18 | 248.59 | 256.94 | - | - | ||
Rg7957NP | 249.95 | 258.93 | 255.16 | - | - | ||
Rg7958 | 253.99 | 260.56 | 267.65 | 284.26 | 279.42 | ||
Rg7959 | 261.36 | 264.71 | 273.72 | - | - | ||
Rg7960 | 270.69 | 283.88 | 291.31 | - | - | ||
Rg7961 | 267.74 | 265.25 | 274.29 | - | - | ||
Rg7962 | 265.18 | 272.73 | 269.49 | 281.90 | - | ||
Rg7963TL | 273.85 | 274.96 | 283.88 | 289.16 | - | ||
Rg7964 | 276.21 | 292.60 | 291.28 | - | - | ||
G4, F & 600 | Rg7965TL | 244.15 | 240.44 | 238.71 | 238.37 | - | |
Rg7966 | 248.71 | 247.53 | 253.78 | - | - | ||
Rg7967TL | 246.74 | 259.19 | 259.71 | - | - | ||
Rg7968 | 246.12 | 251.16 | 251.64 | - | - | ||
Rg7969 | 255.79 | 260.19 | 267.66 | - | - | ||
Rg7970 | 255.48 | 265.50 | 275.49 | - | - | ||
Rg7971 | 268.69 | 285.59 | 283.83 | - | - | ||
Rg7972TL | 265.86 | 262.66 | 272.48 | - | - | ||
Rg7973NP | 263.17 | 276.31 | 275.58 | 282.17 | 294.00 | ||
Rg7974 | 276.12 | 287.03 | 305.52 | - | - | ||
Rg7975 | 269.01 | 276.36 | 287.27 | - | - | ||
Rg7976 | 275.10 | 285.39 | 282.06 | 276.77 | 286.27 |
F: Female; NP: Non-pregnant; TL: total litter loss; -: Not applicable (recorded under gestation body weight).
#: The presented values represent data obtained from females under cohabitation only.
Note 1: The data of females confirmed with mating is excluded under this Appendix and presented as gestation body weight record under Appendix 3.
Note 2: The day 21 & 28 body weight data was not subjected to statistical analysis due to uneven number of variables.
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Body Weight (g) on Gestation Day | ||||
0 | 7 | 14 | 20 | |||
G1, F & 0 | Rg7929 | 259.62 | 280.33 | 315.14 | 386.74 | |
Rg7930 | 257.43 | 275.28 | 300.55 | 337.92 | ||
Rg7931 | 275.73 | 296.72 | 324.16 | 389.04 | ||
Rg7932 | 269.67 | 277.10 | 299.18 | 325.14 | ||
Rg7933 | 275.51 | 288.54 | 331.45 | 411.46 | ||
Rg7934 | 269.35 | 292.38 | 331.75 | 389.30 | ||
Rg7935 | 306.88 | 328.31 | 362.28 | 409.24 | ||
Rg7936 | 279.07 | 301.67 | 337.38 | 425.18 | ||
Rg7937 | 293.10 | 310.60 | 330.12 | 379.23 | ||
Rg7938 | 284.75 | 301.24 | 348.97 | 441.16 | ||
Rg7939 | 283.55 | 289.90 | 315.05 | 401.13 | ||
Rg7940 | 296.73 | 315.24 | 350.52 | 416.92 | ||
G2, F & 150 | Rg7941 | 262.49 | 283.63 | 317.75 | 389.38 | |
Rg7942 | 258.05 | 276.85 | 295.36 | 331.79 | ||
Rg7943 | 265.60 | 287.41 | 323.33 | 359.76 | ||
Rg7944 | 270.09 | 285.37 | 303.19 | 335.18 | ||
Rg7945 | 281.16 | 292.63 | 321.75 | 357.36 | ||
Rg7946 | 267.03 | 279.89 | 304.08 | 341.56 | ||
Rg7947 | 287.16 | 302.43 | 337.50 | 368.22 | ||
Rg7948 | 289.56 | 307.18 | 342.92 | 429.48 | ||
Rg7949NP | 282.73 | 289.26 | 308.91 | 314.63 | ||
Rg7950 | 285.08 | 306.22 | 345.49 | 394.33 | ||
Rg7951 | 289.52 | 304.57 | 343.54 | 391.76 | ||
Rg7952 | 295.04 | 314.68 | 336.45 | 386.12 | ||
G3, F & 300 | Rg7953NP | 250.63 | 258.10 | 269.81 | 270.34 | |
Rg7954 | 268.18 | 277.81 | 308.73 | 358.53 | ||
Rg7955 | 264.02 | 281.16 | 319.97 | 372.12 | ||
Rg7956 | 256.17 | 268.14 | 293.99 | 331.82 | ||
Rg7957NP | 259.31 | 269.73 | 274.80 | 281.62 | ||
Rg7958 | 276.73 | 283.87 | 306.97 | 347.26 | ||
Rg7959 | 274.25 | 283.25 | 301.36 | 334.01 | ||
Rg7960 | 296.35 | 317.35 | 348.86 | 391.22 | ||
Rg7961 | 280.81 | 303.10 | 331.23 | 372.88 | ||
Rg7962 | 292.20 | 304.36 | 331.11 | 370.25 | ||
Rg7963TL | 288.45 | 307.52 | 340.38 | 392.75 | ||
Rg7964 | 303.17 | 318.98 | 355.23 | 473.94 | ||
G4, F & 600 | Rg7965TL | 242.22 | 257.29 | 281.46 | 320.96 | |
Rg7966 | 255.36 | 278.45 | 304.55 | 343.22 | ||
Rg7967TL | 262.43 | 267.64 | 271.55 | 292.30 | ||
Rg7968 | 259.20 | 280.76 | 316.27 | 405.46 | ||
Rg7969 | 271.59 | 280.06 | 301.39 | 365.37 | ||
Rg7970 | 278.06 | 299.85 | 315.42 | 344.16 | ||
Rg7971 | 284.92 | 299.72 | 326.87 | 396.61 | ||
Rg7972TL | 275.92 | 283.45 | 299.26 | 328.05 | ||
Rg7973NP | 291.39 | 306.17 | 318.46 | 315.18 | ||
Rg7974 | 306.21 | 313.09 | 343.71 | 436.77 | ||
Rg7975 | 286.50 | 308.76 | 352.41 | 442.61 | ||
Rg7976 | 284.70 | 301.27 | 333.27 | 361.72 |
F: Female; TL: Total litter loss; NP: Non-pregnant (data excluded for mean calculations and statistical analysis).
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Body Weight (g) on Lactation Day | ||||
1 | 4 | 7 | 13 | |||
G1, F & 0 | Rg7929 | 299.65 | 310.76 | 319.02 | 323.56 | |
Rg7930 | 281.79 | 290.05 | 301.13 | 317.77 | ||
Rg7931 | 298.10 | 294.94 | 302.10 | 321.33 | ||
Rg7932 | 293.35 | 302.99 | 311.48 | 327.26 | ||
Rg7933 | 297.10 | 305.65 | 313.01 | 324.72 | ||
Rg7934 | 289.43 | 300.24 | 310.03 | 333.92 | ||
Rg7935 | 319.62 | 317.39 | 323.17 | 337.36 | ||
Rg7936 | 301.68 | 306.38 | 317.28 | 331.41 | ||
Rg7937 | 326.68 | 337.94 | 345.12 | 352.56 | ||
Rg7938 | 305.56 | 302.76 | 309.25 | 327.63 | ||
Rg7939 | 304.25 | 303.68 | 312.63 | 327.83 | ||
Rg7940 | 319.81 | 327.00 | 338.24 | 356.97 | ||
G2, F & 150 | Rg7941 | 271.19 | 267.87 | 276.39 | 285.16 | |
Rg7942 | 277.56 | 285.63 | 296.63 | 311.38 | ||
Rg7943 | 290.82 | 289.79 | 297.62 | 310.49 | ||
Rg7944 | 281.37 | 279.46 | 285.91 | 299.86 | ||
Rg7945 | 297.58 | 308.52 | 316.27 | 332.71 | ||
Rg7946 | 284.65 | 286.32 | 293.61 | 308.11 | ||
Rg7947 | 306.18 | 314.81 | 322.51 | 331.26 | ||
Rg7948 | 312.02 | 309.11 | 317.64 | 331.37 | ||
Rg7949NP | - | - | - | - | ||
Rg7950 | 305.96 | 314.26 | 323.16 | 347.18 | ||
Rg7951 | 319.46 | 328.37 | 336.16 | 351.28 | ||
Rg7952 | 316.11 | 314.81 | 321.96 | 333.90 | ||
G3, F & 300 | Rg7953NP | - | - | - | - | |
Rg7954 | 284.46 | 291.68 | 300.11 | 326.17 | ||
Rg7955 | 306.72 | 316.30 | 315.03 | 328.10 | ||
Rg7956 | 269.36 | 273.11 | 281.16 | 303.09 | ||
Rg7957NP | - | - | - | - | ||
Rg7958 | 288.19 | 295.36 | 300.13 | 321.48 | ||
Rg7959 | 293.51 | 298.16 | 308.15 | 322.37 | ||
Rg7960 | 308.16 | 306.63 | 315.18 | 334.90 | ||
Rg7961 | 301.79 | 303.29 | 310.53 | 327.98 | ||
Rg7962 | 311.16 | 318.21 | 330.74 | 346.11 | ||
Rg7963TL | 337.13 | 332.54 | 330.18 | 328.91 | ||
Rg7964 | 320.37 | 316.79 | 319.30 | 324.54 | ||
G4, F & 600 | Rg7965TL | 273.45 | 270.68 | 267.44 | 274.45 | |
Rg7966 | 293.57 | 298.46 | 305.90 | 321.42 | ||
Rg7967TL | 271.78 | 267.16 | 264.81 | 277.18 | ||
Rg7968 | 283.58 | 289.53 | 300.26 | 309.18 | ||
Rg7969 | 286.52 | 284.13 | 292.81 | 302.41 | ||
Rg7970 | 291.82 | 288.64 | 295.37 | 298.82 | ||
Rg7971 | 317.61 | 320.20 | 330.19 | 347.83 | ||
Rg7972TL | 271.79 | 250.11 | D | D | ||
Rg7973NP | - | - | - | - | ||
Rg7974 | 314.79 | 316.41 | 320.92 | 337.12 | ||
Rg7975 | 311.76 | 309.79 | 316.48 | 337.71 | ||
Rg7976 | 297.31 | 296.38 | 305.71 | 323.18 |
F: Female; TL: Total litter loss; NP: Non-pregnant; -: Not applicable.
D: Found dead on Lactation day 5.
APPENDIX 5 (Contd…). INDIVIDUAL ANIMAL PERCENT CHANGE IN
BODY WEIGHT GAIN (%) WITH RESPECT TO DAY 1 RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Percent Change in Body Weight (%) during Day | ||||
1 to 7 | 1 to 14 | 1 to 21# | 1 to 28# | |||
G1, F & 0 | Rg7929 | -0.35 | 2.91 | - | - | |
Rg7930 | 3.21 | 5.34 | - | - | ||
Rg7931 | 2.08 | 6.17 | - | - | ||
Rg7932 | 2.81 | 5.47 | - | - | ||
Rg7933 | 1.80 | 6.72 | - | - | ||
Rg7934 | 0.59 | 1.19 | - | - | ||
Rg7935 | 1.45 | 2.88 | 9.52 | - | ||
Rg7936 | 4.24 | 6.53 | - | - | ||
Rg7937 | 5.21 | 8.93 | - | - | ||
Rg7938 | 2.76 | 3.39 | - | - | ||
Rg7939 | 1.59 | 4.97 | - | - | ||
Rg7940 | 3.69 | 6.76 | - | - | ||
G2, F & 150 | Rg7941 | 2.61 | 8.79 | - | - | |
Rg7942 | 3.07 | 6.55 | - | - | ||
Rg7943 | 1.11 | 3.24 | - | - | ||
Rg7944 | 0.59 | 1.95 | - | - | ||
Rg7945 | 3.44 | 6.00 | - | - | ||
Rg7946 | 3.75 | 5.55 | - | - | ||
Rg7947 | 3.56 | 7.90 | - | - | ||
Rg7948 | 0.77 | 7.74 | - | - | ||
Rg7949NP | 6.15 | 5.46 | - | - | ||
Rg7950 | 3.98 | 4.32 | - | - | ||
Rg7951 | 3.16 | 7.85 | 7.12 | - | ||
Rg7952 | 0.86 | 6.53 | - | - | ||
G3, F & 300 | Rg7953NP | 1.05 | -0.83 | - | - | |
Rg7954 | 0.36 | 3.79 | - | - | ||
Rg7955 | -1.77 | 1.95 | - | - | ||
Rg7956 | 0.57 | 3.95 | - | - | ||
Rg7957NP | 3.59 | 2.08 | - | - | ||
Rg7958 | 2.59 | 5.38 | 11.92 | 10.01 | ||
Rg7959 | 1.28 | 4.73 | - | - | ||
Rg7960 | 4.87 | 7.62 | - | - | ||
Rg7961 | -0.93 | 2.45 | - | - | ||
Rg7962 | 2.85 | 1.63 | 6.31 | - | ||
Rg7963TL | 0.41 | 3.66 | 5.59 | - | ||
Rg7964 | 5.93 | 5.46 | - | - | ||
G4, F & 600 | Rg7965TL | -1.52 | -2.23 | -2.37 | - | |
Rg7966 | -0.47 | 2.04 | - | - | ||
Rg7967TL | 5.05 | 5.26 | - | - | ||
Rg7968 | 2.05 | 2.24 | - | - | ||
Rg7969 | 1.72 | 4.64 | - | - | ||
Rg7970 | 3.92 | 7.83 | - | - | ||
Rg7971 | 6.29 | 5.63 | - | - | ||
Rg7972TL | -1.20 | 2.49 | - | - | ||
Rg7973NP | 4.99 | 4.72 | 7.22 | 11.71 | ||
Rg7974 | 3.95 | 10.65 | - | - | ||
Rg7975 | 2.73 | 6.79 | - | - | ||
Rg7976 | 3.74 | 2.53 | 0.61 | 4.06 |
F: Female; NP: Non-pregnant; TL: total litter loss; -: Not applicable (recorded under gestation body weight).
#: The presented values represent data obtained from females under cohabitation. The data of females confirmed with mating was excluded under this appendix and presented under gestation body weight gain record (Appendix 6).
Note: The day 1 to 21 & 1 to 28 body weight gain data was not subjected to statistical analysis due to uneven number of variables.
Group, Sex & Dose | Animal No. | Percent Change in Body Weight Gain (%) during Gestation Day | |||
0 to 7 | 7 to 14 | 14 to 20 | |||
G1, F & 0 | Rg7929 | 7.98 | 12.42 | 22.72 | |
Rg7930 | 6.93 | 9.18 | 12.43 | ||
Rg7931 | 7.61 | 9.25 | 20.01 | ||
Rg7932 | 2.76 | 7.97 | 8.68 | ||
Rg7933 | 4.73 | 14.87 | 24.14 | ||
Rg7934 | 8.55 | 13.47 | 17.35 | ||
Rg7935 | 6.98 | 10.35 | 12.96 | ||
Rg7936 | 8.10 | 11.84 | 26.02 | ||
Rg7937 | 5.97 | 6.28 | 14.88 | ||
Rg7938 | 5.79 | 15.84 | 26.42 | ||
Rg7939 | 2.24 | 8.68 | 27.32 | ||
Rg7940 | 6.24 | 11.19 | 18.94 | ||
G2, F & 150 | Rg7941 | 8.05 | 12.03 | 22.54 | |
Rg7942 | 7.29 | 6.69 | 12.33 | ||
Rg7943 | 8.21 | 12.50 | 11.27 | ||
Rg7944 | 5.66 | 6.24 | 10.55 | ||
Rg7945 | 4.08 | 9.95 | 11.07 | ||
Rg7946 | 4.82 | 8.64 | 12.33 | ||
Rg7947 | 5.32 | 11.60 | 9.10 | ||
Rg7948 | 6.09 | 11.63 | 25.24 | ||
Rg7949NP | 2.31 | 6.79 | 1.85 | ||
Rg7950 | 7.42 | 12.82 | 14.14 | ||
Rg7951 | 5.20 | 12.80 | 14.04 | ||
Rg7952 | 6.66 | 6.92 | 14.76 | ||
G3, F & 300 | Rg7953NP | 2.98 | 4.54 | 0.20 | |
Rg7954 | 3.59 | 11.13 | 16.13 | ||
Rg7955 | 6.49 | 13.80 | 16.30 | ||
Rg7956 | 4.67 | 9.64 | 12.87 | ||
Rg7957NP | 4.02 | 1.88 | 2.48 | ||
Rg7958 | 2.58 | 8.14 | 13.13 | ||
Rg7959 | 3.28 | 6.39 | 10.83 | ||
Rg7960 | 7.09 | 9.93 | 12.14 | ||
Rg7961 | 7.94 | 9.28 | 12.57 | ||
Rg7962 | 4.16 | 8.79 | 11.82 | ||
Rg7963TL | 6.61 | 10.69 | 15.39 | ||
Rg7964 | 5.21 | 11.36 | 33.42 | ||
G4, F & 600 | Rg7965TL | 6.22 | 9.39 | 14.03 | |
Rg7966 | 9.04 | 9.37 | 12.70 | ||
Rg7967TL | 1.99 | 1.46 | 7.64 | ||
Rg7968 | 8.32 | 12.65 | 28.20 | ||
Rg7969 | 3.12 | 7.62 | 21.23 | ||
Rg7970 | 7.84 | 5.19 | 9.11 | ||
Rg7971 | 5.19 | 9.06 | 21.34 | ||
Rg7972TL | 2.73 | 5.58 | 9.62 | ||
Rg7973NP | 5.07 | 4.01 | -1.03 | ||
Rg7974 | 2.25 | 9.78 | 27.08 | ||
Rg7975 | 7.77 | 14.14 | 25.60 | ||
Rg7976 | 5.82 | 10.62 | 8.54 |
F: Female; TL: Total litter loss; NP: Non-pregnant (data excluded for mean calculations and statistical analysis).
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Percent Change in Body Weight Gain (%) during Lactation Day | |||
1 to 4 | 4 to 7 | 7 to 13 | |||
G1, F & 0 | Rg7929 | 3.71 | 2.66 | 1.42 | |
Rg7930 | 2.93 | 3.82 | 5.53 | ||
Rg7931 | -1.06 | 2.43 | 6.37 | ||
Rg7932 | 3.29 | 2.80 | 5.07 | ||
Rg7933 | 2.88 | 2.41 | 3.74 | ||
Rg7934 | 3.73 | 3.26 | 7.71 | ||
Rg7935 | -0.70 | 1.82 | 4.39 | ||
Rg7936 | 1.56 | 3.56 | 4.45 | ||
Rg7937 | 3.45 | 2.12 | 2.16 | ||
Rg7938 | -0.92 | 2.14 | 5.94 | ||
Rg7939 | -0.19 | 2.95 | 4.86 | ||
Rg7940 | 2.25 | 3.44 | 5.54 | ||
G2, F & 150 | Rg7941 | -1.22 | 3.18 | 3.17 | |
Rg7942 | 2.91 | 3.85 | 4.97 | ||
Rg7943 | -0.35 | 2.70 | 4.32 | ||
Rg7944 | -0.68 | 2.31 | 4.88 | ||
Rg7945 | 3.68 | 2.51 | 5.20 | ||
Rg7946 | 0.59 | 2.55 | 4.94 | ||
Rg7947 | 2.82 | 2.45 | 2.71 | ||
Rg7948 | -0.93 | 2.76 | 4.32 | ||
Rg7949NP | - | - | - | ||
Rg7950 | 2.71 | 2.83 | 7.43 | ||
Rg7951 | 2.79 | 2.37 | 4.50 | ||
Rg7952 | -0.41 | 2.27 | 3.71 | ||
G3, F & 300 | Rg7953NP | - | - | - | |
Rg7954 | 2.54 | 2.89 | 8.68 | ||
Rg7955 | 3.12 | -0.40 | 4.15 | ||
Rg7956 | 1.39 | 2.95 | 7.80 | ||
Rg7957NP | - | - | - | ||
Rg7958 | 2.49 | 1.61 | 7.11 | ||
Rg7959 | 1.58 | 3.35 | 4.61 | ||
Rg7960 | -0.50 | 2.79 | 6.26 | ||
Rg7961 | 0.50 | 2.39 | 5.62 | ||
Rg7962 | 2.27 | 3.94 | 4.65 | ||
Rg7963TL | -1.36 | -0.71 | -0.38 | ||
Rg7964 | -1.12 | 0.79 | 1.64 | ||
G4, F & 600 | Rg7965TL | -1.01 | -1.20 | 2.62 | |
Rg7966 | 1.67 | 2.49 | 5.07 | ||
Rg7967TL | -1.48 | -0.88 | 4.67 | ||
Rg7968 | 2.10 | 3.71 | 2.97 | ||
Rg7969 | -0.83 | 3.05 | 3.28 | ||
Rg7970 | -1.09 | 2.33 | 1.17 | ||
Rg7971 | 0.82 | 3.12 | 5.34 | ||
Rg7972TL | -7.98 | D | D | ||
Rg7973NP | - | - | - | ||
Rg7974 | 0.51 | 1.43 | 5.05 | ||
Rg7975 | -0.63 | 2.16 | 6.71 | ||
Rg7976 | -0.31 | 3.15 | 5.71 |
F: Female; TL: Total litter loss; NP: Non-pregnant; -: Not applicable.
D: Found dead on Lactation day 5.
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Feed Consumption (g/animal/day) during Pre-mating period | |
Week 1 | Week 2 | ||
G1, M & 0 | Rg7881 & Rg7882 | 23.0 | 26.5 |
Rg7883 & Rg7884 | 17.5 | 25.2 | |
Rg7885 & Rg7886 | 19.0 | 22.9 | |
Rg7887 & Rg7888 | 21.4 | 23.7 | |
Rg7889 & Rg7890 | 23.2 | 23.8 | |
Rg7891 & Rg7892 | 24.3 | 25.5 | |
G2, M & 150 | Rg7893 & Rg7894 | 19.7 | 24.6 |
Rg7895 & Rg7896 | 24.5 | 25.4 | |
Rg7897 & Rg7898 | 21.8 | 23.4 | |
Rg7899 & Rg7900 | 19.0 | 25.4 | |
Rg7901 & Rg7902 | 23.7 | 24.6 | |
Rg7903 & Rg7904 | 23.0 | 23.5 | |
G3, M & 300 | Rg7905 & Rg7906 | 21.2 | 23.6 |
Rg7907 & Rg7908 | 24.2 | 22.6 | |
Rg7909 & Rg7910 | 21.9 | 21.6 | |
Rg7911 & Rg7912 | 23.5 | 24.8 | |
Rg7913 & Rg7914 | 24.6 | 23.1 | |
Rg7915 & Rg7916 | 20.7 | 24.5 | |
G4, M & 600 | Rg7917 & Rg7918 | 18.9 | 23.5 |
Rg7919 & Rg7920 | 19.4 | 22.8 | |
Rg7921 & Rg7922 | 20.0 | 23.5 | |
Rg7923 & Rg7924 | 22.3 | 22.7 | |
Rg7925 & Rg7926 | 23.8 | 24.9 | |
Rg7927 & Rg7928 | 22.5 | 22.2 |
M: Male.
APPENDIX 8 (Cond…). INDIVIDUAL ANIMAL FEED CONSUMPTION (g/animal/day) RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Feed Consumption (g/animal/day) during Pre-mating period | |
Week 1 | Week 2 | ||
G1, F & 0 | Rg7929 & Rg7930 | 16.8 | 17.8 |
Rg7931 & Rg7932 | 18.5 | 19.6 | |
Rg7933 & Rg7934 | 17.4 | 17.8 | |
Rg7935 & Rg7936 | 17.6 | 17.4 | |
Rg7937 & Rg7938 | 18.9 | 19.8 | |
Rg7939 & Rg7940 | 19.2 | 17.3 | |
G2, F & 150 | Rg7941 & Rg7942 | 17.7 | 18.9 |
Rg7943 & Rg7944 | 16.1 | 15.6 | |
Rg7945 & Rg7946 | 17.6 | 16.9 | |
Rg7947 & Rg7948 | 18.8 | 19.4 | |
Rg7949 & Rg7950 | 19.7 | 19.5 | |
Rg7951 & Rg7952 | 18.5 | 18.7 | |
G3, F & 300 | Rg7953 & Rg7954 | 17.0 | 15.7 |
Rg7955 & Rg7956 | 16.7 | 17.1 | |
Rg7957 & Rg7958 | 18.2 | 18.1 | |
Rg7959 & Rg7960 | 18.4 | 19.8 | |
Rg7961 & Rg7962 | 17.1 | 16.4 | |
Rg7963 & Rg7964 | 20.2 | 18.9 | |
G4, F & 600 | Rg7965 & Rg7966 | 17.2 | 15.1 |
Rg7967 & Rg7968 | 16.0 | 16.6 | |
Rg7969 & Rg7970 | 16.7 | 16.9 | |
Rg7971 & Rg7972 | 16.7 | 17.9 | |
Rg7973 & Rg7974 | 19.0 | 19.2 | |
Rg7974 & Rg7976 | 18.6 | 16.9 |
F: Female.
Group, Sex & Dose | Animal No. | Feed Consumption (g/animal/day) during Gestation Day (GD) | ||
0 to 7 | 7 to 14 | 14 to 20 | ||
G1, F & 0 | Rg7929 | 20.4 | 23.1 | 27.5 |
Rg7930 | 19.7 | 21.2 | 25.3 | |
Rg7931 | 21.3 | 23.6 | 28.0 | |
Rg7932 | 17.9 | 19.8 | 22.9 | |
Rg7933 | 18.7 | 21.7 | 28.2 | |
Rg7934 | 21.7 | 23.2 | 28.0 | |
Rg7935 | 21.2 | 22.5 | 28.0 | |
Rg7936 | 19.6 | 21.0 | 26.2 | |
Rg7937 | 19.5 | 21.0 | 25.6 | |
Rg7938 | 19.5 | 22.5 | 28.7 | |
Rg7939 | 17.7 | 20.0 | 24.2 | |
Rg7940 | 21.0 | 22.9 | 27.9 | |
G2, F & 150 | Rg7941 | 20.7 | 23.3 | 26.4 |
Rg7942 | 19.2 | 20.2 | 24.0 | |
Rg7943 | 20.3 | 22.7 | 27.2 | |
Rg7944 | 19.6 | 19.8 | 24.0 | |
Rg7945 | 18.0 | 19.9 | 24.3 | |
Rg7946 | 19.1 | 20.2 | 24.6 | |
Rg7947 | 19.6 | 21.7 | 26.5 | |
Rg7948 | 20.3 | 22.4 | 26.5 | |
Rg7949NP | 17.4 | 19.6 | 21.8 | |
Rg7950 | 21.7 | 23.8 | 28.4 | |
Rg7951 | 19.1 | 22.0 | 27.2 | |
Rg7952 | 19.6 | 21.6 | 26.3 | |
G3, F & 300 | Rg7953NP | 17.6 | 18.9 | 21.0 |
Rg7954 | 17.4 | 20.1 | 24.9 | |
Rg7955 | 19.6 | 23.3 | 28.0 | |
Rg7956 | 19.1 | 21.7 | 26.1 | |
Rg7957NP | 18.4 | 16.8 | 18.8 | |
Rg7958 | 17.7 | 19.5 | 23.2 | |
Rg7959 | 18.1 | 19.6 | 23.8 | |
Rg7960 | 21.0 | 23.2 | 28.0 | |
Rg7961 | 20.0 | 22.8 | 27.2 | |
Rg7962 | 19.1 | 20.4 | 24.7 | |
Rg7963TL | 21.5 | 24.3 | 28.9 | |
Rg7964 | 19.9 | 21.8 | 28.6 | |
G4, F & 600 | Rg7965TL | 18.8 | 20.9 | 22.9 |
Rg7966 | 19.0 | 20.9 | 25.1 | |
Rg7967TL | 16.9 | 17.5 | 19.5 | |
Rg7968 | 19.2 | 20.7 | 25.6 | |
Rg7969 | 17.7 | 19.3 | 23.5 | |
Rg7970 | 20.6 | 21.9 | 25.3 | |
Rg7971 | 19.0 | 20.3 | 24.2 | |
Rg7972TL | 17.3 | 19.6 | 23.9 | |
Rg7973NP | 18.7 | 17.5 | 19.3 | |
Rg7974 | 17.4 | 19.8 | 25.3 | |
Rg7975 | 22.0 | 22.8 | 28.1 | |
Rg7976 | 18.8 | 20.4 | 26.1 |
F: Female; TL: Total litter loss; NP: Non-pregnant (data excluded for mean calculations and statistical analysis).
Group, Sex & Dose | Animal No. | Feed Consumption (g/animal/day) during Lactation Day (LD) | ||
1 to 4 | 4 to 7 | 7 to 13 | ||
G1, F & 0 | Rg7929 | 28.0 | 33.0 | 39.5 |
Rg7930 | 24.3 | 27.3 | 37.9 | |
Rg7931 | 29.7 | 33.7 | 43.0 | |
Rg7932 | 25.4 | 31.0 | 41.2 | |
Rg7933 | 28.0 | 33.2 | 40.4 | |
Rg7934 | 29.3 | 34.5 | 42.7 | |
Rg7935 | 27.3 | 34.2 | 40.2 | |
Rg7936 | 25.2 | 30.4 | 42.5 | |
Rg7937 | 27.7 | 32.9 | 43.0 | |
Rg7938 | 28.7 | 31.7 | 44.0 | |
Rg7939 | 29.9 | 34.4 | 42.9 | |
Rg7940 | 28.7 | 34.7 | 43.6 | |
G2, F & 150 | Rg7941 | 32.9 | 35.8 | 43.8 |
Rg7942 | 26.5 | 30.9 | 41.5 | |
Rg7943 | 25.8 | 31.0 | 41.3 | |
Rg7944 | 27.5 | 31.8 | 42.2 | |
Rg7945 | 28.0 | 34.2 | 41.0 | |
Rg7946 | 27.7 | 32.7 | 40.2 | |
Rg7947 | 27.0 | 31.7 | 40.5 | |
Rg7948 | 32.1 | 35.4 | 42.1 | |
Rg7949NP | - | - | - | |
Rg7950 | 28.3 | 31.9 | 41.1 | |
Rg7951 | 27.6 | 32.3 | 39.0 | |
Rg7952 | 29.0 | 35.3 | 40.2 | |
G3, F & 300 | Rg7953NP | - | - | - |
Rg7954 | 27.2 | 33.1 | 39.3 | |
Rg7955 | 29.7 | 33.8 | 41.5 | |
Rg7956 | 27.6 | 32.6 | 43.7 | |
Rg7957NP | - | - | - | |
Rg7958 | 28.2 | 33.5 | 40.4 | |
Rg7959 | 26.6 | 32.4 | 40.3 | |
Rg7960 | 28.5 | 32.7 | 43.7 | |
Rg7961 | 26.5 | 30.7 | 38.9 | |
Rg7962 | 25.1 | 30.4 | 39.9 | |
Rg7963TL | 21.3 | 26.0 | 37.9 | |
Rg7964 | 30.3 | 35.4 | 44.0 | |
G4, F & 600 | Rg7965TL | 16.9 | 22.4 | 33.8 |
Rg7966 | 25.5 | 31.4 | 37.0 | |
Rg7967TL | 24.3 | 27.2 | 38.5 | |
Rg7968 | 29.5 | 33.6 | 42.9 | |
Rg7969 | 27.1 | 34.0 | 42.7 | |
Rg7970 | 26.9 | 32.0 | 37.7 | |
Rg7971 | 27.9 | 31.6 | 42.3 | |
Rg7972TL | 21.3 | - | - | |
Rg7973NP | - | - | - | |
Rg7974 | 29.2 | 34.0 | 43.6 | |
Rg7975 | 28.9 | 34.1 | 42.3 | |
Rg7976 | 27.7 | 33.0 | 40.0 |
F: Female; NP: Non-pregnant; TL: Total litter loss; -: Not applicable.
