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EC number: 221-424-4 | CAS number: 3089-17-6
- 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test by Oral Gavage in Sprague Dawley Rats
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 June 2021 to 22 December 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 June 2021 to 22 December 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- As per OECD Guideline for Testing of Chemicals, Number 422, adopted on 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Justification for study design:
- - Basis for dose level selection: There was no information or data available from repeated dose/reproduction toxicity and teratology studies for the test item.
The doses of 0, 111, 333 and 1000 mg/kg body weight/day were selected as control, low, mid and high dose groups for the dose range finding study (BIO-DTX 056) in consultation with the sponsor.
There were no test item-related related changes noted in any of the systemic, reproduction and developmental parameters up to the dose level of 1000 mg/kg body weight/day in the Dose Range Finding Study (BIO-DTX 056).
Hence, the same doses of 0, 111, 333 and 1000 mg/kg body weight/day were selected as control, low, mid and high dose groups respectively, for the present study in consultation with the sponsor. - Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 21 to 29ºC
- Stability under test conditions: The test item was stable for 6 hours and 48 hours at room temperature in 0.5% w/v Carboxymethyl cellulose with the concentrations of 5 mg/mL and 100 mg/mL.
- Solubility of the test substance: The test item was insoluble in distilled water and uniformly suspended in 0.5% w/v Carboxy Methyl Cellulose at the concentration of 100 mg/mL (the highest dose concentration selected for the study considering the dose volume of 10 mL/kg body weight) as per in-house solubility/suspendibility test results.
Hence, 0.5% w/v Carboxymethyl Cellulose was used as vehicle for test item formulations in consultation with sponsor.
0.5% w/v Carboxymethyl Cellulose is a routinely used and universally accepted vehicle of choice for the oral toxicity studies. - Species:
- rat
- Strain:
- Sprague-Dawley
- 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-pregnant: yes
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: Males: 254.36 to 291.64 g; Females: 200.54 to 211.92 g
- Housing: Animals were housed in a standard polypropylene cage (size: L 430 x B 285 x H 150 mm) with stainless steel mesh top grill having facilities for holding pelleted food and drinking water in water bottle fitted with stainless steel sipper tube. Clean sterilized paddy husk was provided as bedding material.
During acclimatization, two animals of same sex were housed.
i. Main Group Animals:
- Pre mating: Per cage two animals of same sex and group were housed.
- Cohabitation Period (mating): Per cage two animals (one male and one female) of same group were housed.
- Post-mating: After confirmation on presence of sperm in the vaginal smear (Day 0 of pregnancy), the mated pairs were separated. Males were housed with their former cage mates while females were housed individually. Sterilized paper shreds were provided as a nesting material for main group females from gestation day 20 onwards.
ii. Recovery Group Animals:
- Maximum of two animals per cage per group of same sex were housed, tunnels were provided as enrichment for the animals which were housed individually.
- Diet (e.g. ad libitum): Altromin maintenance diet
- Water (e.g. ad libitum): Water was provided ad libitum throughout the experimental period. Deep bore-well water passed through reverse osmosis unit was provided in plastic water bottles with stainless steel sipper tubes.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 to 22.9 oC
- Humidity (%): 48 to 63%
- 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: 24 June 2021 To: 16 September 2021 - Route of administration:
- oral: gavage
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 14 days
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy.
- After successful mating each pregnant female was caged (how): After confirmation on presence of sperm in the vaginal smear (Day 0 of pregnancy), the mated pairs were separated. Males were housed with their former cage mates while females were housed individually. Sterilized paper shreds were provided as a nesting material for main group females from gestation day 20 onwards. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity and 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 range of 85 to 115% of the nominal concentration and the relative standard deviation (% RSD) was less than 15%.
- Duration of treatment / exposure:
- The test item or vehicle were administered to the animals through the oral (gavage) route once daily.
The males were treated for two weeks pre-mating, during mating period and up to the day before sacrifice (total of completion of 31 days of administration).
The females were treated for a two-week pre-mating period (14-days), during mating, pregnancy (gestation) and up to lactation day 13 (ranging from a total period of 50 to 62 days).
The females with positive mating signal, but no-evidence of pregnancy / littering were treated during two-week pre-mating period, during mating and further 24 days from the day of positive mating signal (group G1 - one female until experimental day 39; group G2 - one female until experimental day 52, one female until experimental day 46; G3 - two females until experimental day 49; group G4 - one female until experimental day 39).
The recovery group animals were treated until the first scheduled sacrifice of dams (total of 52 days of administration) and kept without treatment for further 18-days of observation period.
The test item/vehicle was administered by oral (gavage) route using a stainless-steel intubation cannula attached to a disposable syringe. All the doses were administered in an equivolume of 10 mL/kg body weight/day with the concentration of 11.1, 33.3 and 100 mg/mL for low, mid, and high dose groups, respectively. Vehicle was administered to the vehicle control group at an equivolume of 10 mL/kg body weight/day.
The actual dose volume for each animal was calculated based on the most recent body weight. The test item formulations were administered as soon as possible after preparation.
The prepared formulations were stirred using magnetic stirrer during administration to maintain homogeneity. - Frequency of treatment:
- Once Daily
- Details on study schedule:
- - Age at mating of the mated animals in the study: 13 to 14 weeks
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Vehicle Control
- Dose / conc.:
- 111 mg/kg bw/day
- Remarks:
- Low Dose
- Dose / conc.:
- 333 mg/kg bw/day
- Remarks:
- Mid Dose
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- High Dose
- No. of animals per sex per dose:
- Main Group: 24 (12 Males + 12 Females)
Recovery Group: 10 (5 Males + 5 Females) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: There was no information or data available from repeated dose/reproduction toxicity and teratology studies for the test item.
Based on the above available information, the doses of 0, 111, 333 and 1000 mg/kg body weight/day were selected as control, low, mid and high dose groups for the dose range finding study (BIO-DTX 056) in consultation with the sponsor.
There were no test item-related related changes noted in any of the systemic, reproduction and developmental parameters up to the dose level of 1000 mg/kg body weight/day in the Dose Range Finding Study (BIO-DTX 056).
Hence, the same doses of 0, 111, 333 and 1000 mg/kg body weight/day were selected as control, low, mid and high dose groups respectively, for the present study in consultation with the sponsor.
- 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 main and recovery groups using Microsoft Excel Spreadsheet, such that body weight variation of animals selected for the study does not exceed ±20% (Males: -6.80 to 11.14%; Females: -12.58 to 8.29%) of the mean body weight of each sex. The grouping was done one day prior to initiation of treatment. Body weight of the animals were analyzed statistically for mean body weight to rule out statistical significant differences between groups within each sex. - Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once daily for general clinical signs of toxicity.
- Cage side observations checked in table [No.1] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Day 1 before treatment and weekly thereafter during treatment.
BODY WEIGHT: Yes
- Time schedule for examinations: The main group males were weighed at receipt, on the first day of dosing, weekly thereafter and at termination.
The main group females were weighed at receipt, on the first day of dosing, weekly thereafter during pre-mating and until confirmation of mating. All the pregnant animals were weighed on gestation days (GD) 0, 7, 14 and 20 and on lactation days (LD) 1, 4, 7, 13 and 14 (terminal body weight). The non-pregnant animals were weighed weekly once until termination and the terminal body weights were recorded before scheduled sacrifice.
The recovery group animals were weighed at receipt, on the first day of dosing, weekly thereafter and at termination. - Oestrous cyclicity (parental animals):
- Oestrus cyclicity was monitored for two weeks after five days of acclimatization to evaluate the normal oestrus cycle (4 to 5 days). Females with normal oestrus cyclicity only were selected for the treatment. Vaginal smears were monitored daily from beginning of the treatment period until evidence of mating. When obtaining vaginal/cervical cells, care was taken to avoid disturbance of mucosa, which may induce pseudopregnancy. The status of oestrus cyclicity of females was determined on termination day.
Recovery group females were not evaluated for oestrus cyclicity - Sperm parameters (parental animals):
- Parameters examined in all males: testis weight, epididymis weight.
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no
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), presence of nipples/areolae in male pups.
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was not determined for pups born or found dead. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All animals were sacrificed after completion of 31 days of treatment. The males were necropsied in randomized manner.
- Maternal animals: All pregnant females were sacrificed on lactation day 14 and the non-pregnant females were sacrificed after 24 days from the last day of confirmation of mating.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [22] were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE
- Dead pups and pups which were sacrificed on PND 4/13, examined for gross abnormalities with particular attention to the external reproductive genitals and the findings were recorded.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. - Statistics:
- The raw data was subjected to computer statistical processing. The computer printout of the data (in the form of an appendix) was verified with the raw data. After verification, the data was subjected to various statistical analyses using SPSS software version 22.
All analysis and comparisons were evaluated at 95% with the level of confidence of P<0.05 respectively, indicated by the aforementioned tests and were designated by the superscripts throughout the report as stated below:
* Statistically significant (P<0.05) change than the vehicle control group.
Note: Data of non-pregnant females was excluded for mean calculations and statistical analysis for reproductive end points but considered for systemic parameters. However, the individual animal data is presented in appendices.
The statistical analysis tests followed for the interpretation of data are as mentioned below:
Parametric - One-way ANOVA
• Body weight (weekly/gestation/lactation)
• Percent Change in body weight (weekly/gestation/lactation)
• Feed consumption (weekly/gestation/lactation)
• Copulatory interval
• Gestation length
• Hematology
• Clinical chemistry
• Urinalysis
• Absolute/relative organ weights
• Functional Observation parameters
• 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:
- The following reproductive performance indices were calculated as mentioned below and presented in the study report,
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
Pre-coital Interval (Days) = Date of confirmation of mating – Date of initiation of cohabitation
Gestation Length (days) = Date of parturition – Date of positive evidence of mating (GD 0)
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 - Offspring viability indices:
- Sex ratio (m/f) = No. of male offspring / Number of female offspring
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/4/7/13 x 100
Sex ratio (m/f) on LD 4/7/13 = No. of male offspring on LD 4/7/13 / No. of female offspring on LD 4/7/13
Post-Implantation Loss (%) = No. of implantations - No. of viable pups / No. of implantations x 100
Post-implantation Loss (No.) = No. of implantations - No. of live births
Postnatal loss on LD 13 (%) = No. of pups alive on postnatal day 13 /No. of live pups at birth x 100
Postnatal Loss on LD 13 (No.) = Live births - pups alive at lactation day 13
Anogenital Distance (AGD) Ratio = Anogenital distance (mm) / Cube root of PND 4 pup weight x 100 - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food efficiency
- ophthalmological examination
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
- other: Thyroid hormonal levels
- Key result
- Critical effects observed:
- no
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Gross pathological findings:
- no effects observed
- Other effects:
- effects observed, non-treatment-related
- 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. However, an incidental statistically significant decrease in mean T4 levels in pups was noted in groups G2, G3 and G4 when compared with vehicle control group.
- Description (incidence and severity):
- The oral administration of test item Hostaperm Red Violet ER 02 over the time of the study, did not produce any indication of developmental toxicity at the dose levels of 111, 333 and 1000 mg/kg body weight/day.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- other: Serum Thyroid hormonal levels (T4)
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
TABLE 1. SUMMARY OF CLINICAL SIGNS OF TOXICITY, DETAILED CLINICAL EXAMINATION AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total No. of Animals |
Clinical Signs of Toxicitya: Observation |
Detailed Clinical Examinationb: Observation |
Mortalityc: No. of Mortalities |
G1, M & 0 |
12 |
N (12) |
NAD (12) |
0 (12) |
G2, M & 111 |
12 |
N (12) |
NAD (12) |
0 (12) |
G3, M & 333 |
12 |
N (12) |
NAD (12) |
0 (12) |
G4, M & 1000 |
12 |
N (12) |
NAD (12) |
0 (12) |
M:
Male; N: Normal; NAD: No Abnormality Detected.
a: observed once daily; b: observed once weekly; c: observed twice daily.
Note:Dark purple colored faeces were noted from day 2 observation throughout the experiment period till termination in group G3 & G4 animals.
TABLE 1 (Contd…). SUMMARY OF CLINICAL SIGNS OF TOXICITY, DETAILED CLINICAL EXAMINATION AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total No. of Animals |
Clinical Signs of Toxicitya: Observation |
Detailed Clinical Examinationb: Observation |
Mortalityc: No. of Mortalities |
G1, F & 0 |
12 |
N (12) |
NAD (12) |
0 (12) |
G2, F & 111 |
12 |
N (12) |
NAD (12) |
0 (12) |
G3, F & 333 |
12 |
N (12) |
NAD (12) |
0 (12) |
G4, F & 1000 |
12 |
N (12) |
NAD (12) |
0 (12) |
F:
Female; N: Normal; NAD: No Abnormality Detected.
a: observed once daily; b: observed once weekly; c: observed twice daily.
Note:Dark purple colored faeces were noted from day 2 observation throughout the experiment period till termination in group G3 & G4 animals.
TABLE 1 (Contd…). SUMMARY OF CLINICAL SIGNS OF TOXICITY, DETAILED CLINICAL EXAMINATION AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total No. of Animals |
Clinical Signs of Toxicitya: Observation |
Detailed Clinical Examinationb: Observation |
Mortalityc: No. of Mortalities |
G1R, M & 0 |
5 |
N (5) |
NAD (5) |
0 (5) |
G4R, M & 1000 |
5 |
N (5) |
NAD (5) |
0 (5) |
G1R, F & 0 |
5 |
N (5) |
NAD (5) |
0 (5) |
G4R, F & 1000 |
5 |
N (5) |
NAD (5) |
0 (5) |
M :
Male; F: Female; R: Recovery; N: Normal; NAD: No abnormality detected.
a: observed once daily; b: observed once weekly; c: observed twice daily.
Note:Dark
purple colored faeces were noted from day 2 throughout the experiment
period till termination in group G4R animals.
TABLE 2. SUMMARY OF BODY WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Body Weight (g) on Day |
|||||
1 |
7 |
14 |
21 |
28 |
|||
G1, M & 0 |
Mean |
400.75 |
421.20 |
438.19 |
446.01 |
458.77 |
|
±SD |
22.07 |
32.34 |
36.49 |
37.08 |
38.53 |
||
n |
12 |
12 |
12 |
12 |
12 |
||
G2, M & 111 |
Mean |
401.74 |
417.26 |
433.41 |
442.75 |
452.56 |
|
±SD |
20.39 |
24.35 |
30.70 |
31.29 |
30.16 |
||
n |
12 |
12 |
12 |
12 |
12 |
||
G3, M & 333 |
Mean |
402.72 |
419.51 |
438.54 |
444.84 |
456.36 |
|
±SD |
19.35 |
23.54 |
30.11 |
27.23 |
24.95 |
||
n |
12 |
12 |
12 |
12 |
12 |
||
G4, M & 1000 |
Mean |
401.99 |
422.76 |
443.74 |
453.94 |
463.38 |
|
±SD |
21.50 |
27.21 |
34.32 |
36.83 |
39.17 |
||
n |
12 |
12 |
12 |
12 |
12 |
M: Male; SD: Standard Deviation; n: Number of Animals.
TABLE 2 (Contd…). SUMMARY OF BODY WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Body Weight (g) on Day |
||||
1 |
7 |
14 |
21# |
|||
G1, F & 0 |
Mean |
250.88 |
257.35 |
267.91 |
280.34 |
|
±SD |
14.86 |
17.17 |
18.25 |
26.26 |
||
n |
12 |
12 |
12 |
3 |
||
G2, F & 111 |
Mean |
251.05 |
256.43 |
266.53 |
272.56 |
|
±SD |
12.78 |
15.62 |
15.30 |
25.98 |
||
n |
12 |
12 |
12 |
3 |
||
G3, F & 333 |
Mean |
251.13 |
256.32 |
261.08 |
260.46 |
|
±SD |
13.59 |
14.00 |
15.94 |
17.45 |
||
n |
12 |
12 |
12 |
4 |
||
G4, F & 1000 |
Mean |
251.24 |
261.46 |
265.51 |
269.05 |
|
±SD |
15.56 |
18.91 |
20.71 |
24.37 |
||
n |
12 |
12 |
12 |
4 |
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 body weight was not subjected to statistical analysis due to uneven number of variables.
TABLE 2 (Contd…). SUMMARY OF BODY WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Body Weight (g) on Day |
||||||||||
1 |
7 |
14 |
21 |
28 |
35 |
42 |
49 |
56 |
63 |
|||
G1R, M & 0 |
Mean |
395.45 |
407.17 |
422.63 |
436.11 |
448.75 |
458.35 |
473.23 |
489.33 |
502.87 |
514.37 |
|
±SD |
21.72 |
21.10 |
31.29 |
32.45 |
32.78 |
34.62 |
33.67 |
33.58 |
34.92 |
37.99 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
G4R, M & 1000 |
Mean |
396.36 |
412.35 |
430.15 |
444.31 |
454.98 |
464.82 |
475.04 |
493.68 |
508.20 |
519.69 |
|
±SD |
20.86 |
20.17 |
12.53 |
16.96 |
17.27 |
14.72 |
15.50 |
9.28 |
11.65 |
11.69 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
G1R, F & 0 |
Mean |
245.24 |
250.97 |
262.44 |
268.72 |
277.56 |
284.92 |
295.96 |
306.72 |
315.86 |
324.75 |
|
±SD |
10.97 |
10.11 |
13.68 |
15.80 |
15.60 |
15.72 |
19.40 |
19.59 |
17.41 |
15.21 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
G4R, F & 1000 |
Mean |
245.66 |
248.99 |
264.41 |
270.43 |
278.43 |
286.33 |
298.35 |
308.32 |
318.51 |
327.87 |
|
±SD |
12.82 |
12.43 |
13.84 |
12.16 |
11.19 |
12.10 |
12.79 |
13.72 |
10.97 |
12.44 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals.
TABLE 3. SUMMARY RECORD OF GESTATION BODY WEIGHT (g)
Group, Sex & Dose (mg/kg body weight/day) |
Body Weight (g) on Gestation Day (GD) |
||||
0 |
7 |
14 |
20 |
||
G1, F & 0 |
Mean |
272.42 |
287.38 |
319.92 |
375.62 |
±SD |
18.33 |
21.41 |
28.89 |
35.87 |
|
n |
11 |
11 |
11 |
11 |
|
G2, F & 111 |
Mean |
269.81 |
286.87 |
328.45 |
391.71 |
±SD |
11.98 |
12.37 |
15.11 |
22.46 |
|
n |
10 |
10 |
10 |
10 |
|
G3, F & 333 |
Mean |
264.91 |
282.42 |
317.51 |
369.85 |
±SD |
15.69 |
14.58 |
20.68 |
32.90 |
|
n |
10 |
10 |
10 |
10 |
|
G4, F & 1000 |
Mean |
273.49 |
291.35 |
327.07 |
382.89 |
±SD |
17.37 |
17.37 |
23.26 |
39.30 |
|
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.
TABLE 4. SUMMARY RECORD OF LACTATION BODY WEIGHT (g)
Group, Sex & Dose (mg/kg body weight/day) |
Body Weight (g) on Lactation Day (LD) |
||||
1 |
4 |
7 |
13 |
||
G1, F & 0 |
Mean |
294.60 |
300.48 |
308.18 |
323.25 |
±SD |
22.07 |
22.28 |
22.06 |
20.39 |
|
n |
11 |
11 |
11 |
11 |
|
G2, F & 111 |
Mean |
306.24 |
309.48 |
314.78 |
330.57 |
±SD |
22.46 |
21.39 |
20.72 |
19.26 |
|
n |
10 |
10 |
10 |
10 |
|
G3, F & 333 |
Mean |
293.35 |
297.31 |
304.48 |
319.65 |
±SD |
19.47 |
20.23 |
20.46 |
22.22 |
|
n |
10 |
10 |
10 |
10 |
|
G4, F & 1000 |
Mean |
303.31 |
306.82 |
313.01 |
325.64 |
±SD |
22.77 |
24.10 |
23.73 |
23.27 |
|
n |
11 |
11 |
11 |
11 |
F: Female; SD: Standard Deviation; n: Number of Dams.
TABLE 5. SUMMARY OF PERCENT CHANGE IN BODY WEIGHT GAIN (%) WITH RESPECT TO DAY 1 RECORD
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, M & 0 |
Mean |
5.01 |
9.25 |
11.19 |
14.36 |
|
±SD |
3.10 |
4.96 |
4.86 |
4.98 |
||
n |
12 |
12 |
12 |
12 |
||
G2, M & 111 |
Mean |
3.84 |
7.80 |
10.13 |
12.59 |
|
±SD |
2.04 |
3.09 |
3.48 |
3.20 |
||
n |
12 |
12 |
12 |
12 |
||
G3, M & 333 |
Mean |
4.15 |
8.89 |
10.50 |
13.42 |
|
±SD |
2.15 |
5.14 |
5.14 |
5.61 |
||
n |
12 |
12 |
12 |
12 |
||
G4, M & 1000 |
Mean |
5.12 |
10.29 |
12.82 |
15.16 |
|
±SD |
1.91 |
3.83 |
4.55 |
5.27 |
||
n |
12 |
12 |
12 |
12 |
M: Male; SD: Standard Deviation; n: Number of Animals.
TABLE 5 (Contd…). SUMMARY OF PERCENTCHANGE IN BODY WEIGHT GAIN (%) WITH RESPECT TO DAY 1 RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Percent Change in Body Weight (%) during Day |
|||
1 to 7 |
1 to 14 |
1 to 21# |
|||
G1, F & 0 |
Mean |
2.56 |
6.78 |
10.07 |
|
±SD |
2.21 |
3.23 |
3.01 |
||
n |
12 |
12 |
3 |
||
G2, F & 111 |
Mean |
2.12 |
6.21 |
9.94 |
|
±SD |
2.46 |
4.16 |
1.49 |
||
n |
12 |
12 |
3 |
||
G3, F & 333 |
Mean |
2.08 |
3.94 |
5.98 |
|
±SD |
1.81 |
2.08 |
1.64 |
||
n |
12 |
12 |
4 |
||
G4, F & 1000 |
Mean |
4.05 |
5.61 |
9.37 |
|
±SD |
3.24 |
3.20 |
3.75 |
||
n |
12 |
12 |
4 |
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.
TABLE 5 (Contd…). SUMMARY OF PERCENTCHANGE IN BODY WEIGHT GAIN (%) WITH RESPECT TO DAY 1 RECORD
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 |
1 to 42 |
1 to 49 |
1 to 56 |
1 to 63 |
|||
G1R, M & 0 |
Mean |
2.98 |
6.83 |
10.25 |
13.47 |
15.92 |
19.69 |
23.73 |
27.13 |
30.00 |
|
±SD |
0.92 |
4.09 |
4.67 |
5.29 |
6.27 |
5.81 |
4.88 |
4.25 |
4.30 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
G4R, M & 1000 |
Mean |
4.06 |
8.66 |
12.20 |
14.91 |
17.44 |
20.09 |
24.77 |
28.45 |
31.32 |
|
±SD |
1.73 |
3.60 |
3.33 |
3.84 |
4.90 |
6.78 |
5.51 |
6.10 |
5.14 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
G1R, F & 0 |
Mean |
2.35 |
7.00 |
9.55 |
13.20 |
16.19 |
20.62 |
25.02 |
28.77 |
32.44 |
|
±SD |
0.72 |
2.36 |
3.15 |
4.61 |
4.45 |
4.14 |
4.54 |
3.55 |
3.44 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
G4R, F & 1000 |
Mean |
1.37 |
7.66 |
10.20 |
13.45 |
16.65 |
21.52 |
25.60 |
29.78 |
33.57 |
|
±SD |
1.07 |
2.71 |
4.80 |
4.07 |
3.73 |
3.02 |
4.10 |
3.75 |
3.31 |
||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals.