& Dose (mg/kg body weight/day) | Animal No. | Total Leucocyte Count | Total Erythrocyte Count | Hemoglobin | Haematocrit | Mean Corpuscular Volume | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin Concentration | Platelet Count |
(WBC) | (RBC) | (HGB) | (HCT) | (MCV) | (MCH) | (MCHC) | (PLT) | ||
(103 cells/µL) | (106 cells/µL) | (g/dL) | (%) | (fL) | (pg) | (g/dL) | (103 cells/µL) | ||
G1, M & 0 | Rg7881 | 9.39 | 7.73 | 15.8 | 48.6 | 62.9 | 20.4 | 32.4 | 952 |
Rg7882 | 29.13 | 7.46 | 12.6 | 38.0 | 50.9 | 16.8 | 33.0 | 1011 | |
Rg7883 | 15.96 | 8.94 | 17.1 | 51.5 | 57.7 | 19.1 | 33.2 | 990 | |
Rg7884 | 11.57 | 9.00 | 16.5 | 48.6 | 54.0 | 18.4 | 34.0 | 1218 | |
Rg7885 | 9.28 | 9.13 | 17.0 | 51.5 | 56.4 | 18.7 | 33.1 | 957 | |
Rg7886 | 14.21 | 8.57 | 16.7 | 48.7 | 56.8 | 19.5 | 34.3 | 1051 | |
Rg7887 | 27.64 | 9.02 | 16.7 | 50.2 | 55.7 | 18.5 | 33.2 | 1303 | |
Rg7888 | 11.82 | 8.80 | 15.6 | 47.1 | 53.5 | 17.7 | 33.1 | 748 | |
Rg7889 | 11.01 | 9.07 | 16.4 | 48.1 | 53.0 | 18.1 | 34.1 | 369 | |
Rg7890 | 11.85 | 9.18 | 16.0 | 48.9 | 53.2 | 17.4 | 32.7 | 992 | |
Rg7891 | 8.24 | 9.86 | 17.2 | 50.7 | 51.4 | 17.4 | 33.9 | 519 | |
Rg7892 | 13.88 | 8.84 | 15.8 | 47.4 | 53.6 | 17.9 | 33.4 | 1175 | |
G2, M & 150 | Rg7893 | 10.71 | 8.90 | 15.2 | 46.2 | 51.9 | 17.1 | 32.9 | 1159 |
Rg7894 | 14.14 | 8.43 | 14.8 | 45.7 | 54.2 | 17.6 | 32.5 | 1068 | |
Rg7895 | 8.25 | 9.73 | 17.2 | 52.0 | 53.4 | 17.6 | 33.0 | 879 | |
Rg7896 | 12.03 | 9.22 | 16.2 | 49.8 | 54.0 | 17.5 | 32.4 | 1244 | |
Rg7897 | 8.52 | 8.51 | 15.1 | 45.1 | 53.0 | 17.7 | 33.4 | 809 | |
Rg7898 | 29.97 | 7.14 | 11.6 | 38.8 | 54.4 | 16.3 | 29.9 | 864 | |
Rg7899 | 9.31 | 9.20 | 16.5 | 50.5 | 54.9 | 18.0 | 32.7 | 1048 | |
Rg7900 | 12.22 | 9.57 | 16.0 | 49.4 | 51.6 | 16.8 | 32.5 | 943 | |
Rg7901 | 11.20 | 9.30 | 16.3 | 50.0 | 53.8 | 17.5 | 32.5 | 1009 | |
Rg7902 | 11.40 | 9.62 | 16.2 | 49.5 | 51.5 | 16.8 | 32.6 | 1438 | |
Rg7903 | 10.24 | 8.57 | 16.0 | 49.1 | 57.3 | 18.7 | 32.6 | 1013 | |
Rg7904 | 9.37 | 8.93 | 15.9 | 48.0 | 53.7 | 17.8 | 33.1 | 1085 |
M: Male.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Mean Platelet Volume | Reticulocyte Count | Neutrophils | Lymphocytes | Monocytes | Eosinophils | Basophils | Absolute Reticulocyte Count |
(MPV) | (Retic) | (Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (Retic) | ||
(fL) | (%) | (%) | (%) | (%) | (%) | (%) | (109 cells/L) | ||
G1, M & 0 | Rg7881 | 6.9 | 2.94 | 30.8 | 62.5 | 3.5 | 1.9 | 0.3 | 227.5 |
Rg7882 | 7.5 | 8.46 | 60.9 | 29.9 | 5.6 | 1.0 | 0.3 | 631.4 | |
Rg7883 | 6.9 | 1.86 | 25.8 | 67.5 | 3.1 | 0.7 | 0.6 | 166.7 | |
Rg7884 | 7.1 | 3.04 | 18.8 | 75.5 | 2.6 | 1.0 | 0.4 | 273.8 | |
Rg7885 | 7.3 | 2.73 | 29.5 | 65.0 | 3.1 | 0.6 | 0.5 | 249.3 | |
Rg7886 | 7.1 | 3.82 | 25.7 | 68.7 | 2.6 | 1.3 | 0.3 | 327.7 | |
Rg7887 | 7.3 | 1.85 | 46.5 | 48.7 | 2.8 | 0.9 | 0.4 | 166.9 | |
Rg7888 | 7.2 | 3.18 | 33.4 | 60.8 | 3.0 | 1.3 | 0.5 | 279.6 | |
Rg7889 | 7.7 | 2.44 | 44.2 | 50.5 | 1.7 | 2.4 | 0.6 | 221.2 | |
Rg7890 | 6.9 | 2.11 | 35.2 | 58.0 | 4.4 | 0.8 | 0.3 | 194.0 | |
Rg7891 | 7.3 | 1.37 | 33.2 | 62.3 | 2.4 | 1.0 | 0.3 | 135.3 | |
Rg7892 | 7.2 | 2.70 | 28.2 | 67.6 | 1.4 | 1.5 | 0.4 | 239.2 | |
G2, M & 150 | Rg7893 | 6.7 | 3.19 | 20.6 | 75.5 | 1.5 | 1.0 | 0.4 | 284.1 |
Rg7894 | 6.8 | 3.53 | 18.2 | 77.3 | 2.0 | 1.0 | 0.3 | 298.0 | |
Rg7895 | 7.2 | 2.56 | 28.0 | 67.5 | 1.8 | 1.6 | 0.5 | 248.9 | |
Rg7896 | 7.1 | 2.85 | 26.1 | 68.3 | 2.6 | 1.5 | 0.3 | 262.4 | |
Rg7897 | 7.0 | 3.98 | 18.3 | 77.5 | 1.6 | 1.2 | 0.4 | 338.2 | |
Rg7898 | 8.0 | 4.28 | 10.2 | 80.4 | 3.2 | 3.8 | 0.6 | 305.6 | |
Rg7899 | 6.9 | 3.63 | 29.9 | 65.1 | 2.2 | 1.2 | 0.4 | 334.3 | |
Rg7900 | 7.3 | 3.22 | 26.8 | 67.4 | 2.7 | 2.2 | 0.3 | 308.1 | |
Rg7901 | 6.9 | 2.95 | 33.7 | 62.8 | 1.5 | 0.9 | 0.4 | 274.8 | |
Rg7902 | 6.9 | 4.29 | 26.2 | 69.5 | 2.4 | 1.0 | 0.3 | 412.5 | |
Rg7903 | 7.7 | 3.45 | 21.5 | 75.6 | 0.7 | 0.7 | 0.3 | 295.9 | |
Rg7904 | 6.5 | 2.43 | 22.9 | 70.6 | 3.3 | 1.4 | 0.4 | 217.3 |
M: Male.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Absolute Neutrophils | Absolute Lymphocytes | Absolute Monocytes | Absolute Eosinophils | Absolute Basophils | Prothrombin Time | Activated Prothrombin Time |
(Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (PT) | (APTT) | ||
(103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (Seconds) | (Seconds) | ||
G1, M & 0 | Rg7881 | 2.89 | 5.87 | 0.33 | 0.18 | 0.02 | 20.1 | 20.5 |
Rg7882 | 17.75 | 8.72 | 1.64 | 0.29 | 0.08 | 24.7 | 16.4 | |
Rg7883 | 4.11 | 10.77 | 0.50 | 0.12 | 0.09 | 20.2 | 22.9 | |
Rg7884 | 2.17 | 8.73 | 0.30 | 0.12 | 0.04 | 20.5 | 29.5 | |
Rg7885 | 2.74 | 6.03 | 0.29 | 0.06 | 0.05 | 14.1 | 21.5 | |
Rg7886 | 3.66 | 9.76 | 0.37 | 0.19 | 0.05 | 20.0 | 13.9 | |
Rg7887 | 12.86 | 13.45 | 0.77 | 0.24 | 0.10 | 20.2 | 22.1 | |
Rg7888 | 3.95 | 7.18 | 0.35 | 0.15 | 0.06 | 18.9 | 12.4 | |
Rg7889 | 4.86 | 5.56 | 0.18 | 0.27 | 0.06 | 19.2 | 19.0 | |
Rg7890 | 4.17 | 6.88 | 0.53 | 0.09 | 0.04 | 20.9 | 13.4 | |
Rg7891 | 2.73 | 5.13 | 0.20 | 0.08 | 0.02 | 17.3 | 11.3 | |
Rg7892 | 3.91 | 9.38 | 0.20 | 0.21 | 0.06 | 17.2 | 19.5 | |
G2, M & 150 | Rg7893 | 2.20 | 8.09 | 0.16 | 0.11 | 0.04 | 17.5 | 18.2 |
Rg7894 | 2.57 | 10.92 | 0.29 | 0.14 | 0.05 | 20.3 | 12.7 | |
Rg7895 | 2.31 | 5.57 | 0.15 | 0.13 | 0.04 | 21.3 | 18.4 | |
Rg7896 | 3.14 | 8.22 | 0.31 | 0.18 | 0.04 | 24.2 | 27.0 | |
Rg7897 | 1.56 | 6.60 | 0.14 | 0.10 | 0.03 | 20.3 | 21.2 | |
Rg7898 | 3.06 | 24.09 | 0.95 | 1.15 | 0.17 | 24.8 | 30.2 | |
Rg7899 | 2.78 | 6.06 | 0.20 | 0.11 | 0.04 | 17.6 | 13.5 | |
Rg7900 | 3.27 | 8.24 | 0.33 | 0.27 | 0.04 | 17.8 | 25.8 | |
Rg7901 | 3.77 | 7.03 | 0.17 | 0.10 | 0.04 | 21.3 | 17.4 | |
Rg7902 | 2.98 | 7.93 | 0.27 | 0.11 | 0.04 | 17.0 | 14.8 | |
Rg7903 | 2.21 | 7.74 | 0.08 | 0.07 | 0.04 | 18.4 | 21.6 | |
Rg7904 | 2.14 | 6.62 | 0.31 | 0.14 | 0.04 | 22.0 | 21.7 |
M: Male.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Total Leucocyte Count | Total Erythrocyte Count | Hemoglobin | Haematocrit | Mean Corpuscular Volume | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin Concentration | Platelet Count |
(WBC) | (RBC) | (HGB) | (HCT) | (MCV) | (MCH) | (MCHC) | (PLT) | ||
(103 cells/µL) | (106 cells/µL) | (g/dL) | (%) | (fL) | (pg) | (g/dL) | (103 cells/µL) | ||
G3, M & 300 | Rg7905 | 11.12 | 8.82 | 15.7 | 48.4 | 54.9 | 17.9 | 32.5 | 1265 |
Rg7906 | 13.66 | 9.14 | 17.5 | 50.5 | 55.3 | 19.2 | 34.7 | 364 | |
Rg7907 | 11.87 | 8.33 | 14.7 | 46.5 | 55.9 | 17.7 | 31.7 | 1024 | |
Rg7908 | 11.01 | 9.08 | 15.5 | 48.7 | 53.7 | 17.1 | 31.8 | 1359 | |
Rg7909 | 10.55 | 8.44 | 15.3 | 47.2 | 55.9 | 18.2 | 32.5 | 1048 | |
Rg7910 | 11.16 | 7.71 | 15.2 | 46.0 | 59.6 | 19.7 | 33.1 | 1228 | |
Rg7911 | 9.20 | 9.09 | 16.0 | 49.1 | 54.0 | 17.6 | 32.6 | 932 | |
Rg7912 | 13.04 | 9.52 | 16.0 | 49.0 | 51.5 | 16.8 | 32.6 | 1099 | |
Rg7913 | 17.95 | 8.84 | 16.2 | 47.1 | 53.3 | 18.3 | 34.3 | 875 | |
Rg7914 | 12.22 | 9.13 | 15.9 | 47.8 | 52.4 | 17.4 | 33.2 | 893 | |
Rg7915 | 19.62 | 9.24 | 16.0 | 49.9 | 54.0 | 17.3 | 32.0 | 899 | |
Rg7916 | 16.00 | 8.65 | 15.9 | 44.9 | 51.9 | 18.4 | 35.5 | 659 | |
G4, M & 600 | Rg7917 | 10.38 | 8.40 | 16.6 | 50.7 | 60.4 | 19.8 | 32.7 | 1018 |
Rg7918 | 6.75 | 8.40 | 15.5 | 44.7 | 53.2 | 18.4 | 34.6 | 971 | |
Rg7919 | 9.99 | 9.56 | 16.7 | 51.2 | 53.6 | 17.4 | 32.5 | 1185 | |
Rg7920 | 8.65 | 8.88 | 15.1 | 45.8 | 51.5 | 17.0 | 32.9 | 1156 | |
Rg7921 | 12.29 | 9.72 | 16.8 | 52.1 | 53.6 | 17.3 | 32.3 | 711 | |
Rg7922 | 10.58 | 8.82 | 15.7 | 49.4 | 56.1 | 17.8 | 31.8 | 824 | |
Rg7923 | 12.51 | 9.43 | 17.2 | 51.7 | 54.8 | 18.3 | 33.3 | 694 | |
Rg7924 | 10.64 | 8.91 | 15.3 | 45.9 | 51.6 | 17.2 | 33.3 | 1436 | |
Rg7925 | 10.59 | 8.76 | 16.4 | 45.5 | 52.0 | 18.7 | 36.0 | 309 | |
Rg7926 | 16.68 | 9.21 | 16.0 | 48.0 | 52.2 | 17.4 | 33.3 | 852 | |
Rg7927 | 11.02 | 9.79 | 16.8 | 51.7 | 52.8 | 17.1 | 32.5 | 605 | |
Rg7928 | 10.12 | 9.87 | 16.4 | 50.3 | 51.0 | 16.7 | 32.7 | 688 |
M: Male.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Mean Platelet Volume | Reticulocyte Count | Neutrophils | Lymphocytes | Monocytes | Eosinophils | Basophils | Absolute Reticulocyte Count |
(MPV) | (Retic) | (Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (Retic) | ||
(fL) | (%) | (%) | (%) | (%) | (%) | (%) | (109 cells/L) | ||
G3, M & 300 | Rg7905 | 6.9 | 2.58 | 35.5 | 59.5 | 2.6 | 0.8 | 0.5 | 227.5 |
Rg7906 | 8.6 | 2.00 | 34.3 | 60.7 | 2.5 | 1.3 | 0.4 | 182.6 | |
Rg7907 | 7.8 | 2.98 | 25.0 | 69.4 | 3.5 | 0.8 | 0.3 | 248.2 | |
Rg7908 | 6.9 | 2.93 | 17.0 | 76.8 | 3.8 | 0.7 | 0.3 | 265.6 | |
Rg7909 | 7.3 | 3.56 | 38.8 | 55.9 | 1.7 | 2.6 | 0.3 | 300.7 | |
Rg7910 | 7.0 | 6.77 | 37.5 | 59.5 | 1.2 | 0.5 | 0.2 | 522.2 | |
Rg7911 | 7.3 | 2.18 | 23.4 | 72.2 | 1.3 | 1.8 | 0.3 | 198.6 | |
Rg7912 | 6.8 | 2.43 | 17.7 | 77.3 | 2.7 | 0.9 | 0.4 | 231.6 | |
Rg7913 | 6.9 | 2.65 | 29.3 | 67.2 | 1.5 | 0.8 | 0.4 | 234.6 | |
Rg7914 | 7.1 | 2.27 | 19.4 | 75.5 | 2.3 | 1.3 | 0.3 | 207.1 | |
Rg7915 | 7.1 | 3.25 | 18.9 | 75.0 | 3.1 | 0.9 | 0.6 | 300.5 | |
Rg7916 | 7.5 | 2.57 | 21.7 | 71.5 | 4.2 | 0.8 | 0.5 | 222.8 | |
G4, M & 600 | Rg7917 | 7.8 | 2.63 | 25.1 | 69.2 | 3.3 | 1.2 | 0.3 | 220.4 |
Rg7918 | 7.1 | 4.17 | 19.7 | 73.8 | 3.5 | 1.4 | 0.2 | 350.1 | |
Rg7919 | 7.3 | 1.22 | 20.7 | 73.0 | 4.2 | 1.0 | 0.3 | 116.7 | |
Rg7920 | 7.2 | 2.96 | 20.6 | 72.9 | 4.7 | 0.6 | 0.3 | 262.8 | |
Rg7921 | 7.0 | 4.09 | 20.1 | 74.7 | 2.1 | 1.6 | 0.3 | 397.5 | |
Rg7922 | 7.0 | 4.24 | 30.5 | 64.9 | 2.9 | 0.5 | 0.2 | 373.5 | |
Rg7923 | 6.9 | 1.75 | 28.2 | 67.1 | 2.2 | 0.8 | 0.3 | 165.3 | |
Rg7924 | 6.8 | 2.94 | 15.8 | 77.9 | 4.4 | 0.6 | 0.4 | 262.0 | |
Rg7925 | 8.6 | 7.40 | 34.6 | 61.1 | 1.1 | 1.7 | 0.5 | 648.7 | |
Rg7926 | 6.6 | 2.26 | 25.7 | 70.0 | 1.6 | 1.6 | 0.4 | 207.7 | |
Rg7927 | 7.2 | 2.96 | 24.8 | 68.3 | 2.9 | 0.9 | 0.6 | 289.4 | |
Rg7928 | 7.4 | 2.35 | 35.9 | 60.4 | 1.3 | 1.1 | 0.3 | 231.9 |
M: Male.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Absolute Neutrophils | Absolute Lymphocytes | Absolute Monocytes | Absolute Eosinophils | Absolute Basophils | Prothrombin Time | Activated Prothrombin Time |
(Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (PT) | (APTT) | ||
(103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (Seconds) | (Seconds) | ||
G3, M & 300 | Rg7905 | 3.95 | 6.62 | 0.29 | 0.09 | 0.05 | 29.0 | 25.6 |
Rg7906 | 4.69 | 8.29 | 0.34 | 0.18 | 0.06 | 23.9 | 26.7 | |
Rg7907 | 2.97 | 8.23 | 0.41 | 0.09 | 0.03 | 22.9 | 26.8 | |
Rg7908 | 1.87 | 8.45 | 0.41 | 0.08 | 0.04 | 21.4 | 15.2 | |
Rg7909 | 4.10 | 5.90 | 0.18 | 0.27 | 0.03 | 20.0 | 20.4 | |
Rg7910 | 4.18 | 6.64 | 0.14 | 0.06 | 0.02 | 20.0 | 19.5 | |
Rg7911 | 2.15 | 6.64 | 0.12 | 0.17 | 0.02 | 22.4 | 23.0 | |
Rg7912 | 2.31 | 10.08 | 0.35 | 0.12 | 0.06 | 22.0 | 28.2 | |
Rg7913 | 5.26 | 12.06 | 0.27 | 0.14 | 0.07 | 24.2 | 21.0 | |
Rg7914 | 2.38 | 9.22 | 0.28 | 0.16 | 0.03 | 26.2 | 13.1 | |
Rg7915 | 3.71 | 14.71 | 0.60 | 0.18 | 0.11 | 19.8 | 22.4 | |
Rg7916 | 3.47 | 11.45 | 0.67 | 0.14 | 0.09 | 23.5 | 23.7 | |
G4, M & 600 | Rg7917 | 2.61 | 7.19 | 0.35 | 0.13 | 0.03 | 18.0 | 18.3 |
Rg7918 | 1.33 | 4.98 | 0.24 | 0.10 | 0.01 | 22.9 | 14.4 | |
Rg7919 | 2.06 | 7.29 | 0.42 | 0.10 | 0.03 | 19.3 | 15.2 | |
Rg7920 | 1.78 | 6.30 | 0.41 | 0.05 | 0.03 | 21.3 | 16.0 | |
Rg7921 | 2.47 | 9.18 | 0.25 | 0.20 | 0.03 | 22.3 | 16.9 | |
Rg7922 | 3.23 | 6.87 | 0.31 | 0.06 | 0.02 | 24.7 | 17.8 | |
Rg7923 | 3.53 | 8.40 | 0.27 | 0.10 | 0.04 | 23.6 | 17.8 | |
Rg7924 | 1.68 | 8.28 | 0.47 | 0.06 | 0.04 | 22.8 | 21.7 | |
Rg7925 | 3.66 | 6.47 | 0.12 | 0.18 | 0.05 | 23.1 | 46.1 | |
Rg7926 | 4.28 | 11.68 | 0.26 | 0.26 | 0.06 | 20.6 | 11.5 | |
Rg7927 | 2.74 | 7.52 | 0.32 | 0.10 | 0.07 | 20.3 | 29.4 | |
Rg7928 | 3.63 | 6.12 | 0.13 | 0.12 | 0.03 | 23.6 | 18.0 |
M: Male.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Total Leucocyte Count | Total Erythrocyte Count | Hemoglobin | Haematocrit | Mean Corpuscular Volume | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin Concentration | Platelet Count |
(WBC) | (RBC) | (HGB) | (HCT) | (MCV) | (MCH) | (MCHC) | (PLT) | ||
(103 cells/µL) | (106 cells/µL) | (g/dL) | (%) | (fL) | (pg) | (g/dL) | (103 cells/µL) | ||
G1, F & 0 | Rg7929 | 10.60 | 8.19 | 15.7 | 47.5 | 58.0 | 19.2 | 33.2 | 1443 |
Rg7930 | 10.65 | 7.59 | 14.7 | 43.2 | 56.9 | 19.3 | 34.0 | 1233 | |
Rg7931 | 11.90 | 8.00 | 14.8 | 46.6 | 58.2 | 18.5 | 31.8 | 962 | |
Rg7932 | 9.57 | 7.51 | 15.3 | 46.6 | 62.1 | 20.4 | 32.9 | 897 | |
Rg7933 | 11.79 | 8.20 | 14.3 | 44.5 | 54.2 | 17.5 | 32.3 | 1134 | |
Rg7934 | 18.27 | 8.12 | 14.4 | 43.9 | 54.0 | 17.8 | 32.9 | 1130 | |
Rg7935 | 12.12 | 6.27 | 13.6 | 42.1 | 67.2 | 21.7 | 32.3 | 1478 | |
Rg7936 | 5.12 | 8.19 | 16.2 | 48.4 | 59.0 | 19.8 | 33.6 | 816 | |
Rg7937 | 12.05 | 7.88 | 15.7 | 44.8 | 56.9 | 19.9 | 35.0 | 913 | |
Rg7938 | 4.28 | 8.72 | 16.8 | 51.8 | 59.4 | 19.3 | 32.4 | 1053 | |
Rg7939 | 6.84 | 7.88 | 14.2 | 44.4 | 56.4 | 18.0 | 31.9 | 1136 | |
Rg7940 | 10.70 | 7.38 | 13.5 | 42.1 | 57.1 | 18.2 | 32.0 | 1071 | |
G2, F & 150 | Rg7941 | 3.86 | 7.55 | 15.7 | 47.2 | 62.6 | 20.8 | 33.2 | 764 |
Rg7942 | 7.43 | 7.92 | 15.1 | 44.4 | 56.1 | 19.0 | 34.0 | 975 | |
Rg7943 | 15.17 | 9.05 | 16.5 | 50.8 | 56.1 | 18.2 | 32.4 | 314 | |
Rg7944 | 5.17 | 7.21 | 14.1 | 44.6 | 61.8 | 19.5 | 31.5 | 1062 | |
Rg7945 | 7.93 | 8.49 | 15.6 | 46.3 | 54.5 | 18.4 | 33.7 | 1198 | |
Rg7946 | 9.57 | 7.51 | 14.5 | 45.4 | 60.5 | 19.3 | 31.9 | 573 | |
Rg7947 | 9.91 | 6.74 | 14.0 | 43.0 | 63.8 | 20.8 | 32.6 | 1277 | |
Rg7948 | 6.38 | 8.40 | 16.0 | 48.2 | 57.3 | 19.1 | 33.3 | 1041 | |
Rg7949 | 6.80 | 8.37 | 14.9 | 45.2 | 54.0 | 17.9 | 33.1 | 999 | |
Rg7950 | 13.60 | 8.20 | 15.1 | 45.5 | 55.5 | 18.4 | 33.1 | 1158 | |
Rg7951 | 13.47 | 6.53 | 12.9 | 40.2 | 61.5 | 19.8 | 32.1 | 924 | |
Rg7952 | 16.68 | 6.46 | 14.2 | 44.2 | 68.5 | 22.0 | 32.2 | 609 |
F: Female.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
& Dose (mg/kg body weight/day) | Animal No. | Mean Platelet Volume | Reticulocyte Count | Neutrophils | Lymphocytes | Monocytes | Eosinophils | Basophils | Absolute Reticulocyte Count |
(MPV) | (Retic) | (Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (Retic) | ||
(fL) | (%) | (%) | (%) | (%) | (%) | (%) | (109 cells/L) | ||
G1, F & 0 | Rg7929 | 7.2 | 2.90 | 33.2 | 54.6 | 4.9 | 5.3 | 0.3 | 237.7 |
Rg7930 | 7.5 | 9.91 | 27.3 | 67.8 | 1.3 | 2.2 | 0.3 | 752.5 | |
Rg7931 | 7.4 | 2.74 | 43.1 | 52.5 | 1.9 | 1.1 | 0.2 | 218.9 | |
Rg7932 | 7.8 | 3.76 | 36.4 | 55.3 | 5.1 | 1.1 | 0.2 | 282.1 | |
Rg7933 | 7.5 | 2.14 | 39.3 | 54.6 | 3.3 | 1.8 | 0.2 | 175.6 | |
Rg7934 | 8.1 | 2.17 | 28.2 | 67.6 | 1.7 | 0.8 | 0.2 | 176.1 | |
Rg7935 | 8.0 | 8.88 | 18.0 | 77.4 | 2.6 | 0.8 | 0.4 | 556.4 | |
Rg7936 | 7.2 | 4.42 | 37.9 | 48.6 | 8.8 | 1.5 | 0.4 | 362.1 | |
Rg7937 | 7.1 | 3.87 | 31.1 | 63.2 | 3.4 | 1.2 | 0.3 | 305.1 | |
Rg7938 | 7.7 | 2.82 | 36.8 | 50.5 | 8.2 | 1.6 | 0.2 | 245.6 | |
Rg7939 | 7.4 | 3.52 | 22.4 | 67.9 | 5.3 | 1.4 | 0.3 | 277.3 | |
Rg7940 | 7.0 | 3.59 | 27.7 | 65.5 | 3.7 | 1.2 | 0.2 | 264.9 | |
G2, F & 150 | Rg7941 | 8.6 | 2.37 | 33.7 | 51.1 | 7.3 | 4.9 | 0.2 | 178.9 |
Rg7942 | 7.5 | 2.60 | 22.8 | 71.1 | 3.3 | 1.8 | 0.2 | 206.1 | |
Rg7943 | 7.6 | 4.73 | 34.6 | 59.6 | 2.1 | 1.9 | 0.3 | 427.9 | |
Rg7944 | 7.7 | 0.00 | 21.6 | 71.3 | 4.3 | 0.9 | 0.2 | 0.0 | |
Rg7945 | 8.7 | 2.81 | 15.3 | 78.7 | 2.3 | 2.4 | 0.3 | 238.7 | |
Rg7946 | 7.9 | 4.52 | 28.6 | 63.7 | 5.2 | 1.3 | 0.3 | 339.4 | |
Rg7947 | 7.5 | 7.42 | 37.3 | 57.8 | 3.1 | 0.5 | 0.3 | 500.5 | |
Rg7948 | 7.2 | 3.12 | 29.7 | 63.6 | 3.8 | 1.3 | 0.2 | 262.3 | |
Rg7949 | 7.3 | 2.02 | 20.5 | 71.8 | 2.1 | 4.0 | 0.3 | 169.2 | |
Rg7950 | 7.4 | 3.30 | 34.2 | 59.0 | 3.8 | 1.2 | 0.3 | 270.7 | |
Rg7951 | 7.3 | 6.52 | 30.2 | 64.6 | 3.1 | 0.6 | 0.3 | 426.0 | |
Rg7952 | 8.6 | 10.56 | 38.7 | 55.3 | 2.5 | 1.9 | 0.3 | 682.2 |
F: Female.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
& Dose (mg/kg body weight/day) | Animal No. | Absolute Neutrophils | Absolute Lymphocytes | Absolute Monocytes | Absolute Eosinophils | Absolute Basophils | Prothrombin Time | Activated Prothrombin Time |
(Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (PT) | (APTT) | ||
(103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (Seconds) | (Seconds) | ||
G1, F & 0 | Rg7929 | 3.52 | 5.79 | 0.52 | 0.56 | 0.04 | 19.9 | 20.2 |
Rg7930 | 2.90 | 7.21 | 0.14 | 0.23 | 0.03 | 21.3 | 27.5 | |
Rg7931 | 5.13 | 6.25 | 0.23 | 0.13 | 0.02 | 22.0 | 20.4 | |
Rg7932 | 3.49 | 5.29 | 0.49 | 0.11 | 0.02 | 18.5 | 24.9 | |
Rg7933 | 4.63 | 6.43 | 0.39 | 0.21 | 0.02 | 23.6 | 20.3 | |
Rg7934 | 5.15 | 12.35 | 0.31 | 0.14 | 0.04 | 22.5 | 17.6 | |
Rg7935 | 2.18 | 9.39 | 0.32 | 0.09 | 0.04 | 22.0 | 29.3 | |
Rg7936 | 1.94 | 2.49 | 0.45 | 0.08 | 0.02 | 21.4 | 22.3 | |
Rg7937 | 3.74 | 7.61 | 0.41 | 0.15 | 0.03 | 23.9 | 26.4 | |
Rg7938 | 1.57 | 2.16 | 0.35 | 0.07 | 0.01 | 21.1 | 17.9 | |
Rg7939 | 1.53 | 4.65 | 0.36 | 0.10 | 0.02 | 21.2 | 20.0 | |
Rg7940 | 2.97 | 7.01 | 0.40 | 0.13 | 0.02 | 31.2 | 21.5 | |
G2, F & 150 | Rg7941 | 1.30 | 1.97 | 0.28 | 0.19 | 0.01 | 22.4 | 26.4 |
Rg7942 | 1.70 | 5.29 | 0.24 | 0.14 | 0.01 | 19.7 | 16.7 | |
Rg7943 | 5.25 | 9.05 | 0.33 | 0.28 | 0.04 | 26.5 | 20.0 | |
Rg7944 | 1.12 | 3.68 | 0.22 | 0.05 | 0.01 | 20.1 | 25.3 | |
Rg7945 | 1.21 | 6.25 | 0.18 | 0.19 | 0.03 | 18.4 | 15.1 | |
Rg7946 | 2.74 | 6.10 | 0.49 | 0.12 | 0.03 | 21.7 | 29.5 | |
Rg7947 | 3.69 | 5.72 | 0.30 | 0.05 | 0.03 | 21.6 | 31.6 | |
Rg7948 | 1.89 | 4.06 | 0.24 | 0.09 | 0.01 | 21.0 | 17.2 | |
Rg7949 | 1.39 | 4.88 | 0.14 | 0.27 | 0.02 | 17.6 | 11.9 | |
Rg7950 | 4.65 | 8.03 | 0.52 | 0.17 | 0.04 | 23.9 | 18.7 | |
Rg7951 | 4.07 | 8.71 | 0.42 | 0.08 | 0.05 | 28.4 | 21.1 | |
Rg7952 | 6.45 | 9.23 | 0.42 | 0.31 | 0.06 | 18.2 | 16.2 |
F: Female.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Total Leucocyte Count | Total Erythrocyte Count | Hemoglobin | Haematocrit | Mean Corpuscular Volume | Mean Corpuscular Hemoglobin | Mean Corpuscular Hemoglobin Concentration | Platelet Count |
(WBC) | (RBC) | (HGB) | (HCT) | (MCV) | (MCH) | (MCHC) | (PLT) | ||
(103 cells/µL) | (106 cells/µL) | (g/dL) | (%) | (fL) | (pg) | (g/dL) | (103 cells/µL) | ||
G3, F & 300 | Rg7953 | 11.24 | 8.08 | 13.8 | 42.3 | 52.3 | 17.1 | 32.6 | 1324 |
Rg7954 | 11.74 | 8.14 | 15.6 | 46.2 | 56.8 | 19.1 | 33.7 | 1021 | |
Rg7955 | 9.91 | 8.34 | 16.1 | 48.2 | 57.8 | 19.3 | 33.4 | 1057 | |
Rg7956 | 16.54 | 5.95 | 12.3 | 41.3 | 69.4 | 20.7 | 29.8 | 899 | |
Rg7957 | 9.20 | 6.50 | 14.2 | 43.0 | 66.2 | 21.8 | 33.0 | 1147 | |
Rg7958 | 13.57 | 7.52 | 14.4 | 45.8 | 59.3 | 18.7 | 31.5 | 911 | |
Rg7959 | 8.79 | 5.64 | 12.2 | 39.6 | 70.1 | 21.6 | 30.8 | 607 | |
Rg7960 | 5.58 | 7.40 | 15.1 | 45.7 | 61.8 | 20.4 | 33.0 | 985 | |
Rg7961 | 19.84 | 6.02 | 12.9 | 41.6 | 69.2 | 21.5 | 31.1 | 891 | |
Rg7962 | 7.68 | 8.28 | 14.7 | 44.7 | 53.9 | 17.8 | 33.0 | 1239 | |
Rg7963 | 10.61 | 7.41 | 13.4 | 41.7 | 56.3 | 18.1 | 32.2 | 1223 | |
Rg7964 | 17.00 | 7.30 | 15.1 | 45.6 | 62.4 | 20.7 | 33.2 | 897 | |
G4, F & 600 | Rg7965 | 13.42 | 7.85 | 16.7 | 50.4 | 64.2 | 21.3 | 33.2 | 794 |
Rg7966 | 10.04 | 8.58 | 16.3 | 50.7 | 59.1 | 19.0 | 32.2 | 1040 | |
Rg7967 | 7.05 | 7.99 | 15.1 | 45.0 | 56.2 | 18.9 | 33.5 | 1438 | |
Rg7968 | 17.02 | 8.11 | 15.4 | 46.5 | 57.3 | 18.9 | 33.1 | 1059 | |
Rg7969 | 14.81 | 7.92 | 15.8 | 49.5 | 62.5 | 19.9 | 31.9 | 1248 | |
Rg7970 | 7.46 | 7.37 | 14.8 | 46.4 | 63.0 | 20.1 | 31.9 | 1737 | |
Rg7971 | 12.64 | 7.56 | 15.2 | 46.0 | 60.9 | 20.1 | 33.0 | 1037 | |
Rg7972 | - | - | - | - | - | - | - | - | |
Rg7973 | 8.66 | 8.33 | 15.8 | 46.7 | 56.1 | 18.9 | 33.7 | 1043 | |
Rg7974 | 13.31 | 8.51 | 14.7 | 45.2 | 53.1 | 17.3 | 32.6 | 1400 | |
Rg7975 | 14.06 | 7.66 | 14.4 | 43.7 | 57.0 | 18.8 | 33.0 | 710 | |
Rg7976 | 10.21 | 7.26 | 15.2 | 46.9 | 64.7 | 20.9 | 32.4 | 794 |
F: Female.
Note: Animal number Rg7972 from group G4 was found dead on lactation day (LD) 5.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Mean Platelet Volume | Reticulocyte Count | Neutrophils | Lymphocytes | Monocytes | Eosinophils | Basophils | Absolute Reticulocyte Count |
(MPV) | (Retic) | (Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (Retic) | ||
(fL) | (%) | (%) | (%) | (%) | (%) | (%) | (109 cells/L) | ||
G3, F & 300 | Rg7953 | 7.9 | 4.03 | 26.4 | 69.1 | 2.0 | 1.5 | 0.3 | 325.9 |
Rg7954 | 7.1 | 3.74 | 31.3 | 63.3 | 3.1 | 1.1 | 0.3 | 304.6 | |
Rg7955 | 8.3 | 3.82 | 41.8 | 53.1 | 2.4 | 1.4 | 0.2 | 318.3 | |
Rg7956 | 7.6 | 11.09 | 29.0 | 65.0 | 3.6 | 0.6 | 0.2 | 659.5 | |
Rg7957 | 7.1 | 5.34 | 28.5 | 65.5 | 2.3 | 1.6 | 0.3 | 346.9 | |
Rg7958 | 8.6 | 2.71 | 41.9 | 42.8 | 4.4 | 0.2 | 0.4 | 209.0 | |
Rg7959 | 8.6 | 9.70 | 21.1 | 64.7 | 7.6 | 0.7 | 0.3 | 547.5 | |
Rg7960 | 7.9 | 4.49 | 39.5 | 53.6 | 1.8 | 1.2 | 0.2 | 332.2 | |
Rg7961 | 8.5 | 12.76 | 19.6 | 73.1 | 4.5 | 1.3 | 0.4 | 767.9 | |
Rg7962 | 6.8 | 12.49 | 24.2 | 68.4 | 3.8 | 2.5 | 0.2 | 170.4 | |
Rg7963 | 7.2 | 6.89 | 19.3 | 76.1 | 2.0 | 1.2 | 0.4 | 510.3 | |
Rg7964 | 7.6 | 2.91 | 47.6 | 46.4 | 4.0 | 0.9 | 0.3 | 212.2 | |
G4, F & 600 | Rg7965 | 7.6 | 4.77 | 21.3 | 71.2 | 3.4 | 3.0 | 0.3 | 374.8 |
Rg7966 | 7.6 | 4.19 | 27.6 | 67.9 | 2.2 | 0.6 | 0.3 | 359.2 | |
Rg7967 | 7.7 | 4.65 | 27.3 | 68.1 | 1.2 | 2.2 | 0.3 | 371.6 | |
Rg7968 | 6.9 | 2.05 | 39.2 | 54.0 | 4.6 | 0.2 | 0.3 | 166.3 | |
Rg7969 | 7.6 | 3.62 | 17.8 | 77.9 | 2.1 | 0.5 | 0.4 | 286.4 | |
Rg7970 | 7.5 | 3.11 | 23.8 | 71.4 | 1.8 | 1.4 | 0.4 | 229.3 | |
Rg7971 | 7.6 | 5.03 | 37.3 | 55.5 | 4.5 | 1.2 | 0.2 | 380.1 | |
Rg7972 | - | - | - | - | - | - | - | - | |
Rg7973 | 8.4 | 2.85 | 32.3 | 60.6 | 2.4 | 3.3 | 0.4 | 237.7 | |
Rg7974 | 7.9 | 1.06 | 13.1 | 82.7 | 1.9 | 1.1 | 0.3 | 89.9 | |
Rg7975 | 7.7 | 2.51 | 38.4 | 57.2 | 2.5 | 0.9 | 0.1 | 192.3 | |
Rg7976 | 7.9 | 4.50 | 15.6 | 81.1 | 1.4 | 0.6 | 0.3 | 326.5 |
F: Female.
Note: Animal number Rg7972 from group G4 was found dead on lactation day (LD) 5.
APPENDIX 11 (Contd…). INDIVIDUAL ANIMAL HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Absolute Neutrophils | Absolute Lymphocytes | Absolute Monocytes | Absolute Eosinophils | Absolute Basophils | Prothrombin Time | Activated Prothrombin Time |
(Neut) | (Lymph) | (Mono) | (Eos) | (Baso) | (PT) | (APTT) | ||
(103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (103 cells/µL) | (Seconds) | (Seconds) | ||
G3, F & 300 | Rg7953 | 2.97 | 7.77 | 0.23 | 0.17 | 0.04 | 21.4 | 33.9 |
Rg7954 | 3.68 | 7.44 | 0.36 | 0.13 | 0.03 | 21.0 | 18.4 | |
Rg7955 | 4.15 | 5.27 | 0.24 | 0.14 | 0.02 | 23.0 | 15.1 | |
Rg7956 | 4.80 | 10.75 | 0.60 | 0.09 | 0.04 | 18.7 | 30.1 | |
Rg7957 | 2.62 | 6.03 | 0.21 | 0.15 | 0.03 | 20.7 | 21.5 | |
Rg7958 | 5.69 | 5.81 | 0.60 | 0.03 | 0.05 | 17.2 | 19.5 | |
Rg7959 | 1.86 | 5.69 | 0.67 | 0.06 | 0.03 | 22.4 | 30.2 | |
Rg7960 | 2.20 | 2.99 | 0.10 | 0.07 | 0.01 | 17.4 | 15.5 | |
Rg7961 | 3.90 | 14.50 | 0.89 | 0.26 | 0.09 | 17.9 | 21.9 | |
Rg7962 | 1.86 | 5.25 | 0.29 | 0.19 | 0.02 | 15.1 | 19.4 | |
Rg7963 | 2.04 | 8.07 | 0.21 | 0.13 | 0.04 | 23.7 | 32.2 | |
Rg7964 | 8.09 | 7.88 | 0.68 | 0.15 | 0.04 | 20.7 | 18.4 | |
G4, F & 600 | Rg7965 | 2.86 | 9.56 | 0.46 | 0.40 | 0.04 | 22.5 | 16.8 |
Rg7966 | 2.77 | 6.82 | 0.22 | 0.07 | 0.03 | 21.4 | 19.2 | |
Rg7967 | 1.92 | 4.80 | 0.09 | 0.16 | 0.02 | 18.1 | 26.6 | |
Rg7968 | 6.68 | 9.19 | 0.78 | 0.04 | 0.05 | 20.8 | 21.1 | |
Rg7969 | 2.63 | 11.53 | 0.31 | 0.07 | 0.06 | 16.6 | 19.4 | |
Rg7970 | 1.78 | 5.33 | 0.13 | 0.11 | 0.03 | 21.4 | 19.6 | |
Rg7971 | 4.71 | 7.01 | 0.57 | 0.15 | 0.02 | 20.5 | 16.1 | |
Rg7972 | - | - | - | - | - | - | - | |
Rg7973 | 2.80 | 5.24 | 0.21 | 0.28 | 0.04 | 23.2 | 19.7 | |
Rg7974 | 1.74 | 11.01 | 0.26 | 0.14 | 0.03 | 22.3 | 20.1 | |
Rg7975 | 5.40 | 8.05 | 0.35 | 0.13 | 0.02 | 19.4 | 20.4 | |
Rg7976 | 1.59 | 8.28 | 0.14 | 0.06 | 0.03 | 19.1 | 29.3 |
F: Female.
Note: Animal number Rg7972 from group G4 was found dead on lactation day (LD) 5.
& Dose (mg/kg body weight/day) | Animal No. | Stages of the Oestrus Cyclicity on Experimental Day | ||||||||||||||||||||||||||||
Pre-mating period |
| Mating period |
| At termination | ||||||||||||||||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | |||||
G1 & 0 | Rg7929 | M | D | D | P | E | M | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | D | ||
Rg7930 | M | D | P | E | M | D | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | P | |||
Rg7931 | P | E | M | D | D | P | E | M | D | D | P | E | M | D | P | E+ | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7932 | E | M | D | D | P | E | M | D | P | E | M | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7933 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | D | |||
Rg7934 | D | P | E | M | D | P | E | M | D | D | P | E | M | D | P | E+ | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7935 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E+ | - | - | - | D | |||
Rg7936 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | D | |||
Rg7937 | M | D | P | E | M | D | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7938 | E | M | D | D | P | E | M | D | P | E | M | D | P | E | D | D | P | E+ | - | - | - | - | - | - | - | - | D | |||
Rg7939 | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7940 | D | P | E | M | D | D | P | E | M | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | D | |||
G2 & 150 | Rg7941 | E | M | D | D | P | E | M | D | P | E | M | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | M | ||
Rg7942 | D | P | E | M | D | D | P | E | M | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | P | |||
Rg7943 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | D | |||
Rg7944 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | E | |||
Rg7945 | M | D | D | P | E | M | D | P | E | M | D | D | P | E | M | D | P | E+ | - | - | - | - | - | - | - | - | P | |||
Rg7946 | M | D | D | P | E | M | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7947 | D | P | E | M | D | D | P | E | M | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | D | |||
Rg7948 | M | D | D | P | E | M | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7949NP | M | D | D | P | E | M | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | P | |||
Rg7950 | D | P | E | M | D | D | P | E | M | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7951 | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | P | E | E+ | D | |||
Rg7952 | D | P | E | M | D | P | E | M | D | D | P | E | M | D | D | P | E+ | - | - | - | - | - | - | - | - | - | D |
F: Female; P: Proestrus: E: Oestrus: M: Metestrus: D: Diestrus; -: Not applicable; NP: Non-pregnant.
APPENDIX 12 (Contd…). INDIVIDUAL ANIMAL VAGINAL SMEAR EXAMINATION RECORD FOR DETERMINATION OF
OESTRUS CYCLICITY
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Stages of the Oestrus Cyclicity on Experimental Day | |||||||||||||||||||||||||||||||||||
Pre-mating period |
| Mating period |
| At termination | |||||||||||||||||||||||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | |||||
G3 & 300 | Rg7953NP | M | D | D | P | E | M | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | E | ||
Rg7954 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7955 | D | P | E | M | D | D | P | E | M | D | P | E | M | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7956 | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7957NP | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | P | E | M | D | P | E+ | - | - | - | - | - | - | - | - | - | - | - | - | P | |||
Rg7958 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | D | D | P | E | M | D | P | E+ | - | - | M | |||
Rg7959 | D | P | E | D | D | P | E | M | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7960 | E | M | D | D | P | E | M | D | P | E | M | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | M | |||
Rg7961 | P | E | D | D | P | E | M | D | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7962 | M | D | D | P | E | M | D | P | E | M | D | D | P | E | D | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | M | |||
Rg7963TL | E | M | D | P | E | M | D | D | P | E | M | D | P | E | M | D | D | P | E | M | D | P | E+ | - | - | - | - | - | - | - | - | - | - | E | |||
Rg7964 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
G4 & 600 | Rg7965TL | M | D | D | P | E | M | D | P | E | M | D | D | P | E | D | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | P | ||
Rg7966 | P | E | M | D | D | P | E | M | D | P | E | M | D | P | E | M | D | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7967TL | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | P | |||
Rg7968 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | P | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7969 | D | P | E | M | D | D | P | E | M | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | M | |||
Rg7970 | E | M | D | D | P | E | M | D | P | E | M | D | P | E | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | M | |||
Rg7971 | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7972TL | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||
Rg7973NP | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | D | D | P | E | M | D | D | D | P | E+ | E | |||
Rg7974 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7975 | E | M | D | D | P | E | M | D | P | E | M | D | P | E | M | D | P | E+ | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | D | |||
Rg7976 | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | M | D | D | P | E | D | D | E | E+ | - | D |
F: Female; P: Proestrus: E: Oestrus: M: Metestrus: D: Diestrus; -: Not applicable; NP: Non-pregnant; TL: Total litter loss.
APPENDIX 12 (Contd…). INDIVIDUAL ANIMAL VAGINAL SMEAR EXAMINATION RECORD FOR DETERMINATION OF
OESTRUS CYCLICITY
Group, Sex & Dose weight/day) | Animal No. | No. of Oestrus Cycles | Length of Oestrus Cycle (Days) | Mean Oestrus Cycle Length (Days) | |||||||
Total | Regular | Irregular | Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | ||||
G1 & 0 | Rg7929 | 2 | 2 | 0 | 4 | 5 | - | - | - | 4.5 | |
Rg7930 | 2 | 2 | 0 | 5 | 5 | - | - | - | 5.0 | ||
Rg7931 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | 4.7 | ||
Rg7932 | 3 | 3 | 0 | 5 | 4 | 4 | - | - | 4.3 | ||
Rg7933 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | 4.7 | ||
Rg7934 | 3 | 3 | 0 | 4 | 5 | 4 | - | - | 4.3 | ||
Rg7935 | 4 | 4 | 0 | 5 | 5 | 5 | 5 | - | 5.0 | ||
Rg7936 | 3 | 3 | 0 | 5 | 5 | 5 | - | - | 5.0 | ||
Rg7937 | 2 | 2 | 0 | 5 | 5 | - | - | - | 5.0 | ||
Rg7938 | 4 | 4 | 0 | 5 | 4 | 4 | 4 | - | 4.3 | ||
Rg7939 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | 4.7 | ||
Rg7940 | 3 | 3 | 0 | 5 | 4 | 4 | - | - | 4.3 | ||
G2 & 150 | Rg7941 | 3 | 3 | 0 | 5 | 4 | 4 | - | - | 4.3 | |
Rg7942 | 3 | 3 | 0 | 5 | 4 | 4 | - | - | 4.3 | ||
Rg7943 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | 4.7 | ||
Rg7944 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | 4.7 | ||
Rg7945 | 3 | 3 | 0 | 4 | 5 | 4 | - | - | 4.3 | ||
Rg7946 | 2 | 2 | 0 | 4 | 5 | - | - | - | 4.5 | ||
Rg7947 | 3 | 3 | 0 | 5 | 4 | 5 | - | - | 4.7 | ||
Rg7948 | 2 | 2 | 0 | 4 | 5 | - | - | - | 4.5 | ||
Rg7949NP | 2 | 2 | 0 | 4 | 5 | - | - | - | 4.5 | ||
Rg7950 | 3 | 3 | 0 | 5 | 4 | 4 | - | - | 4.3 | ||
Rg7951 | 5 | 5 | 0 | 5 | 5 | 5 | 5 | 4 | 4.8 | ||
Rg7952 | 3 | 3 | 0 | 4 | 5 | 5 | - | - | 4.7 |
F: Female; -: Not applicable; NP: Non-pregnant.
APPENDIX 12 (Contd…). INDIVIDUAL ANIMAL VAGINAL SMEAR EXAMINATION RECORD FOR DETERMINATION OF
OESTRUS CYCLICITY
Group, Sex & Dose weight/day) | Animal No. | No. of Oestrus Cycles | Length of Oestrus Cycle (Days) | Mean Oestrus Cycle Length (Days) | ||||||||
Total | Regular | Irregular | Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | ||||
G3 & 300 | Rg7953NP | 2 | 2 | 0 | 4 | 5 | - | - | - | - | 4.5 | |
Rg7954 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | - | 4.7 | ||
Rg7955 | 3 | 2 | 1 | 5 | 4 | 3 | - | - | - | 4.0 | ||
Rg7956 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | - | 4.7 | ||
Rg7957NP | 4 | 4 | 0 | 5 | 5 | 4 | 4 | - | - | 4.5 | ||
Rg7958 | 6 | 6 | 0 | 5 | 5 | 5 | 5 | 4 | 4 | 4.7 | ||
Rg7959 | 3 | 3 | 0 | 4 | 4 | 4 | - | - | - | 4.0 | ||
Rg7960 | 3 | 3 | 0 | 5 | 4 | 4 | - | - | - | 4.3 | ||
Rg7961 | 3 | 3 | 0 | 4 | 5 | 5 | - | - | - | 4.7 | ||
Rg7962 | 4 | 4 | 0 | 4 | 5 | 4 | 5 | - | - | 4.5 | ||
Rg7963TL | 5 | 5 | 0 | 4 | 5 | 4 | 5 | 4 | - | 4.4 | ||
Rg7964 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | - | 4.7 | ||
G4 & 600 | Rg7965TL | 4 | 4 | 0 | 4 | 5 | 5 | 4 | - | - | 4.5 | |
Rg7966 | 4 | 4 | 0 | 5 | 4 | 4 | 5 | - | - | 4.5 | ||
Rg7967TL | 3 | 3 | 0 | 5 | 5 | 4 | - | - | - | 4.7 | ||
Rg7968 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | - | 4.7 | ||
Rg7969 | 4 | 4 | 0 | 5 | 4 | 5 | 4 | - | - | 4.5 | ||
Rg7970 | 3 | 3 | 0 | 5 | 4 | 4 | - | - | - | 4.3 | ||
Rg7971 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | - | 4.7 | ||
Rg7972TL | 3 | 3 | 0 | 5 | 5 | 4 | - | - | - | 4.7 | ||
Rg7973NP | 6 | 5 | 1 | 5 | 5 | 5 | 5 | 4 | 6 | 5.0 | ||
Rg7974 | 3 | 3 | 0 | 5 | 5 | 4 | - | - | - | 4.7 | ||
Rg7975 | 4 | 4 | 0 | 5 | 4 | 4 | 4 | - | - | 4.3 | ||
Rg7976 | 6 | 5 | 1 | 5 | 5 | 5 | 5 | 5 | 3 | 4.7 |
F: Female; -: Not applicable; NP: Non-pregnant; TL: Total litter loss.
Group & Dose | Dam No. | Delivery Record At birth | Sex Ratio (m/f) at Birth | Live Birth Index | |||||||||||||||
Litter Size (No.) | Live Pups (No.) | Dead Pups (No.) | Cannibalized Pups (No.) | ||||||||||||||||
Male | Female | Total | Male | Female | Total | Undetermined | Male | Female | Total | ||||||||||
G1 & 0 | Rg7929 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||
Rg7930 | 8 | 3 | 5 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 100.00 | ||||||
Rg7931 | 13 | 7 | 6 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.2 | 100.00 | ||||||
Rg7932 | 8 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | ||||||
Rg7933 | 11 | 9 | 2 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4.5 | 100.00 | ||||||
Rg7934 | 9 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | ||||||
Rg7935 | 13 | 7 | 6 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.2 | 100.00 | ||||||
Rg7936 | 12 | 6 | 6 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | ||||||
Rg7937 | 5 | 2 | 3 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | ||||||
Rg7938 | 17 | 10 | 7 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.4 | 100.00 | ||||||
Rg7939 | 13 | 8 | 5 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.6 | 100.00 | ||||||
Rg7940 | 8 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | ||||||
G2 & 150 | Rg7941 | 16 | 6 | 10 | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 100.00 | |||||
Rg7942 | 8 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | ||||||
Rg7943 | 10 | 6 | 3 | 9 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2.0 | 90.00 | ||||||
Rg7944 | 10 | 3 | 7 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.4 | 100.00 | ||||||
Rg7945 | 8 | 5 | 3 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.7 | 100.00 | ||||||
Rg7946 | 7 | 3 | 3 | 6 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1.0 | 85.71 | ||||||
Rg7947 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | ||||||
Rg7948 | 16 | 8 | 8 | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | ||||||
Rg7949NP | - | - | - | - | - | - | - | - | - | - | - | - | - | ||||||
Rg7950 | 4 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100.00 | ||||||
Rg7951 | 6 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | ||||||
Rg7952 | 12 | 6 | 6 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 |
m/f: Male/Female; NP: Non-pregnant; -: Not applicable; %: Percentage
APPENDIX 13 (Contd…). INDIVIDUAL DAM/LITTER DELIVERY AND LITTER OBSERVATIONS RECORD
& Dose | Dam No. | Delivery Record At birth | Sex Ratio (m/f) at Birth | Live Birth Index | |||||||||||||||
Litter Size (No.) | Live Pups (No.) | Dead Pups (No.) | Cannibalized Pups (No.) | ||||||||||||||||
Male | Female | Total | Male | Female | Total | Undetermined | Male | Female | Total | ||||||||||
G3 & 300 | Rg7953NP | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7954 | 4 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100.00 | ||||||
Rg7955 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | ||||||
Rg7956 | 13 | 7 | 6 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.2 | 100.00 | ||||||
Rg7957NP | - | - | - | - | - | - | - | - | - | - | - | - | - | ||||||
Rg7958 | 6 | 3 | 1 | 4 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 3.0 | 66.67 | ||||||
Rg7959 | 9 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | ||||||
Rg7960 | 13 | 8 | 4 | 12 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 2.0 | 92.31 | ||||||
Rg7961 | 11 | 5 | 6 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | ||||||
Rg7962 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | ||||||
Rg7963TL | 6 | 0 | 0 | 0 | 4 | 2 | 6 | 0 | 0 | 0 | 0 | - | 0.00 | ||||||
Rg7964 | 18 | 7 | 11 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 100.00 | ||||||
G4 & 600 | Rg7965TL | 3 | 1 | 0 | 1 | 0 | 2 | 2 | 0 | 0 | 0 | 0 | - | 33.33 | |||||
Rg7966 | 7 | 3 | 4 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | ||||||
Rg7967TL | 6 | 0 | 0 | 0 | 2 | 4 | 6 | 0 | 0 | 0 | 0 | - | 0.00 | ||||||
Rg7968 | 14 | 8 | 6 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.3 | 100.00 | ||||||
Rg7969 | 13 | 4 | 8 | 12 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0.5 | 92.31 | ||||||
Rg7970 | 10 | 4 | 6 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | ||||||
Rg7971 | 12 | 4 | 8 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.5 | 100.00 | ||||||
Rg7972TL | 15 | 3 | 8 | 11 | 2 | 2 | 4 | 0 | 0 | 0 | 0 | 0.4 | 73.33 | ||||||
Rg7973NP | - | - | - | - | - | - | - | - | - | - | - | - | - | ||||||
Rg7974 | 19 | 8 | 10 | 18 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0.8 | 94.74 | ||||||
Rg7975 | 14 | 6 | 8 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | ||||||
Rg7976 | 9 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 |
m/f: Male/Female; NP: Non-pregnant; TL: Total litter loss; -: Not applicable; %: Percentage.
APPENDIX 13 (Contd…). INDIVIDUAL DAM/LITTER DELIVERY AND LITTER OBSERVATIONS RECORD
& Dose weight/day) | Dam No. | LD 1 to 4 | Sex Ratio (m/f) on LD 4 | Pup Survival Index (%) [LD 1 to 4] | ||||||||||||
Live Pups (No.) | Dead Pups (No.) | Cannibalized Pups (No.) | ||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||
G1 & 0 | Rg7929 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | ||||
Rg7930 | 3 | 5 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 100.00 | |||||
Rg7931 | 7 | 6 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 1.2 | 100.00 | |||||
Rg7932 | 3 | 3 | 6 | 0 | 1 | 1 | 1 | 0 | 1 | 1.0 | 75.00 | |||||
Rg7933 | 9 | 2 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 4.5 | 100.00 | |||||
Rg7934 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||
Rg7935 | 7 | 6 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 1.2 | 100.00 | |||||
Rg7936 | 6 | 6 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7937 | 2 | 3 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | |||||
Rg7938 | 10 | 7 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 1.4 | 100.00 | |||||
Rg7939 | 8 | 5 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 1.6 | 100.00 | |||||
Rg7940 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
G2 & 150 | Rg7941 | 6 | 10 | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 100.00 | ||||
Rg7942 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7943 | 6 | 3 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 100.00 | |||||
Rg7944 | 3 | 7 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.4 | 100.00 | |||||
Rg7945 | 5 | 3 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.7 | 100.00 | |||||
Rg7946 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7947 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||
Rg7948 | 8 | 8 | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7949NP | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7950 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100.00 | |||||
Rg7951 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7952 | 6 | 6 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 |
m/f: Male/Female; LD: Lactation Day; NP: Non-pregnant; -: Not applicable; %: Percentage.
APPENDIX 13 (Contd…). INDIVIDUAL DAM/LITTER DELIVERY AND LITTER OBSERVATIONS RECORD
Group & Dose weight/day) | Dam No. | LD 1 to 4 | Sex Ratio (m/f) on LD 4 | Pup Survival Index (%) [LD 1 to 4] | ||||||||||||
Live Pups (No.) | Dead Pups (No.) | Cannibalized Pups (No.) | ||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||
G3 & 300 | Rg7953NP | - | - | - | - | - | - | - | - | - | - | - | ||||
Rg7954 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100.00 | |||||
Rg7955 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||
Rg7956 | 7 | 6 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 1.2 | 100.00 | |||||
Rg7957NP | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7958 | 3 | 1 | 4 | 1 | 1 | 2 | 0 | 0 | 0 | 3.0 | 50.00 | |||||
Rg7959 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||
Rg7960 | 7 | 4 | 11 | 1 | 0 | 1 | 0 | 0 | 0 | 1.8 | 91.67 | |||||
Rg7961 | 5 | 6 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||
Rg7962 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||
Rg7963TL | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7964 | 7 | 10 | 17 | 0 | 1 | 1 | 0 | 0 | 0 | 0.7 | 94.44 | |||||
G4 & 600 | Rg7965TL | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | - | 0.00 | ||||
Rg7966 | 3 | 4 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||
Rg7967TL | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7968 | 8 | 6 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 1.3 | 100.00 | |||||
Rg7969 | 3 | 7 | 10 | 1 | 1 | 2 | 0 | 0 | 0 | 0.4 | 83.33 | |||||
Rg7970 | 4 | 6 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | |||||
Rg7971 | 4 | 8 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0.5 | 100.00 | |||||
Rg7972TL | 0 | 0 | 0 | 3 | 8 | 11 | 0 | 0 | 0 | - | 0.00 | |||||
Rg7973NP | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7974 | 7 | 10 | 17 | 1 | 0 | 1 | 0 | 0 | 0 | 0.7 | 94.44 | |||||
Rg7975 | 6 | 8 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||
Rg7976 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 |
m/f: Male/Female; LD: Lactation Day; NP: Non-pregnant; TL: Total litter loss; -: Not applicable; %: Percentage.
APPENDIX 13 (Contd…). INDIVIDUAL DAM/LITTER DELIVERY AND LITTER OBSERVATIONS RECORD
Group & Dose | Dam No. | Pups Sacrificed for Litter Standardization / Hormonal analysis (No.) |
| Live Pups (No.) on LD 4 after Litter Standardization / Hormonal analysis (No.) |
| LD 5 to 7 |
| Sex Ratio (m/f) on LD 7 |
| Pup Survival Index (%) [LD 5 to 7] | ||||||||||||||
Live Pups (No.) | Dead Pups (No.) |
| Cannibalized (No.) | |||||||||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||||
G1 & 0 | Rg7929 | 0 | 0 | 0 | 6 | 4 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | ||||||
Rg7930 | 0 | 0 | 0 | 3 | 5 | 8 | 3 | 5 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 100.00 | |||||||
Rg7931 | 0 | 2 | 2 | 7 | 4 | 11 | 7 | 4 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 1.8 | 100.00 | |||||||
Rg7932 | 0
| 0 | 0 | 3 | 3 | 6 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||||
Rg7933 | 0 | 1 | 1 | 9 | 1 | 10 | 9 | 1 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 9.0 | 100.00 | |||||||
Rg7934 | 0 | 0 | 0 | 4 | 5 | 9 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||||
Rg7935 | 0 | 2 | 2 | 7 | 4 | 11 | 7 | 4 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 1.8 | 100.00 | |||||||
Rg7936 | 0 | 2 | 2 | 6 | 4 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||||
Rg7937 | 0 | 0 | 0 | 2 | 3 | 5 | 2 | 3 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | |||||||
Rg7938 | 0 | 2 | 2 | 10 | 5 | 15 | 10 | 5 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 100.00 | |||||||
Rg7939 | 0 | 2 | 2 | 8 | 3 | 11 | 8 | 3 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 2.7 | 100.00 | |||||||
Rg7940 | 0 | 0 | 0 | 4 | 4 | 8 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||||
G2 & 150 | Rg7941 | 0 | 2 | 2 | 6 | 8 | 14 | 6 | 8 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | ||||||
Rg7942 | 0 | 0 | 0 | 4 | 4 | 8 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||||
Rg7943 | 0 | 0 | 0 | 6 | 3 | 9 | 6 | 3 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 100.00 | |||||||
Rg7944 | 0 | 0 | 0 | 3 | 7 | 10 | 3 | 7 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.4 | 100.00 | |||||||
Rg7945 | 0 | 0 | 0 | 5 | 3 | 8 | 5 | 3 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.7 | 100.00 | |||||||
Rg7946 | 0 | 0 | 0 | 3 | 3 | 6 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||||
Rg7947 | 0 | 0 | 0 | 6 | 4 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||||
Rg7948 | 0 | 2 | 2 | 8 | 6 | 14 | 8 | 6 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 1.3 | 100.00 | |||||||
Rg7949NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||||
Rg7950 | 0 | 0 | 0 | 4 | 0 | 4 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100.00 | |||||||
Rg7951 | 0 | 0 | 0 | 3 | 3 | 6 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||||
Rg7952 | 0 | 2 | 2 | 6 | 4 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 |
m/f: Male/Female; LD: Lactation Day; NP: Non-pregnant; -: Not applicable; %: Percentage.
APPENDIX 13 (Contd…). INDIVIDUAL DAM/LITTER DELIVERY AND LITTER OBSERVATIONS RECORD
Group & Dose | Dam No.. | Pups Sacrificed for Litter Standardization / Hormonal analysis (No.) |
| Live Pups (No.) on LD 4 after Litter Standardization / Hormonal analysis (No.) |
| LD 5 to 7 |
| Sex Ratio (m/f) on LD 7 |
| Pup Survival Index (%) [LD 5 to 7] | ||||||||||||||
Live Pups (No.) |
| Dead Pups (No.) |
| Cannibalized (No.) | ||||||||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||||
G3 & 300 | Rg7953NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | ||||||
Rg7954 | 0 | 0 | 0 | 4 | 0 | 4 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100.00 | |||||||
Rg7955 | 0 | 0 | 0 | 6 | 4 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||||
Rg7956 | 0 | 2 | 2 | 7 | 4 | 11 | 7 | 4 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 1.8 | 100.00 | |||||||
Rg7957NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||||
Rg7958 | 0 | 0 | 0 | 3 | 1 | 4 | 3 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 3.0 | 100.00 | |||||||
Rg7959 | 0 | 0 | 0 | 4 | 5 | 9 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||||
Rg7960 | 0 | 1 | 1 | 7 | 3 | 10 | 7 | 3 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 2.3 | 100.00 | |||||||
Rg7961 | 0 | 1 | 1 | 5 | 5 | 10 | 5 | 5 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||||
Rg7962 | 0 | 0 | 0 | 6 | 4 | 10 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||||
Rg7963TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||||
Rg7964 | 0 | 2 | 2 | 7 | 8 | 15 | 7 | 8 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0.9 | 100.00 | |||||||
G4 & 600 | Rg7965TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | ||||||
Rg7966 | 0 | 0 | 0 | 3 | 4 | 7 | 3 | 4 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||||
Rg7967TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||||
Rg7968 | 0 | 2 | 2 | 8 | 4 | 12 | 8 | 4 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 100.00 | |||||||
Rg7969 | 0 | 0 | 0 | 3 | 7 | 10 | 3 | 7 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.4 | 100.00 | |||||||
Rg7970 | 0 | 0 | 0 | 4 | 6 | 10 | 4 | 6 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | |||||||
Rg7971 | 0 | 2 | 2 | 4 | 6 | 10 | 4 | 6 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | |||||||
Rg7972TL | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||||
Rg7973NP | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||||
Rg7974 | 0 | 2 | 2 | 7 | 8 | 15 | 7 | 8 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0.9 | 100.00 | |||||||
Rg7975 | 0 | 2 | 2 | 6 | 6 | 12 | 6 | 6 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||||
Rg7976 | 0 | 0 | 0 | 4 | 5 | 9 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 |
m/f: Male/Female; LD: Lactation Day; NP: Non-pregnant; TL: Total litter loss; -: Not applicable; %: Percentage.
APPENDIX 13 (Contd…). INDIVIDUAL DAM/LITTER DELIVERY AND LITTER OBSERVATIONS RECORD
& Dose weight/day) | Dam No. | LD 8 to 13 | Sex Ratio (m/f) on LD 13 | Pup Survival Index (%) [LD 8 to 13] | ||||||||||||
Live Pups (No.) | Dead Pups (No.) | Cannibalized (No.) | ||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||
G1 & 0 | Rg7929 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | ||||
Rg7930 | 3 | 5 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0.6 | 100.00 | |||||
Rg7931 | 7 | 4 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 1.8 | 100.00 | |||||
Rg7932 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7933 | 9 | 1 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 9.0 | 100.00 | |||||
Rg7934 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||
Rg7935 | 7 | 4 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 1.8 | 100.00 | |||||
Rg7936 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||
Rg7937 | 2 | 3 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | |||||
Rg7938 | 10 | 5 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 100.00 | |||||
Rg7939 | 8 | 3 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 2.7 | 100.00 | |||||
Rg7940 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
G2 & 150 | Rg7941 | 6 | 8 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | ||||
Rg7942 | 4 | 4 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7943 | 6 | 3 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 100.00 | |||||
Rg7944 | 3 | 7 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.4 | 100.00 | |||||
Rg7945 | 5 | 3 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 1.7 | 100.00 | |||||
Rg7946 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7947 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||
Rg7948 | 8 | 6 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 1.3 | 100.00 | |||||
Rg7949NP | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7950 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100.00 | |||||
Rg7951 | 3 | 3 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7952 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 |
m/f: Male/Female; LD: Lactation Day; NP: Non-pregnant; -: Not applicable; %: Percentage.
APPENDIX 13 (Contd…). INDIVIDUAL DAM/LITTER DELIVERY AND LITTER OBSERVATIONS RECORD
& Dose weight/day) | Dam No. | LD 8 to 13 | Sex Ratio (m/f) on LD 13 | Pup Survival Index (%) [LD 8 to 13] | ||||||||||||
Live Pups (No.) | Dead Pups (No.) | Cannibalized (No.) | ||||||||||||||
Male | Female | Total | Male | Female | Total | Male | Female | Total | ||||||||
G3 & 300 | Rg7953NP | - | - | - | - | - | - | - | - | - | - | - | ||||
Rg7954 | 4 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100.00 | |||||
Rg7955 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||
Rg7956 | 7 | 4 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 1.8 | 100.00 | |||||
Rg7957NP | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7958 | 3 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 3.0 | 100.00 | |||||
Rg7959 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||
Rg7960 | 7 | 3 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 2.3 | 100.00 | |||||
Rg7961 | 5 | 5 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7962 | 6 | 4 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 1.5 | 100.00 | |||||
Rg7963TL | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7964 | 7 | 8 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0.9 | 100.00 | |||||
G4 & 600 | Rg7965TL | - | - | - | - | - | - | - | - | - | - | - | ||||
Rg7966 | 3 | 4 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 | |||||
Rg7967TL | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7968 | 8 | 4 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 100.00 | |||||
Rg7969 | 3 | 7 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.4 | 100.00 | |||||
Rg7970 | 4 | 6 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | |||||
Rg7971 | 4 | 6 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0.7 | 100.00 | |||||
Rg7972TL | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7973NP | - | - | - | - | - | - | - | - | - | - | - | |||||
Rg7974 | 7 | 8 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0.9 | 100.00 | |||||
Rg7975 | 6 | 6 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 1.0 | 100.00 | |||||
Rg7976 | 4 | 5 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 100.00 |
m/f: Male/Female; LD: Lactation Day; NP: Non-pregnant; TL: Total litter loss; -: Not applicable; %: Percentage.
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Initiation of Cohabitation (Date) | Confirmation of Mating (Date) | Status of Mating (Evident of mating or not-mated) | Capability of Impregnating a Female (Capable/In-capable) | |
G1, M & 0 | Rg7881 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7882 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | ||
Rg7883 | 3-May-2022 | 5-May-2022 | Evident of mating | Capable | ||
Rg7884 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | ||
Rg7885 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | ||
Rg7886 | 3-May-2022 | 5-May-2022 | Evident of mating | Capable | ||
Rg7887 | 3-May-2022 | 12-May-2022 | Evident of mating | Capable | ||
Rg7888 | 3-May-2022 | 8-May-2022 | Evident of mating | Capable | ||
Rg7889 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | ||
Rg7890 | 3-May-2022 | 7-May-2022 | Evident of mating | Capable | ||
Rg7891 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | ||
Rg7892 | 3-May-2022 | 5-May-2022 | Evident of mating | Capable | ||
G2, M & 150 | Rg7893 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7894 | 3-May-2022 | 5-May-2022 | Evident of mating | Capable | ||
Rg7895 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | ||
Rg7896 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | ||
Rg7897 | 3-May-2022 | 7-May-2022 | Evident of mating | Capable | ||
Rg7898 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | ||
Rg7899 | 3-May-2022 | 7-May-2022 | Evident of mating | Capable | ||
Rg7900 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | ||
Rg7901 | 3-May-2022 | 4-May-2022 | Evident of mating | In-capable | ||
Rg7902 | 3-May-2022 | 5-May-2022 | Evident of mating | Capable | ||
Rg7903 | 3-May-2022 | 15-May-2022 | Evident of mating | Capable | ||
Rg7904 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable |
M: Male.