TABLE 6. SUMMARY RECORD OF PERCENT CHANGE IN BODY WEIGHT GAIN (%) DURING GESTATION PERIOD
Group, Sex & Dose (mg/kg body weight/day) |
Percent Change in Body Weight Gain (%) during Gestation Day (GD) |
|||
0 to 7 |
7 to 14 |
14 to 20 |
||
G1, F & 0 |
Mean |
5.46 |
11.22 |
17.44 |
±SD |
1.77 |
2.82 |
4.18 |
|
n |
11 |
11 |
11 |
|
G2, F & 111 |
Mean |
6.35 |
14.52 |
19.23 |
±SD |
2.12 |
3.20 |
3.16 |
|
n |
10 |
10 |
10 |
|
G3, F & 333 |
Mean |
6.67 |
12.40 |
16.35 |
±SD |
1.92 |
3.55 |
3.43 |
|
n |
10 |
10 |
10 |
|
G4, F & 1000 |
Mean |
6.56 |
12.23 |
16.88 |
±SD |
1.60 |
3.35 |
4.81 |
|
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.
TABLE 7. SUMMARY RECORD OF PERCENT CHANGE IN BODY WEIGHT GAIN (%) DURING LACTATION PERIOD
Group, Sex & Dose (mg/kg body weight/day) |
Percent Change in Body Weight Gain (%) during Lactation Day (LD) |
|||
1 to 4 |
4 to 7 |
7 to 13 |
||
G1, F & 0 |
Mean |
2.01 |
2.58 |
4.96 |
±SD |
0.96 |
0.73 |
1.51 |
|
n |
11 |
11 |
11 |
|
G2, F & 111 |
Mean |
1.08 |
1.74 |
5.07 |
±SD |
0.86 |
0.95 |
1.60 |
|
n |
10 |
10 |
10 |
|
G3, F & 333 |
Mean |
1.35 |
2.42 |
4.98 |
±SD |
0.95 |
1.29 |
1.32 |
|
n |
10 |
10 |
10 |
|
G4, F & 1000 |
Mean |
1.14 |
2.04 |
4.06 |
±SD |
1.00 |
0.93 |
0.83 |
|
n |
11 |
11 |
11 |
F: Female; SD: Standard Deviation; n: Number of Dams.
TABLE 8. SUMMARY OF FEED CONSUMPTION (g/animal/day) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Feed Consumption (g/animal/day) during Pre-mating Period |
||
Week 1 |
Week 2 |
||
G1, M & 0 |
Mean |
21.31 |
24.01 |
±SD |
2.38 |
1.81 |
|
n |
12 (6) |
12 (6) |
|
G2, M & 111 |
Mean |
21.39 |
23.12 |
±SD |
1.76 |
0.75 |
|
n |
12 (6) |
12 (6) |
|
G3, M & 333 |
Mean |
22.25 |
23.93 |
±SD |
2.39 |
1.85 |
|
n |
12 (6) |
12 (6) |
|
G4, M & 1000 |
Mean |
22.28 |
24.17 |
±SD |
1.23 |
0.67 |
|
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
Group, Sex & Dose (mg/kg body weight/day) |
Feed Consumption (g/animal/day) during Pre-mating Period |
||
Week 1 |
Week 2 |
||
G1, F & 0 |
Mean |
18.14 |
19.17 |
±SD |
1.56 |
1.22 |
|
n |
12 (6) |
12 (6) |
|
G2, F & 111 |
Mean |
17.79 |
20.11 |
±SD |
1.85 |
1.70 |
|
n |
12 (6) |
12 (6) |
|
G3, F & 333 |
Mean |
18.26 |
19.22 |
±SD |
1.99 |
1.31 |
|
n |
12 (6) |
12 (6) |
|
G4, F & 1000 |
Mean |
18.43 |
20.07 |
±SD |
2.28 |
1.22 |
|
n |
12 (6) |
12 (6) |
F: Female; SD: Standard Deviation; n: Number of Animals (Number of cages).
TABLE 8 (Contd…). SUMMARY OF FEED CONSUMPTION (g/animal/day) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Feed Consumption (g/animal/day) |
||||||||
Week 1 |
Week 2 |
Week 3 |
Week 4 |
Week 5 |
Week 6 |
Week 7 |
Week 8 |
Week 9 |
||
G1R, M & 0 |
Mean |
23.52 |
24.34 |
25.11 |
26.35 |
27.86 |
29.05 |
30.75 |
31.83 |
32.47 |
±SD |
3.71 |
1.67 |
1.55 |
1.27 |
0.97 |
1.11 |
0.47 |
3.66 |
3.01 |
|
n |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
|
G4R, M & 1000 |
Mean |
22.84 |
23.75 |
24.26 |
27.17 |
28.86 |
30.05 |
31.07 |
32.19 |
33.03 |
±SD |
0.77 |
1.04 |
1.34 |
2.09 |
2.61 |
2.18 |
2.12 |
1.59 |
1.67 |
|
n |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
|
G1R, F & 0 |
Mean |
17.44 |
18.36 |
19.45 |
10.21 |
23.17 |
24.20 |
25.35 |
26.19 |
27.04 |
±SD |
1.79 |
0.40 |
0.40 |
9.72 |
0.99 |
0.82 |
0.62 |
0.41 |
0.99 |
|
n |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
|
G4R, F & 1000 |
Mean |
17.21 |
19.05 |
20.42 |
11.29 |
24.18 |
25.37 |
26.19 |
27.14 |
27.89 |
±SD |
0.69 |
1.77 |
0.91 |
10.38 |
0.03 |
0.80 |
0.84 |
0.69 |
0.68 |
|
n |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
5 (3) |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals(Number of cages).
TABLE 9. SUMMARY RECORD OF FEED CONSUMPTION (g/animal/day) DURING GESTATION PERIOD
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 |
19.02 |
21.07 |
25.81 |
SD |
0.70 |
1.95 |
1.63 |
|
n |
11 |
11 |
11 |
|
G2, F & 111 |
Mean |
19.23 |
22.20 |
26.84 |
SD |
0.88 |
1.81 |
1.78 |
|
n |
10 |
10 |
10 |
|
G3, F & 333 |
Mean |
19.00 |
21.49 |
26.11 |
SD |
0.74 |
1.39 |
1.26 |
|
n |
10 |
10 |
10 |
|
G4, F & 1000 |
Mean |
19.43 |
22.01 |
26.67 |
SD |
0.58 |
1.70 |
1.97 |
|
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.
TABLE 10. SUMMARY RECORD OF FEED CONSUMTION (g/animal/day) DURING LACTATION PERIOD
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 |
25.21 |
35.80 |
40.88 |
SD |
1.20 |
7.26 |
1.43 |
|
n |
11 |
11 |
11 |
|
G2, F & 111 |
Mean |
24.58 |
32.72 |
41.09 |
SD |
1.34 |
0.99 |
0.98 |
|
n |
10 |
10 |
10 |
|
G3, F & 333 |
Mean |
25.11 |
32.75 |
40.54 |
SD |
1.42 |
1.16 |
0.94 |
|
n |
10 |
10 |
10 |
|
G4, F & 1000 |
Mean |
23.94 |
33.14 |
39.84 |
SD |
5.99 |
1.28 |
1.03 |
|
n |
11 |
11 |
11 |
F: Female; SD: Standard Deviation; n: Number of Dams.
TABLE 11. SUMMARY OF OPHTHALMOLOGICAL EXAMINATION RECORD
Day -1 (Grouping and randomization) |
||||||||
Group, Sex & Dose weight/day) → |
G1, M & 0 |
G2, M & 111 |
G3, M & 333 |
G4, M & 1000 |
||||
Number of Animals→ |
12 |
12 |
12 |
12 |
||||
Observations↓ |
||||||||
Eye→ Region↓ |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
Eye Lids |
N |
N |
N |
N |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
N |
N |
N |
N |
M: Male; N: Normal; LE: Left Eye; RE: Right Eye.
TABLE 11 (Contd…). SUMMARY OF OPHTHALMOLOGICAL EXAMINATION RECORD
Day -1 (Grouping and randomization) |
||||||||
Group, Sex & Dose weight/day) → |
G1, F & 0 |
G2, F & 111 |
G3, F & 333 |
G4, F & 1000 |
||||
Number of Animals→ |
12 |
12 |
12 |
12 |
||||
Observations↓ |
||||||||
Eye→ Region↓ |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
Eye Lids |
N |
N |
N |
N |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
N |
N |
N |
N |
F: Female; N: Normal; LE: Left Eye; RE: Right Eye.
TABLE 11 (Contd…). SUMMARY OF OPHTHALMOLOGICAL EXAMINATION RECORD
Day -1 (Grouping and randomization) |
||||
Group, Sex & Dose weight/day) → |
G1R, M & 0 |
G4R, M & 1000 |
||
Number of Animals→ |
5 |
5 |
||
Observations↓ |
||||
Eye→ Region↓ |
LE |
RE |
LE |
RE |
Eye Lids |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
M: Male; R: Recovery; N: Normal; LE: Left Eye; RE: Right Eye.
TABLE 11 (Contd…). SUMMARY OF OPHTHALMOLOGICAL EXAMINATION RECORD
Day -1 (Grouping and randomization) |
||||
Group, Sex & Dose weight/day) → |
G1R, F & 0 |
G4R, F & 1000 |
||
Number of Animals→ |
5 |
5 |
||
Observations↓ |
||||
Eye→ Region↓ |
LE |
RE |
LE |
RE |
Eye Lids |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
F: Female; R: Recovery; N: Normal; LE: Left Eye; RE: Right Eye.
TABLE 11 (Contd…). SUMMARY OF OPHTHALMOLOGICAL EXAMINATION RECORD
Day 30 |
||||||||
Group, Sex & Dose weight/day) → |
G1, M & 0 |
G2, M & 111 |
G3, M & 333 |
G4, M & 1000 |
||||
Number of Animals→ |
12 |
12 |
12 |
12 |
||||
Observations↓ |
||||||||
Eye→ Region↓ |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
Eye Lids |
N |
N |
N |
N |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
N |
N |
N |
N |
Other findings: |
N |
N |
N |
N |
N |
N |
N |
N |
M: Male; N: Normal; LE: Left Eye; RE: Right Eye.
TABLE 11 (Contd…). SUMMARY OF OPHTHALMOLOGICAL EXAMINATION RECORD
Pregnant/Littered females: Lactation day 13; Non-pregnant females: (Experimental day 39 to 52) |
||||||||
Group, Sex & Dose weight/day) → |
G1, F & 0 |
G2, F & 111 |
G3, F & 333 |
G4, F & 1000 |
||||
Number of Animals→ |
12 |
12 |
12 |
12 |
||||
Observations↓ |
||||||||
Eye→ Region↓ |
LE |
RE |
LE |
RE |
LE |
RE |
LE |
RE |
Eye Lids |
N |
N |
N |
N |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
N |
N |
N |
N |
Other findings: |
N |
N |
N |
N |
N |
N |
N |
N |
F: Female; N: Normal; LE: Left Eye; RE: Right Eye.
TABLE 11 (Contd…). SUMMARY OF OPHTHALMOLOGICAL EXAMINATION RECORD
Day 65 |
||||
Group, Sex & Dose weight/day) → |
G1R, M & 0 |
G4R, M & 1000 |
||
Number of Animals→ |
5 |
5 |
||
Observations↓ |
||||
Eye→ Region↓ |
LE |
RE |
LE |
RE |
Eye Lids |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
Other findings: |
N |
N |
N |
N |
M: Male; R: Recovery; N: Normal; LE: Left Eye; RE: Right Eye.
TABLE 11 (Contd…). SUMMARY OF OPHTHALMOLOGICAL EXAMINATION RECORD
Day 65 |
||||
Group, Sex & Dose weight/day) → |
G1R, F & 0 |
G4R, F & 1000 |
||
Number of Animals→ |
5 |
5 |
||
Observations↓ |
||||
Eye→ Region↓ |
LE |
RE |
LE |
RE |
Eye Lids |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
Other findings: |
N |
N |
N |
N |
F: Female; R: Recovery; N: Normal; LE: Left Eye; RE: Right Eye.