APPENDIX 14 (Contd…). INDIVIDUAL ANIMAL REPRODUCTIVE PERFORMANCE RECORD
Group, Sex & Dose weight/day) | Animal No. | Initiation of Cohabitation (Date) | Confirmation of Mating (Date) | Status of Mating (Evident of mating or not-mated) | Capability of Impregnating a Female (Capable/In-capable) |
G3, M & 300 | Rg7905 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable |
Rg7906 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | |
Rg7907 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7908 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7909 | 3-May-2022 | 10-May-2022 | Evident of mating | In-capable | |
Rg7910 | 3-May-2022 | - | - | In-capable | |
Rg7911 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7912 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7913 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | |
Rg7914 | 3-May-2022 | 13-May-2022 | Evident of mating | Capable | |
Rg7915 | 3-May-2022 | 12-May-2022 | Evident of mating | Capable | |
Rg7916 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | |
G4, M & 600 | Rg7917 | 3-May-2022 | 12-May-2022 | Evident of mating | Capable |
Rg7918 | 3-May-2022 | 10-May-2022 | Evident of mating | Capable | |
Rg7919 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | |
Rg7920 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | |
Rg7921 | 3-May-2022 | 10-May-2022 | Evident of mating | Capable | |
Rg7922 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7923 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7924 | 3-May-2022 | 4-May-2022 | Evident of mating | Capable | |
Rg7925 | 3-May-2022 | - | - | In-capable | |
Rg7926 | 3-May-2022 | 6-May-2022 | Evident of mating | Capable | |
Rg7927 | 3-May-2022 | 7-May-2022 | Evident of mating | Capable | |
Rg7928 | 3-May-2022 | - | - | In-capable |
APPENDIX 14 (Contd…). INDIVIDUAL ANIMAL REPRODUCTIVE PERFORMANCE RECORD
Group, Sex & Dose weight/day) | Animal No. | Initiation of Cohabitation (Date) | Confirmation of Mating (Date) | Pre-Coital Interval / Copulatory Interval | Parturition (Date) | Gestation Length (Days) | |
G1, F & 0 | Rg7929 | 3-May-2022 | 4-May-2022 | 1 |
| 26-May-22 | 22 |
Rg7930 | 3-May-2022 | 4-May-2022 | 1 | 27-May-22 | 23 | ||
Rg7931 | 3-May-2022 | 5-May-2022 | 2 | 27-May-22 | 22 | ||
Rg7932 | 3-May-2022 | 4-May-2022 | 1 | 26-May-22 | 22 | ||
Rg7933 | 3-May-2022 | 6-May-2022 | 3 | 27-May-22 | 21 | ||
Rg7934 | 3-May-2022 | 5-May-2022 | 2 | 27-May-22 | 22 | ||
Rg7935 | 3-May-2022 | 12-May-2022 | 9 | 03-Jun-22 | 22 | ||
Rg7936 | 3-May-2022 | 8-May-2022 | 5 | 30-May-22 | 22 | ||
Rg7937 | 3-May-2022 | 4-May-2022 | 1 | 27-May-22 | 23 | ||
Rg7938 | 3-May-2022 | 7-May-2022 | 4 | 28-May-22 | 21 | ||
Rg7939 | 3-May-2022 | 4-May-2022 | 1 | 26-May-22 | 22 | ||
Rg7940 | 3-May-2022 | 5-May-2022 | 2 | 27-May-22 | 22 | ||
G2, F & 150 | Rg7941 | 3-May-2022 | 4-May-2022 | 1 |
| 26-May-22 | 22 |
Rg7942 | 3-May-2022 | 5-May-2022 | 2 | 28-May-22 | 23 | ||
Rg7943 | 3-May-2022 | 6-May-2022 | 3 | 27-May-22 | 21 | ||
Rg7944 | 3-May-2022 | 6-May-2022 | 3 | 28-May-22 | 22 | ||
Rg7945 | 3-May-2022 | 7-May-2022 | 4 | 29-May-22 | 22 | ||
Rg7946 | 3-May-2022 | 4-May-2022 | 1 | 27-May-22 | 23 | ||
Rg7947 | 3-May-2022 | 7-May-2022 | 4 | 30-May-22 | 23 | ||
Rg7948 | 3-May-2022 | 4-May-2022 | 1 | 26-May-22 | 22 | ||
Rg7949NP | 3-May-2022 | 4-May-2022 | 1 | - | - | ||
Rg7950 | 3-May-2022 | 5-May-2022 | 2 | 27-May-22 | 22 | ||
Rg7951 | 3-May-2022 | 15-May-2022 | 12 | 06-Jun-22 | 22 | ||
Rg7952 | 3-May-2022 | 6-May-2022 | 3 | 29-May-22 | 23 |
F: Female; NP: Non-pregnant; -: Not applicable.
APPENDIX 14 (Contd…). INDIVIDUAL ANIMAL REPRODUCTIVE PERFORMANCE RECORD
Group, Sex & Dose weight/day) | Animal No. | Initiation of Cohabitation (Date) | Cohabitation with Proven Male (Date) | Proven Male No. | Confirmation of Mating (Date) | Pre-Coital Interval / Copulatory Interval | Parturition (Date) | Gestation Length (Days) | |
G3, F & 300 | Rg7953NP | 3-May-2022 | - | - | 4-May-2022 | 1 |
| - | - |
Rg7954 | 3-May-2022 | - | - | 6-May-2022 | 3 | 27-May-22 | 21 | ||
Rg7955 | 3-May-2022 | - | - | 4-May-2022 | 1 | 26-May-22 | 22 | ||
Rg7956 | 3-May-2022 | - | - | 4-May-2022 | 1 | 27-May-22 | 23 | ||
Rg7957NP | 3-May-2022 | - | - | 10-May-2022 | 7 | - | - | ||
Rg7958 | 3-May-2022 | 17-May-2022 | Rg7905 | 20-May-2022 | 17 | 11-Jun-22 | 22 | ||
Rg7959 | 3-May-2022 | - | - | 4-May-2022 | 1 | 27-May-22 | 23 | ||
Rg7960 | 3-May-2022 | - | - | 4-May-2022 | 1 | 26-May-22 | 22 | ||
Rg7961 | 3-May-2022 | - | - | 6-May-2022 | 3 | 29-May-22 | 23 | ||
Rg7962 | 3-May-2022 | - | - | 13-May-2022 | 10 | 05-Jun-22 | 23 | ||
Rg7963TL | 3-May-2022 | - | - | 12-May-2022 | 9 | 03-Jun-22 | 22 | ||
Rg7964 | 3-May-2022 | - | - | 6-May-2022 | 3 | 27-May-22 | 21 | ||
G4, F & 600 | Rg7965TL | 3-May-2022 | - | - | 12-May-2022 | 9 |
| 03-Jun-22 | 22 |
Rg7966 | 3-May-2022 | - | - | 10-May-2022 | 7 | 02-Jun-22 | 23 | ||
Rg7967TL | 3-May-2022 | - | - | 6-May-2022 | 3 | 29-May-22 | 23 | ||
Rg7968 | 3-May-2022 | - | - | 6-May-2022 | 3 | 27-May-22 | 21 | ||
Rg7969 | 3-May-2022 | - | - | 10-May-2022 | 7 | 02-Jun-22 | 23 | ||
Rg7970 | 3-May-2022 | - | - | 4-May-2022 | 1 | 27-May-22 | 23 | ||
Rg7971 | 3-May-2022 | - | - | 4-May-2022 | 1 | 26-May-22 | 22 | ||
Rg7972TL | 3-May-2022 | - | - | 4-May-2022 | 1 | 26-May-22 | 22 | ||
Rg7973NP | 3-May-2022 | 17-May-2022 | Rg7922 | 22-May-2022 | 19 | - | - | ||
Rg7974 | 3-May-2022 | - | - | 6-May-2022 | 3 | 28-May-22 | 22 | ||
Rg7975 | 3-May-2022 | - | - | 7-May-2022 | 4 | 29-May-22 | 22 | ||
Rg7976 | 3-May-2022 | 17-May-2022 | Rg7923 | 21-May-2022 | 18 | 11-Jun-22 | 21 |
F: Female; NP: Non-pregnant; TL: Total litter loss; -: Not applicable.
APPENDIX 14 (Contd…). INDIVIDUAL ANIMAL REPRODUCTIVE PERFORMANCE RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Status of Mating (Evident of mating or not-mated) | Status of Fertility (Fertile or In-Fertile) - with evidence of implantations | Status of Pregnancy (Pregnant/Non-pregnant/ Dam with total implantation loss) | Gestation Status (with live born pups/without live born pups/non-pregnant) | Status of Parturition (Littered/ Not Littered/ Non-pregnant) | |
G1, F & 0 | Rg7929 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | |
Rg7930 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7931 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7932 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7933 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7934 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7935 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7936 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7937 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7938 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7939 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7940 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
G2, F & 150 | Rg7941 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | |
Rg7942 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7943 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7944 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7945 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7946 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7947 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7948 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7949 | Evident of mating | In-Fertile | Non-pregnant | Non-pregnant | Non-pregnant | ||
Rg7950 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7951 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7952 | Evident of mating | Fertile | Pregnant | with live born pups | Littered |
F: Female.
APPENDIX 14 (Contd…). INDIVIDUAL ANIMAL REPRODUCTIVE PERFORMANCE RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Status of Mating (Evident of mating or not-mated) | Status of Fertility (Fertile or In-Fertile) - with evidence of implantations | Status of Pregnancy (Pregnant/Non-pregnant/ Dam with total implantation loss) | Gestation Status (with live born pups/without live born pups/non-pregnant) | Status of Parturition (Littered/ Not Littered/ Non-pregnant) | |
G3, F & 300 | Rg7953 | Evident of mating | In-Fertile | Non-pregnant | Non-pregnant | Non-pregnant | |
Rg7954 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7955 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7956 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7957 | Evident of mating | In-Fertile | Non-pregnant | Non-pregnant | Non-pregnant | ||
Rg7958 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7959 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7960 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7961 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7962 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7963 | Evident of mating | Fertile | Pregnant | without live born pups | Littered | ||
Rg7964 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
G4, F & 600 | Rg7965 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | |
Rg7966 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7967 | Evident of mating | Fertile | Pregnant | without live born pups | Littered | ||
Rg7968 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7969 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7970 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7971 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7972 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7973 | Evident of mating | In-Fertile | Non-pregnant | Non-pregnant | Non-pregnant | ||
Rg7974 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7975 | Evident of mating | Fertile | Pregnant | with live born pups | Littered | ||
Rg7976 | Evident of mating | Fertile | Pregnant | with live born pups | Littered |
F: Female.
APPENDIX 14 (Contd…). INDIVIDUAL ANIMAL REPRODUCTIVE PERFORMANCE RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Post-implantation Loss |
| Post-natal Loss (% | ||||
No. of Implantations | No. of Viable (Live) Pups | Post-implantation Loss (No.) | Post-implantation Loss (%) | Total No. of Pups Found Dead/ Cannibalized during lactation period | Post-natal Loss (%) | |||
G1, F & 0 | Rg7929 | 10 | 10 | 0 | 0.00 | 0 | 0.00 | |
Rg7930 | 10 | 8 | 2 | 20.00 | 0 | 0.00 | ||
Rg7931 | 13 | 13 | 0 | 0.00 | 0 | 0.00 | ||
Rg7932 | 10 | 8 | 2 | 20.00 | 2 | 25.00 | ||
Rg7933 | 12 | 11 | 1 | 8.33 | 0 | 0.00 | ||
Rg7934 | 9 | 9 | 0 | 0.00 | 0 | 0.00 | ||
Rg7935 | 13 | 13 | 0 | 0.00 | 0 | 0.00 | ||
Rg7936 | 13 | 12 | 1 | 7.69 | 0 | 0.00 | ||
Rg7937 | 8 | 5 | 3 | 37.50 | 0 | 0.00 | ||
Rg7938 | 17 | 17 | 0 | 0.00 | 0 | 0.00 | ||
Rg7939 | 13 | 13 | 0 | 0.00 | 0 | 0.00 | ||
Rg7940 | 10 | 8 | 2 | 20.00 | 0 | 0.00 | ||
G2, F & 150 | Rg7941 | 16 | 16 | 0 | 0.00 | 0 | 0.00 | |
Rg7942 | 8 | 8 | 0 | 0.00 | 0 | 0.00 | ||
Rg7943 | 10 | 9 | 1 | 10.00 | 0 | 0.00 | ||
Rg7944 | 10 | 10 | 0 | 0.00 | 0 | 0.00 | ||
Rg7945 | 8 | 8 | 0 | 0.00 | 0 | 0.00 | ||
Rg7946 | 7 | 6 | 1 | 14.29 | 0 | 0.00 | ||
Rg7947 | 11 | 10 | 1 | 9.09 | 0 | 0.00 | ||
Rg7948 | 16 | 16 | 0 | 0.00 | 0 | 0.00 | ||
Rg7949NP | - | - | - | - | - | - | ||
Rg7950 | 5 | 4 | 1 | 20.00 | 0 | 0.00 | ||
Rg7951 | 7 | 6 | 1 | 14.29 | 0 | 0.00 | ||
Rg7952 | 12 | 12 | 0 | 0.00 | 0 | 0.00 |
F: Female; NP: Non-pregnant; -: Not applicable. The uterus of each dam was observed for implantation sites and recorded the count for comparison of number of implantation sites with the number of pups born for each litter to calculate the post-implantation loss. The uterus of females with no visible implantation sites (non-pregnants) was immersed in 10% v/v Ammonium Sulphide staining solution under fume hood to visualize the implantation sites that might have undergone very early resorptions, there were no such incidences noted.
APPENDIX 14 (Contd…). INDIVIDUAL ANIMAL REPRODUCTIVE PERFORMANCE RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Post-implantation Loss |
| Post-natal Loss | ||||
No. of Implantations | No. of Viable (Live) Pups | Post-implantation Loss (No.) | Post-implantation Loss (%) | Total No. of Pups Found Dead/ Cannibalized during lactation period | Post-natal Loss (%) | |||
G3, F & 300 | Rg7953NP | - | - | - | - | - | - | |
Rg7954 | 6 | 4 | 2 | 33.33 | 0 | 0.00 | ||
Rg7955 | 10 | 10 | 0 | 0.00 | 0 | 0.00 | ||
Rg7956 | 14 | 13 | 1 | 7.14 | 0 | 0.00 | ||
Rg7957NP | - | - | - | - | - | - | ||
Rg7958 | 6 | 4 | 2 | 33.33 | 0 | 0.00 | ||
Rg7959 | 9 | 9 | 0 | 0.00 | 0 | 0.00 | ||
Rg7960 | 13 | 12 | 1 | 7.69 | 1 | 8.33 | ||
Rg7961 | 11 | 11 | 0 | 0.00 | 0 | 0.00 | ||
Rg7962 | 10 | 10 | 0 | 0.00 | 0 | 0.00 | ||
Rg7963TL | 6 | 0 | 6 | 100.00 | - | - | ||
Rg7964 | 18 | 18 | 0 | 0.00 | 1 | 5.56 | ||
G4, F & 600 | Rg7965TL | 4 | 1 | 3 | 75.00 | 1 | 100.00 | |
Rg7966 | 7 | 7 | 0 | 0.00 | 0 | 0.00 | ||
Rg7967TL | 6 | 0 | 6 | 100.00 | - | - | ||
Rg7968 | 14 | 14 | 0 | 0.00 | 0 | 0.00 | ||
Rg7969 | 13 | 12 | 1 | 7.69 | 2 | 16.67 | ||
Rg7970 | 10 | 10 | 0 | 0.00 | 0 | 0.00 | ||
Rg7971 | 13 | 12 | 1 | 7.69 | 0 | 0.00 | ||
Rg7972TL | 15 | 11 | 4 | 26.67 | 11 | 100.00 | ||
Rg7973NP | - | - | - | - | - | - | ||
Rg7974 | 19 | 18 | 1 | 5.26 | 1 | 5.56 | ||
Rg7975 | 14 | 14 | 0 | 0.00 | 0 | 0.00 | ||
Rg7976 | 12 | 9 | 3 | 25.00 | 0 | 0.00 |
F: Female; NP: Non-pregnant; -: Not applicable. The uterus of each dam was observed for implantation sites and recorded the count for comparison of number of implantation sites with the number of pups born for each litter to calculate the post-implantation loss. The uterus of females with no visible implantation sites (non-pregnants) was immersed in 10% v/v Ammonium Sulphide staining solution under fume hood to visualize the implantation sites that might have undergone very early resorptions, there were no such incidences noted; TL: Total litter loss.
& Dose (mg/kg body weight/day) | Animal No. | Testes | Epididymides | Kidneys | Prostate | Seminal vesicles with coagulating glands | Thyroid along with parathyroidWP |
G1, M & 0 | Rg7881 | 3.8807 | 1.4964 | 2.5304 | 1.1093 | 1.4062 | 0.0340 |
Rg7882 | 3.4921 | 1.3721 | 2.5656 | 1.2260 | 2.2563 | 0.0302 | |
Rg7883 | 3.8659 | 1.3228 | 2.6587 | 0.8776 | 1.2015 | 0.0212 | |
Rg7884 | 3.4098 | 1.5214 | 2.4207 | 1.1282 | 1.6421 | 0.0316 | |
Rg7885 | 3.4133 | 1.3702 | 2.6790 | 1.7690 | 0.9984 | 0.0265 | |
Rg7886 | 3.5072 | 1.5137 | 2.5259 | 1.5692 | 1.9274 | 0.0247 | |
Rg7887 | 3.4715 | 1.3974 | 2.7676 | 1.1128 | 1.6104 | 0.0242 | |
Rg7888 | 3.0776 | 1.1773 | 2.7656 | 1.1395 | 1.3014 | 0.0197 | |
Rg7889 | 3.0928 | 1.3721 | 3.2424 | 1.5711 | 1.6984 | 0.0213 | |
Rg7890 | 3.9113 | 1.7116 | 3.1429 | 1.8321 | 1.3481 | 0.0351 | |
Rg7891 | 3.5321 | 1.6449 | 2.8530 | 1.8289 | 1.0841 | 0.0352 | |
Rg7892 | 3.5457 | 1.4755 | 3.3962 | 1.5568 | 2.3786 | 0.0302 | |
G2, M & 150 | Rg7893 | 2.4986 | 1.2463 | 2.4540 | 1.6181 | 0.9306 | 0.0161 |
Rg7894 | 3.1687 | 1.3139 | 2.4160 | 1.4580 | 0.9316 | 0.0180 | |
Rg7895 | 2.8852 | 1.3895 | 2.4815 | 1.2402 | 2.0428 | 0.0164 | |
Rg7896 | 3.1300 | 1.6499 | 2.7928 | 2.1846 | 0.7481 | 0.0229 | |
Rg7897 | 3.1559 | 1.4758 | 2.7684 | 1.3075 | 1.3608 | 0.0232 | |
Rg7898 | 3.3664 | 1.6931 | 2.1196 | 0.9316 | 1.5001 | 0.0364 | |
Rg7899 | 3.3915 | 1.4012 | 2.7685 | 1.2040 | 1.9423 | 0.0360 | |
Rg7900 | 3.8532 | 1.6340 | 3.2447 | 0.9630 | 2.4361 | 0.0355 | |
Rg7901 | 3.6580 | 1.4233 | 2.3119 | 0.8082 | 2.2596 | 0.0242 | |
Rg7902 | 3.6148 | 1.2703 | 2.5002 | 1.2016 | 1.7682 | 0.0374 | |
Rg7903 | 3.2487 | 1.3287 | 2.4755 | 1.1664 | 1.3909 | 0.0320 | |
Rg7904 | 3.4087 | 1.7544 | 2.8452 | 0.8920 | 1.8619 | 0.0263 |
M: Male; WP: Weighed post-fixation.
APPENDIX 15 (Contd…). INDIVIDUAL ANIMAL ABSOLUTE ORGAN WEIGHT (g) RECORD
& Dose (mg/kg body weight/day) | Animal No. | Testes | Epididymides | Kidneys | Prostate | Seminal vesicles with coagulating glands | Thyroid along with parathyroidWP |
G3, M & 300 | Rg7905 | 3.6763 | 1.6759 | 2.3142 | 1.1524 | 1.9635 | 0.0118 |
Rg7906 | 3.4168 | 1.1793 | 2.3490 | 1.1240 | 1.3095 | 0.0242 | |
Rg7907 | 3.2109 | 1.5249 | 2.6119 | 1.1680 | 2.5289 | 0.0182 | |
Rg7908 | 3.7364 | 1.4106 | 2.5556 | 1.6398 | 1.3295 | 0.0361 | |
Rg7909 | 3.3085 | 1.3697 | 2.6053 | 1.9112 | 0.6056 | 0.0423 | |
Rg7910 | 3.3714 | 1.4084 | 2.4193 | 1.2204 | 1.0983 | 0.0357 | |
Rg7911 | 3.5574 | 1.6958 | 2.8582 | 1.8926 | 0.9801 | 0.0285 | |
Rg7912 | 3.1496 | 1.4567 | 3.0852 | 1.6232 | 1.3842 | 0.0246 | |
Rg7913 | 3.4221 | 1.4231 | 2.7552 | 1.2292 | 0.6750 | 0.0187 | |
Rg7914 | 3.4968 | 1.3689 | 2.3712 | 1.4957 | 0.6719 | 0.0362 | |
Rg7915 | 3.6762 | 1.4170 | 2.7818 | 0.9372 | 1.7386 | 0.0317 | |
Rg7916 | 3.4978 | 1.3815 | 3.3779 | 0.9268 | 1.1547 | 0.0261 | |
G4, M & 600 | Rg7917 | 3.4384 | 1.6469 | 2.7352 | 1.7403 | 0.9210 | 0.0416 |
Rg7918 | 3.0408 | 1.2076 | 2.0371 | 0.5184 | 1.3941 | 0.0197 | |
Rg7919 | 3.4915 | 1.2366 | 2.1886 | 1.0257 | 1.0894 | 0.0282 | |
Rg7920 | 3.3301 | 1.4170 | 2.1523 | 2.1602 | 0.8860 | 0.0288 | |
Rg7921 | 3.0049 | 1.4437 | 2.3150 | 1.0912 | 0.8026 | 0.0219 | |
Rg7922 | 3.5876 | 1.3914 | 3.0741 | 1.1245 | 1.1757 | 0.0331 | |
Rg7923 | 3.6243 | 1.2751 | 2.6246 | 1.1896 | 1.2759 | 0.0201 | |
Rg7924 | 2.9285 | 1.2562 | 2.3008 | 1.0067 | 1.0249 | 0.0212 | |
Rg7925 | 3.7875 | 1.3375 | 2.4083 | 1.0365 | 1.2819 | 0.0337 | |
Rg7926 | 3.0179 | 1.2915 | 2.6101 | 1.0935 | 0.4108 | 0.0157 | |
Rg7927 | 3.2982 | 1.3757 | 2.6425 | 1.4034 | 0.6823 | 0.0379 | |
Rg7928 | 3.6400 | 1.7420 | 2.4308 | 0.4752 | 1.7295 | 0.0287 |
M: Male; WP: Weighed post-fixation.
APPENDIX 15 (Contd…). INDIVIDUAL ANIMAL ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Ovaries | Uterus with cervix | Kidneys | Thyroid along with parathyroidWP |
G1, F & 0 | Rg7929 | 0.1181 | 0.5310 | 1.7077 | 0.02864 |
Rg7930 | 0.1328 | 0.8546 | 1.6728 | 0.03684 | |
Rg7931 | 0.1223 | 0.4808 | 1.6902 | 0.02470 | |
Rg7932 | 0.1070 | 0.7679 | 2.1539 | 0.03747 | |
Rg7933 | 0.1406 | 0.4739 | 1.8975 | 0.03321 | |
Rg7934 | 0.1414 | 0.4182 | 2.0847 | 0.02780 | |
Rg7935 | 0.1562 | 0.6886 | 2.4033 | 0.03828 | |
Rg7936 | 0.1361 | 0.4991 | 1.6651 | 0.03298 | |
Rg7937 | 0.1602 | 0.6584 | 2.0873 | 0.03185 | |
Rg7938 | 0.1789 | 0.6217 | 1.9246 | 0.02671 | |
Rg7939 | 0.1422 | 0.4219 | 2.0432 | 0.03960 | |
Rg7940 | 0.1156 | 0.6629 | 1.7216 | 0.03583 | |
G2, F & 150 | Rg7941 | 0.1268 | 0.3975 | 1.6917 | 0.01541 |
Rg7942 | 0.1179 | 0.5863 | 1.8526 | 0.02073 | |
Rg7943 | 0.1350 | 0.4152 | 1.7113 | 0.02153 | |
Rg7944 | 0.1433 | 0.6231 | 1.5743 | 0.02570 | |
Rg7945 | 0.1750 | 0.8359 | 2.0521 | 0.02124 | |
Rg7946 | 0.1369 | 0.3726 | 1.7433 | 0.02393 | |
Rg7947 | 0.1291 | 0.6467 | 1.6569 | 0.01932 | |
Rg7948 | 0.1368 | 0.5693 | 2.0950 | 0.02191 | |
Rg7949NP | 0.1519 | 0.4048 | 2.2494 | 0.02786 | |
Rg7950 | 0.1768 | 0.8803 | 1.8787 | 0.01944 | |
Rg7951 | 0.1337 | 0.7270 | 1.9202 | 0.03247 | |
Rg7952 | 0.1263 | 0.4659 | 1.5930 | 0.01747 |
F: Female; NP: Non-pregnant; WP: Weighed post-fixation.
APPENDIX 15 (Contd…). INDIVIDUAL ANIMAL ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Ovaries | Uterus with cervix | Kidneys | Thyroid along with parathyroidWP |
G3, F & 300 | Rg7953NP | 0.1232 | 0.6151 | 2.2932 | 0.02201 |
Rg7954 | 0.1501 | 0.4777 | 1.6953 | 0.01979 | |
Rg7955 | 0.1611 | 0.5942 | 1.9249 | 0.02605 | |
Rg7956 | 0.1197 | 0.5203 | 1.7678 | 0.02112 | |
Rg7957NP | 0.1203 | 0.7372 | 1.7257 | 0.03071 | |
Rg7958 | 0.1458 | 0.6352 | 1.9085 | 0.02138 | |
Rg7959 | 0.1234 | 0.6019 | 1.9338 | 0.02453 | |
Rg7960 | 0.1254 | 0.4293 | 2.1321 | 0.03188 | |
Rg7961 | 0.1339 | 0.5447 | 1.6980 | 0.02225 | |
Rg7962 | 0.1121 | 0.6214 | 1.8164 | 0.01622 | |
Rg7963TL | 0.1206 | 0.6354 | 1.8296 | 0.01791 | |
Rg7964 | 0.1253 | 0.4037 | 1.9074 | 0.02302 | |
G4, F & 600 | Rg7965TL | 0.1629 | 0.8380 | 1.8342 | 0.01252 |
Rg7966 | 0.1508 | 0.3943 | 1.9646 | 0.01632 | |
Rg7967TL | 0.1312 | 0.7546 | 1.6219 | 0.02677 | |
Rg7968 | 0.0963 | 0.3517 | 1.7453 | 0.01378 | |
Rg7969 | 0.1219 | 0.4040 | 1.5696 | 0.02414 | |
Rg7970 | 0.1570 | 0.7175 | 1.8822 | 0.01929 | |
Rg7971 | 0.1267 | 0.4595 | 1.9943 | 0.02474 | |
Rg7972TL | - | - | - | - | |
Rg7973NP | 0.1287 | 0.8198 | 2.0372 | 0.02226 | |
Rg7974 | 0.1763 | 0.5460 | 1.9225 | 0.03069 | |
Rg7975 | 0.1384 | 0.4911 | 2.4342 | 0.02382 | |
Rg7976 | 0.1573 | 0.4341 | 2.3267 | 0.01030 |
F: Female; NP: Non-pregnant; TL: Total litter loss; WP: Weighed post-fixation; -: Not applicable.
Note: Animal number Rg7972 from group G4 was found dead on lactation day (LD) 5.
M: Male.
APPENDIX 16 (Contd…). INDIVIDUAL ANIMAL TERMINAL BODY WEIGHT (g) AND ORGAN WEIGHT RELATIVE TO TERMINAL BODY WEIGHT (%) RECORD
& Dose (mg/kg body weight/day) | Animal No. | Terminal Body Weight (g) | Testes | Epididymides | Kidneys | Prostate | Seminal vesicles with coagulating glands | Thyroid along with parathyroid |
G3, M & 300 | Rg7905 | 343.35 | 1.0707 | 0.4881 | 0.6740 | 0.3356 | 0.5719 | 0.0034 |
Rg7906 | 327.46 | 1.0434 | 0.3601 | 0.7173 | 0.3432 | 0.3999 | 0.0074 | |
Rg7907 | 384.58 | 0.8349 | 0.3965 | 0.6792 | 0.3037 | 0.6576 | 0.0047 | |
Rg7908 | 406.90 | 0.9183 | 0.3467 | 0.6281 | 0.4030 | 0.3267 | 0.0089 | |
Rg7909 | 386.59 | 0.8558 | 0.3543 | 0.6739 | 0.4944 | 0.1567 | 0.0109 | |
Rg7910 | 343.56 | 0.9813 | 0.4099 | 0.7042 | 0.3552 | 0.3197 | 0.0104 | |
Rg7911 | 439.84 | 0.8088 | 0.3855 | 0.6498 | 0.4303 | 0.2228 | 0.0065 | |
Rg7912 | 419.47 | 0.7509 | 0.3473 | 0.7355 | 0.3870 | 0.3300 | 0.0059 | |
Rg7913 | 402.79 | 0.8496 | 0.3533 | 0.6840 | 0.3052 | 0.1676 | 0.0046 | |
Rg7914 | 372.72 | 0.9382 | 0.3673 | 0.6362 | 0.4013 | 0.1803 | 0.0097 | |
Rg7915 | 391.09 | 0.9400 | 0.3623 | 0.7113 | 0.2396 | 0.4446 | 0.0081 | |
Rg7916 | 419.06 | 0.8347 | 0.3297 | 0.8061 | 0.2212 | 0.2755 | 0.0062 | |
G4, M & 600 | Rg7917 | 348.19 | 0.9875 | 0.4730 | 0.7855 | 0.4998 | 0.2645 | 0.0119 |
Rg7918 | 313.48 | 0.9700 | 0.3852 | 0.6498 | 0.1654 | 0.4447 | 0.0063 | |
Rg7919 | 322.85 | 1.0815 | 0.3830 | 0.6779 | 0.3177 | 0.3374 | 0.0087 | |
Rg7920 | 346.65 | 0.9607 | 0.4088 | 0.6209 | 0.6232 | 0.2556 | 0.0083 | |
Rg7921 | 339.92 | 0.8840 | 0.4247 | 0.6810 | 0.3210 | 0.2361 | 0.0064 | |
Rg7922 | 393.75 | 0.9111 | 0.3534 | 0.7807 | 0.2856 | 0.2986 | 0.0084 | |
Rg7923 | 399.47 | 0.9073 | 0.3192 | 0.6570 | 0.2978 | 0.3194 | 0.0050 | |
Rg7924 | 346.13 | 0.8461 | 0.3629 | 0.6647 | 0.2908 | 0.2961 | 0.0061 | |
Rg7925 | 372.23 | 1.0175 | 0.3593 | 0.6470 | 0.2785 | 0.3444 | 0.0091 | |
Rg7926 | 368.77 | 0.8184 | 0.3502 | 0.7078 | 0.2965 | 0.1114 | 0.0043 | |
Rg7927 | 391.73 | 0.8420 | 0.3512 | 0.6746 | 0.3583 | 0.1742 | 0.0097 | |
Rg7928 | 370.06 | 0.9836 | 0.4707 | 0.6569 | 0.1284 | 0.4674 | 0.0078 |
M: Male.
APPENDIX 16 (Contd…). INDIVIDUAL ANIMAL TERMINAL BODY WEIGHT (g) AND ORGAN WEIGHT RELATIVE TO TERMINAL BODY WEIGHT (%) RECORD
F: Female; NP: Non-pregnant.
APPENDIX 16 (Contd…). INDIVIDUAL ANIMAL TERMINAL BODY WEIGHT (g) AND ORGAN WEIGHT RELATIVE TO TERMINAL BODY WEIGHT (%) RECORD
F: Female; NP: Non-pregnant; TL: Total litter loss; -: Not applicable.
Note: Animal number Rg7972 from group G4 was found dead on lactation day (LD) 5.
Group, Sex & Dose (mg/kg body weight/day) | Animal No. | Serum T4 Levels Adj. Result (ng/mL) | |
G1, M & 0 | Rg7881 | 79.075 | |
Rg7882 | 66.183 | ||
Rg7883 | 71.065 | ||
Rg7884 | 78.519 | ||
Rg7885 | 87.218 | ||
Rg7886 | 75.502 | ||
Rg7887 | 75.771 | ||
Rg7888 | 88.909 | ||
Rg7889 | 75.524 | ||
Rg7890 | 72.562 | ||
Rg7891 | 70.901 | ||
Rg7892 | 68.967 | ||
G2, M & 150 | Rg7893 | 96.343 | |
Rg7894 | 83.789 | ||
Rg7895 | 82.394 | ||
Rg7896 | 67.584 | ||
Rg7897 | 71.482 | ||
Rg7898 | 69.949 | ||
Rg7899 | 83.568 | ||
Rg7900 | 88.183 | ||
Rg7901 | 79.215 | ||
Rg7902 | 71.961 | ||
Rg7903 | 79.171 | ||
Rg7904 | 70.679 | ||
G3, M & 300 | Rg7905 | 70.061 | |
Rg7906 | 79.718 | ||
Rg7907 | 66.205 | ||
Rg7908 | 77.560 | ||
Rg7909 | 71.735 | ||
Rg7910 | 68.674 | ||
Rg7911 | 72.812 | ||
Rg7912 | 76.587 | ||
Rg7913 | 78.949 | ||
Rg7914 | 71.682 | ||
Rg7915 | 65.586 | ||
Rg7916 | 76.096 | ||
G4, M & 600 | Rg7917 | 67.635 | |
Rg7918 | 65.066 | ||
Rg7919 | 65.783 | ||
Rg7920 | 62.272 | ||
Rg7921 | 60.302 | ||
Rg7922 | 79.287 | ||
Rg7923 | 67.910 | ||
Rg7924 | 72.162 | ||
Rg7925 | 73.517 | ||
Rg7926 | 71.682 | ||
Rg7927 | 71.632 | ||
Rg7928 | 61.909 |
M: Male; ng/mL: nanogram per mL.
& Dose (mg/kg body weight/day) | Dam No. | Pup No. → | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 |
G1 & 0 | Rg7929 | Sex → | M | M | M | M | M | M | F | F | F | F | - | - | - | - | - | - | - |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | ||
Rg7930 | Sex → | M | M | M | F | F | F | F | F | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - | ||
Rg7931 | Sex → | M | M | M | M | M | M | M | F | F | F | F | F | F | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - | ||
Rg7932 | Sex → | M | M | M | M | F | F | F | F | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | $ | N | N | N | @ | - | - | - | - | - | - | - | - | - | ||
Rg7933 | Sex → | M | M | M | M | M | M | M | M | M | F | F | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | NTS | - | - | - | - | - | - | ||
Rg7934 | Sex → | M | M | M | M | F | F | F | F | F | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | ||
Rg7935 | Sex → | M | M | M | M | M | M | M | F | F | F | F | F | F | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - | ||
Rg7936 | Sex → | M | M | M | M | M | M | F | F | F | F | F | F | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - | - | ||
Rg7937 | Sex → | M | M | F | F | F | - | - | - | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | ||
Rg7938 | Sex → | M | M | M | M | M | M | M | M | M | M | F | F | F | F | F | F | F | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | ||
Rg7939 | Sex → | M | M | M | M | M | M | M | M | F | F | F | F | F | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - | ||
Rg7940 | Sex → | M | M | M | M | F | F | F | F | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - |
N: Normal; PND: Postnatal day; M: Male; F: Female; -: Not applicable.
TS: Observed until PND 4 and terminally sacrificed for blood collection.
@: Pale coloured PND 1 to 3, Dead on PND 4; $: Normal PND 1 and Cannibalized on PND 2.
APPENDIX 18 (Contd…). INDIVIDUAL PUP OBSERVATION PER LITTER RECORD DURING POSTNATAL PERIOD
Group & Dose (mg/kg body weight/day) | Dam No. | Pup No. → | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 |
G2 & 150 | Rg7941 | Sex → | M | M | M | M | M | M | F | F | F | F | F | F | F | F | F | F |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | ||
Rg7942 | Sex → | M | M | M | M | F | F | F | F | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | ||
Rg7943 | Sex → | M | M | M | M | M | M | F | F | F | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | ||
Rg7944 | Sex → | M | M | M | F | F | F | F | F | F | F | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | ||
Rg7945 | Sex → | M | M | M | M | M | F | F | F | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | ||
Rg7946 | Sex → | M | M | M | F | F | F | - | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | ||
Rg7947 | Sex → | M | M | M | M | M | M | F | F | F | F | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | ||
Rg7948 | Sex → | M | M | M | M | M | M | M | M | F | F | F | F | F | F | F | F | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | ||
Rg7949 |
| Non-pregnant | ||||||||||||||||
Rg7950 | Sex → | M | M | M | M | - | - | - | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | ||
Rg7951 | Sex → | M | M | M | F | F | F | - | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | ||
Rg7952 | Sex → | M | M | M | M | M | M | F | F | F | F | F | F | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - |
N: Normal; PND: Postnatal day; M: Male; F: Female; -: Not applicable.
TS: Observed until PND 4 and terminally sacrificed for blood collection.
APPENDIX 18 (Contd…). INDIVIDUAL PUP OBSERVATION PER LITTER RECORD DURING POSTNATAL PERIOD
Group & Dose (mg/kg body weight/day) | Dam No. | Pup No. → | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 |
G3 & 300 | Rg7953 |
| Non-pregnant | |||||||||||||||||
Rg7954 | Sex → | M | M | M | M | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | ||
Rg7955 | Sex → | M | M | M | M | M | M | F | F | F | F | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | ||
Rg7956 | Sex → | M | M | M | M | M | M | M | F | F | F | F | F | F | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - | - | ||
Rg7957 |
| Non-pregnant | ||||||||||||||||||
Rg7958 | Sex → | M | M | M | F | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | - | - | - | ||
Rg7959 | Sex → | M | M | M | M | F | F | F | F | F | - | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - | ||
Rg7960 | Sex → | M | M | M | M | M | M | M | M | F | F | F | F | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | HS | N | N | N | N | NTS | - | - | - | - | - | - | ||
Rg7961 | Sex → | M | M | M | M | M | F | F | F | F | F | F | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | NTS | - | - | - | - | - | - | - | ||
Rg7962 | Sex → | M | M | M | M | M | M | F | F | F | F | - | - | - | - | - | - | - | - | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | ||
Rg7963 |
| Total litter loss | ||||||||||||||||||
Rg7964 | Sex → | M | M | M | M | M | M | M | F | F | F | F | F | F | F | F | F | F | F | |
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | N | N | N (PND1) D (PND2) | N | N | NTS | NTS |
N: Normal; PND: Postnatal day; M: Male; F: Female; -: Not applicable; D: Dead.
TS: Observed until PND 4 and terminally sacrificed for blood collection.
HS: Haemorrhagic Spot on nose and head region on PND 1 and Dead on PND 2.
APPENDIX 18 (Contd…). INDIVIDUAL PUP OBSERVATION PER LITTER RECORD DURING POSTNATAL PERIOD
Group & Dose (mg/kg body weight/day) | Dam No. | Pup No. → | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | |
G4 & 600 | Rg7965 | Sex → | M | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
PND 1 to 4 | N (PND 1 to 3) D (PND 4) | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||
Rg7966 | Sex → | M | M | M | F | F | F | F | - | - | - | - | - | - | - | - | - | - | - | ||
PND 1 to 13 | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - | - | - | |||
Rg7967 |
| Total litter loss |
| ||||||||||||||||||
Rg7968 | Sex → | M | M | M | M | M | M | M | M | F | F | F | F | F | F | - | - | - | - | ||
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - | |||
Rg7969 | Sex → | M | M | M | M | F | F | F | F | F | F | F | F | - | - | - | - | - | - | ||
PND 1 to 13 | N | N | N (PND1) D (PND2) | N | N | N | N | N | N | N | N (PND1) D (PND2) | N | - | - | - | - | - | - | |||
Rg7970 | Sex → | M | M | M | M | F | F | F | F | F | F | - | - | - | - | - | - | - | - | ||
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | |||
Rg7971 | Sex → | M | M | M | M | F | F | F | F | F | F | F | F | - | - | - | - | - | - | ||
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - | - | - | |||
Rg7972 | Sex → | M | M | M | F | F | F | F | F | F | F | F | - | - | - | - | - | - | - | ||
PND 1 to 2 | @ | @ | @ | @ | @ | @ | @ | @ | @ | @ | @ | - | - | - | - | - | - | - | |||
Rg7973 |
| Non-pregnant |
| ||||||||||||||||||
Rg7974 | Sex → | M | M | M | M | M | M | M | M | F | F | F | F | F | F | F | F | F | F | ||
PND 1 to 13 | N (PND1) D (PND2) | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | |||
Rg7975 | Sex → | M | M | M | M | M | M | F | F | F | F | F | F | F | F | - | - | - | - | ||
PND 1 to 13 | N | N | N | N | N | N | N | N | N | N | N | N | NTS | NTS | - | - | - | - | |||
Rg7976 | Sex → | M | M | M | M | F | F | F | F | F | - | - | - | - | - | - | - | - | - | ||
PND 1 to 13 | N | N | N | N | N | N | N | N | N | - | - | - | - | - | - | - | - | - | |||
N: Normal; PND: Postnatal day; M: Male; F: Female; -: Not applicable; D: Dead.
TS: Observed until PND 4 and terminally sacrificed for blood collection.
@: Noted with hypothermia on PND 1 and found dead on PND 2.
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | Mean | ||
Male | Female | ||||||||||||||||||
G1 & 0 | Rg7929 | PND 1 | M | 7.19 | 6.94 | 7.23 | 6.87 | 6.81 | 6.79 | - | - | - | - | - | - | - | 6.97 | 6.79 | |
F | - | - | - | - | - | - | 6.66 | 6.92 | 6.81 | 6.77 | - | - | - | ||||||
PND 4 | M | 12.04 | 11.79 | 12.14 | 11.26 | 11.57 | 11.41 | - | - | - | - | - | - | - | 11.70 | 11.04 | |||
F | - | - | - | - | - | - | 11.08 | 11.21 | 10.98 | 10.87 | - | - | - | ||||||
PND 7 | M | 16.74 | 15.27 | 16.01 | 15.54 | 15.72 | 15.16 | - | - | - | - | - | - | - | 15.74 | 15.02 | |||
F | - | - | - | - | - | - | 15.01 | 14.98 | 14.96 | 15.13 | - | - | - | ||||||
PND 13 | M | 29.81 | 28.46 | 30.03 | 27.47 | 27.36 | 26.67 | - | - | - | - | - | - | - | 28.30 | 26.82 | |||
F | - | - | - | - | - | - | 24.78 | 27.81 | 27.22 | 27.48 | - | - | - | ||||||
Rg7930 | PND 1 | M | 7.07 | 6.96 | 6.91 | - | - | - | - | - | - | - | - | - | - | 6.98 | 6.80 | ||
F | - | - | - | 6.79 | 6.83 | 6.92 | 6.77 | 6.68 | - | - | - | - | - | ||||||
PND 4 | M | 12.47 | 12.04 | 11.85 | - | - | - | - | - | - | - | - | - | - | 12.12 | 11.55 | |||
F | - | - | - | 11.43 | 11.62 | 11.71 | 11.53 | 11.48 | - | - | - | - | - | ||||||
PND 7 | M | 16.08 | 15.90 | 15.63 | - | - | - | - | - | - | - | - | - | - | 15.87 | 15.33 | |||
F | - | - | - | 15.21 | 15.46 | 15.51 | 15.08 | 15.38 | - | - | - | - | - | ||||||
PND 13 | M | 30.81 | 29.47 | 29.83 | - | - | - | - | - | - | - | - | - | - | 30.04 | 28.80 | |||
F | - | - | - | 28.79 | 29.86 | 28.27 | 28.75 | 28.34 | - | - | - | - | - | ||||||
Rg7931 | PND 1 | M | 7.20 | 6.89 | 6.40 | 6.58 | 6.73 | 6.81 | 6.95 | - | - | - | - | - | - | 6.79 | 6.60 | ||
F | - | - | - | - | - | - | - | 6.98 | 6.80 | 6.56 | 6.44 | 6.48 | 6.36 | ||||||
PND 4 | M | 12.01 | 11.41 | 10.72 | 10.61 | 10.81 | 10.94 | 11.27 | - | - | - | - | - | - | 11.11 | 10.64 | |||
F | - | - | - | - | - | - | - | 11.49 | 10.67 | 10.48 | 10.51 | 10.37 | 10.31 | ||||||
PND 7 | M | 16.32 | 15.58 | 15.39 | 14.78 | 14.94 | 15.12 | 15.36 | - | - | - | - | - | - | 15.36 | 14.51 | |||
F | - | - | - | - | - | - | - | 14.93 | 14.34 | 14.31 | 14.47 | - | - | ||||||
PND 13 | M | 29.73 | 28.16 | 27.49 | 28.03 | 28.56 | 29.01 | 28.16 | - | - | - | - | - | - | 28.45 | 27.09 | |||
F | - | - | - | - | - | - | - | 26.42 | 27.03 | 26.88 | 28.03 | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | Mean | ||
Male | Female | ||||||||||||||||
G1 & 0 | Rg7932 | PND 1 | M | 6.89 | 7.35 | 7.08 | 3.66 | - | - | - | - | - | - | - | 6.25 | 5.81 | |
F | - | - | - | - | 6.72 | 6.29 | 6.96 | 3.25 | - | - | - | ||||||
PND 4 | M | 11.91 | 12.41 | 12.01 | - | - | - | - | - | - | - | - | 12.11 | 10.87 | |||
F | - | - | - | - | 10.94 | 10.57 | 11.11 | - | - | - | - | ||||||
PND 7 | M | 16.01 | 16.54 | 15.78 | - | - | - | - | - | - | - | - | 16.11 | 14.99 | |||
F | - | - | - | - | 14.92 | 14.66 | 15.38 | - | - | - | - | ||||||
PND 13 | M | 29.54 | 30.21 | 28.91 | - | - | - | - | - | - | - | - | 29.55 | 28.10 | |||
F | - | - | - | - | 28.26 | 27.74 | 28.31 | - | - | - | - | ||||||
Rg7933 | PND 1 | M | 6.83 | 7.16 | 6.94 | 6.68 | 7.03 | 6.71 | 6.89 | 6.77 | 6.96 | - | - | 6.89 | 6.47 | ||
F | - | - | - | - | - | - | - | - | - | 6.55 | 6.39 | ||||||
PND 4 | M | 11.42 | 12.16 | 11.39 | 10.47 | 12.08 | 10.84 | 10.77 | 10.61 | 11.47 | - | - | 11.25 | 10.57 | |||
F | - | - | - | - | - | - | - | - | - | 10.72 | 10.41 | ||||||
PND 7 | M | 15.38 | 16.01 | 15.61 | 14.86 | 15.78 | 14.67 | 15.03 | 14.76 | 15.11 | - | - | 15.25 | 14.51 | |||
F | - | - | - | - | - | - | - | - | - | 14.51 | - | ||||||
PND 13 | M | 28.48 | 30.01 | 29.16 | 28.33 | 29.04 | 27.66 | 28.09 | 27.76 | 28.24 | - | - | 28.53 | 27.56 | |||
F | - | - | - | - | - | - | - | - | - | 27.56 | - | ||||||
Rg7934 | PND 1 | M | 6.69 | 6.94 | 6.73 | 7.06 | - | - | - | - | - | - | - | 6.86 | 6.49 | ||
F | - | - | - | - | 6.47 | 6.41 | 6.66 | 6.39 | 6.54 | - | - | ||||||
PND 4 | M | 10.72 | 11.41 | 10.91 | 12.16 | - | - | - | - | - | - | - | 11.30 | 10.50 | |||
F | - | - | - | - | 10.61 | 10.54 | 10.49 | 10.41 | 10.44 | - | - | ||||||
PND 7 | M | 14.67 | 15.49 | 15.13 | 16.27 | - | - | - | - | - | - | - | 15.39 | 14.51 | |||
F | - | - | - | - | 14.66 | 14.41 | 14.64 | 14.31 | 14.51 | - | - | ||||||
PND 13 | M | 28.06 | 28.46 | 28.73 | 30.14 | - | - | - | - | - | - | - | 28.85 | 27.84 | |||
F | - | - | - | - | 28.36 | 27.38 | 28.14 | 27.06 | 28.27 | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | Mean | ||
Male | Female | ||||||||||||||||||
G1 & 0 | Rg7935 | PND 1 | M | 6.48 | 6.30 | 6.17 | 7.22 | 6.91 | 6.76 | 6.26 | - | - | - | - | - | - | 6.59 | 6.48 | |
F | - | - | - | - | - | - | - | 6.45 | 6.69 | 6.53 | 6.17 | 6.08 | 6.94 | ||||||
PND 4 | M | 10.23 | 10.47 | 10.36 | 12.03 | 11.98 | 10.67 | 10.41 | - | - | - | - | - | - | 10.88 | 10.41 | |||
F | - | - | - | - | - | - | - | 10.33 | 10.51 | 10.63 | 10.08 | 10.11 | 10.79 | ||||||
PND 7 | M | 14.24 | 14.57 | 14.72 | 15.97 | 15.88 | 14.72 | 14.46 | - | - | - | - | - | - | 14.94 | 14.30 | |||
F | - | - | - | - | - | - | - | 14.31 | 14.27 | 14.58 | 14.03 | - | - | ||||||
PND 13 | M | 27.68 | 28.01 | 27.98 | 29.14 | 28.86 | 27.66 | 27.24 | - | - | - | - | - | - | 28.08 | 27.57 | |||
F | - | - | - | - | - | - | - | 27.43 | 28.03 | 26.98 | 27.84 | - | - | ||||||
Rg7936 | PND 1 | M | 6.89 | 7.21 | 7.01 | 6.95 | 6.81 | 6.61 | - | - | - | - | - | - | - | 6.91 | 6.37 | ||
F | - | - | - | - | - | - | 6.43 | 6.37 | 6.31 | 6.54 | 6.18 | 6.41 | - | ||||||
PND 4 | M | 11.11 | 12.06 | 11.47 | 10.72 | 10.94 | 10.58 | - | - | - | - | - | - | - | 11.15 | 10.36 | |||
F | - | - | - | - | - | - | 10.31 | 10.33 | 10.45 | 10.62 | 10.27 | 10.19 | - | ||||||
PND 7 | M | 15.35 | 15.20 | 14.91 | 14.97 | 15.05 | 15.33 | - | - | - | - | - | - | - | 15.14 | 14.82 | |||
F | - | - | - | - | - | - | 14.90 | 14.84 | 15.01 | 14.52 | - | - | - | ||||||
PND 13 | M | 28.14 | 28.06 | 27.79 | 28.25 | 28.14 | 28.65 | - | - | - | - | - | - | - | 28.17 | 27.92 | |||
F | - | - | - | - | - | - | 27.63 | 28.03 | 28.34 | 27.66 | - | - | - | ||||||
Rg7937 | PND 1 | M | 6.83 | 7.16 | - | - | - | - | - | - | - | - | - | - | - | 7.00 | 6.82 | ||
F | - | - | 6.79 | 6.92 | 6.74 | - | - | - | - | - | - | - | - | ||||||
PND 4 | M | 11.27 | 12.21 | - | - | - | - | - | - | - | - | - | - | - | 11.74 | 10.94 | |||
F | - | - | 10.94 | 11.01 | 10.87 | - | - | - | - | - | - | - | - | ||||||
PND 7 | M | 15.87 | 14.98 | - | - | - | - | - | - | - | - | - | - | - | 15.43 | 14.81 | |||
F | - | - | 14.72 | 15.04 | 14.68 | - | - | - | - | - | - | - | - | ||||||
PND 13 | M | 29.47 | 30.08 | - | - | - | - | - | - | - | - | - | - | - | 29.78 | 28.50 | |||
F | - | - | 27.96 | 28.49 | 29.06 | - | - | - | - | - | - | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | Mean | ||
Male | Female | ||||||||||||||||||||||
G1 & 0 | Rg7938 | PND 1 | M | 6.27 | 6.44 | 5.93 | 6.31 | 6.25 | 6.19 | 6.78 | 6.47 | 6.58 | 6.41 | - | - | - | - | - | - | - | 6.36 | 5.92 | |
F | - | - | - | - | - | - | - | - | - | - | 5.88 | 6.14 | 6.01 | 6.00 | 5.69 | 5.93 | 5.76 | ||||||
PND 4 | M | 10.14 | 10.53 | 10.02 | 10.29 | 10.37 | 10.41 | 10.89 | 10.63 | 10.44 | 10.93 | - | - | - | - | - | - | - | 10.47 | 9.97 | |||
F | - | - | - | - | - | - | - | - | - | - | 9.91 | 10.17 | 10.03 | 9.97 | 9.86 | 10.03 | 9.84 | ||||||
PND 7 | M | 14.60 | 14.36 | 14.18 | 14.26 | 14.51 | 14.12 | 13.98 | 13.62 | 14.22 | 13.59 | - | - | - | - | - | - | - | 14.14 | 13.70 | |||
F | - | - | - | - | - | - | - | - | - | - | 13.96 | 14.01 | 13.19 | 13.37 | 13.99 | - | - | ||||||
PND 13 | M | 27.59 | 27.14 | 27.36 | 27.01 | 28.11 | 27.19 | 26.76 | 26.88 | 27.43 | 26.19 | - | - | - | - | - | - | - | 27.17 | 26.16 | |||
F | - | - | - | - | - | - | - | - | - | - | 25.98 | 26.27 | 26.11 | 25.43 | 27.03 | - | - | ||||||
Rg7939 | PND 1 | M | 6.79 | 7.12 | 6.88 | 6.73 | 6.99 | 7.08 | 7.01 | 6.63 | - | - | - | - | - | - | - | - | - | 6.90 | 6.39 | ||
F | - | - | - | - | - | - | - | - | 6.41 | 6.39 | 6.58 | 6.27 | 6.31 | - | - | - | - | ||||||
PND 4 | M | 10.91 | 12.16 | 11.41 | 11.09 | 12.01 | 12.11 | 12.07 | 11.26 | - | - | - | - | - | - | - | - | - | 11.63 | 10.54 | |||
F | - | - | - | - | - | - | - | - | 10.72 | 10.51 | 10.79 | 10.38 | 10.29 | - | - | - | - | ||||||
PND 7 | M | 15.14 | 15.57 | 14.96 | 15.01 | 15.69 | 15.23 | 14.78 | 14.69 | - | - | - | - | - | - | - | - | - | 15.13 | 13.93 | |||
F | - | - | - | - | - | - | - | - | 14.16 | 13.97 | 13.67 | - | - | - | - | - | - | ||||||
PND 13 | M | 27.91 | 28.32 | 27.81 | 29.03 | 28.44 | 27.61 | 26.94 | 27.03 | - | - | - | - | - | - | - | - | - | 27.89 | 26.81 | |||
F | - | - | - | - | - | - | - | - | 28.11 | 26.34 | 25.99 | - | - | - | - | - | - | ||||||
Rg7940 | PND 1 | M | 7.11 | 6.87 | 6.91 | 6.81 | - | - | - | - | - | - | - | - | - | - | - | - | - | 6.93 | 6.65 | ||
F | - | - | - | - | 6.66 | 6.75 | 6.49 | 6.71 | - | - | - | - | - | - | - | - | - | ||||||
PND 4 | M | 12.31 | 11.41 | 11.72 | 11.27 | - | - | - | - | - | - | - | - | - | - | - | - | - | 11.68 | 10.81 | |||
F | - | - | - | - | 10.94 | 10.81 | 10.66 | 10.84 | - | - | - | - | - | - | - | - | - | ||||||
PND 7 | M | 16.27 | 15.86 | 15.71 | 15.76 | - | - | - | - | - | - | - | - | - | - | - | - | - | 15.90 | 14.95 | |||
F | - | - | - | - | 14.96 | 15.03 | 14.89 | 14.93 | - | - | - | - | - | - | - | - | - | ||||||
PND 13 | M | 30.41 | 29.71 | 28.97 | 29.12 | - | - | - | - | - | - | - | - | - | - | - | - | - | 29.55 | 28.75 | |||
F | - | - | - | - | 28.69 | 28.95 | 28.66 | 28.71 | - | - | - | - | - | - | - | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | Mean | ||
Male | Female | |||||||||||||||||||||
G2 & 150 | Rg7941 | PND 1 | M | 6.45 | 6.71 | 6.29 | 6.83 | 6.66 | 6.59 | - | - | - | - | - | - | - | - | - | - | 6.59 | 6.02 | |
F | - | - | - | - | - | - | 6.11 | 6.38 | 6.01 | 5.93 | 5.49 | 6.21 | 6.17 | 6.03 | 5.86 | 5.97 | ||||||
PND 4 | M | 10.27 | 10.58 | 10.11 | 10.94 | 10.87 | 10.41 | - | - | - | - | - | - | - | - | - | - | 10.53 | 10.02 | |||
F | - | - | - | - | - | - | 10.01 | 10.21 | 9.97 | 9.86 | 9.72 | 10.11 | 10.31 | 10.00 | 9.94 | 10.04 | ||||||
PND 7 | M | 14.16 | 14.47 | 13.98 | 15.03 | 14.79 | 14.26 | - | - | - | - | - | - | - | - | - | - | 14.45 | 13.41 | |||
F | - | - | - | - | - | - | 13.83 | 13.49 | 12.86 | 13.10 | 12.94 | 13.37 | 13.54 | 14.15 | - | - | ||||||
PND 13 | M | 28.11 | 27.91 | 26.98 | 28.23 | 28.46 | 27.81 | - | - | - | - | - | - | - | - | - | - | 27.92 | 26.81 | |||
F | - | - | - | - | - | - | 26.54 | 27.23 | 26.71 | 25.83 | 27.26 | 26.49 | 26.41 | 28.00 | - | - | ||||||
Rg7942 | PND 1 | M | 6.79 | 7.06 | 6.81 | 6.75 | - | - | - | - | - | - | - | - | - | - | - | - | 6.85 | 6.59 | ||
F | - | - | - | - | 6.61 | 6.59 | 6.73 | 6.41 | - | - | - | - | - | - | - | - | ||||||
PND 4 | M | 11.14 | 12.26 | 11.07 | 11.44 | - | - | - | - | - | - | - | - | - | - | - | - | 11.48 | 10.77 | |||
F | - | - | - | - | 10.91 | 10.97 | 10.46 | 10.73 | - | - | - | - | - | - | - | - | ||||||
PND 7 | M | 15.49 | 15.33 | 16.13 | 15.67 | - | - | - | - | - | - | - | - | - | - | - | - | 15.66 | 14.84 | |||
F | - | - | - | - | 14.90 | 14.75 | 15.06 | 14.65 | - | - | - | - | - | - | - | - | ||||||
PND 13 | M | 28.59 | 28.16 | 29.38 | 28.41 | - | - | - | - | - | - | - | - | - | - | - | - | 28.64 | 28.10 | |||
F | - | - | - | - | 27.96 | 28.14 | 28.33 | 27.98 | - | - | - | - | - | - | - | - | ||||||
Rg7943 | PND 1 | M | 6.70 | 6.53 | 6.19 | 6.87 | 6.63 | 6.76 | - | - | - | - | - | - | - | - | - | - | 6.61 | 6.43 | ||
F | - | - | - | - | - | - | 6.32 | 6.25 | 6.71 | - | - | - | - | - | - | - | ||||||
PND 4 | M | 10.94 | 10.72 | 10.49 | 11.01 | 10.83 | 10.69 | - | - | - | - | - | - | - | - | - | - | 10.78 | 10.44 | |||
F | - | - | - | - | - | - | 10.41 | 10.29 | 10.63 | - | - | - | - | - | - | - | ||||||
PND 7 | M | 15.76 | 15.11 | 14.38 | 15.24 | 14.79 | 14.77 | - | - | - | - | - | - | - | - | - | - | 15.01 | 14.32 | |||
F | - | - | - | - | - | - | 14.34 | 14.26 | 14.36 | - | - | - | - | - | - | - | ||||||
PND 13 | M | 29.79 | 28.56 | 27.94 | 28.48 | 27.66 | 28.12 | - | - | - | - | - | - | - | - | - | - | 28.43 | 27.99 | |||
F | - | - | - | - | - | - | 27.34 | 27.62 | 29.01 | - | - | - | - | - | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | Mean | ||
Male | Female | |||||||||||||||
G2 & 150 | Rg7944 | PND 1 | M | 6.61 | 6.74 | 6.58 | - | - | - | - | - | - | - | 6.64 | 6.25 | |
F | - | - | - | 6.91 | 6.01 | 6.32 | 6.14 | 6.11 | 6.07 | 6.21 | ||||||
PND 4 | M | 11.20 | 10.89 | 11.04 | - | - | - | - | - | - | - | 11.04 | 10.54 | |||
F | - | - | - | 10.14 | 10.57 | 10.26 | 10.93 | 10.49 | 10.72 | 10.66 | ||||||
PND 7 | M | 15.41 | 15.17 | 14.96 | - | - | - | - | - | - | - | 15.18 | 14.70 | |||
F | - | - | - | 15.01 | 14.73 | 14.58 | 14.46 | 14.82 | 14.93 | 14.36 | ||||||
PND 13 | M | 28.79 | 28.46 | 27.85 | - | - | - | - | - | - | - | 28.37 | 27.58 | |||
F | - | - | - | 27.96 | 27.67 | 27.32 | 27.43 | 27.41 | 28.02 | 27.26 | ||||||
Rg7945 | PND 1 | M | 6.92 | 7.11 | 6.87 | 6.97 | 6.68 | - | - | - | - | - | 6.91 | 6.57 | ||
F | - | - | - | - | - | 6.57 | 6.72 | 6.41 | - | - | ||||||
PND 4 | M | 11.16 | 12.11 | 10.99 | 11.16 | 10.84 | - | - | - | - | - | 11.25 | 10.54 | |||
F | - | - | - | - | - | 10.47 | 10.76 | 10.38 | - | - | ||||||
PND 7 | M | 15.56 | 15.21 | 15.38 | 14.87 | 14.76 | - | - | - | - | - | 15.16 | 14.95 | |||
F | - | - | - | - | - | 15.05 | 14.98 | 14.83 | - | - | ||||||
PND 13 | M | 29.16 | 28.72 | 29.14 | 28.96 | 27.16 | - | - | - | - | - | 28.63 | 27.94 | |||
F | - | - | - | - | - | 28.14 | 28.01 | 27.68 | - | - | ||||||
Rg7946 | PND 1 | M | 7.03 | 6.95 | 6.56 | - | - | - | - | - | - | - | 6.85 | 6.51 | ||
F | - | - | - | 6.83 | 6.42 | 6.29 | - | - | - | - | ||||||
PND 4 | M | 12.19 | 11.87 | 10.94 | - | - | - | - | - | - | - | 11.67 | 10.92 | |||
F | - | - | - | 10.99 | 11.01 | 10.76 | - | - | - | - | ||||||
PND 7 | M | 16.01 | 15.59 | 15.14 | - | - | - | - | - | - | - | 15.58 | 15.09 | |||
F | - | - | - | 15.03 | 15.27 | 14.96 | - | - | - | - | ||||||
PND 13 | M | 30.26 | 29.18 | 29.04 | - | - | - | - | - | - | - | 29.49 | 28.49 | |||
F | - | - | - | 28.89 | 28.47 | 28.12 | - | - | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | Mean | ||
Male | Female | |||||||||||||||||||||
G2 & 150 | Rg7947 | PND 1 | M | 6.71 | 6.59 | 7.14 | 7.02 | 6.84 | 6.92 | - | - | - | - | - | - | - | - | - | - | 6.87 | 6.39 | |
F | - | - | - | - | - | - | 6.41 | 6.49 | 6.34 | 6.33 | - | - | - | - | - | - | ||||||
PND 4 | M | 10.57 | 10.63 | 12.27 | 11.88 | 10.91 | 10.83 | - | - | - | - | - | - | - | - | - | - | 11.18 | 10.38 | |||
F | - | - | - | - | - | - | 10.34 | 10.61 | 10.14 | 10.43 | - | - | - | - | - | - | ||||||
PND 7 | M | 15.45 | 15.91 | 15.87 | 14.99 | 16.02 | 15.33 | - | - | - | - | - | - | - | - | - | - | 15.60 | 14.79 | |||
F | - | - | - | - | - | - | 14.90 | 14.75 | 14.84 | 14.66 | - | - | - | - | - | - | ||||||
PND 13 | M | 28.76 | 28.69 | 29.12 | 28.03 | 29.84 | 27.96 | - | - | - | - | - | - | - | - | - | - | 28.73 | 28.01 | |||
F | - | - | - | - | - | - | 28.34 | 28.66 | 27.39 | 27.64 | - | - | - | - | - | - | ||||||
Rg7948 | PND 1 | M | 6.39 | 6.61 | 6.48 | 6.57 | 6.94 | 6.77 | 6.63 | 6.42 | - | - | - | - | - | - | - | - | 6.60 | 6.04 | ||
F | - | - | - | - | - | - | - | - | 6.10 | 6.05 | 6.25 | 5.91 | 6.17 | 6.02 | 5.83 | 6.00 | ||||||
PND 4 | M | 10.51 | 10.79 | 10.41 | 10.38 | 11.01 | 10.86 | 10.58 | 10.39 | - | - | - | - | - | - | - | - | 10.62 | 10.06 | |||
F | - | - | - | - | - | - | - | - | 10.08 | 9.97 | 10.19 | 9.88 | 10.29 | 10.00 | 9.97 | 10.06 | ||||||
PND 7 | M | 13.93 | 14.16 | 14.44 | 13.73 | 15.41 | 14.87 | 14.35 | 13.23 | - | - | - | - | - | - | - | - | 14.27 | 13.29 | |||
F | - | - | - | - | - | - | - | - | 13.61 | 12.94 | 13.29 | 13.18 | 13.62 | 13.08 | - | - | ||||||
PND 13 | M | 26.83 | 27.54 | 27.91 | 26.88 | 28.14 | 27.39 | 27.76 | 27.18 | - | - | - | - | - | - | - | - | 27.45 | 26.70 | |||
F | - | - | - | - | - | - | - | - | 27.03 | 26.14 | 26.44 | 27.01 | 26.84 | 26.72 | - | - | ||||||
Rg7949 | Non-pregnant | |||||||||||||||||||||
Rg7950 | PND 1 | M | 6.57 | 6.88 | 6.99 | 7.18 | - | - | - | - | - | - | - | - | - | - | - | - | 6.91 | - | ||
PND 4 | M | 11.27 | 11.72 | 12.11 | 12.34 | - | - | - | - | - | - | - | - | - | - | - | - | 11.86 | - | |||
PND 7 | M | 16.14 | 15.85 | 15.97 | 15.78 | - | - | - | - | - | - | - | - | - | - | - | - | 15.94 | - | |||
PND 13 | M | 30.76 | 29.78 | 30.04 | 28.99 | - | - | - | - | - | - | - | - | - | - | - | - | 29.89 | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | Mean | ||
Male | Female | |||||||||||||||||
G2 & 150 | Rg7951 | PND 1 | M | 7.16 | 6.98 | 6.95 | - | - | - | - | - | - | - | - | - | 7.03 | 6.96 | |
F | - | - | - | 7.10 | 6.90 | 6.87 | - | - | - | - | - | - | ||||||
PND 4 | M | 12.23 | 12.01 | 11.83 | - | - | - | - | - | - | - | - | - | 12.02 | 11.69 | |||
F | - | - | - | 11.79 | 11.58 | 11.69 | - | - | - | - | - | - | ||||||
PND 7 | M | 16.13 | 16.27 | 15.98 | - | - | - | - | - | - | - | - | - | 16.13 | 15.63 | |||
F | - | - | - | 15.47 | 15.63 | 15.79 | - | - | - | - | - | - | ||||||
PND 13 | M | 30.03 | 29.97 | 29.78 | - | - | - | - | - | - | - | - | - | 29.93 | 29.02 | |||
F | - | - | - | 29.06 | 28.86 | 29.13 | - | - | - | - | - | - | ||||||
Rg7952 | PND 1 | M | 6.69 | 6.74 | 7.07 | 6.59 | 6.88 | 7.03 | - | - | - | - | - | - | 6.83 | 6.29 | ||
F | - | - | - | - | - | - | 6.43 | 6.27 | 6.09 | 6.51 | 6.34 | 6.11 | ||||||
PND 4 | M | 11.33 | 11.14 | 12.08 | 10.84 | 10.75 | 11.96 | - | - | - | - | - | - | 11.35 | 10.45 | |||
F | - | - | - | - | - | - | 10.67 | 10.53 | 10.32 | 10.76 | 10.15 | 10.28 | ||||||
PND 7 | M | 15.11 | 14.83 | 14.92 | 14.37 | 14.90 | 15.06 | - | - | - | - | - | - | 14.87 | 14.23 | |||
F | - | - | - | - | - | - | 14.54 | 14.25 | 14.18 | 13.94 | - | - | ||||||
PND 13 | M | 28.64 | 28.14 | 27.77 | 28.16 | 28.11 | 29.08 | - | - | - | - | - | - | 28.32 | 27.33 | |||
F | - | - | - | - | - | - | 27.46 | 27.53 | 27.36 | 26.98 | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | Mean | ||
Male | Female | ||||||||||||||||||
G3 & 300 | Rg7953 | Non-pregnant | |||||||||||||||||
Rg7954 | PND 1 | M | 6.69 | 6.83 | 7.18 | 6.54 | - | - | - | - | - | - | - | - | - | 6.81 | - | ||
PND 4 | M | 11.21 | 11.76 | 12.31 | 10.97 | - | - | - | - | - | - | - | - | - | 11.56 | - | |||
PND 7 | M | 15.91 | 15.98 | 16.13 | 15.75 | - | - | - | - | - | - | - | - | - | 15.94 | - | |||
PND 13 | M | 30.26 | 30.17 | 30.28 | 30.11 | - | - | - | - | - | - | - | - | - | 30.21 | - | |||
Rg7955 | PND 1 | M | 6.97 | 7.03 | 6.86 | 6.81 | 6.79 | 7.08 | - | - | - | - | - | - | - | 6.92 | 6.53 | ||
F | - | - | - | - | - | - | 6.44 | 6.59 | 6.48 | 6.61 | - | - | - | ||||||
PND 4 | M | 11.49 | 12.17 | 11.58 | 11.56 | 10.94 | 12.01 | - | - | - | - | - | - | - | 11.63 | 10.70 | |||
F | - | - | - | - | - | - | 10.59 | 10.43 | 10.66 | 11.13 | - | - | - | ||||||
PND 7 | M | 15.75 | 16.41 | 16.14 | 15.93 | 15.27 | 16.13 | - | - | - | - | - | - | - | 15.94 | 15.14 | |||
F | - | - | - | - | - | - | 15.08 | 14.93 | 14.98 | 15.56 | - | - | - | ||||||
PND 13 | M | 28.44 | 29.91 | 30.06 | 29.41 | 28.47 | 29.76 | - | - | - | - | - | - | - | 29.34 | 28.47 | |||
F | - | - | - | - | - | - | 28.51 | 28.23 | 28.47 | 28.66 | - | - | - | ||||||
Rg7956 | PND 1 | M | 6.95 | 6.72 | 6.88 | 6.91 | 6.60 | 6.77 | 7.16 | - | - | - | - | - | - | 6.86 | 6.53 | ||
F | - | - | - | - | - | - | - | 6.40 | 6.48 | 6.36 | 6.66 | 6.75 | 6.52 | ||||||
PND 4 | M | 11.41 | 10.93 | 11.16 | 12.01 | 10.44 | 10.68 | 11.94 | - | - | - | - | - | - | 11.22 | 10.49 | |||
F | - | - | - | - | - | - | - | 10.51 | 10.29 | 10.31 | 10.56 | 10.79 | 10.48 | ||||||
PND 7 | M | 15.90 | 15.82 | 14.98 | 14.86 | 15.48 | 15.33 | 15.72 | - | - | - | - | - | - | 15.44 | 15.11 | |||
F | - | - | - | - | - | - | - | 14.93 | 15.16 | 15.25 | 15.10 | - | - | ||||||
PND 13 | M | 28.19 | 28.27 | 28.16 | 27.91 | 28.46 | 28.67 | 28.97 | - | - | - | - | - | - | 28.38 | 27.72 | |||