TABLE 12. SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
Day 30 |
||||||
Parameters↓ |
Group & Sex |
G1 & M |
G2 & M |
G3 & M |
G4 & M |
|
Dose (mg/kg body weight/day) |
0 |
111 |
333 |
1000 |
||
Number of Animals (randomly selected) |
5 |
5 |
5 |
5 |
||
Home Cage Observations |
||||||
Home cage posture |
1 |
1 |
1 |
1 |
||
Respiratory pattern |
1 |
1 |
1 |
1 |
||
Clonic involuntary movements |
1 |
1 |
1 |
1 |
||
Tonic involuntary movements |
1 |
1 |
1 |
1 |
||
Vocalization |
1 |
1 |
1 |
1 |
||
Palpebral closure |
1 |
1 |
1 |
1 |
||
Handling Observations |
||||||
Ease of removal from the cage |
2 |
2 |
2 |
2 |
||
Ease of handling animal in hand |
2 |
2 |
2 |
2 |
||
Red or crusty deposits |
Eyes |
1 |
1 |
1 |
1 |
|
Nose |
1 |
1 |
1 |
1 |
||
Mouth |
1 |
1 |
1 |
1 |
||
Lacrimation |
1 |
1 |
1 |
1 |
||
Salivation |
1 |
1 |
1 |
1 |
||
Fur appearance |
1 |
1 |
1 |
1 |
||
Piloerection |
1 |
1 |
1 |
1 |
||
Eye prominence |
1 |
1 |
1 |
1 |
||
Muscle tone |
1 |
1 |
1 |
1 |
||
Home Cage Observations:Home cage posture - 1=Normal; Respiratory pattern - 1=Normal; Clonic involuntary movements - 1=None; Tonic involuntary movements - 1=None; Vocalization - 1=None; Palpebral closure - 1=Normal;Handling Observations:Ease of removal from the cage - 2=Normal; Ease of handling animal in hand - 2=Normal; Red or crusty deposits - 1=Absent; Lacrimation - 1=None; Salivation- 1=None; Fur appearance - 1=Normal; Piloerection - 1=None; Eye Prominence - 1=Normal; Muscle tone - 1=Normal |
TABLE 12 (Contd…). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
Day 30 |
||||||
Parameters↓ |
Group & Sex |
G1 & M |
G2 & M |
G3 & M |
G4 & M |
|
Dose (mg/kg body weight/day) |
0 |
111 |
333 |
1000 |
||
Number of Animals (randomly selected) |
5 |
5 |
5 |
5 |
||
Open Field Observations |
||||||
Mobility |
1 |
1 |
1 |
1 |
||
Gait |
1 |
1 |
1 |
1 |
||
Arousal |
3 |
3 |
3 |
3 |
||
Number of rearing |
Mean |
4.4 |
4.8 |
4.8 |
4.8 |
|
±SD |
1.1 |
0.8 |
0.8 |
0.8 |
||
Number of urine pools |
Mean |
3.4 |
3.8 |
3.8 |
3.8 |
|
±SD |
0.5 |
0.8 |
0.8 |
0.8 |
||
Number of defecations |
Mean |
3.4 |
3.2 |
3.4 |
3.2 |
|
±SD |
0.5 |
0.8 |
0.5 |
0.4 |
||
Clonic involuntary movement |
1 |
1 |
1 |
1 |
||
Tonic involuntary movement |
1 |
1 |
1 |
1 |
||
Stereotype behaviour |
1 |
1 |
1 |
1 |
||
Number of grooming |
Mean |
3.4 |
3.2 |
3.4 |
3.2 |
|
±SD |
0.5 |
0.8 |
0.5 |
0.8 |
||
Sensory Observations |
||||||
Approach response |
2 |
2 |
2 |
2 |
||
Auditory response |
2 |
2 |
2 |
2 |
||
Touch response |
2 |
2 |
2 |
2 |
||
Pupil reflex |
2 |
2 |
2 |
2 |
||
Tail pinch response |
2 |
2 |
2 |
2 |
||
Righting reflex |
1 |
1 |
1 |
1 |
||
Physiological Observation |
||||||
Body temperature (°F) |
Mean |
98.4 |
98.4 |
98.1 |
98.4 |
|
±SD |
0.5 |
0.4 |
0.3 |
0.5 |
||
Open Field Observations: Mobility- 1=Normal;Gait- 1=Normal;Arousal- 3=Normal;Clonic involuntary movement- 1=None;Tonic involuntary movement -1=None;Stereotype behaviour -1=Absent;Sensory Observations:Approach response- 2=Normal;Auditory response- 2=Normal;Touch response -2=Normal;Pupil reflex- 2=Normal;Tail pinch response- 2=Normal;Righting reflex- 1=Present |
TABLE 12 (Contd…). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB)
Lactation Day 13 |
||||||
Parameters↓ |
Group & Sex |
G1 & F |
G2 & F |
G3 & F |
G4 & F |
|
Dose (mg/kg body weight/day) |
0 |
111 |
333 |
1000 |
||
Number of Animals (randomly selected) |
5 |
5 |
5 |
5 |
||
Home Cage Observations |
||||||
Home cage posture |
1 |
1 |
1 |
1 |
||
Respiratory pattern |
1 |
1 |
1 |
1 |
||
Clonic involuntary movements |
1 |
1 |
1 |
1 |
||
Tonic involuntary movements |
1 |
1 |
1 |
1 |
||
Vocalization |
1 |
1 |
1 |
1 |
||
Palpebral closure |
1 |
1 |
1 |
1 |
||
Handling Observations |
||||||
Ease of removal from the cage |
2 |
2 |
2 |
2 |
||
Ease of handling animal in hand |
2 |
2 |
2 |
2 |
||
Red or crusty deposits |
Eyes |
1 |
1 |
1 |
1 |
|
Nose |
1 |
1 |
1 |
1 |
||
Mouth |
1 |
1 |
1 |
1 |
||
Lacrimation |
1 |
1 |
1 |
1 |
||
Salivation |
1 |
1 |
1 |
1 |
||
Fur appearance |
1 |
1 |
1 |
1 |
||
Piloerection |
1 |
1 |
1 |
1 |
||
Eye prominence |
1 |
1 |
1 |
1 |
||
Muscle tone |
1 |
1 |
1 |
1 |
||
Home Cage Observations:Home cage posture - 1=Normal; Respiratory pattern - 1=Normal; Clonic involuntary movements - 1=None; Tonic involuntary movements - 1=None; Vocalization - 1=None; Palpebral closure - 1=Normal;Handling Observations:Ease of removal from the cage - 2=Normal; Ease of handling animal in hand - 2=Normal; Red or crusty deposits - 1=Absent; Lacrimation - 1=None; Salivation- 1=None; Fur appearance - 1=Normal; Piloerection - 1=None; Eye Prominence - 1=Normal; Muscle tone - 1=Normal |
TABLE 12 (Contd…). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB)
Lactation Day 13 |
||||||
Parameters↓ |
Group & Sex |
G1 & F |
G2 & F |
G3 & F |
G4 & F |
|
Dose (mg/kg body weight/day) |
0 |
111 |
333 |
1000 |
||
Number of Animals (randomly selected) |
5 |
5 |
5 |
5 |
||
Open Field Observations |
||||||
Mobility |
1 |
1 |
1 |
1 |
||
Gait |
1 |
1 |
1 |
1 |
||
Arousal |
3 |
3 |
3 |
3 |
||
Number of rearing |
Mean |
4.8 |
4.8 |
4.8 |
4.8 |
|
±SD |
0.8 |
0.8 |
0.8 |
0.8 |
||
Numbers of urine pools |
Mean |
3.6 |
3.8 |
3.6 |
3.8 |
|
±SD |
0.5 |
0.8 |
0.5 |
0.8 |
||
Number of defecations |
Mean |
3.4 |
3.0 |
2.8 |
3.2 |
|
±SD |
0.9 |
0.7 |
0.8 |
0.4 |
||
Clonic involuntary movement |
1 |
1 |
1 |
1 |
||
Tonic involuntary movement |
1 |
1 |
1 |
1 |
||
Stereotype behaviour |
1 |
1 |
1 |
1 |
||
Number of grooming |
Mean |
3.2 |
3.2 |
2.6 |
3.0 |
|
±SD |
0.4 |
0.8 |
0.5 |
0.7 |
||
Sensory Observations |
||||||
Approach response |
2 |
2 |
2 |
2 |
||
Auditory response |
2 |
2 |
2 |
2 |
||
Touch response |
2 |
2 |
2 |
2 |
||
Pupil reflex |
2 |
2 |
2 |
2 |
||
Tail pinch response |
2 |
2 |
2 |
2 |
||
Righting reflex |
1 |
1 |
1 |
1 |
||
Physiological Observation |
||||||
Body temperature (°F) |
Mean |
98.4 |
98.4 |
98.8 |
98.7 |
|
±SD |
0.6 |
0.5 |
0.5 |
0.8 |
||
Open Field Observations: Mobility- 1=Normal;Gait- 1=Normal;Arousal- 3=Normal;Clonic involuntary movement- 1=None;Tonic involuntary movement -1=None;Stereotype behaviour -1=Absent;Sensory Observations:Approach response- 2=Normal;Auditory response- 2=Normal;Touch response -2=Normal;Pupil reflex- 2=Normal;Tail pinch response- 2=Normal;Righting reflex- 1=Present |
TABLE 12 (Contd…). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB)
Day 65 |
||||
Parameters↓ |
Group & Sex |
G1R & M |
G4R & M |
|
Dose (mg/kg body weight/day) |
0 |
1000 |
||
Number of Animals |
5 |
5 |
||
Home Cage Observations |
||||
Home cage posture |
1 |
1 |
||
Respiratory pattern |
1 |
1 |
||
Clonic involuntary movements |
1 |
1 |
||
Tonic involuntary movements |
1 |
1 |
||
Vocalization |
1 |
1 |
||
Palpebral closure |
1 |
1 |
||
Handling Observations |
||||
Ease of removal from the cage |
2 |
2 |
||
Ease of handling animal in hand |
2 |
2 |
||
Red or crusty deposits |
Eyes |
1 |
1 |
|
Nose |
1 |
1 |
||
Mouth |
1 |
1 |
||
Lacrimation |
1 |
1 |
||
Salivation |
1 |
1 |
||
Fur appearance |
1 |
1 |
||
Piloerection |
1 |
1 |
||
Eye prominence |
1 |
1 |
||
Muscle tone |
1 |
1 |
||