F | - | - | - | - | - | - | - | 27.45 | 28.12 | 27.63 | 27.66 | - | - | ||||||
Rg7957 | Non-pregnant |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | Mean | ||
Male | Female | |||||||||||||||||
G3 & 300 | Rg7958 | PND 1 | M | 7.11 | 6.98 | 7.02 | - | - | - | - | - | - | - | - | - | 7.04 | 6.87 | |
F | - | - | - | 6.87 | - | - | - | - | - | - | - | - | ||||||
PND 4 | M | 12.34 | 11.53 | 12.42 | - | - | - | - | - | - | - | - | - | 12.10 | 11.18 | |||
F | - | - | - | 11.18 | - | - | - | - | - | - | - | - | ||||||
PND 7 | M | 16.31 | 15.94 | 16.27 | - | - | - | - | - | - | - | - | - | 16.17 | 15.66 | |||
F | - | - | - | 15.66 | - | - | - | - | - | - | - | - | ||||||
PND 13 | M | 29.69 | 29.52 | 28.97 | - | - | - | - | - | - | - | - | - | 29.39 | 28.90 | |||
F | - | - | - | 28.90 | - | - | - | - | - | - | - | - | ||||||
Rg7959 | PND 1 | M | 6.93 | 6.85 | 7.10 | 6.96 | - | - | - | - | - | - | - | - | 6.96 | 6.55 | ||
F | - | - | - | - | 6.49 | 6.77 | 6.50 | 6.61 | 6.38 | - | - | - | ||||||
PND 4 | M | 11.72 | 11.21 | 12.16 | 11.81 | - | - | - | - | - | - | - | - | 11.73 | 10.66 | |||
F | - | - | - | - | 10.72 | 10.58 | 10.72 | 10.81 | 10.47 | - | - | - | ||||||
PND 7 | M | 15.70 | 15.25 | 15.38 | 14.67 | - | - | - | - | - | - | - | - | 15.25 | 14.98 | |||
F | - | - | - | - | 14.53 | 15.16 | 15.25 | 15.06 | 14.92 | - | - | - | ||||||
PND 13 | M | 28.97 | 29.05 | 28.71 | 28.69 | - | - | - | - | - | - | - | - | 28.86 | 28.04 | |||
F | - | - | - | - | 27.49 | 28.17 | 28.56 | 27.93 | 28.04 | - | - | - | ||||||
Rg7960 | PND 1 | M | 6.73 | 6.49 | 7.07 | 6.88 | 6.71 | 6.64 | 6.41 | 6.79 | - | - | - | - | 6.72 | 6.37 | ||
F | - | - | - | - | - | - | - | - | 6.29 | 6.48 | 6.37 | 6.35 | ||||||
PND 4 | M | 10.88 | 10.57 | 12.14 | 11.71 | 11.08 | 10.72 | - | 11.01 | - | - | - | - | 11.16 | 10.45 | |||
F | - | - | - | - | - | - | - | - | 10.49 | 10.61 | 10.41 | 10.29 | ||||||
PND 7 | M | 14.69 | 14.47 | 16.17 | 15.87 | 15.61 | 14.76 | - | 15.01 | - | - | - | - | 15.23 | 14.17 | |||
F | - | - | - | - | - | - | - | - | 13.92 | 14.46 | 14.13 | - | ||||||
PND 13 | M | 27.53 | 27.85 | 29.91 | 28.78 | 29.03 | 27.47 | - | 28.11 | - | - | - | - | 28.38 | 27.61 | |||
F | - | - | - | - | - | - | - | - | 27.43 | 27.31 | 28.08 | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/ day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | Mean | ||
Male | Female | |||||||||||||||||||||||
G3 & 300 | Rg7961 | PND 1 | M | 6.77 | 6.95 | 7.01 | 7.21 | 6.83 | - | - | - | - | - | - | - | - | - | - | - | - | - | 6.95 | 6.34 | |
F | - | - | - | - | - | 6.47 | 6.41 | 6.37 | 6.54 | 6.19 | 6.07 | - | - | - | - | - | - | - | ||||||
PND 4 | M | 10.91 | 11.16 | 12.05 | 12.10 | 10.88 | - | - | - | - | - | - | - | - | - | - | - | - | - | 11.42 | 10.35 | |||
F | - | - | - | - | - | 10.22 | 10.37 | 10.42 | 10.19 | 10.50 | 10.40 | - | - | - | - | - | - | - | ||||||
PND 7 | M | 14.63 | 14.98 | 14.44 | 14.85 | 15.02 | - | - | - | - | - | - | - | - | - | - | - | - | - | 14.78 | 14.17 | |||
F | - | - | - | - | - | 14.26 | 14.19 | 13.94 | 13.99 | 14.47 | - | - | - | - | - | - | - | - | ||||||
PND 13 | M | 28.17 | 28.61 | 27.75 | 28.03 | 28.68 | - | - | - | - | - | - | - | - | - | - | - | - | - | 28.25 | 27.50 | |||
F | - | - | - | - | - | 27.67 | 27.46 | 26.98 | 27.43 | 27.95 | - | - | - | - | - | - | - | - | ||||||
Rg7962 | PND 1 | M | 6.93 | 6.49 | 6.85 | 6.99 | 7.06 | 6.40 | - | - | - | - | - | - | - | - | - | - | - | - | 6.79 | 6.40 | ||
F | - | - | - | - | - | - | 6.53 | 6.16 | 6.70 | 6.21 | - | - | - | - | - | - | - | - | ||||||
PND 4 | M | 11.29 | 10.47 | 10.93 | 11.47 | 12.11 | 10.58 | - | - | - | - | - | - | - | - | - | - | - | - | 11.14 | 10.56 | |||
F | - | - | - | - | - | - | 10.72 | 10.39 | 10.67 | 10.44 | - | - | - | - | - | - | - | - | ||||||
PND 7 | M | 15.87 | 15.03 | 15.41 | 15.36 | 16.41 | 14.98 | - | - | - | - | - | - | - | - | - | - | - | - | 15.51 | 14.97 | |||
F | - | - | - | - | - | - | 15.03 | 14.76 | 14.93 | 15.14 | - | - | - | - | - | - | - | - | ||||||
PND 13 | M | 28.73 | 28.14 | 28.36 | 28.47 | 30.03 | 28.11 | - | - | - | - | - | - | - | - | - | - | - | - | 28.64 | 28.15 | |||
F | - | - | - | - | - | - | 28.26 | 27.99 | 27.78 | 28.58 | - | - | - | - | - | - | - | - | ||||||
Rg7963 | Total litter loss | |||||||||||||||||||||||
Rg7964 | PND 1 | M | 6.23 | 5.94 | 6.01 | 6.41 | 6.26 | 5.88 | 6.07 | - | - | - | - | - | - | - | - | - | - | - | 6.11 | 5.84 | ||
F | - | - | - | - | - | - | - | 5.51 | 5.83 | 6.00 | 5.81 | 5.92 | 6.04 | 5.47 | 5.76 | 5.94 | 5.91 | 6.04 | ||||||
PND 4 | M | 10.47 | 10.03 | 10.14 | 10.63 | 10.38 | 10.01 | 10.16 | - | - | - | - | - | - | - | - | - | - | - | 10.26 | 9.94 | |||
F | - | - | - | - | - | - | - | 9.84 | 10.01 | 10.07 | 9.98 | 10.04 | 10.10 | - | 9.47 | 10.00 | 9.89 | 10.01 | ||||||
PND 7 | M | 14.78 | 14.11 | 14.36 | 14.51 | 14.03 | 13.98 | 15.16 | - | - | - | - | - | - | - | - | - | - | - | 14.42 | 13.98 | |||
F | - | - | - | - | - | - | - | 13.73 | 13.91 | 14.02 | 14.26 | 13.93 | 14.41 | - | 13.72 | 13.89 | - | - | ||||||
PND 13 | M | 26.97 | 27.03 | 27.41 | 27.66 | 27.38 | 26.89 | 28.14 | - | - | - | - | - | - | - | - | - | - | - | 27.35 | 26.73 | |||
F | - | - | - | - | - | - | - | 26.58 | 26.81 | 27.00 | 27.18 | 25.94 | 27.48 | - | 26.74 | 26.08 | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | Mean | ||
Male | Female | |||||||||||||||||||
G4 & 600 | Rg7965 | PND 1 | M | 5.01 | - | - | - | - | - | - | - | - | - | - | - | - | - | 5.01 | - | |
Rg7966 | PND 1 | M | 6.97 | 7.22 | 7.12 | - | - | - | - | - | - | - | - | - | - | - | 7.10 | 6.92 | ||
F | - | - | - | 6.80 | 6.92 | 6.86 | 7.09 | - | - | - | - | - | - | - | ||||||
PND 4 | M | 12.34 | 12.28 | 12.30 | - | - | - | - | - | - | - | - | - | - | - | 12.31 | 12.07 | |||
F | - | - | - | 12.18 | 11.96 | 12.05 | 12.09 | - | - | - | - | - | - | - | ||||||
PND 7 | M | 15.94 | 16.08 | 16.11 | - | - | - | - | - | - | - | - | - | - | - | 16.04 | 15.84 | |||
F | - | - | - | 15.73 | 15.66 | 16.03 | 15.94 | - | - | - | - | - | - | - | ||||||
PND 13 | M | 28.46 | 29.31 | 29.73 | - | - | - | - | - | - | - | - | - | - | - | 29.17 | 27.86 | |||
F | - | - | - | 28.53 | 27.49 | 28.46 | 26.94 | - | - | - | - | - | - | - | ||||||
Rg7967 | Total litter loss | |||||||||||||||||||
Rg7968 | PND 1 | M | 6.88 | 6.50 | 6.73 | 6.95 | 7.10 | 6.47 | 6.80 | 6.64 | - | - | - | - | - | - | 6.76 | 6.40 | ||
F | - | - | - | - | - | - | - | - | 6.43 | 6.54 | 6.35 | 6.70 | 6.25 | 6.12 | ||||||
PND 4 | M | 11.27 | 10.46 | 10.69 | 11.41 | 12.03 | 10.51 | 10.72 | 10.46 | - | - | - | - | - | - | 10.94 | 10.38 | |||
F | - | - | - | - | - | - | - | - | 10.29 | 10.71 | 10.38 | 10.64 | 10.09 | 10.17 | ||||||
PND 7 | M | 14.86 | 15.20 | 14.42 | 14.68 | 14.74 | 15.15 | 14.27 | 14.90 | - | - | - | - | - | - | 14.78 | 14.34 | |||
F | - | - | - | - | - | - | - | - | 13.96 | 14.55 | 14.69 | 14.16 | - | - | ||||||
PND 13 | M | 28.18 | 29.14 | 27.76 | 27.94 | 27.73 | 28.41 | 27.28 | 28.03 | - | - | - | - | - | - | 28.06 | 27.21 | |||
F | - | - | - | - | - | - | - | - | 26.44 | 27.67 | 27.33 | 27.40 | - | - | ||||||
Rg7969 | PND 1 | M | 6.55 | 6.93 | 6.86 | 6.99 | - | - | - | - | - | - | - | - | - | - | 6.83 | 6.47 | ||
F | - | - | - | - | 6.18 | 6.35 | 6.50 | 6.72 | 6.38 | 6.41 | 6.61 | 6.64 | - | - | ||||||
PND 4 | M | 11.26 | 11.13 | - | 10.96 | - | - | - | - | - | - | - | - | - | - | 11.12 | 11.03 | |||
F | - | - | - | - | 11.39 | 11.03 | 10.90 | 11.17 | 10.87 | 10.56 | - | 11.31 | - | - | ||||||
PND 7 | M | 15.56 | 15.79 | - | 14.98 | - | - | - | - | - | - | - | - | - | - | 15.44 | 14.90 | |||
F | - | - | - | - | 15.31 | 15.05 | 14.59 | 15.21 | 14.39 | 14.27 | - | 15.46 | - | - | ||||||
PND 13 | M | 29.24 | 28.17 | - | 27.36 | - | - | - | - | - | - | - | - | - | - | 28.26 | 27.58 | |||
F | - | - | - | - | 28.42 | 27.61 | 27.42 | 28.41 | 27.36 | 26.59 | - | 27.27 | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight /day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | Mean | ||
Male | Female | |||||||||||||||||||||||
G4 & 600 | Rg7970 | PND 1 | M | 6.73 | 6.96 | 6.60 | 7.01 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 6.83 | 6.52 | |
F | - | - | - | - | 6.72 | 6.42 | 6.50 | 6.38 | 6.42 | 6.68 | - | - | - | - | - | - | - | - | ||||||
PND 4 | M | 10.87 | 11.41 | 10.78 | 12.21 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 11.32 | 10.56 | |||
F | - | - | - | - | 10.81 | 10.57 | 10.36 | 10.27 | 10.58 | 10.77 | - | - | - | - | - | - | - | - | ||||||
PND 7 | M | 14.31 | 14.96 | 14.40 | 14.17 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 14.46 | 14.48 | |||
F | - | - | - | - | 14.85 | 13.99 | 14.16 | 14.58 | 14.60 | 14.70 | - | - | - | - | - | - | - | - | ||||||
PND 13 | M | 27.78 | 28.94 | 27.66 | 28.11 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 28.12 | 27.41 | |||
F | - | - | - | - | 27.86 | 26.45 | 27.31 | 27.63 | 27.42 | 27.77 | - | - | - | - | - | - | - | - | ||||||
Rg7971 | PND 1 | M | 6.72 | 6.91 | 6.58 | 6.71 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 6.73 | 6.32 | ||
F | - | - | - | - | 6.28 | 6.21 | 6.37 | 6.54 | 6.41 | 6.35 | 6.26 | 6.14 | - | - | - | - | - | - | ||||||
PND 4 | M | 10.69 | 11.09 | 10.76 | 10.51 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 10.76 | 10.28 | |||
F | - | - | - | - | 10.37 | 10.48 | 10.21 | 10.56 | 10.60 | 10.10 | 10.19 | 9.74 | - | - | - | - | - | - | ||||||
PND 7 | M | 14.97 | 15.61 | 14.86 | 14.79 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 15.06 | 14.60 | |||
F | - | - | - | - | 14.78 | 15.01 | 14.32 | 14.54 | 14.46 | 14.51 | - | - | - | - | - | - | - | - | ||||||
PND 13 | M | 28.01 | 28.61 | 28.43 | 27.94 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 28.25 | 27.50 | |||
F | - | - | - | - | 27.27 | 28.24 | 26.98 | 27.23 | 27.54 | 27.73 | - | - | - | - | - | - | - | - | ||||||
Rg7972 | PND 1 | M | 4.79 | 3.86 | 3.83 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | 4.16 | 4.10 | ||
F | - | - | - | 4.11 | 4.35 | 4.21 | 3.28 | 3.96 | 4.49 | 4.28 | 4.12 | - | - | - | - | - | - | - | ||||||
Rg7973 | Non-pregnant | |||||||||||||||||||||||
Rg7974 | PND 1 | M | 6.01 | 6.09 | 6.27 | 6.33 | 6.17 | 5.94 | 6.87 | 6.73 | - | - | - | - | - | - | - | - | - | - | 6.30 | 5.92 | ||
F | - | - | - | - | - | - | - | - | 5.47 | 6.21 | 6.07 | 5.88 | 5.91 | 5.66 | 6.04 | 6.11 | 6.01 | 5.86 | ||||||
PND 4 | M | - | 10.23 | 10.46 | 10.19 | 10.08 | 10.00 | 11.14 | 10.86 | - | - | - | - | - | - | - | - | - | - | 10.42 | 9.99 | |||
F | - | - | - | - | - | - | - | - | 9.91 | 10.10 | 10.02 | 9.76 | 10.03 | 9.74 | 10.14 | 10.21 | 10.06 | 9.92 | ||||||
PND 7 | M | - | 14.51 | 14.67 | 14.91 | 14.38 | 14.05 | 15.23 | 13.92 | - | - | - | - | - | - | - | - | - | - | 14.52 | 13.97 | |||
F | - | - | - | - | - | - | - | - | 14.35 | 13.87 | 14.06 | 13.98 | 13.77 | 14.13 | 13.66 | 13.95 | - | - | ||||||
PND 13 | M | - | 27.23 | 28.01 | 27.96 | 27.78 | 27.49 | 28.17 | 26.38 | - | - | - | - | - | - | - | - | - | - | 27.57 | 26.87 | |||
F | - | - | - | - | - | - | - | - | 27.41 | 26.21 | 26.97 | 26.87 | 26.91 | 27.04 | 26.44 | 27.11 | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
APPENDIX 19 (Contd…). INDIVIDUAL PUP WEIGHT (g) AND MEAN PUP WEIGHT (g) PER LITTER RECORD
Group & Dose (mg/kg body weight/day) | Dam No. | Post-natal Day ↓ | Pup No. → Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | Mean | ||
Male | Female | |||||||||||||||||||
G4 & 600 | Rg7975 | PND 1 | M | 6.81 | 6.09 | 6.93 | 7.11 | 6.97 | 6.68 | - | - | - | - | - | - | - | - | 6.77 | 6.19 | |
F | - | - | - | - | - | - | 6.07 | 5.98 | 6.21 | 6.37 | 6.18 | 6.47 | 6.06 | 6.21 | ||||||
PND 4 | M | 10.63 | 10.27 | 11.11 | 12.03 | 10.87 | 10.76 | - | - | - | - | - | - | - | - | 10.95 | 10.12 | |||
F | - | - | - | - | - | - | 9.98 | 10.01 | 10.07 | 10.26 | 10.19 | 10.52 | 9.81 | 10.14 | ||||||
PND 7 | M | 14.40 | 14.63 | 14.95 | 14.72 | 15.01 | 14.95 | - | - | - | - | - | - | - | - | 14.78 | 14.38 | |||
F | - | - | - | - | - | - | 13.84 | 14.16 | 14.24 | 14.60 | 14.87 | 14.59 | - | - | ||||||
PND 13 | M | 28.11 | 27.92 | 28.69 | 27.17 | 28.79 | 28.03 | - | - | - | - | - | - | - | - | 28.12 | 27.40 | |||
F | - | - | - | - | - | - | 26.98 | 26.94 | 27.27 | 27.63 | 28.10 | 27.46 | - | - | ||||||
Rg7976 | PND 1 | M | 6.67 | 6.83 | 6.89 | 7.11 | - | - | - | - | - | - | - | - | - | - | 6.88 | 6.52 | ||
F | - | - | - | - | 6.57 | 6.49 | 6.81 | 6.43 | 6.32 | - | - | - | - | - | ||||||
PND 4 | M | 10.35 | 10.42 | 10.81 | 11.33 | - | - | - | - | - | - | - | - | - | - | 10.73 | 10.49 | |||
F | - | - | - | - | 10.73 | 10.68 | 10.45 | 9.79 | 10.82 | - | - | - | - | - | ||||||
PND 7 | M | 14.79 | 15.01 | 15.28 | 15.46 | - | - | - | - | - | - | - | - | - | - | 15.14 | 14.56 | |||
F | - | - | - | - | 14.83 | 14.61 | 14.37 | 14.08 | 14.91 | - | - | - | - | - | ||||||
PND 13 | M | 29.77 | 30.11 | 29.48 | 28.63 | - | - | - | - | - | - | - | - | - | - | 29.50 | 27.61 | |||
F | - | - | - | - | 27.94 | 27.41 | 27.28 | 28.06 | 27.38 | - | - | - | - | - |
M: Male; F: Female; PND: Postnatal Day; -: Not applicable.
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| Mean | |
Male | Female | ||||||||||||||||||
G1 & 0 | Rg7929 | P.Wt. (g) | M | 12.04 | 11.79 | 12.14 | 11.26 | 11.57 | 11.41 | - | - | - | - | - | - | - |
| 11.70 | 11.04 |
F | - | - | - | - | - | - | 11.08 | 11.21 | 10.98 | 10.87 | - | - | - | ||||||
AGD Measurement (mm) | M | 5.61 | 5.29 | 5.58 | 5.08 | 5.31 | 5.14 | - | - | - | - | - | - | - | 5.34 | 2.73 | |||
F | - | - | - | - | - | - | 2.79 | 2.63 | 2.81 | 2.67 | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.29 | 2.28 | 2.30 | 2.24 | 2.26 | 2.25 | - | - | - | - | - | - | - | 2.27 | 2.23 | |||
F | - | - | - | - | - | - | 2.23 | 2.24 | 2.22 | 2.22 | - | - | - | ||||||
AGD Ratio | M | 2.45 | 2.32 | 2.43 | 2.27 | 2.35 | 2.28 | - | - | - | - | - | - | - | 2.35 | 1.22 | |||
F | - | - | - | - | - | - | 1.25 | 1.18 | 1.26 | 1.21 | - | - | - |
| |||||
Rg7930 | P.Wt. (g) | M | 12.47 | 12.04 | 11.85 | - | - | - | - | - | - | - | - | - | - |
| 12.12 | 11.55 | |
F | - | - | - | 11.43 | 11.62 | 11.71 | 11.53 | 11.48 | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.49 | 5.26 | 5.41 | - | - | - | - | - | - | - | - | - | - | 5.39 | 2.86 | |||
F | - | - | - | 2.79 | 2.92 | 2.93 | 2.88 | 2.77 | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.32 | 2.29 | 2.28 | - | - | - | - | - | - | - | - | - | - | 2.30 | 2.26 | |||
F | - | - | - | 2.25 | 2.27 | 2.27 | 2.26 | 2.26 | - | - | - | - | - | ||||||
AGD Ratio | M | 2.37 | 2.29 | 2.37 | - | - | - | - | - | - | - | - | - | - | 2.35 | 1.26 | |||
F | - | - | - | 1.24 | 1.29 | 1.29 | 1.27 | 1.23 | - | - | - | - | - |
| |||||
Rg7931 | P.Wt. (g) | M | 12.01 | 11.41 | 10.72 | 10.61 | 10.81 | 10.94 | 11.27 | - | - | - | - | - | - |
| 11.11 | 10.64 | |
F | - | - | - | - | - | - | - | 11.49 | 10.67 | 10.48 | 10.51 | 10.37 | 10.31 | ||||||
AGD Measurement (mm) | M | 5.33 | 5.17 | 4.96 | 4.83 | 5.07 | 5.11 | 5.42 | - | - | - | - | - | - | 5.13 | 2.59 | |||
F | - | - | - | - | - | - | - | 2.86 | 2.69 | 2.48 | 2.71 | 2.42 | 2.38 | ||||||
Cube Root of P.Wt. | M | 2.29 | 2.25 | 2.20 | 2.20 | 2.21 | 2.22 | 2.24 | - | - | - | - | - | - | 2.23 | 2.20 | |||
F | - | - | - | - | - | - | - | 2.26 | 2.20 | 2.19 | 2.19 | 2.18 | 2.18 | ||||||
AGD Ratio | M | 2.33 | 2.30 | 2.25 | 2.20 | 2.29 | 2.30 | 2.42 | - | - | - | - | - | - | 2.30 | 1.18 | |||
F | - | - | - | - | - | - | - | 1.27 | 1.22 | 1.13 | 1.24 | 1.11 | 1.09 |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 |
| Mean | |
Male | Female | ||||||||||||||||
G1 & 0 | Rg7932 | P.Wt. (g) | M | 11.91 | 12.41 | 12.01 | - | - | - | - | - | - | - | - |
| 12.11 | 10.87 |
F | - | - | - | - | 10.94 | 10.57 | 11.11 | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.46 | 5.67 | 5.31 | - | - | - | - | - | - | - | - | 5.48 | 2.78 | |||
F | - | - | - | - | 2.86 | 2.58 | 2.91 | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.28 | 2.32 | 2.29 | - | - | - | - | - | - | - | - | 2.30 | 2.22 | |||
F | - | - | - | - | 2.22 | 2.19 | 2.23 | - | - | - | - | ||||||
AGD Ratio | M | 2.39 | 2.45 | 2.32 | - | - | - | - | - | - | - | - | 2.39 | 1.26 | |||
F | - | - | - | - | 1.29 | 1.18 | 1.30 | - | - | - | - |
| |||||
Rg7933 | P.Wt. (g) | M | 11.42 | 12.16 | 11.39 | 10.47 | 12.08 | 10.84 | 10.77 | 10.61 | 11.47 | - | - |
| 11.25 | 10.57 | |
F | - | - | - | - | - | - | - | - | - | 10.72 | 10.41 | ||||||
AGD Measurement (mm) | M | 5.24 | 5.61 | 5.39 | 4.74 | 5.48 | 5.03 | 4.87 | 4.72 | 5.27 | - | - | 5.15 | 2.67 | |||
F | - | - | - | - | - | - | - | - | - | 2.82 | 2.51 | ||||||
Cube Root of P.Wt. | M | 2.25 | 2.30 | 2.25 | 2.19 | 2.29 | 2.21 | 2.21 | 2.20 | 2.26 | - | - | 2.24 | 2.19 | |||
F | - | - | - | - | - | - | - | - | - | 2.20 | 2.18 | ||||||
AGD Ratio | M | 2.33 | 2.44 | 2.40 | 2.17 | 2.39 | 2.27 | 2.21 | 2.15 | 2.34 | - | - | 2.30 | 1.21 | |||
F | - | - | - | - | - | - | - | - | - | 1.28 | 1.15 |
| |||||
Rg7934 | P.Wt. (g) | M | 10.72 | 11.41 | 10.91 | 12.16 | - | - | - | - | - | - | - |
| 11.30 | 10.50 | |
F | - | - | - | - | 10.61 | 10.54 | 10.49 | 10.41 | 10.44 | - | - | ||||||
AGD Measurement (mm) | M | 4.84 | 5.14 | 5.01 | 5.47 | - | - | - | - | - | - | - | 5.12 | 2.62 | |||
F | - | - | - | - | 2.61 | 2.53 | 2.72 | 2.66 | 2.57 | - | - | ||||||
Cube Root of P.Wt. | M | 2.20 | 2.25 | 2.22 | 2.30 | - | - | - | - | - | - | - | 2.24 | 2.19 | |||
F | - | - | - | - | 2.20 | 2.19 | 2.19 | 2.18 | 2.19 | - | - | ||||||
AGD Ratio | M | 2.20 | 2.28 | 2.26 | 2.38 | - | - | - | - | - | - | - | 2.28 | 1.20 | |||
F | - | - | - | - | 1.19 | 1.15 | 1.24 | 1.22 | 1.18 | - | - |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| Mean | |
Male | Female | ||||||||||||||||||
G1 & 0 | Rg7935 | P.Wt. (g) | M | 10.23 | 10.47 | 10.36 | 12.03 | 11.98 | 10.67 | 10.41 | - | - | - | - | - | - |
| 10.88 | 10.41 |
F | - | - | - | - | - | - | - | 10.33 | 10.51 | 10.63 | 10.08 | 10.11 | 10.79 | ||||||
AGD Measurement (mm) | M | 4.86 | 5.21 | 5.11 | 4.93 | 4.77 | 4.88 | 4.92 | - | - | - | - | - | - | 4.95 | 2.61 | |||
F | - | - | - | - | - | - | - | 2.90 | 2.49 | 2.66 | 2.87 | 2.33 | 2.42 | ||||||
Cube Root of P.Wt. | M | 2.17 | 2.19 | 2.18 | 2.29 | 2.29 | 2.20 | 2.18 | - | - | - | - | - | - | 2.21 | 2.18 | |||
F | - | - | - | - | - | - | - | 2.18 | 2.19 | 2.20 | 2.16 | 2.16 | 2.21 | ||||||
AGD Ratio | M | 2.24 | 2.38 | 2.34 | 2.15 | 2.08 | 2.22 | 2.25 | - | - | - | - | - | - | 2.24 | 1.20 | |||
F | - | - | - | - | - | - | - | 1.33 | 1.14 | 1.21 | 1.33 | 1.08 | 1.10 |
| |||||
Rg7936 | P.Wt. (g) | M | 11.11 | 12.06 | 11.47 | 10.72 | 10.94 | 10.58 | - | - | - | - | - | - | - |
| 11.15 | 10.36 | |
F | - | - | - | - | - | - | 10.31 | 10.33 | 10.45 | 10.62 | 10.27 | 10.19 | - | ||||||
AGD Measurement (mm) | M | 5.08 | 5.37 | 5.14 | 4.96 | 4.99 | 5.01 | - | - | - | - | - | - | - | 5.09 | 2.50 | |||
F | - | - | - | - | - | - | 2.41 | 2.38 | 2.66 | 2.72 | 2.47 | 2.34 | - | ||||||
Cube Root of P.Wt. | M | 2.23 | 2.29 | 2.26 | 2.20 | 2.22 | 2.20 | - | - | - | - | - | - | - | 2.23 | 2.18 | |||
F | - | - | - | - | - | - | 2.18 | 2.18 | 2.19 | 2.20 | 2.17 | 2.17 | - | ||||||
AGD Ratio | M | 2.28 | 2.34 | 2.28 | 2.25 | 2.25 | 2.28 | - | - | - | - | - | - | - | 2.28 | 1.14 | |||
F | - | - | - | - | - | - | 1.11 | 1.09 | 1.22 | 1.24 | 1.14 | 1.08 | - |
| |||||
Rg7937 | P.Wt. (g) | M | 11.27 | 12.21 | - | - | - | - | - | - | - | - | - | - | - |
| 11.74 | 10.94 | |
F | - | - | 10.94 | 11.01 | 10.87 | - | - | - | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.27 | 5.66 | - | - | - | - | - | - | - | - | - | - | - | 5.47 | 2.91 | |||
F | - | - | 2.91 | 2.97 | 2.86 | - | - | - | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.24 | 2.30 | - | - | - | - | - | - | - | - | - | - | - | 2.27 | 2.22 | |||
F | - | - | 2.22 | 2.22 | 2.22 | - | - | - | - | - | - | - | - | ||||||
AGD Ratio | M | 2.35 | 2.46 | - | - | - | - | - | - | - | - | - | - | - | 2.40 | 1.31 | |||
F | - | - | 1.31 | 1.34 | 1.29 | - | - | - | - | - | - | - | - |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/ day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 |
| Mean | |
Male | Female | ||||||||||||||||||||||
G1 & 0 | Rg7938 | P.Wt. (g) | M | 10.14 | 10.53 | 10.02 | 10.29 | 10.37 | 10.41 | 10.89 | 10.63 | 10.44 | 10.93 | - | - | - | - | - | - | - |
| 10.47 | 9.97 |
F | - | - | - | - | - | - | - | - | - | - | 9.91 | 10.17 | 10.03 | 9.97 | 9.86 | 10.03 | 9.84 | ||||||
AGD Measurement (mm) | M | 4.69 | 4.83 | 4.61 | 4.72 | 4.73 | 4.92 | 5.01 | 4.78 | 4.66 | 5.11 | - | - | - | - | - | - | - | 4.81 | 2.42 | |||
F | - | - | - | - | - | - | - | - | - | - | 2.37 | 2.43 | 2.31 | 2.52 | 2.47 | 2.38 | 2.43 | ||||||
Cube Root of P.Wt. | M | 2.16 | 2.19 | 2.16 | 2.18 | 2.18 | 2.18 | 2.22 | 2.20 | 2.19 | 2.22 | - | - | - | - | - | - | - | 2.19 | 2.15 | |||
F | - | - | - | - | - | - | - | - | - | - | 2.15 | 2.17 | 2.16 | 2.15 | 2.14 | 2.16 | 2.14 | ||||||
AGD Ratio | M | 2.17 | 2.20 | 2.14 | 2.17 | 2.17 | 2.25 | 2.26 | 2.17 | 2.13 | 2.30 | - | - | - | - | - | - | - | 2.20 | 1.12 | |||
F | - | - | - | - | - | - | - | - | - | - | 1.10 | 1.12 | 1.07 | 1.17 | 1.15 | 1.10 | 1.13 |
| |||||
Rg7939 | P.Wt. (g) | M | 10.91 | 12.16 | 11.41 | 11.09 | 12.01 | 12.11 | 12.07 | 11.26 | - | - | - | - | - | - | - | - | - |
| 11.63 | 10.54 | |
F | - | - | - | - | - | - | - | - | 10.72 | 10.51 | 10.79 | 10.38 | 10.29 | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.01 | 5.53 | 5.21 | 5.19 | 5.46 | 5.63 | 5.28 | 5.14 | - | - | - | - | - | - | - | - | - | 5.31 | 2.63 | |||
F | - | - | - | - | - | - | - | - | 2.79 | 2.61 | 2.84 | 2.48 | 2.41 | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.22 | 2.30 | 2.25 | 2.23 | 2.29 | 2.30 | 2.29 | 2.24 | - | - | - | - | - | - | - | - | - | 2.27 | 2.19 | |||
F | - | - | - | - | - | - | - | - | 2.20 | 2.19 | 2.21 | 2.18 | 2.18 | - | - | - | - | ||||||
AGD Ratio | M | 2.26 | 2.40 | 2.31 | 2.33 | 2.38 | 2.45 | 2.30 | 2.29 | - | - | - | - | - | - | - | - | - | 2.34 | 1.20 | |||
F | - | - | - | - | - | - | - | - | 1.27 | 1.19 | 1.29 | 1.14 | 1.11 | - | - | - | - |
| |||||
Rg7940 | P.Wt. (g) | M | 12.31 | 11.41 | 11.72 | 11.27 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 11.68 | 10.81 | |
F | - | - | - | - | 10.94 | 10.81 | 10.66 | 10.84 | - | - | - | - | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.41 | 5.07 | 5.26 | 5.18 | - | - | - | - | - | - | - | - | - | - | - | - | - | 5.23 | 2.88 | |||
F | - | - | - | - | 2.94 | 2.88 | 2.73 | 2.96 | - | - | - | - | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.31 | 2.25 | 2.27 | 2.24 | - | - | - | - | - | - | - | - | - | - | - | - | - | 2.27 | 2.21 | |||
F | - | - | - | - | 2.22 | 2.21 | 2.20 | 2.21 | - | - | - | - | - | - | - | - | - | ||||||
AGD Ratio | M | 2.34 | 2.25 | 2.32 | 2.31 | - | - | - | - | - | - | - | - | - | - | - | - | - | 2.31 | 1.30 | |||
F | - | - | - | - | 1.32 | 1.30 | 1.24 | 1.34 | - | - | - | - | - | - | - | - | - |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 |
| Mean | |
Male | Female | |||||||||||||||||||||
G2 & 150 | Rg7941 | P.Wt. (g) | M | 10.27 | 10.58 | 10.11 | 10.94 | 10.87 | 10.41 | - | - | - | - | - | - | - | - | - | - |
| 10.53 | 10.02 |
F | - | - | - | - | - | - | 10.01 | 10.21 | 9.97 | 9.86 | 9.72 | 10.11 | 10.31 | 10.00 | 9.94 | 10.04 | ||||||
AGD Measurement (mm) | M | 4.98 | 4.87 | 4.81 | 5.14 | 5.01 | 4.93 | - | - | - | - | - | - | - | - | - | - | 4.96 | 2.44 | |||
F | - | - | - | - | - | - | 2.39 | 2.61 | 2.33 | 2.37 | 2.48 | 2.51 | 2.46 | 2.36 | 2.40 | 2.44 | ||||||
Cube Root of P.Wt. | M | 2.17 | 2.20 | 2.16 | 2.22 | 2.22 | 2.18 | - | - | - | - | - | - | - | - | - | - | 2.19 | 2.16 | |||
F | - | - | - | - | - | - | 2.16 | 2.17 | 2.15 | 2.14 | 2.13 | 2.16 | 2.18 | 2.15 | 2.15 | 2.16 | ||||||
AGD Ratio | M | 2.29 | 2.22 | 2.22 | 2.32 | 2.26 | 2.26 | - | - | - | - | - | - | - | - | - | - | 2.26 | 1.13 | |||
F | - | - | - | - | - | - | 1.11 | 1.20 | 1.08 | 1.11 | 1.16 | 1.16 | 1.13 | 1.10 | 1.12 | 1.13 |
| |||||