Home Cage Observations:Home cage posture - 1=Normal; Respiratory pattern - 1=Normal; Clonic involuntary movements - 1=None; Tonic involuntary movements - 1=None; Vocalization - 1=None; Palpebral closure - 1=Normal;Handling Observations:Ease of removal from the cage - 2=Normal; Ease of handling animal in hand - 2=Normal; Red or crusty deposits - 1=Absent; Lacrimation - 1=None; Salivation- 1=None; Fur appearance - 1=Normal; Piloerection - 1=None; Eye Prominence - 1=Normal; Muscle tone - 1=Normal |
TABLE 12 (Contd…). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB)
Day 65 |
||||
Parameters↓ |
Group & Sex |
G1R & M |
G4R & M |
|
Dose (mg/kg body weight/day) |
0 |
1000 |
||
Number of Animals |
5 |
5 |
||
Open Field Observations |
||||
Mobility |
1 |
1 |
||
Gait |
1 |
1 |
||
Arousal |
3 |
3 |
||
Number of rearing |
Mean |
5.0 |
4.4 |
|
±SD |
1.0 |
1.1 |
||
Numbers of urine pools |
Mean |
3.6 |
3.4 |
|
±SD |
0.5 |
0.5 |
||
Number of defecations |
Mean |
3.6 |
3.4 |
|
±SD |
0.5 |
0.5 |
||
Clonic involuntary movement |
1 |
1 |
||
Tonic involuntary movement |
1 |
1 |
||
Stereotype behaviour |
1 |
1 |
||
Number of grooming |
Mean |
3.6 |
3.2 |
|
±SD |
0.5 |
0.4 |
||
Sensory Observations |
||||
Approach response |
2 |
2 |
||
Auditory response |
2 |
2 |
||
Touch response |
2 |
2 |
||
Pupil reflex |
2 |
2 |
||
Tail pinch response |
2 |
2 |
||
Righting reflex |
1 |
1 |
||
Physiological Observation |
||||
Body temperature (°F) |
Mean |
98.5 |
98.6 |
|
±SD |
0.5 |
0.5 |
||
Open Field Observations: Mobility- 1=Normal;Gait- 1=Normal;Arousal- 3=Normal;Clonic involuntary movement- 1=None;Tonic involuntary movement -1=None;Stereotype behaviour -1=Absent;Sensory Observations:Approach response- 2=Normal;Auditory response- 2=Normal;Touch response -2=Normal;Pupil reflex- 2=Normal;Tail pinch response- 2=Normal;Righting reflex- 1=Present |
TABLE 12 (Contd…). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB)
Day 65 |
||||
Parameters↓ |
Group & Sex |
G1R & F |
G4R & F |
|
Dose (mg/kg body weight/day) |
0 |
1000 |
||
Number of Animals |
5 |
5 |
||
Home Cage Observations |
||||
Home cage posture |
1 |
1 |
||
Respiratory pattern |
1 |
1 |
||
Clonic involuntary movements |
1 |
1 |
||
Tonic involuntary movements |
1 |
1 |
||
Vocalization |
1 |
1 |
||
Palpebral closure |
1 |
1 |
||
Handling Observations |
||||
Ease of removal from the cage |
2 |
2 |
||
Ease of handling animal in hand |
2 |
2 |
||
Red or crusty deposits |
Eyes |
1 |
1 |
|
Nose |
1 |
1 |
||
Mouth |
1 |
1 |
||
Lacrimation |
1 |
1 |
||
Salivation |
1 |
1 |
||
Fur appearance |
1 |
1 |
||
Piloerection |
1 |
1 |
||
Eye prominence |
1 |
1 |
||
Muscle tone |
1 |
1 |
||
Home Cage Observations:Home cage posture - 1=Normal; Respiratory pattern - 1=Normal; Clonic involuntary movements - 1=None; Tonic involuntary movements - 1=None; Vocalization - 1=None; Palpebral closure - 1=Normal;Handling Observations:Ease of removal from the cage - 2=Normal; Ease of handling animal in hand - 2=Normal; Red or crusty deposits - 1=Absent; Lacrimation - 1=None; Salivation- 1=None; Fur appearance - 1=Normal; Piloerection - 1=None; Eye Prominence - 1=Normal; Muscle tone - 1=Normal |
TABLE 12 (Contd…). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB)
Day 65 |
||||
Parameters↓ |
Group & Sex |
G1R & F |
G4R & F |
|
Dose (mg/kg body weight/day) |
0 |
1000 |
||
Number of Animals |
5 |
5 |
||
Open Field Observations |
||||
Mobility |
1 |
1 |
||
Gait |
1 |
1 |
||
Arousal |
3 |
3 |
||
Number of rearing |
Mean |
5.0 |
4.8 |
|
±SD |
1.0 |
0.8 |
||
Numbers of urine pools |
Mean |
3.6 |
3.8 |
|
±SD |
0.5 |
0.8 |
||
Number of defecations |
Mean |
3.4 |
3.0 |
|
±SD |
0.9 |
0.7 |
||
Clonic involuntary movement |
1 |
1 |
||
Tonic involuntary movement |
1 |
1 |
||
Stereotype behaviour |
1 |
1 |
||
Number of grooming |
Mean |
3.2 |
3.2 |
|
±SD |
0.4 |
0.8 |
||
Sensory Observations |
||||
Approach response |
2 |
2 |
||
Auditory response |
2 |
2 |
||
Touch response |
2 |
2 |
||
Pupil reflex |
2 |
2 |
||
Tail pinch response |
2 |
2 |
||
Righting reflex |
1 |
1 |
||
Physiological Observation |
||||
Body temperature (°F) |
Mean |
98.4 |
98.3 |
|
±SD |
0.5 |
0.7 |
||
Open Field Observations: Mobility- 1=Normal;Gait- 1=Normal;Arousal- 3=Normal;Clonic involuntary movement- 1=None;Tonic involuntary movement -1=None;Stereotype behaviour -1=Absent;Sensory Observations:Approach response- 2=Normal;Auditory response- 2=Normal;Touch response -2=Normal;Pupil reflex- 2=Normal;Tail pinch response- 2=Normal;Righting reflex- 1=Present |
TABLE 13. SUMMARY OF LOCOMOTOR ACTIVITY / MOVEMENT COUNTS RECORD
Day 30 |
||
Group, Sex & Dose (mg/kg body weight/day) |
Movement Counts (no.) |
|
G1, M & 0 |
Mean |
1911.4 |
±SD |
108.9 |
|
n |
5 |
|
G2, M & 111 |
Mean |
1961.8 |
±SD |
138.9 |
|
n |
5 |
|
G3, M & 333 |
Mean |
1954.2 |
±SD |
126.1 |
|
n |
5 |
|
G4, M & 1000 |
Mean |
1931.4 |
±SD |
104.0 |
|
n |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 13 (Contd…). SUMMARY OF LOCOMOTOR ACTIVITY / MOVEMENT COUNTS RECORD
Lactation Day 13 |
||
Group, Sex & Dose (mg/kg body weight/day) |
Movement Counts (no.) |
|
G1, F & 0 |
Mean |
1923.4 |
±SD |
102.7 |
|
n |
5 |
|
G2, F & 111 |
Mean |
1941.4 |
±SD |
125.1 |
|
n |
5 |
|
G3, F & 333 |
Mean |
1989.0 |
±SD |
103.1 |
|
n |
5 |
|
G4, F & 1000 |
Mean |
1973.2 |
±SD |
84.7 |
|
n |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 13 (Contd…). SUMMARY OF LOCOMOTOR ACTIVITY / MOVEMENT COUNTS RECORD
Day 65 |
||
Group, Sex & Dose (mg/kg body weight/day) |
Movement Counts (no.) |
|
G1R, M & 0 |
Mean |
2014.2 |
±SD |
210.7 |
|
n |
5 |
|
G4R, M & 1000 |
Mean |
1980.6 |
±SD |
197.8 |
|
n |
5 |
|
G1R, F & 0 |
Mean |
1943.4 |
±SD |
87.8 |
|
n |
5 |
|
G4R, F & 1000 |
Mean |
1956.2 |
±SD |
91.6 |
|
n |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: Number of Animals.
TABLE 14. SUMMARY OF AVERAGE GRIP STRENGTH (kgf) MEASUREMENT RECORD
Day 30 |
|||
Group, Sex & Dose (mg/kg body weight/day) |
Grip Strength (kgf) |
||
Forelimb |
Hindlimb |
||
G1, M & 0 |
Mean |
1.529 |
0.510 |
±SD |
0.023 |
0.025 |
|
n |
5 |
5 |
|
G2, M & 111 |
Mean |
1.501 |
0.539 |
±SD |
0.020 |
0.021 |
|
n |
5 |
5 |
|
G3, M & 333 |
Mean |
1.521 |
0.552* |
±SD |
0.048 |
0.008 |
|
n |
5 |
5 |
|
G4, M & 1000 |
Mean |
1.539 |
0.544* |
±SD |
0.040 |
0.015 |
|
n |
5 |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected); *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 14 (Contd…). SUMMARY OF AVERAGE GRIP STRENGTH (kgf) MEASUREMENT RECORD
Lactation Day 13 |
|||
Group, Sex & Dose (mg/kg body weight/day) |
Grip Strength (kgf) |
||
Forelimb |
Hindlimb |
||
G1, F & 0 |
Mean |
1.496 |
0.508 |
±SD |
0.009 |
0.008 |
|
n |
5 |
5 |
|
G2, F & 111 |
Mean |
1.493 |
0.488 |
±SD |
0.010 |
0.015 |
|
n |
5 |
5 |
|
G3, F & 333 |
Mean |
1.496 |
0.493 |
±SD |
0.009 |
0.021 |
|
n |
5 |
5 |
|
G4, F & 1000 |
Mean |
1.498 |
0.499 |
±SD |
0.011 |
0.020 |
|
n |
5 |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 14 (Contd…). SUMMARY OF AVERAGE GRIP STRENGTH (kgf) MEASUREMENT RECORD
Day 65 |
|||
Group, Sex & Dose (mg/kg body weight/day) |
Grip Strength (kgf) |
||
Forelimb |
Hindlimb |
||
G1R, M & 0 |
Mean |
1.515 |
0.534 |
±SD |
0.020 |
0.035 |
|
n |
5 |
5 |
|
G4R, M & 1000 |
Mean |
1.528 |
0.533 |
±SD |
0.029 |
0.009 |
|
n |
5 |
5 |
|
G1R, F & 0 |
Mean |
1.516 |
0.499 |
±SD |
0.031 |
0.021 |
|
n |
5 |
5 |
|
G4R, F & 1000 |
Mean |
1.503 |
0.481 |
±SD |
0.012 |
0.012 |
|
n |
5 |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals.
TABLE 15. SUMMARY OF AVERAGE HINDLIMB FOOT SPLAY (cm) RECORD
Day 30 |
||
Group, Sex & Dose (mg/kg body weight/day) |
Hindlimb Foot Splay (cm) |
|
G1, M & 0 |
Mean |
9.0 |
±SD |
1.0 |
|
n |
5 |
|
G2, M & 111 |
Mean |
8.8 |
±SD |
1.3 |
|
n |
5 |
|
G3, M & 333 |
Mean |
9.3 |
±SD |
0.6 |
|
n |
5 |
|
G4, M & 1000 |
Mean |
8.6 |
±SD |
0.6 |
|
n |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 15 (Contd…). SUMMARY OF AVERAGE HINDLIMB FOOT SPLAY (cm) RECORD
Lactation Day 13 |
||
Group, Sex & Dose (mg/kg body weight/day) |
Hindlimb Foot Splay (cm) |
|
G1, F & 0 |
Mean |
8.0 |
±SD |
0.5 |
|
n |
5 |
|
G2, F & 111 |
Mean |
7.9 |
±SD |
0.5 |
|
n |
5 |
|
G3, F & 333 |
Mean |
8.1 |
±SD |
1.0 |
|
n |
5 |
|
G4, F & 1000 |
Mean |
8.5 |
±SD |
0.9 |
|
n |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 15 (Contd…). SUMMARY OF AVERAGE HINDLIMB FOOT SPLAY (cm) RECORD
Day 65 |
||
Group, Sex & Dose (mg/kg body weight/day) |
Hindlimb Foot Splay (cm) |
|
G1R, M & 0 |
Mean |
8.6 |
±SD |
0.3 |
|
n |
5 |
|
G4R, M & 1000 |
Mean |
9.0 |
±SD |
0.4 |
|
n |
5 |
|
G1R, F & 0 |
Mean |
8.4 |
±SD |
0.4 |
|
n |
5 |
|
G4R, F & 1000 |
Mean |
7.6* |
±SD |
0.2 |
|
n |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals; *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 16. SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Leucocyte Count |
Total Erythrocyte Count |
Haemoglobin |
Haematocrit |
Mean Corpuscular Volume |
Mean Corpuscular Haemoglobin |
Mean Corpuscular Haemoglobin Concentration |
Platelet Count |
Mean Platelet Volume |
|
(WBC) |
(RBC) |
(HGB) |
(HCT) |
(MCV) |
(MCH) |
(MCHC) |
(PLT) |
(MPV) |
||
(103cells/µL) |
(106cells/µL) |
(g/dL) |
(%) |
(fL) |
(pg) |
(g/dL) |
(103cells/µL) |
(fL) |
||
G1, M & 0 |
Mean |
8.26 |
9.64 |
17.56 |
52.80 |
55.00 |
18.30 |
33.26 |
776.40 |
7.72 |
±SD |
1.95 |
1.09 |
1.34 |
4.49 |
3.09 |
1.14 |
0.53 |
330.86 |
0.52 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 111 |
Mean |
9.68 |
9.37 |
16.82 |
51.32 |
54.72 |
17.94 |
32.80 |
1135.20 |
7.46 |
±SD |
2.59 |
0.15 |
0.33 |
0.89 |
1.12 |
0.29 |
0.58 |
184.30 |
0.19 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 333 |
Mean |
8.67 |
9.40 |
16.58 |
50.78 |
54.12 |
17.64 |
32.62 |
962.60 |
7.72 |
±SD |
3.67 |
0.62 |
0.87 |
1.91 |
1.72 |
0.59 |
0.70 |
256.00 |
0.52 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
8.14 |
9.35 |
16.88 |
52.02 |
55.74 |
18.06 |
32.46 |
1017.60 |
7.50 |
±SD |
2.42 |
0.54 |
0.55 |
1.58 |
2.71 |
0.74 |
0.53 |
93.02 |
0.38 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 16 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Reticulocyte Count |
Neutrophils |
Lymphocytes |
Monocytes |
Eosinophils |
Basophils |
|
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
||
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
||
G1, M & 0 |
Mean |
2.25 |
23.48 |
72.02 |
2.38 |
0.44 |
0.80 |
±SD |
1.24 |
9.09 |
9.80 |
1.15 |
0.17 |
0.49 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 111 |
Mean |
1.87 |
19.66 |
75.74 |
2.28 |
1.04 |
0.54 |
±SD |
0.64 |
3.44 |
3.55 |
0.74 |
0.59 |
0.23 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 333 |
Mean |
1.87 |
21.98 |
70.58 |
2.40 |
1.04 |
0.62 |
±SD |
0.60 |
5.35 |
7.57 |
2.37 |
0.34 |
0.61 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
2.01 |
20.86 |
75.78 |
1.42 |
0.72 |
0.54 |
±SD |
0.79 |
3.34 |
2.92 |
0.23 |
0.25 |
0.15 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 16 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Absolute Reticulocyte Count |
Absolute Neutrophils |
Absolute Lymphocytes |
Absolute Monocytes |
Absolute Eosinophils |
Absolute Basophils |
Prothrombin Time |
Activated Prothrombin Time |
|
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
(PT) |
(APTT) |
||
(109cells/L) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(Seconds) |
(Seconds) |
||
G1, M & 0 |
Mean |
212.96 |
1.83 |
6.07 |
0.19 |
0.04 |
0.07 |
15.54 |
22.26 |
±SD |
101.87 |
0.42 |
2.01 |
0.08 |
0.02 |
0.06 |
0.78 |
6.12 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 111 |
Mean |
174.50 |
1.91 |
7.33 |
0.23 |
0.10* |
0.05 |
15.72 |
25.28 |
±SD |
56.93 |
0.64 |
1.96 |
0.10 |
0.04 |
0.02 |
1.03 |
1.56 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 333 |
Mean |
175.20 |
1.80 |
5.98 |
0.27 |
0.09* |
0.07 |
16.72 |
24.30 |
±SD |
59.25 |
0.52 |
1.97 |
0.39 |
0.03 |
0.11 |
1.49 |
1.59 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
184.78 |
1.70 |
6.17 |
0.11 |
0.06 |
0.04 |
15.98 |
26.78 |
±SD |
67.09 |
0.55 |
1.89 |
0.04 |
0.02 |
0.02 |
0.89 |
1.29 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected); *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 16 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Leucocyte Count |
Total Erythrocyte Count |
Haemoglobin |
Haematocrit |
Mean Corpuscular Volume |
Mean Corpuscular Haemoglobin |
Mean Corpuscular Haemoglobin Concentration |
Platelet Count |
Mean Platelet Volume |
|
(WBC) |
(RBC) |
(HGB) |
(HCT) |
(MCV) |
(MCH) |
(MCHC) |
(PLT) |
(MPV) |
||
(103cells/µL) |
(106cells/µL) |
(g/dL) |
(%) |
(fL) |
(pg) |
(g/dL) |
(103cells/µL) |
(fL) |
||
G1, F & 0 |
Mean |
10.56 |
7.85 |
15.74 |
46.26 |
59.02 |
20.04 |
34.04 |
752.60 |
6.02 |
±SD |
3.78 |
0.45 |
0.65 |
3.16 |
4.16 |
1.08 |
0.91 |
361.58 |
0.64 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 111 |
Mean |
11.38 |
7.41 |
14.66 |
44.60 |
60.26 |
19.74 |
32.82 |
1130.00 |
6.72 |
±SD |
3.45 |
0.68 |
1.58 |
3.35 |
1.37 |
0.42 |
1.34 |
672.21 |
0.54 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 333 |
Mean |
9.62 |
7.95 |
15.56 |
46.34 |
58.34 |
19.60 |
33.60 |
1030.20 |
6.42 |
±SD |
3.95 |
0.28 |
0.72 |
2.05 |
3.12 |
0.81 |
1.07 |
104.22 |
0.57 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
12.38 |
7.39 |
14.68 |
43.46 |
59.06 |
19.98 |
33.80 |
1003.00 |
6.92 |
±SD |
3.58 |
0.76 |
0.89 |
2.75 |
3.76 |
1.58 |
0.63 |
227.17 |
0.68 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 16 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Reticulocyte Count |
Neutrophils |
Lymphocytes |
Monocytes |
Eosinophils |
Basophils |
|
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
||
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
||
G1, F & 0 |
Mean |
2.28 |
32.72 |
60.66 |
3.68 |
1.46 |
0.60 |
±SD |
0.87 |
15.77 |
16.88 |
1.06 |
0.98 |
0.23 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 111 |
Mean |
4.52 |
30.00 |
62.56 |
4.60 |
1.18 |
0.42 |
±SD |
4.56 |
11.00 |
11.24 |
1.35 |
0.63 |
0.19 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 333 |
Mean |
1.49 |
25.26 |
66.92 |
4.46 |
1.22 |
0.80 |
±SD |
0.67 |
9.73 |
12.89 |
4.23 |
0.33 |
1.12 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
4.16 |
37.00 |
57.76 |
3.10 |
0.88 |
0.28 |
±SD |
2.72 |
20.56 |
20.80 |
0.97 |
0.47 |
0.11 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 16 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Absolute Reticulocyte Count |
Absolute Neutrophils |
Absolute Lymphocytes |
Absolute Monocytes |
Absolute Eosinophils |
Absolute Basophils |
Prothrombin Time |
Activated Prothrombin Time |
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
(PT) |
(APTT) |
||
(109cells/L) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(Seconds) |
(Seconds) |
||
G1, F & 0 |
Mean |
177.36 |
3.64 |
6.21 |
0.40 |
0.15 |
0.06 |
17.60 |
23.34 |
±SD |
60.94 |
2.11 |
2.30 |
0.19 |
0.09 |
0.03 |
1.02 |
2.05 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 111 |
Mean |
313.86 |
3.59 |
6.91 |
0.56 |
0.12 |
0.05 |
22.06 |
27.48 |
±SD |
276.22 |
2.17 |
1.72 |
0.29 |
0.04 |
0.02 |
8.41 |
10.47 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 333 |
Mean |
117.60 |
2.64 |
6.29 |
0.39 |
0.12 |
0.06 |
16.88 |
22.08 |
±SD |
50.69 |
2.06 |
2.26 |
0.31 |
0.07 |
0.08 |
3.84 |
7.81 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
291.70 |
4.81 |
6.94 |
0.38 |
0.10 |
0.04 |
15.66 |
19.92 |
±SD |
145.98 |
3.66 |
3.06 |
0.17 |
0.03 |
0.02 |
3.85 |
5.41 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 16 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Leucocyte Count |
Total Erythrocyte Count |
Haemoglobin |
Haematocrit |
Mean Corpuscular Volume |
Mean Corpuscular Haemoglobin |
Mean Corpuscular Haemoglobin Concentration |
Platelet Count |
Mean Platelet Volume |
|
(WBC) |
(RBC) |
(HGB) |
(HCT) |
(MCV) |
(MCH) |
(MCHC) |
(PLT) |
(MPV) |
||
(103cells/µL) |
(106cells/µL) |
(g/dL) |
(%) |
(fL) |
(pg) |
(g/dL) |
(103cells/µL) |
(fL) |
||
G1R, M & 0 |
Mean |
9.13 |
9.21 |
16.04 |
48.76 |
52.94 |
17.42 |
32.92 |
894.80 |
6.50 |
±SD |
0.78 |
0.14 |
0.43 |
1.79 |
1.78 |
0.39 |
0.42 |
134.10 |
0.31 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
9.55 |
9.14 |
15.80 |
48.54 |
53.08 |
17.30 |
32.62 |
1071.80 |
6.42 |
±SD |
1.05 |
0.32 |
0.65 |
2.25 |
0.91 |
0.30 |
0.57 |
268.87 |
0.37 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
6.97 |
7.65 |
14.26 |
42.16 |
55.20 |
18.64 |
33.78 |
873.60 |
6.32 |
±SD |
2.14 |
0.43 |
0.65 |
2.05 |
1.99 |
0.70 |
0.29 |
80.79 |
0.19 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
7.59 |
7.73 |
14.32 |
42.78 |
55.34 |
18.48 |
33.46 |
739.60 |
6.52 |
±SD |
3.51 |
0.22 |
0.57 |
1.63 |
2.15 |
0.70 |
0.25 |
253.21 |
0.13 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals.