Rg7942 | P.Wt. (g) | M | 11.14 | 12.26 | 11.07 | 11.44 | - | - | - | - | - | - | - | - | - | - | - | - |
| 11.48 | 10.77 | |
F | - | - | - | - | 10.91 | 10.97 | 10.46 | 10.73 | - | - | - | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.27 | 5.56 | 5.19 | 5.21 | - | - | - | - | - | - | - | - | - | - | - | - | 5.31 | 2.90 | |||
F | - | - | - | - | 2.91 | 3.02 | 2.86 | 2.81 | - | - | - | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.23 | 2.31 | 2.23 | 2.25 | - | - | - | - | - | - | - | - | - | - | - | - | 2.26 | 2.21 | |||
F | - | - | - | - | 2.22 | 2.22 | 2.19 | 2.21 | - | - | - | - | - | - | - | - | ||||||
AGD Ratio | M | 2.36 | 2.41 | 2.33 | 2.31 | - | - | - | - | - | - | - | - | - | - | - | - | 2.35 | 1.31 | |||
F | - | - | - | - | 1.31 | 1.36 | 1.31 | 1.27 | - | - | - | - | - | - | - | - |
| |||||
Rg7943 | P.Wt. (g) | M | 10.94 | 10.72 | 10.49 | 11.01 | 10.83 | 10.69 | - | - | - | - | - | - | - | - | - | - |
| 10.78 | 10.44 | |
F | - | - | - | - | - | - | 10.41 | 10.29 | 10.63 | - | - | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.11 | 4.96 | 4.81 | 5.27 | 5.03 | 4.86 | - | - | - | - | - | - | - | - | - | - | 5.01 | 2.64 | |||
F | - | - | - | - | - | - | 2.72 | 2.36 | 2.83 | - | - | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.22 | 2.20 | 2.19 | 2.22 | 2.21 | 2.20 | - | - | - | - | - | - | - | - | - | - | 2.21 | 2.19 | |||
F | - | - | - | - | - | - | 2.18 | 2.18 | 2.20 | - | - | - | - | - | - | - | ||||||
AGD Ratio | M | 2.30 | 2.25 | 2.20 | 2.37 | 2.27 | 2.21 | - | - | - | - | - | - | - | - | - | - | 2.27 | 1.21 | |||
F | - | - | - | - | - | - | 1.25 | 1.09 | 1.29 | - | - | - | - | - | - | - |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 |
| Mean | |
Male | Female | |||||||||||||||
G2 & 150 | Rg7944 | P.Wt. (g) | M | 11.20 | 10.89 | 11.04 | - | - | - | - | - | - | - |
| 11.04 | 10.54 |
F | - | - | - | 10.14 | 10.57 | 10.26 | 10.93 | 10.49 | 10.72 | 10.66 | ||||||
AGD Measurement (mm) | M | 5.13 | 4.96 | 5.08 | - | - | - | - | - | - | - | 5.06 | 2.73 | |||
F | - | - | - | 2.64 | 2.75 | 2.62 | 2.96 | 2.59 | 2.82 | 2.76 | ||||||
Cube Root of P.Wt. | M | 2.24 | 2.22 | 2.23 | - | - | - | - | - | - | - | 2.23 | 2.19 | |||
F | - | - | - | 2.16 | 2.19 | 2.17 | 2.22 | 2.19 | 2.20 | 2.20 | ||||||
AGD Ratio | M | 2.29 | 2.24 | 2.28 | - | - | - | - | - | - | - | 2.27 | 1.25 | |||
F | - | - | - | 1.22 | 1.25 | 1.21 | 1.33 | 1.18 | 1.28 | 1.25 |
| |||||
Rg7945 | P.Wt. (g) | M | 11.16 | 12.11 | 10.99 | 11.16 | 10.84 | - | - | - | - | - |
| 11.25 | 10.54 | |
F | - | - | - | - | - | 10.47 | 10.76 | 10.38 | - | - | ||||||
AGD Measurement (mm) | M | 5.21 | 5.48 | 5.03 | 5.16 | 5.04 | - | - | - | - | - | 5.18 | 2.70 | |||
F | - | - | - | - | - | 2.74 | 2.86 | 2.49 | - | - | ||||||
Cube Root of P.Wt. | M | 2.23 | 2.30 | 2.22 | 2.23 | 2.21 | - | - | - | - | - | 2.24 | 2.19 | |||
F | - | - | - | - | - | 2.19 | 2.21 | 2.18 | - | - | ||||||
AGD Ratio | M | 2.33 | 2.39 | 2.26 | 2.31 | 2.28 | - | - | - | - | - | 2.31 | 1.23 | |||
F | - | - | - | - | - | 1.25 | 1.30 | 1.14 | - | - |
| |||||
Rg7946 | P.Wt. (g) | M | 12.19 | 11.87 | 10.94 | - | - | - | - | - | - | - |
| 11.67 | 10.92 | |
F | - | - | - | 10.99 | 11.01 | 10.76 | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.57 | 5.31 | 5.08 | - | - | - | - | - | - | - | 5.32 | 2.95 | |||
F | - | - | - | 2.93 | 3.06 | 2.87 | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.30 | 2.28 | 2.22 | - | - | - | - | - | - | - | 2.27 | 2.22 | |||
F | - | - | - | 2.22 | 2.22 | 2.21 | - | - | - | - | ||||||
AGD Ratio | M | 2.42 | 2.33 | 2.29 | - | - | - | - | - | - | - | 2.35 | 1.33 | |||
F | - | - | - | 1.32 | 1.38 | 1.30 | - | - | - | - |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 |
| Mean | |
Male | Female | |||||||||||||||||||||
G2 & 150 | Rg7947 | P.Wt. (g) | M | 10.57 | 10.63 | 12.27 | 11.88 | 10.91 | 10.83 | - | - | - | - | - | - | - | - | - | - |
| 11.18 | 10.38 |
F | - | - | - | - | - | - | 10.34 | 10.61 | 10.14 | 10.43 | - | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 4.75 | 4.92 | 5.58 | 5.28 | 5.11 | 4.96 | - | - | - | - | - | - | - | - | - | - | 5.10 | 2.51 | |||
F | - | - | - | - | - | - | 2.43 | 2.71 | 2.38 | 2.53 | - | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.19 | 2.20 | 2.31 | 2.28 | 2.22 | 2.21 | - | - | - | - | - | - | - | - | - | - | 2.24 | 2.18 | |||
F | - | - | - | - | - | - | 2.18 | 2.20 | 2.16 | 2.18 | - | - | - | - | - | - | ||||||
AGD Ratio | M | 2.16 | 2.24 | 2.42 | 2.31 | 2.30 | 2.24 | - | - | - | - | - | - | - | - | - | - | 2.28 | 1.15 | |||
F | - | - | - | - | - | - | 1.12 | 1.23 | 1.10 | 1.16 | - | - | - | - | - | - |
| |||||
Rg7948 | P.Wt. (g) | M | 10.51 | 10.79 | 10.41 | 10.38 | 11.01 | 10.86 | 10.58 | 10.39 | - | - | - | - | - | - | - | - |
| 10.62 | 10.06 | |
F | - | - | - | - | - | - | - | - | 10.08 | 9.97 | 10.19 | 9.88 | 10.29 | 10.00 | 9.97 | 10.06 | ||||||
AGD Measurement (mm) | M | 4.79 | 4.93 | 4.68 | 4.72 | 5.33 | 5.26 | 4.97 | 4.79 | - | - | - | - | - | - | - | - | 4.93 | 2.43 | |||
F | - | - | - | - | - | - | - | - | 2.38 | 2.41 | 2.34 | 2.66 | 2.47 | 2.31 | 2.44 | 2.41 | ||||||
Cube Root of P.Wt. | M | 2.19 | 2.21 | 2.18 | 2.18 | 2.22 | 2.21 | 2.20 | 2.18 | - | - | - | - | - | - | - | - | 2.20 | 2.16 | |||
F | - | - | - | - | - | - | - | - | 2.16 | 2.15 | 2.17 | 2.15 | 2.18 | 2.15 | 2.15 | 2.16 | ||||||
AGD Ratio | M | 2.19 | 2.23 | 2.14 | 2.16 | 2.40 | 2.38 | 2.26 | 2.20 | - | - | - | - | - | - | - | - | 2.24 | 1.12 | |||
F | - | - | - | - | - | - | - | - | 1.10 | 1.12 | 1.08 | 1.24 | 1.14 | 1.07 | 1.13 | 1.12 |
| |||||
Rg7949 | Non-pregnant | |||||||||||||||||||||
Rg7950 | P.Wt. (g) | M | 11.27 | 11.72 | 12.11 | 12.34 | - | - | - | - | - | - | - | - | - | - | - | - |
| 11.86 |
| |
AGD Measurement (mm) | M | 5.21 | 5.11 | 5.43 | 5.57 | - | - | - | - | - | - | - | - | - | - | - | - | 5.33 | ||||
Cube Root of P.Wt. | M | 2.24 | 2.27 | 2.30 | 2.31 | - | - | - | - | - | - | - | - | - | - | - | - | 2.28 | ||||
AGD Ratio | M | 2.32 | 2.25 | 2.36 | 2.41 | - | - | - | - | - | - | - | - | - | - | - | - | 2.34 |
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
| Mean | |
Male | Female | |||||||||||||||||
G2 & 150 | Rg7951 | P.Wt. (g) | M | 12.23 | 12.01 | 11.83 | - | - | - | - | - | - | - | - | - |
| 12.02 | 11.69 |
F | - | - | - | 11.79 | 11.58 | 11.69 | - | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.47 | 5.33 | 5.18 | - | - | - | - | - | - | - | - | - | 5.33 | 2.90 | |||
F | - | - | - | 2.93 | 2.87 | 2.91 | - | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.30 | 2.29 | 2.28 | - | - | - | - | - | - | - | - | - | 2.29 | 2.27 | |||
F | - | - | - | 2.28 | 2.26 | 2.27 | - | - | - | - | - | - | ||||||
AGD Ratio | M | 2.37 | 2.33 | 2.27 | - | - | - | - | - | - | - | - | - | 2.32 | 1.28 | |||
F | - | - | - | 1.29 | 1.27 | 1.28 | - | - | - | - | - | - |
| |||||
Rg7952 | P.Wt. (g) | M | 11.33 | 11.14 | 12.08 | 10.84 | 10.75 | 11.96 | - | - | - | - | - | - |
| 11.35 | 10.45 | |
F | - | - | - | - | - | - | 10.67 | 10.53 | 10.32 | 10.76 | 10.15 | 10.28 | ||||||
AGD Measurement (mm) | M | 4.98 | 5.06 | 5.49 | 4.93 | 4.88 | 5.26 | - | - | - | - | - | - | 5.10 | 2.57 | |||
F | - | - | - | - | - | - | 2.69 | 2.63 | 2.42 | 2.81 | 2.38 | 2.47 | ||||||
Cube Root of P.Wt. | M | 2.25 | 2.23 | 2.29 | 2.21 | 2.21 | 2.29 | - | - | - | - | - | - | 2.25 | 2.19 | |||
F | - | - | - | - | - | - | 2.20 | 2.19 | 2.18 | 2.21 | 2.17 | 2.17 | ||||||
AGD Ratio | M | 2.22 | 2.27 | 2.39 | 2.23 | 2.21 | 2.30 | - | - | - | - | - | - | 2.27 | 1.17 | |||
F | - | - | - | - | - | - | 1.22 | 1.20 | 1.11 | 1.27 | 1.10 | 1.14 |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| Mean | |
Male | Female | ||||||||||||||||||
G3 & 300 | Rg7953 | Non-pregnant | |||||||||||||||||
Rg7954 | P.Wt. (g) | M | 11.21 | 11.76 | 12.31 | 10.97 | - | - | - | - | - | - | - | - | - |
| 11.56 | - | |
AGD Measurement (mm) | M | 5.01 | 5.36 | 5.47 | 4.99 | - | - | - | - | - | - | - | - | - | 5.21 | - | |||
Cube Root of P.Wt. | M | 2.24 | 2.27 | 2.31 | 2.22 | - | - | - | - | - | - | - | - | - | 2.26 | - | |||
AGD Ratio | M | 2.24 | 2.36 | 2.37 | 2.25 | - | - | - | - | - | - | - | - | - | 2.30 | - | |||
Rg7955 | P.Wt. (g) | M | 11.49 | 12.17 | 11.58 | 11.56 | 10.94 | 12.01 | - | - | - | - | - | - | - |
| 11.63 | 10.70 | |
F | - | - | - | - | - | - | 10.59 | 10.43 | 10.66 | 11.13 | - | - | - | ||||||
AGD Measurement (mm) | M | 5.24 | 5.66 | 5.37 | 5.49 | 5.18 | 5.53 | - | - | - | - | - | - | - | 5.41 | 2.83 | |||
F | - | - | - | - | - | - | 2.86 | 2.69 | 2.81 | 2.97 | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.26 | 2.30 | 2.26 | 2.26 | 2.22 | 2.29 | - | - | - | - | - | - | - | 2.27 | 2.20 | |||
F | - | - | - | - | - | - | 2.20 | 2.18 | 2.20 | 2.23 | - | - | - | ||||||
AGD Ratio | M | 2.32 | 2.46 | 2.37 | 2.43 | 2.33 | 2.41 | - | - | - | - | - | - | - | 2.39 | 1.29 | |||
F | - | - | - | - | - | - | 1.30 | 1.23 | 1.28 | 1.33 | - | - | - |
| |||||
Rg7956 | P.Wt. (g) | M | 11.41 | 10.93 | 11.16 | 12.01 | 10.44 | 10.68 | 11.94 | - | - | - | - | - | - |
| 11.22 | 10.49 | |
F | - | - | - | - | - | - | - | 10.51 | 10.29 | 10.31 | 10.56 | 10.79 | 10.48 | ||||||
AGD Measurement (mm) | M | 5.14 | 4.98 | 5.26 | 5.51 | 4.76 | 4.83 | 5.11 | - | - | - | - | - | - | 5.08 | 2.58 | |||
F | - | - | - | - | - | - | - | 2.51 | 2.36 | 2.47 | 2.68 | 2.81 | 2.63 | ||||||
Cube Root of P.Wt. | M | 2.25 | 2.22 | 2.23 | 2.29 | 2.19 | 2.20 | 2.29 | - | - | - | - | - | - | 2.24 | 2.19 | |||
F | - | - | - | - | - | - | - | 2.19 | 2.18 | 2.18 | 2.19 | 2.21 | 2.19 | ||||||
AGD Ratio | M | 2.28 | 2.24 | 2.35 | 2.41 | 2.18 | 2.19 | 2.24 | - | - | - | - | - | - | 2.27 | 1.18 | |||
F | - | - | - | - | - | - | - | 1.15 | 1.09 | 1.13 | 1.22 | 1.27 | 1.20 |
| |||||
Rg7957 | Non-pregnant |
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
| Mean | |
Male | Female | |||||||||||||||||
G3 & 300 | Rg7958 | P.Wt. (g) | M | 12.34 | 11.53 | 12.42 | - | - | - | - | - | - | - | - | - |
| 12.10 | 11.18 |
F | - | - | - | 11.18 | - | - | - | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 4.82 | 5.03 | 4.65 | - | - | - | - | - | - | - | - | - | 4.83 | 2.79 | |||
F | - | - | - | 2.79 | - | - | - | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.31 | 2.26 | 2.32 | - | - | - | - | - | - | - | - | - | 2.30 | 2.24 | |||
F | - | - | - | 2.24 | - | - | - | - | - | - | - | - | ||||||
AGD Ratio | M | 2.09 | 2.23 | 2.01 | - | - | - | - | - | - | - | - | - | 2.11 | 1.25 | |||
F | - | - | - | 1.25 | - | - | - | - | - | - | - | - |
| |||||
Rg7959 | P.Wt. (g) | M | 11.72 | 11.21 | 12.16 | 11.81 | - | - | - | - | - | - | - | - |
| 11.73 | 10.66 | |
F | - | - | - | - | 10.72 | 10.58 | 10.72 | 10.81 | 10.47 | - | - | - | ||||||
AGD Measurement (mm) | M | 5.15 | 5.01 | 5.48 | 5.21 | - | - | - | - | - | - | - | - | 5.21 | 2.73 | |||
F | - | - | - | - | 2.72 | 2.68 | 2.79 | 2.94 | 2.54 | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.27 | 2.24 | 2.30 | 2.28 | - | - | - | - | - | - | - | - | 2.27 | 2.20 | |||
F | - | - | - | - | 2.20 | 2.20 | 2.20 | 2.21 | 2.19 | - | - | - | ||||||
AGD Ratio | M | 2.27 | 2.24 | 2.38 | 2.29 | - | - | - | - | - | - | - | - | 2.29 | 1.24 | |||
F | - | - | - | - | 1.23 | 1.22 | 1.27 | 1.33 | 1.16 | - | - | - |
| |||||
Rg7960 | P.Wt. (g) | M | 10.88 | 10.57 | 12.14 | 11.71 | 11.08 | 10.72 | - | 11.01 | - | - | - | - |
| 11.16 | 10.45 | |
F | - | - | - | - | - | - | - | - | 10.49 | 10.61 | 10.41 | 10.29 | ||||||
AGD Measurement (mm) | M | 5.09 | 4.96 | 5.62 | 5.37 | 5.01 | 4.88 | - | 5.08 | - | - | - | - | 5.14 | 2.57 | |||
F | - | - | - | - | - | - | - | - | 2.59 | 2.71 | 2.52 | 2.46 | ||||||
Cube Root of P.Wt. | M | 2.22 | 2.19 | 2.30 | 2.27 | 2.23 | 2.20 | - | 2.22 | - | - | - | - | 2.23 | 2.19 | |||
F | - | - | - | - | - | - | - | - | 2.19 | 2.20 | 2.18 | 2.18 | ||||||
AGD Ratio | M | 2.30 | 2.26 | 2.45 | 2.36 | 2.25 | 2.21 | - | 2.28 | - | - | - | - | 2.30 | 1.18 | |||
F | - | - | - | - | - | - | - | - | 1.18 | 1.23 | 1.15 | 1.13 |
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/ day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 |
| Mean | |
Male | Female | |||||||||||||||||||||||
G3 & 300 | Rg7961 | P.Wt. (g) | M | 10.91 | 11.16 | 12.05 | 12.10 | 10.88 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 11.42 | 10.35 |
F | - | - | - | - | - | 10.22 | 10.37 | 10.42 | 10.19 | 10.50 | 10.40 | - | - | - | - | - | - | - |
| |||||
AGD Measurement (mm) | M | 5.03 | 5.16 | 5.53 | 5.47 | 4.96 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 5.23 | 2.48 | ||
F | - | - | - | - | - | 2.48 | 2.41 | 2.56 | 2.36 | 2.61 | 2.44 | - | - | - | - | - | - | - |
| |||||
Cube Root of P.Wt. | M | 2.22 | 2.23 | 2.29 | 2.30 | 2.22 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 2.25 | 2.18 | ||
F | - | - | - | - | - | 2.17 | 2.18 | 2.18 | 2.17 | 2.19 | 2.18 | - | - | - | - | - | - | - |
| |||||
AGD Ratio | M | 2.27 | 2.31 | 2.41 | 2.38 | 2.24 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 2.32 | 1.14 | ||
F | - | - | - | - | - | 1.14 | 1.11 | 1.17 | 1.09 | 1.19 | 1.12 | - | - | - | - | - | - | - |
| |||||
Rg7962 | P.Wt. (g) | M | 11.29 | 10.47 | 10.93 | 11.47 | 12.11 | 10.58 | - | - | - | - | - | - | - | - | - | - | - | - |
| 11.14 | 10.56 | |
F | - | - | - | - | - | - | 10.72 | 10.39 | 10.67 | 10.44 | - | - | - | - | - | - | - | - |
| |||||
AGD Measurement (mm) | M | 5.21 | 4.77 | 5.01 | 5.31 | 5.46 | 4.63 | - | - | - | - | - | - | - | - | - | - | - | - |
| 5.07 | 2.63 | ||
F | - | - | - | - | - | - | 2.72 | 2.41 | 2.83 | 2.54 | - | - | - | - | - | - | - | - |
| |||||
Cube Root of P.Wt. | M | 2.24 | 2.19 | 2.22 | 2.26 | 2.30 | 2.20 | - | - | - | - | - | - | - | - | - | - | - | - |
| 2.23 | 2.19 | ||
F | - | - | - | - | - | - | 2.20 | 2.18 | 2.20 | 2.19 | - | - | - | - | - | - | - | - |
| |||||
AGD Ratio | M | 2.32 | 2.18 | 2.26 | 2.35 | 2.38 | 2.11 | - | - | - | - | - | - | - | - | - | - | - | - |
| 2.27 | 1.20 | ||
F | - | - | - | - | - | - | 1.23 | 1.10 | 1.29 | 1.16 | - | - | - | - | - | - | - | - |
| |||||
Rg7963 | Total litter loss | |||||||||||||||||||||||
Rg7964 | P.Wt. (g) | M | 10.47 | 10.03 | 10.14 | 10.63 | 10.38 | 10.01 | 10.16 | - | - | - | - | - | - | - | - | - | - | - |
| 10.26 | 9.94 | |
F | - | - | - | - | - | - | - | 9.84 | 10.01 | 10.07 | 9.98 | 10.04 | 10.10 | - | 9.47 | 10.00 | 9.89 | 10.01 |
| |||||
AGD Measurement (mm) | M | 4.58 | 4.71 | 4.66 | 4.92 | 4.61 | 4.68 | 4.79 | - | - | - | - | - | - | - | - | - | - | - |
| 4.71 | 2.42 | ||
F | - | - | - | - | - | - | - | 2.31 | 2.37 | 2.41 | 2.36 | 2.51 | 2.44 | - | 2.38 | 2.49 | 2.41 | 2.48 |
| |||||
Cube Root of P.Wt. | M | 2.19 | 2.16 | 2.16 | 2.20 | 2.18 | 2.16 | 2.17 | - | - | - | - | - | - | - | - | - | - | - |
| 2.17 | 2.15 | ||
F | - | - | - | - | - | - | - | 2.14 | 2.16 | 2.16 | 2.15 | 2.16 | 2.16 | - | 2.12 | 2.15 | 2.15 | 2.16 |
| |||||
AGD Ratio | M | 2.09 | 2.18 | 2.15 | 2.24 | 2.11 | 2.17 | 2.21 | - | - | - | - | - | - | - | - | - | - | - |
| 2.17 | 1.12 | ||
F | - | - | - | - | - | - | - | 1.08 | 1.10 | 1.12 | 1.10 | 1.16 | 1.13 | - | 1.12 | 1.16 | 1.12 | 1.15 |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Mean | |
Male | Female | |||||||||||||||||||
G4 & 600 | Rg7965 | Total litter loss | ||||||||||||||||||
Rg7966 | P.Wt. (g) | M | 12.34 | 12.28 | 12.30 | - | - | - | - | - | - | - | - | - | - | - |
| 12.31 | 12.07 | |
F | - | - | - | 12.18 | 11.96 | 12.05 | 12.09 | - | - | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 4.94 | 4.80 | 5.11 | - | - | - | - | - | - | - | - | - | - | - | 4.95 | 2.69 | |||
F | - | - | - | 2.45 | 2.73 | 2.91 | 2.66 | - | - | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.31 | 2.31 | 2.31 | - | - | - | - | - | - | - | - | - | - | - | 2.31 | 2.29 | |||
F | - | - | - | 2.30 | 2.29 | 2.29 | 2.30 | - | - | - | - | - | - | - | ||||||
AGD Ratio | M | 2.14 | 2.08 | 2.21 | - | - | - | - | - | - | - | - | - | - | - | 2.14 | 1.17 | |||
F | - | - | - | 1.06 | 1.19 | 1.27 | 1.16 | - | - | - | - | - | - | - |
| |||||
Rg7967 | Total litter loss | |||||||||||||||||||
Rg7968 | P.Wt. (g) | M | 11.27 | 10.46 | 10.69 | 11.41 | 12.03 | 10.51 | 10.72 | 10.46 | - | - | - | - | - | - |
| 10.94 | 10.38 | |
F | - | - | - | - | - | - | - | - | 10.29 | 10.71 | 10.38 | 10.64 | 10.09 | 10.17 | ||||||
AGD Measurement (mm) | M | 5.27 | 4.69 | 4.83 | 5.14 | 5.30 | 4.71 | 4.92 | 4.64 | - | - | - | - | - | - | 4.94 | 2.56 | |||
F | - | - | - | - | - | - | - | - | 2.39 | 2.76 | 2.48 | 2.74 | 2.34 | 2.65 | ||||||
Cube Root of P.Wt. | M | 2.24 | 2.19 | 2.20 | 2.25 | 2.29 | 2.19 | 2.20 | 2.19 | - | - | - | - | - | - | 2.22 | 2.18 | |||
F | - | - | - | - | - | - | - | - | 2.18 | 2.20 | 2.18 | 2.20 | 2.16 | 2.17 | ||||||
AGD Ratio | M | 2.35 | 2.14 | 2.19 | 2.28 | 2.31 | 2.15 | 2.23 | 2.12 | - | - | - | - | - | - | 2.22 | 1.17 | |||
F | - | - | - | - | - | - | - | - | 1.10 | 1.25 | 1.14 | 1.25 | 1.08 | 1.22 |
| |||||
Rg7969 | P.Wt. (g) | M | 11.26 | 11.13 | - | 10.96 | - | - | - | - | - | - | - | - | - | - |
| 11.12 | 11.03 | |
F | - | - | - | - | 11.39 | 11.03 | 10.90 | 11.17 | 10.87 | 10.56 | - | 11.31 | - | - | ||||||
AGD Measurement (mm) | M | 5.18 | 4.96 | - | 5.08 | - | - | - | - | - | - | - | - | - | - | 5.07 | 2.72 | |||
F | - | - | - | - | 2.60 | 2.79 | 2.93 | 2.62 | 2.76 | 2.81 | - | 2.54 | - | - | ||||||
Cube Root of P.Wt. | M | 2.24 | 2.23 | - | 2.22 | - | - | - | - | - | - | - | - | - | - | 2.23 | 2.23 | |||
F | - | - | - | - | 2.25 | 2.23 | 2.22 | 2.24 | 2.22 | 2.19 | - | 2.24 | - | - | ||||||
AGD Ratio | M | 2.31 | 2.22 | - | 2.29 | - | - | - | - | - | - | - | - | - | - | 2.27 | 1.22 | |||
F | - | - | - | - | 1.16 | 1.25 | 1.32 | 1.17 | 1.25 | 1.28 | - | 1.13 | - | - |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/ day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 |
| Mean | |
Male | Female | |||||||||||||||||||||||
G4 & 600 | Rg7970 | P.Wt. (g) | M | 10.87 | 11.41 | 10.78 | 12.21 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 11.32 | 10.56 |
F | - | - | - | - | 10.81 | 10.57 | 10.36 | 10.27 | 10.58 | 10.77 | - | - | - | - | - | - | - | - |
| |||||
AGD Measurement (mm) | M | 4.97 | 5.34 | 4.87 | 5.58 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 5.19 | 2.66 | ||
F | - | - | - | - | 2.81 | 2.59 | 2.63 | 2.38 | 2.62 | 2.91 | - | - | - | - | - | - | - | - |
| |||||
Cube Root of P.Wt. | M | 2.22 | 2.25 | 2.21 | 2.30 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 2.24 | 2.19 | ||
F | - | - | - | - | 2.21 | 2.19 | 2.18 | 2.17 | 2.20 | 2.21 | - | - | - | - | - | - | - | - |
| |||||
AGD Ratio | M | 2.24 | 2.37 | 2.20 | 2.42 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 2.31 | 1.21 | ||
F | - | - | - | - | 1.27 | 1.18 | 1.21 | 1.09 | 1.19 | 1.32 | - | - | - | - | - | - | - | - |
| |||||
Rg7971 | P.Wt. (g) | M | 10.69 | 11.09 | 10.76 | 10.51 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 10.76 | 10.28 | |
F | - | - | - | - | 10.37 | 10.48 | 10.21 | 10.56 | 10.60 | 10.10 | 10.19 | 9.74 | - | - | - | - | - | - |
| |||||
AGD Measurement (mm) | M | 4.88 | 5.11 | 5.01 | 4.91 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 4.98 | 2.48 | ||
F | - | - | - | - | 2.48 | 2.52 | 2.66 | 2.69 | 2.41 | 2.39 | 2.34 | 2.31 | - | - | - | - | - | - |
| |||||
Cube Root of P.Wt. | M | 2.20 | 2.23 | 2.21 | 2.19 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 2.21 | 2.17 | ||
F | - | - | - | - | 2.18 | 2.19 | 2.17 | 2.19 | 2.20 | 2.16 | 2.17 | 2.14 | - | - | - | - | - | - |
| |||||
AGD Ratio | M | 2.22 | 2.29 | 2.27 | 2.24 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| 2.25 | 1.14 | ||
F | - | - | - | - | 1.14 | 1.15 | 1.23 | 1.23 | 1.10 | 1.11 | 1.08 | 1.08 | - | - | - | - | - | - |
| |||||
Rg7972 | Total litter loss | |||||||||||||||||||||||
Rg7973 | Non-pregnant | |||||||||||||||||||||||
Rg7974 | P.Wt. (g) | M | - | 10.23 | 10.46 | 10.19 | 10.08 | 10.00 | 11.14 | 10.86 | - | - | - | - | - | - | - | - | - | - |
| 10.42 | 9.99 | |
F | - | - | - | - | - | - | - | - | 9.91 | 10.10 | 10.02 | 9.76 | 10.03 | 9.74 | 10.14 | 10.21 | 10.06 | 9.92 |
| |||||
AGD Measurement (mm) | M | - | 4.68 | 4.90 | 4.63 | 4.71 | 4.77 | 5.16 | 5.03 | - | - | - | - | - | - | - | - | - | - |
| 4.84 | 2.44 | ||
F | - | - | - | - | - | - | - | - | 2.36 | 2.46 | 2.51 | 2.33 | 2.29 | 2.45 | 2.66 | 2.47 | 2.53 | 2.36 |
| |||||
Cube Root of P.Wt. | M | - | 2.17 | 2.19 | 2.17 | 2.16 | 2.15 | 2.23 | 2.21 | - | - | - | - | - | - | - | - | - | - |
| 2.18 | 2.15 | ||
F | - | - | - | - | - | - | - | - | 2.15 | 2.16 | 2.16 | 2.14 | 2.16 | 2.14 | 2.16 | 2.17 | 2.16 | 2.15 |
| |||||
AGD Ratio | M | - | 2.16 | 2.24 | 2.14 | 2.18 | 2.21 | 2.31 | 2.27 | - | - | - | - | - | - | - | - | - | - |
| 2.22 | 1.13 | ||
F | - | - | - | - | - | - | - | - | 1.10 | 1.14 | 1.16 | 1.09 | 1.06 | 1.15 | 1.23 | 1.14 | 1.17 | 1.10 |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
APPENDIX 20 (Contd…). INDIVIDUAL PUP ANOGENITAL DISTANCE (mm) AND MEAN ANOGENITAL DISTANCE (AGD) RATIO PER LITTER ON POSTNATAL DAY 4 RECORD
Group & Dose (mg/kg body weight/day) | Dam No. |
| Pup No.→ Sex↓ | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Mean | |
Male | Female | |||||||||||||||||||
G4 & 600 | Rg7975 | P.Wt. (g) | M | 10.63 | 10.27 | 11.11 | 12.03 | 10.87 | 10.76 | - | - | - | - | - | - | - | - |
| 10.95 | 10.12 |
F | - | - | - | - | - | - | 9.98 | 10.01 | 10.07 | 10.26 | 10.19 | 10.52 | 9.81 | 10.14 | ||||||
AGD Measurement (mm) | M | 4.78 | 4.63 | 5.11 | 5.43 | 5.01 | 4.96 | - | - | - | - | - | - | - | - | 4.99 | 2.46 | |||
F | - | - | - | - | - | - | 2.33 | 2.38 | 2.52 | 2.47 | 2.64 | 2.41 | 2.53 | 2.41 | ||||||
Cube Root of P.Wt. | M | 2.20 | 2.17 | 2.23 | 2.29 | 2.22 | 2.21 | - | - | - | - | - | - | - | - | 2.22 | 2.16 | |||
F | - | - | - | - | - | - | 2.15 | 2.16 | 2.16 | 2.17 | 2.17 | 2.19 | 2.14 | 2.16 | ||||||
AGD Ratio | M | 2.17 | 2.13 | 2.29 | 2.37 | 2.26 | 2.25 | - | - | - | - | - | - | - | - | 2.25 | 1.14 | |||
F | - | - | - | - | - | - | 1.08 | 1.10 | 1.17 | 1.14 | 1.22 | 1.10 | 1.18 | 1.11 |
| |||||
Rg7976 | P.Wt. (g) | M | 10.35 | 10.42 | 10.81 | 11.33 | - | - | - | - | - | - | - | - | - | - |
| 10.73 | 10.49 | |
F | - | - | - | - | 10.73 | 10.68 | 10.45 | 9.79 | 10.82 | - | - | - | - | - | ||||||
AGD Measurement (mm) | M | 5.05 | 4.73 | 4.89 | 5.10 | - | - | - | - | - | - | - | - | - | - | 4.94 | 2.42 | |||
F | - | - | - | - | 2.42 | 2.38 | 2.51 | 2.35 | 2.46 | - | - | - | - | - | ||||||
Cube Root of P.Wt. | M | 2.18 | 2.18 | 2.21 | 2.25 | - | - | - | - | - | - | - | - | - | - | 2.21 | 2.19 | |||
F | - | - | - | - | 2.21 | 2.20 | 2.19 | 2.14 | 2.21 | - | - | - | - | - | ||||||
AGD Ratio | M | 2.32 | 2.17 | 2.21 | 2.27 | - | - | - | - | - | - | - | - | - | - | 2.24 | 1.11 | |||
F | - | - | - | - | 1.10 | 1.08 | 1.15 | 1.10 | 1.11 | - | - | - | - | - |
|
M: Male; F: Female; mm: Millimetre; P.Wt.: Pup weight; -: Not applicable.
Group & Dose (mg/kg body weight/day) | Dam No. | No. of male pups observed for retention of nipple | No. of male pups observed with retention of nipple |
G1 & 0 | Rg7929 | 6 | 0 |
Rg7930 | 3 | 0 | |
Rg7931 | 7 | 0 | |
Rg7932 | 3 | 0 | |
Rg7933 | 9 | 0 | |
Rg7934 | 4 | 0 | |
Rg7935 | 7 | 0 | |
Rg7936 | 6 | 0 | |
Rg7937 | 2 | 0 | |
Rg7938 | 10 | 0 | |
Rg7939 | 7 | 0 | |
Rg7940 | 4 | 0 | |
G2 & 150 | Rg7941 | 6 | 0 |
Rg7942 | 4 | 0 | |
Rg7943 | 6 | 0 | |
Rg7944 | 3 | 0 | |
Rg7945 | 5 | 0 | |
Rg7946 | 3 | 0 | |
Rg7947 | 6 | 0 | |
Rg7948 | 8 | 0 | |
Rg7949 | Non-pregnant | ||
Rg7950 | 4 | 0 | |
Rg7951 | 3 | 0 | |
Rg7952 | 6 | 0 | |
G3 & 300 | Rg7953 | Non-pregnant | |
Rg7954 | 4 | 0 | |
Rg7955 | 6 | 0 | |
Rg7956 | 7 | 0 | |
Rg7957 | Non-pregnant | ||
Rg7958 | 3 | 0 | |
Rg7959 | 4 | 0 | |
Rg7960 | 7 | 0 | |
Rg7961 | 5 | 0 | |
Rg7962 | 6 | 0 | |
Rg7963 | Total litter loss | ||
Rg7964 | 7 | 0 | |
G4 & 600 | Rg7965 | Total litter loss | |
Rg7966 | 3 | 0 | |
Rg7967 | Total litter loss | ||
Rg7968 | 8 | 0 | |
Rg7969 | 3 | 0 | |
Rg7970 | 4 | 0 | |
Rg7971 | 4 | 0 | |
Rg7972 | Total litter loss | ||
Rg7973 | Non-pregnant | ||
Rg7974 | 7 | 0 | |
Rg7975 | 6 | 0 | |
Rg7976 | 4 | 0 |
PND: Postnatal day.