TABLE 16 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Reticulocyte Count |
Neutrophils |
Lymphocytes |
Monocytes |
Eosinophils |
Basophils |
|
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
||
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
||
G1R, M & 0 |
Mean |
1.63 |
25.28 |
69.00 |
1.76 |
2.30 |
0.88 |
±SD |
0.26 |
6.62 |
7.82 |
0.49 |
0.89 |
0.26 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
2.03 |
21.70 |
73.32 |
1.48 |
2.02 |
0.60 |
±SD |
0.50 |
5.52 |
5.80 |
0.37 |
0.36 |
0.29 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
1.84 |
26.12 |
68.68 |
2.30 |
1.34 |
0.68 |
±SD |
0.36 |
9.06 |
8.57 |
1.19 |
0.45 |
0.15 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
2.48* |
29.02 |
64.16 |
2.40 |
2.86* |
0.64 |
±SD |
0.39 |
7.89 |
6.96 |
0.87 |
1.30 |
0.13 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals; *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 16 (Contd…). SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Absolute Reticulocyte Count |
Absolute Neutrophils |
Absolute Lymphocytes |
Absolute Monocytes |
Absolute Eosinophils |
Absolute Basophils |
Prothrombin Time |
Activated Prothrombin Time |
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
(PT) |
(APTT) |
||
(109cells/L) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(Seconds) |
(Seconds) |
||
G1R, M & 0 |
Mean |
150.40 |
2.27 |
6.35 |
0.16 |
0.21 |
0.08 |
16.00 |
21.56 |
±SD |
23.36 |
0.40 |
1.23 |
0.04 |
0.07 |
0.02 |
2.04 |
2.05 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
186.92 |
2.06 |
7.02 |
0.14 |
0.19 |
0.05 |
15.50 |
22.48 |
±SD |
52.68 |
0.53 |
1.09 |
0.04 |
0.04 |
0.03 |
1.17 |
3.12 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
140.08 |
1.78 |
4.83 |
0.15 |
0.09 |
0.05 |
14.98 |
24.56 |
±SD |
23.05 |
0.73 |
1.73 |
0.05 |
0.02 |
0.01 |
0.53 |
1.98 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
192.10* |
2.06 |
4.98 |
0.17 |
0.25 |
0.05 |
15.92 |
19.34* |
±SD |
30.17 |
0.60 |
2.77 |
0.07 |
0.24 |
0.02 |
1.17 |
2.34 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals; *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 17. SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Glucose |
Urea |
Creatinine |
Total Cholesterol |
Triglycerides |
Total Protein |
Albumin |
|
(GLU) |
- |
(CRE) |
(CHO) |
(TRI) |
(TPR) |
(ALB) |
||
(mg/dL) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
(g/dL) |
(g/dL) |
||
G1, M & 0 |
Mean |
126.60 |
30.52 |
0.58 |
51.60 |
25.60 |
7.74 |
3.47 |
±SD |
15.47 |
2.56 |
0.03 |
3.36 |
2.30 |
0.26 |
0.19 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 111 |
Mean |
123.60 |
33.30 |
0.57 |
60.60 |
30.40 |
7.24* |
3.55 |
±SD |
5.55 |
3.91 |
0.04 |
4.83 |
6.07 |
0.33 |
0.15 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 333 |
Mean |
122.60 |
33.78 |
0.60 |
58.00 |
29.40 |
7.44 |
3.65 |
±SD |
12.92 |
2.83 |
0.03 |
6.71 |
7.73 |
0.22 |
0.29 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
131.00 |
36.04 |
0.59 |
56.00 |
27.00 |
7.58 |
3.68 |
±SD |
19.79 |
4.26 |
0.02 |
9.57 |
6.16 |
0.29 |
0.24 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected); *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 17 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Alanine |
Aspartate |
Alkaline |
Total Bilirubin |
Calcium |
Phosphorous |
|
(ALT) |
(AST) |
(ALP) |
(BIT) |
(CAL) |
(PHO) |
||
(U/L) |
(U/L) |
(U/L) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
||
G1, M & 0 |
Mean |
61.20 |
111.20 |
125.80 |
0.05 |
9.36 |
6.48 |
±SD |
16.93 |
12.34 |
21.11 |
0.01 |
0.11 |
0.58 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 111 |
Mean |
47.40 |
93.20 |
120.00 |
0.06 |
9.64 |
6.54 |
±SD |
8.96 |
13.46 |
31.92 |
0.03 |
0.47 |
0.62 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 333 |
Mean |
40.00 |
81.60* |
127.20 |
0.06 |
10.40* |
6.82 |
±SD |
5.96 |
12.30 |
38.01 |
0.03 |
1.05 |
0.62 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
52.20 |
91.80 |
114.80 |
0.06 |
9.94 |
6.62 |
±SD |
24.52 |
18.69 |
28.70 |
0.02 |
0.30 |
0.49 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected) ; *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 17 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Globulin |
Albumin/ Globulin ratio |
Blood Urea Nitrogen |
Sodium |
Potassium |
Chloride |
|
(GLO) |
(A/G Ratio) |
(BUN) |
(Na) |
(K) |
(CLO) |
||
(g/dL) |
- |
(mg/dL) |
(mmol/L) |
(mmol/L) |
(mmol/L) |
||
G1, M & 0 |
Mean |
4.27 |
0.82 |
14.24 |
141.64 |
3.96 |
104.10 |
±SD |
0.30 |
0.09 |
1.19 |
0.94 |
0.25 |
2.51 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 111 |
Mean |
3.69* |
0.97 |
15.54 |
142.16 |
3.71 |
105.38 |
±SD |
0.38 |
0.12 |
1.83 |
0.53 |
0.15 |
1.40 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 333 |
Mean |
3.79* |
0.97 |
15.77 |
142.44 |
3.86 |
105.78 |
±SD |
0.12 |
0.10 |
1.32 |
0.93 |
0.36 |
1.73 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
3.90 |
0.95 |
16.82 |
142.76 |
3.85 |
106.40 |
±SD |
0.29 |
0.11 |
1.99 |
0.66 |
0.09 |
0.86 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals (randomly selected); *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 17 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Glucose |
Urea |
Creatinine |
Total Cholesterol |
Triglycerides |
Total Protein |
Albumin |
|
(GLU) |
- |
(CRE) |
(CHO) |
(TRI) |
(TPR) |
(ALB) |
||
(mg/dL) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
(g/dL) |
(g/dL) |
||
G1, F & 0 |
Mean |
102.20 |
48.68 |
0.54 |
76.60 |
78.60 |
7.32 |
3.63 |
±SD |
26.22 |
8.11 |
0.05 |
22.67 |
26.83 |
1.08 |
0.67 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 111 |
Mean |
121.20 |
51.14 |
0.52 |
67.80 |
59.40 |
7.34 |
3.41 |
±SD |
29.64 |
13.28 |
0.03 |
17.67 |
23.65 |
0.75 |
0.30 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 333 |
Mean |
103.80 |
44.78 |
0.57 |
75.60 |
43.20 |
7.56 |
3.58 |
±SD |
13.81 |
19.81 |
0.04 |
14.91 |
21.48 |
0.29 |
0.32 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
114.60 |
51.66 |
0.57 |
75.80 |
105.20 |
7.76 |
3.70 |
±SD |
16.44 |
16.16 |
0.07 |
20.44 |
68.28 |
0.58 |
0.11 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 17 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Alanine |
Aspartate |
Alkaline |
Total Bilirubin |
Calcium |
Phosphorous |
|
(ALT) |
(AST) |
(ALP) |
(BIT) |
(CAL) |
(PHO) |
||
(U/L) |
(U/L) |
(U/L) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
||
G1, F & 0 |
Mean |
84.60 |
119.40 |
164.40 |
0.03 |
10.06 |
5.92 |
±SD |
14.43 |
14.31 |
75.62 |
0.04 |
1.06 |
0.95 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 111 |
Mean |
113.80 |
143.80 |
420.00 |
0.02 |
9.42 |
5.50 |
±SD |
66.08 |
71.78 |
367.29 |
0.02 |
0.64 |
1.64 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 333 |
Mean |
96.20 |
99.40 |
305.80 |
0.06 |
10.04 |
6.06 |
±SD |
82.35 |
16.01 |
412.83 |
0.02 |
0.85 |
1.93 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
88.60 |
101.80 |
212.40 |
0.03 |
10.38 |
6.38 |
±SD |
46.69 |
22.65 |
81.17 |
0.04 |
0.91 |
3.11 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 17 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Globulin |
Albumin/Globulin ratio |
Blood Urea Nitrogen |
Sodium |
Potassium |
Chloride |
|
(GLO) |
(A/G Ratio) |
(BUN) |
(Na) |
(K) |
(CLO) |
||
(g/dL) |
- |
(mg/dL) |
(mmol/L) |
(mmol/L) |
(mmol/L) |
||
G1, F & 0 |
Mean |
3.69 |
0.98 |
22.72 |
143.04 |
4.02 |
106.18 |
±SD |
0.50 |
0.11 |
3.79 |
1.34 |
0.81 |
2.96 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 111 |
Mean |
3.93 |
0.88 |
23.87 |
142.18 |
3.57 |
107.22 |
±SD |
0.66 |
0.14 |
6.20 |
1.47 |
0.28 |
3.01 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 333 |
Mean |
3.98 |
0.91 |
20.90 |
142.36 |
3.60 |
107.94 |
±SD |
0.40 |
0.16 |
9.25 |
1.61 |
0.33 |
2.63 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
4.06 |
0.92 |
24.11 |
142.62 |
3.86 |
107.06 |
±SD |
0.50 |
0.09 |
7.55 |
1.62 |
0.40 |
3.20 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; SD: Standard Deviation; n: Number of Animals (randomly selected).
TABLE 17 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Glucose |
Urea |
Creatinine |
Total Cholesterol |
Triglycerides |
Total Protein |
Albumin |
|
(GLU) |
- |
(CRE) |
(CHO) |
(TRI) |
(TPR) |
(ALB) |
||
(mg/dL) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
(g/dL) |
(g/dL) |
||
G1R, M & 0 |
Mean |
99.80 |
27.36 |
0.55 |
59.60 |
23.00 |
6.98 |
3.10 |
±SD |
6.53 |
3.92 |
0.02 |
16.21 |
5.52 |
0.26 |
0.07 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
99.40 |
25.74 |
0.56 |
68.80 |
31.60 |
7.12 |
3.05 |
±SD |
10.53 |
1.19 |
0.03 |
8.76 |
10.78 |
0.11 |
0.04 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
120.40 |
35.68 |
0.61 |
106.40 |
49.60 |
8.44 |
4.10 |
±SD |
7.16 |
7.57 |
0.02 |
17.07 |
34.09 |
0.56 |
0.18 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
104.00* |
31.42 |
0.59 |
89.20 |
41.60 |
8.04 |
3.70 |
±SD |
13.49 |
2.25 |
0.01 |
16.98 |
11.87 |
0.42 |
0.44 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: Number of Animals; *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 17 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Alanine aminotransferase |
Aspartate aminotransferase |
Alkaline phosphatase |
Total Bilirubin |
Calcium |
Phosphorous |
|
(ALT) |
(AST) |
(ALP) |
(BIT) |
(CAL) |
(PHO) |
||
(U/L) |
(U/L) |
(U/L) |
(mg/dL) |
(mg/dL) |
(mg/dL) |
||
G1R, M & 0 |
Mean |
52.00 |
101.80 |
99.00 |
0.02 |
10.42 |
5.72 |
±SD |
40.34 |
53.17 |
23.40 |
0.02 |
0.37 |
0.34 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
42.60 |
98.40 |
105.20 |
0.02 |
10.02 |
5.26 |
±SD |
9.86 |
18.49 |
29.84 |
0.01 |
0.15 |
0.50 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
54.00 |
94.00 |
70.80 |
0.02 |
11.20 |
4.20 |
±SD |
28.82 |
36.89 |
40.92 |
0.02 |
0.45 |
0.38 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
53.80 |
103.20 |
69.00 |
0.04 |
10.90 |
4.42 |
±SD |
21.53 |
39.30 |
60.10 |
0.02 |
0.37 |
0.18 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: Number of Animals.