Group & Dose | PND 13 Pups of | Serum T4 Levels (ng/mL) | |
G1 & 0 | Rg7929 | 72.036 | |
Rg7930 | 73.297 | ||
Rg7931 | 76.932 | ||
Rg7932 | 67.019 | ||
Rg7933 | 68.273 | ||
Rg7934 | 78.125 | ||
Rg7935 | 56.910 | ||
Rg7936 | 61.920 | ||
Rg7937 | 74.127 | ||
Rg7938 | 78.793 | ||
Rg7939 | 64.721 | ||
Rg7940 | 69.237 | ||
G2 & 150 | Rg7941 | 71.908 | |
Rg7942 | 70.305 | ||
Rg7943 | 73.968 | ||
Rg7944 | 69.914 | ||
Rg7945 | 68.930 | ||
Rg7946 | 63.802 | ||
Rg7947 | 65.542 | ||
Rg7948 | 74.004 | ||
Rg7949 | Non-pregnant | ||
Rg7950 | 69.219 | ||
Rg7951 | 83.023 | ||
Rg7952 | 63.045 | ||
G3 & 300 | Rg7953 | Non-pregnant | |
Rg7954 | 69.133 | ||
Rg7955 | 72.622 | ||
Rg7956 | 76.274 | ||
Rg7957 | Non-pregnant | ||
Rg7958 | 73.188 | ||
Rg7959 | 68.655 | ||
Rg7960 | 65.898 | ||
Rg7961 | 62.987 | ||
Rg7962 | 66.473 | ||
Rg7963 | Total litter loss | ||
Rg7964 | 62.050 | ||
G4 & 600 | Rg7965 | Total litter loss | |
Rg7966 | 83.026 | ||
Rg7967 | Total litter loss | ||
Rg7968 | 78.716 | ||
Rg7969 | 59.340 | ||
Rg7970 | 63.219 | ||
Rg7971 | 64.132 | ||
Rg7972 | Total litter loss | ||
Rg7973 | Non-pregnant | ||
Rg7974 | 65.965 | ||
Rg7975 | 56.200 | ||
Rg7976 | 72.101 |
ng/mL: nano gram per mL.
Pathology report
TABLE 1. SUMMARY OF GROSS PATHOLOGY FINDINGS
Reference Appendices 1 and 2
Sex | Male | Female | ||||||
Route of administration | Oral Gavage | |||||||
Treatment | Vehicle Control | Low dose | Mid dose | High dose | Vehicle Control | Low dose | Mid dose | High dose |
Group | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 |
Dose (mg/kg body weight/day) | 0 | 150 | 300 | 600 | 0 | 150 | 300 | 600 |
Number of animals | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 |
No. of dead rats during treatment | - | - | - | - | - | - | - | 1 |
No. of moribund sacrificed rats | - | - | - | - | - | - | - | - |
No. of terminally sacrificed rats | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 11 |
No of rats showing gross pathology | - | - | - | 12 | - | - | - | 8 |
Stomach (non-glandular)- Thickened, mucosa | - | - | - | 12 | - | - | - | 7 |
Uterus-implantation, present | - | - | - | - | - | - | - | 1 |
Autolyzed | - | - | - | - | - | - | - | 1 |
G: Group; -: Not applicable.
TABLE 2. SUMMARY OF GROSS PATHOLOGY FINDINGS RECORD OF PUPS
Reference Appendices3, 4 and 5
Group | G1 | G2 | G3 | G4 | |||||
Dose (mg/kg body weight/day) | 0 | 150 | 300 | 600 | |||||
Sex | Male | Female | Male | Female | Male | Female | Male | Female | |
No. of Dead Pups at Birth | - | - | 2 | - | 6 | 3 | 6 | 8 | |
External Gross Pathology Findings | NAD | - | - | 2 | - | 6 | 3 | 6 | 8 |
Internal Gross Pathology Findings | NAD | - | - | 2 | - | 6 | 3 | 6 | 8 |
No. of cannabalised pups on PND 2 | 1 | - | - | - | - | - | - | - | |
External Gross Pathology Findings | Preclude evaluation | 1 | - | - | - | - | - | - | - |
Internal Gross Pathology Findings | Not applicable | 1 | - | - | - | - | - | - | - |
No. of dead pups on PND 2 | - | - | - | - | 1 | - | - | - | |
External Gross Pathology Findings | Skin -forehead discoloration, red | - | - | - | - | 1 | - | - | - |
NAD | - | - | - | - | - | - | 5 | 9 | |
Internal Gross Pathology Findings | NAD | - | - | - | - | 1 | - | 5 | 9 |
No. of dead pups on PND 3 | - | - | - | - | - | 1 | - | - | |
External Gross Pathology Findings | NAD | - | - | - | - | - | 1 | - | - |
Internal Gross Pathology Findings | NAD | - | - | - | - | - | 1 | - | - |
No. of dead pups on PND 4 | - | 1 | - | - | - | - | 1 | - | |
External Gross Pathology Findings | NAD | - | - | - | - | - | - | - | - |
Internal Gross Pathology Findings | NAD | - | - | - | - | - | - | - | - |
No. of pups sacrificed on PND 4 | - | 11 | - | 6 | - | 6 | - | 8 | |
External Gross Pathology Findings | NAD | - | 11 | - | 6 | - | 6 | - | 8 |
Internal Gross Pathology Findings | NAD | - | 11 | - | 6 | - | 6 | - | 8 |
No. of pups sacrificed on lactation PND 13 | 69 | 45 | 54 | 45 | 49 | 34 | 39 | 46 | |
External Gross Pathology Findings | NAD | 69 | 45 | 54 | 45 | 49 | 34 | 39 | 46 |
Internal Gross Pathology Findings | NAD | 69 | 45 | 54 | 45 | 49 | 34 | 39 | 46 |
NAD: No Abnormality Detected; PND: Post-natal Day; -: Not Applicable.
TABLE 3. SUMMARY OF HISTOPATHOLOGY FINDINGS
Reference Appendices 6 and 7
Route of administration | Oral Gavage | ||||
Sex | Male | Female | |||
Vehicle /Test item | Vehicle Control | High dose | Vehicle Control | High dose | |
Dose (mg/kg body weight/day) | 0 | 600 | 0 | 600 | |
Group | G1 | G4 | G1 | G4 | |
Number of Animals | 12 | 12 | 12 | 12 | |
Epididymides | Number examined | 12 | 12 | X | X |
Within normal limits | 12 | 12 | X | X | |
Testes | Number examined | 12 | 12 | X | X |
Within normal limits | 12 | 12 | X | X | |
Stomach | Number examined | 12 | 12 | 12 | 12 |
Within normal limits | 12 | - | 12 | 1 | |
Autolysis precluded evaluation | - | - | - | 1 | |
Hyperplasia, squamous cell, non-glandular | Mild | - | - | - | 3 |
Moderate | - | 2 | - | - | |
Marked | - | 10 | - | 7 | |
Hyperkeratosis, non-glandular | Minimal | - | 2 | - | 1 |
Mild | - | 10 | - | 6 | |
Ovaries | Number examined | X | X | 12 | 12 |
Within normal limits | X | X | 12 | 11 | |
Partially autolyzed | X | X | X | 1 | |
Vagina | Number examined | X | X | 12 | 12 |
Within normal limits | X | X | 12 | 12 | |
Stages of estrus cycle | Proestrus | X | X | 7 | 3 |
Estrus | X | X | - | 1 | |
Metestrus | X | X | 1 | - | |
Diestrus | X | X | 4 | 8 |
X: Not applicable; -:
TABLE 4. SUMMARY OF HISTOPATHOLOGY FINDINGS OF TARGET ORGAN
Reference Appendices 8 and 9
Route of administration | Oral Gavage | ||||
Vehicle /Test item | Low dose | Mid dose | |||
Dose (mg/kg body weight/day) | 150 | 300 | |||
Group | G2 | G3 | |||
Sex | Male | Female | Male | Female | |
Number of Animals | 12 | 12 | 12 | 12 | |
Stomach | Number examined | 12 | 12 | 12 | 12 |
Within normal limits | 12 | 12 | - | 1 | |
Hyperplasia, squamous cell, non-glandular | Mild | - | - | 12 | 11 |
Hyperkeratosis, non-glandular | Minimal | - | - | 2 | - |
Cyst, squamous, non-glandular | Present | - | - | 1 | - |
-: Not applicable.
APPENDIX 1. INDIVIDUAL ANIMAL GROSS PATHOLOGY FINDINGS OF MALES
Group & Dose (mg/kg body weight/day) | Animal No. | Type of Sacrifice | Gross Pathology Observations | |
External | Internal | |||
G1 & 0 | Rg7881 | TS | NAD | NAD |
Rg7882 | TS | NAD | NAD | |
Rg7883 | TS | NAD | NAD | |
Rg7884 | TS | NAD | NAD | |
Rg7885 | TS | NAD | NAD | |
Rg7886 | TS | NAD | NAD | |
Rg7887 | TS | NAD | NAD | |
Rg7888 | TS | NAD | NAD | |
Rg7889 | TS | NAD | NAD | |
Rg7890 | TS | NAD | NAD | |
Rg7891 | TS | NAD | NAD | |
Rg7892 | TS | NAD | NAD | |
G2 & 150 | Rg7893 | TS | NAD | NAD |
Rg7894 | TS | NAD | NAD | |
Rg7895 | TS | NAD | NAD | |
Rg7896 | TS | NAD | NAD | |
Rg7897 | TS | NAD | NAD | |
Rg7898 | TS | NAD | NAD | |
Rg7899 | TS | NAD | NAD | |
Rg7900 | TS | NAD | NAD | |
Rg7901 | TS | NAD | NAD | |
Rg7902 | TS | NAD | NAD | |
Rg7903 | TS | NAD | NAD | |
Rg7904 | TS | NAD | NAD |
TS: Terminal Sacrifice; NAD: No Abnormality Detected.
APPENDIX 1 (Contd..,) INDIVIDUAL ANIMAL GROSS PATHOLOGY FINDINGS OF MALES
Group & Dose (mg/kg body weight/day) | Animal No. | Type of Sacrifice | Gross Pathology Observations | |
External | Internal | |||
G3 & 300 | Rg7905 | TS | NAD | NAD |
Rg7906 | TS | NAD | NAD | |
Rg7907 | TS | NAD | NAD | |
Rg7908 | TS | NAD | NAD | |
Rg7909 | TS | NAD | NAD | |
Rg7910 | TS | NAD | NAD | |
Rg7911 | TS | NAD | NAD | |
Rg7912 | TS | NAD | NAD | |
Rg7913 | TS | NAD | NAD | |
Rg7914 | TS | NAD | NAD | |
Rg7915 | TS | NAD | NAD | |
Rg7916 | TS | NAD | NAD | |
G4 & 600 | Rg7917 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa |
Rg7918 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7919 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7920 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7921 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7922 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7923 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7924 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7925 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7926 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7927 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7928 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa |
TS: Terminal Sacrifice; NAD: No Abnormality Detected.
APPENDIX 2. INDIVIDUAL ANIMAL GROSS PATHOLOGY FINDINGS OF FEMALES
Group & Dose (mg/kg body weight/day) | Animal No. | Type of Sacrifice | Gross Pathology Observations | |
External | Internal | |||
G1 & 0 | Rg7929 | TS | NAD | NAD |
Rg7930 | TS | NAD | NAD | |
Rg7931 | TS | NAD | NAD | |
Rg7932 | TS | NAD | NAD | |
Rg7933 | TS | NAD | NAD | |
Rg7934 | TS | NAD | NAD | |
Rg7935 | TS | NAD | NAD | |
Rg7936 | TS | NAD | NAD | |
Rg7937 | TS | NAD | NAD | |
Rg7938 | TS | NAD | NAD | |
Rg7939 | TS | NAD | NAD | |
Rg7940 | TS | NAD | NAD | |
G2 & 150 | Rg7941 | TS | NAD | NAD |
Rg7942 | TS | NAD | NAD | |
Rg7943 | TS | NAD | NAD | |
Rg7944 | TS | NAD | NAD | |
Rg7945 | TS | NAD | NAD | |
Rg7946 | TS | NAD | NAD | |
Rg7947 | TS | NAD | NAD | |
Rg7948 | TS | NAD | NAD | |
Rg7949 | TS | NAD | NAD | |
Rg7950 | TS | NAD | NAD | |
Rg7951 | TS | NAD | NAD | |
Rg7952 | TS | NAD | NAD |
TS: Terminal Sacrifice; NAD: No Abnormality Detected.
APPENDIX 2 (Contd…) INDIVIDUAL ANIMAL GROSS PATHOLOGY FINDINGS OF FEMALES
Group & Dose (mg/kg body weight/day) | Animal No. | Type of Sacrifice | Gross Pathology Observations | |
External | Internal | |||
G3 & 300 | Rg7953 | TS | NAD | NAD |
Rg7954 | TS | NAD | NAD | |
Rg7955 | TS | NAD | NAD | |
Rg7956 | TS | NAD | NAD | |
Rg7957 | TS | NAD | NAD | |
Rg7958 | TS | NAD | NAD | |
Rg7959 | TS | NAD | NAD | |
Rg7960 | TS | NAD | NAD | |
Rg7961 | TS | NAD | NAD | |
Rg7962 | TS | NAD | NAD | |
Rg7963 | TS | NAD | NAD | |
Rg7964 | TS | NAD | NAD | |
G4 & 600 | Rg7965 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa |
Rg7966 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7967 | TS | NAD | NAD | |
Rg7968 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7969 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7970 | TS | NAD | NAD | |
Rg7971 | TS | NAD | NAD | |
Rg7972 | D | NAD | Autolyzed #Uterus-implantation, present | |
Rg7973 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7974 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa | |
Rg7975 | TS | NAD | NAD | |
Rg7976 | TS | NAD | Stomach (non-glandular)- Thickened, mucosa |
TS: Terminal Sacrifice; D: Dead; NAD: No Abnormality Detected; # Normal observation and not a pathological change.
APPENDIX 3. INDIVIDUAL GROSS PATHOLOGY FINDINGS RECORD OF DEAD PUPS
M: Male; F: Female; D: Dead; C: Cannabalised; NAD: No Abnormality Detected; PND: Post-Natal Day;
-: Not Applicable.
APPENDIX 4. INDIVIDUAL GROSS PATHOLOGY FINDINGS RECORD OF PUPS – PND 4
Group & Dose (mg/kg body weight/day) | Animal No. | Type of Sacrifice (on PND 4) | Pup No. | Gross Pathological Observations | |
F | External | Internal | |||
G1 & 0 | Rg7939 | TS | 12 & 13 | NAD | NAD |
Rg7931 | TS | 12 & 13 | NAD | NAD | |
Rg7933 | TS | 11 | NAD | NAD | |
Rg7938 | TS | 16 & 17 | NAD | NAD | |
Rg7936 | TS | 11 & 12 | NAD | NAD | |
Rg7935 | TS | 12 & 13 | NAD | NAD | |
G2 & 150 | Rg7941 | TS | 15 & 16 | NAD | NAD |
Rg7948 | TS | 15 & 16 | NAD | NAD | |
Rg7952 | TS | 11 & 12 | NAD | NAD | |
G3 & 300 | Rg7960 | TS | 12 | NAD | NAD |
Rg7956 | TS | 12 & 13 | NAD | NAD | |
Rg7964 | TS | 17 & 18 | NAD | NAD | |
Rg7961 | TS | 11 | NAD | NAD | |
G4 & 600 | Rg7971 | TS | 11 & 12 | NAD | NAD |
Rg7968 | TS | 13 & 14 | NAD | NAD | |
Rg7974 | TS | 17 & 18 | NAD | NAD | |
Rg7975 | TS | 13 & 14 | NAD | NAD |
TS: Terminal sacrifice; M: Male; F: Female; NAD: No Abnormality Detected; PND: Post-Natal Day.
APPENDIX 5. INDIVIDUAL GROSS PATHOLOGY FINDINGS RECORD OF PUPS – PND 13
Group & Dose (mg/kg body weight/day) | Animal No. | Type of Sacrifice (on PND 13) | Pup No. | Gross Pathological Observations | ||
M | F | External | Internal | |||
G1 & 0 | Rg7929 | TS | 1 & 6 | 7 to 10 | NAD | NAD |
Rg7930 | TS | 1 to 3 | 4 to 8 | NAD | NAD | |
Rg7931 | TS | 1 to 7 | 8 to 11 | NAD | NAD | |
Rg7932 | TS | 1 to 3 | 5 to 7 | NAD | NAD | |
Rg7933 | TS | 1 to 9 | 10 | NAD | NAD | |
Rg7934 | TS | 1 to 4 | 5 to 9 | NAD | NAD | |
Rg7935 | TS | 1 to 7 | 8 to 11 | NAD | NAD | |
Rg7936 | TS | 1 to 6 | 7 to 10 | NAD | NAD | |
Rg7937 | TS | 1 & 2 | 3 to 5 | NAD | NAD | |
Rg7938 | TS | 1 to 10 | 11 to 15 | NAD | NAD | |
Rg7939 | TS | 1 to 8 | 9 to 11 | NAD | NAD | |
Rg7940 | TS | 1 to 4 | 5 to 8 | NAD | NAD | |
G2 & 150 | Rg7941 | TS | 1 to 6 | 7 to 14 | NAD | NAD |
Rg7942 | TS | 1 to 4 | 5 to 8 | NAD | NAD | |
Rg7943 | TS | 1 to 6 | 7 to 9 | NAD | NAD | |
Rg7944 | TS | 1 to 3 | 4 to 10 | NAD | NAD | |
Rg7945 | TS | 1 to 5 | 6 to 8 | NAD | NAD | |
Rg7946 | TS | 1 to 3 | 4 to 6 | NAD | NAD | |
Rg7947 | TS | 1 to 6 | 7 to 10 | NAD | NAD | |
Rg7948 | TS | 1 to 8 | 9 to 14 | NAD | NAD | |
Rg7950 | TS | 1 to 4 | - | NAD | NAD | |
Rg7951 | TS | 1 to 3 | 4 to 6 | NAD | NAD | |
Rg7952 | TS | 1 to 6 | 7 to 10 | NAD | NAD |
TS: Terminal sacrifice; M: Male; F: Female; NAD: No Abnormality Detected; PND: Post-Natal Day.
APPENDIX 5 (Contd..,) INDIVIDUAL GROSS PATHOLOGY FINDINGS RECORD OF PUPS – PND 13
Group & Dose (mg/kg body weight/day) | Animal No. | Type of Sacrifice (on PND 13) | Pup No. | Gross Pathological Observations | ||
M | F | External | Internal | |||
G3 & 300 | Rg7954 | TS | 1 to 4 | - | NAD | NAD |
Rg7955 | TS | 1 to 6 | 7 to 10 | NAD | NAD | |
Rg7956 | TS | 1 to 7 | 8 to 11 | NAD | NAD | |
Rg7958 | TS | 1 to 3 | 4 | NAD | NAD | |
Rg7959 | TS | 1 to 4 | 5 to 9 | NAD | NAD | |
Rg7960 | TS | 1 to 6 & 8 | 9 to 11 | NAD | NAD | |
Rg7961 | TS | 1 to 5 | 6 to 10 | NAD | NAD | |
Rg7962 | TS | 1 to 6 | 7 to 10 | NAD | NAD | |
Rg7964 | TS | 1 to 7 | 8 to 13 15 & 16 | NAD | NAD | |
G4 & 600 | Rg7966 | TS | 1 to 3 | 4 to 7 | NAD | NAD |
Rg7968 | TS | 1 to 8 | 9 to 12 | NAD | NAD | |
Rg7969 | TS | 1, 2 & 4 | 5 to 10 & 12 | NAD | NAD | |
Rg7970 | TS | 1 to 4 | 5 to 10 | NAD | NAD | |
Rg7971 | TS | 1 to 4 | 5 to 10 | NAD | NAD | |
Rg7974 | TS | 2 to 8 | 9 to 16 | NAD | NAD | |
Rg7975 | TS | 1 to 6 | 7 to 12 | NAD | NAD | |
Rg7976 | TS | 1 to 4 | 5 to 9 | NAD | NAD |
TS: Terminal sacrifice; M: Male; F: Female; NAD: No Abnormality Detected; PND: Post-Natal Day.
APPENDIX 6. INDIVIDUAL ANIMAL HISTOPATHOLOGY FINDINGS OF MALES
Group Details | G1, Vehicle Control | |||||||||||
Dose (mg/kg body weight/day) | 0 | |||||||||||
Animal Numbers | Rg7881 | Rg7882 | Rg7883 | Rg7884 | Rg7885 | Rg7886 | Rg7887 | Rg7888 | Rg7889 | Rg7890 | Rg7891 | Rg7892 |
ORGANS / LESIONS |
| |||||||||||
Epididymides | N | N | N | N | N | N | N | N | N | N | N | N |
Testes | N | N | N | N | N | N | N | N | N | N | N | N |
Stomach | N | N | N | N | N | N | N | N | N | N | N | N |
Group Details | G4, High Dose | |||||||||||
Dose (mg/kg body weight/day) | 600 | |||||||||||
Animal Numbers | Rg7917 | Rg7918 | Rg7919 | Rg7920 | Rg7921 | Rg7922 | Rg7923 | Rg7924 | Rg7925 | Rg7926 | Rg7927 | Rg7928 |
ORGANS / LESIONS |
| |||||||||||
Epididymides | N | N | N | N | N | N | N | N | N | N | N | N |
Testes | N | N | N | N | N | N | N | N | N | N | N | N |
Stomach | N | N | N | N | N | N | N | N | N | N | N | N |
Hyperplasia, squamous cell, non-glandular | d-3 | d-3 | d-4 | d-4 | d-4 | d-4 | d-4 | d-4 | d-4 | d-4 | d-4 | d-4 |
Hyperkeratosis, non-glandular | d-2 | d-1 | d-2 | d-1 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 |
1: Minimal; 2: Mild; 3: Moderate; 4: Marked; d: Diffuse; N: Normal or within normal histological limits unless specified
APPENDIX 7. INDIVIDUAL ANIMAL HISTOPATHOLOGY FINDINGS OF FEMALES
Group Details | G1, Vehicle Control | |||||||||||
Dose (mg/kg body weight/day) | 0 | |||||||||||
Animal Numbers | Rg7929 | Rg7930 | Rg7931 | Rg7932 | Rg7933 | Rg7934 | Rg7935 | Rg7936 | Rg7937 | Rg7938 | Rg7939 | Rg7940 |
ORGANS / LESIONS |
| |||||||||||
Ovaries | N | N | N | N | N | N | N | N | N | N | N | N |
Stomach | N | N | N | N | N | N | N | N | N | N | N | N |
Vagina | N | N | N | N | N | N | N | N | N | N | N | N |
Stages of estrus cycle | D | P | P | P | D | D | P | M | P | P | D | P |
Group Details | G4, High dose | |||||||||||
Dose (mg/kg body weight/day) | 600 | |||||||||||
Animal Numbers | Rg7965 | Rg7966 | Rg7967 | Rg7968 | Rg7969 | Rg7970 | Rg7971 | Rg7972 | Rg7973 | Rg7974 | Rg7975 | Rg7976 |
ORGANS / LESIONS |
| |||||||||||
Ovaries | N | N | N | N | N | N | N | PA | N | N | N | N |
Stomach | N | N | N | N | N | N | N | A | N | N | N | N |
Hyperplasia, squamous cell, non-glandular | d-4 | d-4 | d-2 | d-4 | d-4 | d-2 | - | - | d-4 | d-4 | d-2 | d-4 |
Hyperkeratosis, non-glandular | d-1 | d-2 | - | d-2 | d-2 | - | - | - | d-2 | d-2 | - | d-2 |
Vagina | N | N | N | N | N | N | N | N | N | N | N | N |
Stages of estrus cycle | D | D | P | P | D | D | D | E | D | P | D | D |
1: Minimal; 2: Mild; 3: Moderate; 4: Marked; d: Diffuse; N: Normal or within normal histological limits unless specified; A: Autolysis precluded evaluation; PA: Partially autolysed; P: Proestrus; E: Estrus; M: Metestrus; D: Diestrus; -: No incidence
APPENDIX 8. INDIVIDUAL ANIMAL HISTOPATHOLOGY FINDINGS OF MALES (TARGET ORGAN)
Group Details | G2, Low dose | |||||||||||
Dose (mg/kg body weight/day) | 150 | |||||||||||
Animal Numbers | Rg7893 | Rg7894 | Rg7895 | Rg7896 | Rg7897 | Rg7898 | Rg7899 | Rg7900 | Rg7901 | Rg7902 | Rg7903 | Rg7904 |
ORGANS / LESIONS |
| |||||||||||
Stomach | N | N | N | N | N | N | N | N | N | N | N | N |
Group Details | G3, Mid dose | |||||||||||
Dose (mg/kg body weight/day) | 300 | |||||||||||
Animal Numbers | Rg7905 | Rg7906 | Rg7907 | Rg7908 | Rg7909 | Rg7910 | Rg7911 | Rg7912 | Rg7913 | Rg7914 | Rg7915 | Rg7916 |
ORGANS / LESIONS |
| |||||||||||
Stomach |
|
|
|
|
|
|
|
|
|
|
|
|
Hyperplasia, squamous cell, non-glandular | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 |
Hyperkeratosis, non-glandular | d-1 | - | - | - | - | - | d-1 | - | - | - | - | - |
Cyst, squamous, non-glandular | - | - | - | - | - | - | P | - | - | - | - | - |
1: Minimal; 2: Mild; d: Diffuse; N: Normal or within normal histological limits unless specified; P: Lesion present but not graded; -: No incidence
APPENDIX 9. INDIVIDUAL ANIMAL HISTOPATHOLOGY FINDINGS OF FEMALES (TARGET ORGAN)
Group Details | G2, Low dose | |||||||||||
Dose (mg/kg body weight/day) | 150 | |||||||||||
Animal Numbers | Rg7941 | Rg7942 | Rg7943 | Rg7944 | Rg7945 | Rg7946 | Rg7947 | Rg7948 | Rg7949 | Rg7950 | Rg7951 | Rg7952 |
ORGANS / LESIONS |
| |||||||||||
Stomach | N | N | N | N | N | N | N | N | N | N | N | N |
Group Details | G3, Mid dose | |||||||||||
Dose (mg/kg body weight/day) | 300 | |||||||||||
Animal Numbers | Rg7953 | Rg7954 | Rg7955 | Rg7956 | Rg7957 | Rg7958 | Rg7959 | Rg7960 | Rg7961 | Rg7962 | Rg7963 | Rg7964 |
ORGANS / LESIONS |
| |||||||||||
Stomach | N | N | N | N | N | N | N | N | N | N | N | N |
Hyperplasia, squamous cell, non-glandular | d-2 | d-2 | d-2 | d-2 | d-2 | - | d-2 | d-2 | d-2 | d-2 | d-2 | d-2 |
2: Mild; d: Diffuse; N: Normal or within normal histological limits unless specified; -: No incidence
APPENDIX 10. INDIVIDUAL ANIMAL HISTOPATHOLOGY FINDINGS OF GROSS LESION
Group Details | G3, Mid dose |
Dose (mg/kg body weight/day) | 300 |
Dam Number/ Pup Number/ Sex | Rg7960/ 7/ Male |
ORGANS / LESIONS |
|
Skin | N |
Haemorrhage | 2 |
Infiltrate, mononuclear cell | mf-2 |
2: Mild; mf: Multifocal; N: Normal or within normal histological limits unless specified
Applicant's summary and conclusion
- Conclusions:
- Conclusion:
In conclusion, the oral administration of test item Cyclic Glucamide C12-C14 over the time of the study, carried out according to the OECD guideline 421 (for males with a total of 35 days and for females ranging from 50 to 65 days) with the dose levels of 150, 300 and 600 mg/kg body weight/day noted with below mentioned results.
At the dose level of 150 mg/kg body weight/day, the test item did not reveal any adverse systemic toxicity effects except, a minimal reduction in body weights in males. However, there was no indication of reproduction and developmental toxicity at this dose level under experimental conditions employed.
At the dose level of 300 mg/kg body weight/day, animals noted with some of the systemic toxicity effects such as reduced body weights in males, minimal increase in post-implantation loss, and histopathological findings such as hyperplasia, squamous cell, non-glandular and hyperkeratosis, non-glandular in stomach. No adverse test item related changes were observed in birth parameters. There were no test item related effects noted in any of the reproductive and developmental end points at this dose level, except a minimal and not statistically significant increase in post-implantation loss.
It was concluded that there were no adverse effects noted on male and female reproductive performance/indices of adult animals from the tested dose groups
G2 (150 mg/kg body weight/day) and G3 (300 mg/kg body weight/day) when compared with vehicle control group.
At the dose level of 600 mg/kg body weight/day, animals noted with treatment related clinical signs of toxicity, reduced body weights and feed consumption, increased post-implantation loss, increase in postnatal loss and histopathological findings such as hyperplasia, squamous cell, non-glandular and hyperkeratosis, non-glandular in stomach. - Executive summary:
The objective of this Reproduction/ Developmental Toxicity Screening Test of Cyclic Glucamide C12-C14 by Oral Gavage in Sprague Dawley rats was to determine the possible health hazards likely to arise from repeated exposure to the test item over a relatively limited period of time. This study was also conducted to provide initial information on possible effects on male and female reproductive performance such as gonadal function, mating behavior, conception, development of the conceptus and parturition and to estimate the No Observed Effect Level (NOEL).
A total of 96 (48 males + 48 females) Sprague Dawley rats were selected for the study and distributed to four groups (G1, G2, G3 and G4). Each group consisted of 12 males and 12 females. The animals in group G1 were administered with vehicle [distilled water], animals in groups G2, G3 and G4 were administered with test item at the dose levels of 150, 300 and 600 mg/kg body weight/day for low, mid and high dose levels, respectively. Vehicle and test item formulations were administered orally by gavage with the dose volume of 10 mL/kg body weight/day once daily at similar times on each day for 7 days a week.
The males from all groups were administered with test item during pre-mating
(14-days), during mating and during post-mating period (total of 35 days). The pregnant females from all groups were administered with test item during pre-mating (14-days), during mating, pregnancy (gestation) and up to lactation day 13, ranging from 49 to 65 days. The non-pregnant females were administered with test item during pre-mating (14-days), during mating until confirmed as mated and further 25 to 26 days from the day of confirmation of mating, ranging from 40 to 58 days.The test item formulations were stable up to 48 hours at room temperature in distilled water with the concentrations of 15 mg/mL and 60 mg/mL. The dose concentration analysis for prepared test item formulations during treatment period was performed during week 1 and 4. The obtained mean results were within the range of 90 to 110% of nominal concentration and the relative standard deviation (% RSD) was less than 10%.
For systemic toxicity assessment, all the survived animals of both sexes were observed once daily for clinical signs, twice daily for mortality and morbidity and once in a week for detailed clinical examination. Body weight of all the survived animals of both sexes were recorded once in a week until termination. Further, the body weight of all pregnant females was recorded on gestation day (GD) 0, 7, 14 and 20 during pregnancy and on lactation day (LD) 1, 4, 7, 13 and 14 during lactation. Body weight of all non-pregnant females was recorded once in a week until termination. Feed consumption for all the survived animals of both sexes were recorded once in a week during pre-mating. Further, feed consumption of all pregnant females was recorded during GD 0 to 7, 7 to 14 and 14 to 20 and during LD 1 to 4, 4 to 7 and 7 to 13. The investigations of haematology for all males and survived females from all groups was conducted at termination. Serum thyroxine hormone (T4) levels were estimated for all group males by ELISA method. The organs were collected and weighed on the day of termination for all males and survived females and organ weight relative to terminal body weight was calculated. All the animals of both sexes were observed for both external and internal gross pathological changes during conduct of necropsy. Histopathological examination was conducted on the tissues collected from the groups G1 and G4 animals with special emphasis on stages of spermatogenesis in the male gonads and histopathology of interstitial testicular cell structure, stomach (both sexes). Histopathological examination was extended to lower dose groups G2 and G3 due to noted microscopic changes in non-glandular part of stomach.
For reproductive toxicity assessment, all the males were evaluated for reproductive performances such as, mating and fertility indices. All the females were evaluated for reproductive performances such as, mating, fertility, gestation and parturition indices. The females were also evaluated for pre-coital interval and gestation length. All females were evaluated for oestrus cyclicity during pre-mating period and the vaginal smear examination was continued until evidence of mating. At birth (delivery) parameters such as, number of live/dead pups born, litter size, sex ratio (m/f) and live birth index per litter were observed / calculated. The litter observations during lactation period such as, number of survived or dead pups, sex ratio (m/f) and pup survival index per litter were observed / calculated. The total number of implantation sites was recorded for each litter during necropsy and the post-implantation and postnatal losses per litter was calculated.
For developmental toxicity assessment, all survived pups from each litter were observed once daily for external behavioural changes and twice daily for mortality until termination [postnatal day (PND) 13]. All pups from each litter were weighed individually on PND 1, 4, 7 and 13 and measured for anogenital distance on PND 4. All male pups were observed for retention of nipples on PND 13. All the pups were subjected for both external and internal gross pathological changes during conduct of necropsy. The collected serum from PND 13 pups was subjected to estimation of thyroxine hormone (T4) levels using ELISA method.
In group G2, there were no clinical signs of toxicity and no mortality/morbidity noted in any of the animals of both sexes. A minimal reduction in mean body weight and percent change in mean body weight gain was noted in males. There were no changes noted in mean feed consumption during all phases of the treatment period. The investigations of haematology and serum thyroxine hormone (T4) levels did not affect by the test item exposure. The absolute and relative organ weights did not reveal any changes in both sexes. The gross pathological examinations did not reveal any changes in both sexes. The histopathological examination of stomach did not reveal any changes in both sexes. There were no test item related effects noted in any of the reproductive and developmental end points at this dose level.
In group G3, there were no clinical signs of toxicity and no mortality/morbidity noted in any of the animals of both sexes. A minimal to moderate reduction in mean body weight and percent change in mean body weight gain was noted in males. No changes were noted in mean feed consumption during all phases of the treatment period. The investigations of haematology and serum thyroxine hormone (T4) levels did not affect by the test item exposure. The absolute and relative organ weights did not reveal any changes in both sexes. The gross pathological examinations did not reveal any changes in both sexes. The histopathological examination of stomach noted with hyperplasia, cyst, squamous cell, non-glandular and hyperkeratosis, non-glandular in stomach. There were no test item related effects noted in any of the reproductive and developmental end points at this dose level, except a minimal and not statistically significant increase in post-implantation loss.
In group G4, all the animals of both sexes were noted with wetness around mouth after dose administration and continued until termination. These noted observations can be due to surfactant nature of the test item which led to form foam or wetness near to route of administration (mouth). However, 1 out 12 treated females, noted with lethargy, perinasal staining and rough hair coat along with the post-dose wetness around mouth from treatment day 39 and found dead on treatment day 41. A reduction in mean body weight, percent change in mean body weight gain and feed consumption was noted. The investigations of haematology and serum thyroxine hormone (T4) levels did not affect by the test item exposure. The absolute and relative organ weights did not reveal any changes in both sexes. Majority of the animals noted with treatment related thickened mucosa of non-glandular part of stomach during conduct of necropsy. The histopathological examination of stomach noted with hyperplasia, squamous cell, non-glandular and hyperkeratosis, non-glandular in stomach. There were no test item related effects noted in any of the reproductive and developmental end points at this dose level, except an increase in post-implantation loss. There were no adverse test item related effects noted on reproductive and developmental end points at this dose level. However, treatment related increase in post-implantation loss and postnatal loss was noted at this dose level.
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