TABLE 17 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Globulin |
Albumin/ Globulin ratio |
Blood Urea Nitrogen |
Sodium |
Potassium |
Chloride |
|
(GLO) |
(A/G Ratio) |
(BUN) |
(Na) |
(K) |
(CLO) |
||
(g/dL) |
- |
(mg/dL) |
(mmol/L) |
(mmol/L) |
(mmol/L) |
||
G1R, M & 0 |
Mean |
3.88 |
0.80 |
12.77 |
142.82 |
3.56 |
105.48 |
±SD |
0.27 |
0.06 |
1.83 |
0.36 |
0.41 |
0.92 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
4.07 |
0.75 |
12.01 |
143.16 |
3.59 |
108.06* |
±SD |
0.15 |
0.04 |
0.56 |
0.68 |
0.41 |
1.65 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
4.34 |
0.95 |
16.65 |
142.62 |
3.45 |
105.76 |
±SD |
0.42 |
0.08 |
3.53 |
0.94 |
0.17 |
1.52 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
4.34 |
0.85 |
14.66 |
142.26 |
3.62 |
106.40 |
±SD |
0.21 |
0.12 |
1.05 |
1.41 |
0.48 |
2.88 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: Number of Animals; *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 18. SUMMARY OF URINALYSIS RECORD
Examination |
Group, Sex & Dose (mg/kg body weight/day) |
G1, M & 0 |
G2, M & 111 |
G3, M & 333 |
G4, M & 1000 |
|
Number of Animals (randomly selected) |
5 |
5 |
5 |
5 |
||
Physical Examination |
Color |
Pale Yellow |
5 |
5 |
5 |
5 |
Appearance |
Clear |
5 |
5 |
5 |
5 |
|
Volume (mL) |
Mean |
10.6 |
10.2 |
11.0 |
11.4 |
|
±SD |
0.7 |
1.4 |
0.8 |
0.4 |
||
Chemical Examination |
pH |
Mean |
7.5 |
7.4 |
7.4 |
7.5 |
±SD |
0.0 |
0.4 |
0.5 |
0.0 |
||
Specific Gravity |
Mean |
1.008 |
1.011 |
1.009 |
1.009 |
|
±SD |
0.003 |
0.002 |
0.002 |
0.002 |
||
Urobilinogen (mg/dL) |
Mean |
0.2 |
0.2 |
0.2 |
0.2 |
|
±SD |
0.0 |
0.0 |
0.0 |
0.0 |
||
Bilirubin (mg/dL) |
Neg |
5 |
5 |
5 |
5 |
|
Ketones (mg/dL) |
Neg |
2 |
- |
2 |
1 |
|
5 |
3 |
5 |
3 |
4 |
||
Blood (Ery/µL) |
Neg |
5 |
4 |
5 |
5 |
|
Ca80 |
- |
1 |
- |
- |
||
Protein (mg/dL) |
Neg |
3 |
- |
3 |
1 |
|
Trace |
2 |
4 |
1 |
4 |
||
30 |
- |
1 |
1 |
- |
||
Nitrite |
Neg |
4 |
4 |
5 |
1 |
|
Pos |
1 |
1 |
- |
4 |
||
Leucocytes |
Neg |
3 |
- |
3 |
1 |
|
Ca15 |
1 |
1 |
1 |
2 |
||
Ca70 |
1 |
3 |
1 |
2 |
||
Ca125 |
- |
1 |
- |
- |
||
Glucose (mg/dL) |
Neg |
5 |
5 |
5 |
5 |
|
Microalbumin (mg/dL) |
Neg |
- |
- |
2 |
1 |
|
>15 |
2 |
5 |
2 |
4 |
||
15 |
3 |
- |
1 |
- |
||
Microscopic Examination |
Epi Cells |
0 |
3 |
4 |
2 |
4 |
0-1 |
1 |
1 |
2 |
1 |
||
1-2 |
1 |
- |
1 |
- |
||
Casts |
Absent |
4 |
4 |
4 |
5 |
|
Present |
1 |
1 |
1 |
- |
||
Crystals |
Present |
5 |
5 |
5 |
5 |
M:
Male; SD: Standard Deviation; Pos: Positive; Neg: Negative; Ca:
Calculated.
>=:
Greater than or equal to; >: Greater than.
TABLE 18 (Contd…). SUMMARY OF URINALYSIS RECORD
Examination |
Group, Sex & Dose (mg/kg body weight/day) |
G1R, M & 0 |
G4R, M &1000 |
G1R, F & 0 |
G4R, F & 1000 |
|
Number of Animals (randomly selected) |
5 |
5 |
5 |
5 |
||
Physical Examination |
Color |
Pale Yellow |
2 |
5 |
3 |
3 |
Yellow |
3 |
- |
2 |
2 |
||
Appearance |
Clear |
3 |
2 |
4 |
4 |
|
Turbid |
2 |
3 |
1 |
1 |
||
Volume (mL) |
Mean |
6.4 |
8.6 |
7.9 |
7.8 |
|
±SD |
1.7 |
3.1 |
2.2 |
0.8 |
||
Chemical Examination |
pH |
Mean |
6.7 |
7.3 |
6.8 |
7.6 |
±SD |
0.9 |
0.4 |
1.0 |
1.0 |
||
Specific Gravity |
Mean |
1.020 |
1.014 |
1.014 |
1.012 |
|
±SD |
0.007 |
0.002 |
0.007 |
0.008 |
||
Urobilinogen (mg/dL) |
Mean |
0.2 |
0.2 |
0.2 |
0.6 |
|
±SD |
0.0 |
0.0 |
0.0 |
0.8 |
||
Bilirubin (mg/dL) |
Neg |
2 |
5 |
5 |
2 |
|
1 |
3 |
- |
- |
3 |
||
Ketones (mg/dL) |
Neg |
1 |
2 |
5 |
5 |
|
5 |
4 |
3 |
- |
- |
||
Blood (Ery/µL) |
Neg |
5 |
5 |
5 |
4 |
|
Ca10 |
- |
- |
- |
1 |
||
Protein (mg/dL) |
Neg |
2 |
5 |
4 |
2 |
|
Trace |
2 |
- |
1 |
- |
||
30 |
1 |
- |
- |
- |
||
100 |
- |
- |
- |
1 |
||
>=300 |
- |
- |
- |
2 |
||
Nitrite |
Neg |
3 |
5 |
5 |
5 |
|
Pos |
2 |
- |
- |
- |
||
Leucocytes |
Neg |
- |
1 |
3 |
2 |
|
Ca15 |
1 |
4 |
2 |
- |
||
Ca70 |
4 |
- |
- |
3 |
||
Glucose (mg/dL) |
Neg |
5 |
5 |
5 |
5 |
|
Microalbumin (mg/dL) |
Neg |
- |
1 |
3 |
1 |
|
>15 |
3 |
- |
1 |
3 |
||
15 |
2 |
4 |
1 |
1 |
||
Microscopic Examination\ |
Epi Cells |
0 |
3 |
3 |
2 |
2 |
0-1 |
1 |
2 |
2 |
1 |
||
1-2 |
1 |
- |
1 |
- |
||
2-3 |
- |
- |
- |
2 |
||
Casts |
Absent |
5 |
2 |
5 |
4 |
|
Present |
- |
3 |
- |
1 |
||
Crystals |
Absent |
- |
2 |
1 |
2 |
|
Present |
5 |
3 |
4 |
3 |
M:
Male; F: Female; R: Recovery; SD: Standard Deviation; Pos: Positive;
Neg: Negative.
Ca: Calculated; >=: Greater than
or equal to; >: Greater than.
TABLE 19. SUMMARY OF VAGINAL SMEAR EXAMINATION RECORD FOR DETERMINATION OF OESTRUS CYCLICITY
Group, Sex & Dose |
Total No. of Females Evaluated |
Females with Complete Regular Cycles |
Females with at least one Irregular Oestrus Cycle |
Average Length of Oestrus Cycle (Days) |
||
G1, F & 0 |
12 |
n |
11 |
1 |
Mean |
4.65 |
% |
91.7 |
8.3 |
±SD |
0.41 |
||
n |
12 |
|||||
G2, F & 111 |
12 |
n |
11 |
0 |
Mean |
4.43 |
% |
91.7 |
0.0 |
±SD |
0.42 |
||
n |
12 |
|||||
G3, F & 333 |
12 |
n |
12 |
0 |
Mean |
4.68 |
% |
100.0 |
0.0 |
±SD |
0.27 |
||
n |
12 |
|||||
G4, F & 1000 |
12 |
n |
11 |
1 |
Mean |
4.53 |
% |
91.7 |
8.3 |
±SD |
0.34 |
||
n |
12 |
F: Female; SD: Standard Deviation; n: Number of Animals.
TABLE 20. SUMMARY OF DELIVERY AND LITTER OBSERVATIONS RECORD
Group, Sex & 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, F & 0 |
Mean |
12.18 |
6.27 |
5.73 |
12.00 |
0.18 |
0.00 |
0.18 |
0.00 |
0.00 |
0.00 |
0.00 |
|
1.14 |
98.86 |
||||
±SD |
2.68 |
1.90 |
1.35 |
2.41 |
0.40 |
0.00 |
0.40 |
0.00 |
0.00 |
0.00 |
0.00 |
0.42 |
2.54 |
||||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||||||
G2, F & 111 |
Mean |
12.20 |
|
6.00 |
6.00 |
12.00 |
|
0.10 |
0.10 |
0.20 |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
1.12 |
|
98.70 |
±SD |
3.29 |
1.94 |
1.89 |
3.09 |
0.32 |
0.32 |
0.42 |
0.00 |
0.00 |
0.00 |
0.00 |
0.57 |
2.76 |
||||||
n |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
||||||
G3, F & 333 |
Mean |
10.90 |
|
5.30 |
5.50 |
10.80 |
|
0.10 |
0.00 |
0.10 |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
1.00 |
|
99.41 |
±SD |
2.77 |
2.00 |
1.27 |
2.53 |
0.32 |
0.00 |
0.32 |
0.00 |
0.00 |
0.00 |
0.00 |
0.39 |
1.86 |
||||||
n |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
||||||
G4, F & 1000 |
Mean |
12.82 |
|
6.36 |
6.09 |
12.45 |
|
0.18 |
0.18 |
0.36 |
|
0.00 |
0.00 |
0.00 |
0.00 |
|
1.16 |
|
96.57 |
±SD |
1.99 |
2.11 |
1.64 |
2.54 |
0.40 |
0.60 |
0.92 |
0.00 |
0.00 |
0.00 |
0.00 |
0.71 |
9.11 |
||||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
F: Female; SD: Standard Deviation; n: Number of Dams; m/f: Male/Female; %: Percentage.
TABLE 20 (Contd…). SUMMARY RECORD OF DELIVERY AND LITTER OBSERVATIONS
Group, Sex & Dose weight/day) |
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, F & 0 |
Mean |
6.27 |
5.73 |
12.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.14 |
100.00 |
||||
±SD |
1.90 |
1.35 |
2.41 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.42 |
0.00 |
|||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
|||||
G2, F & 111 |
Mean |
6.00 |
6.00 |
12.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.12 |
100.00 |
||||
±SD |
1.94 |
1.89 |
3.09 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.57 |
0.00 |
|||||
n |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
|||||
G3, F & 333 |
Mean |
5.30 |
5.50 |
10.80 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.00 |
100.00 |
||||
±SD |
2.00 |
1.27 |
2.53 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.39 |
0.00 |
|||||
n |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
|||||
G4, F & 1000 |
Mean |
6.36 |
6.09 |
12.45 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.16 |
100.00 |
||||
±SD |
2.11 |
1.64 |
2.54 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.71 |
0.00 |
|||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
F: Female; SD: Standard Deviation; n: Number of Dams; m/f: Male/Female; %: Percentage.
TABLE 20 (Contd…). SUMMARY RECORD OF DELIVERY AND LITTER OBSERVATIONS
Group, Sex & Dose |
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, F & 0 |
Mean |
0.00 |
1.09 |
1.09 |
6.27 |
4.64 |
10.91 |
6.27 |
4.64 |
10.91 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.55 |
100.00 |
||||||
±SD |
0.00 |
1.04 |
1.04 |
1.90 |
1.36 |
1.58 |
1.90 |
1.36 |
1.58 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.86 |
0.00 |
|||||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
|||||||
G2, F & 111 |
Mean |
0.00 |
1.20 |
1.20 |
6.00 |
4.80 |
10.80 |
6.00 |
4.80 |
10.80 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.37 |
100.00 |
||||||
±SD |
0.00 |
1.03 |
1.03 |
1.94 |
1.23 |
2.20 |
1.94 |
1.23 |
2.20 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.62 |
0.00 |
|||||||
n |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
|||||||
G3, F & 333 |
Mean |
0.00 |
0.70 |
0.70 |
5.30 |
4.80 |
10.10 |
5.30 |
4.80 |
10.10 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.21 |
100.00 |
||||||
±SD |
0.00 |
0.95 |
0.95 |
2.00 |
1.03 |
1.73 |
2.00 |
1.03 |
1.73 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.67 |
0.00 |
|||||||
n |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
|||||||
G4, F & 1000 |
Mean |
0.00 |
1.64 |
1.64 |
6.36 |
4.45 |
10.82 |
6.36 |
4.45 |
10.82 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
2.07 |
100.00 |
||||||
±SD |
0.00 |
0.81 |
0.81 |
2.11 |
1.57 |
1.99 |
2.11 |
1.57 |
1.99 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
2.39 |
0.00 |
|||||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
F: Female; SD: Standard Deviation; n: Number of Dams; LD: Lactation Day; m/f: Male/Female.
TABLE 20 (Contd…). SUMMARY RECORD OF DELIVERY AND LITTER OBSERVATIONS
Group, Sex & 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, F & 0 |
Mean |
6.27 |
4.64 |
10.91 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.55 |
100.00 |
||||
±SD |
1.90 |
1.36 |
1.58 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.86 |
0.00 |
|||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
|||||
G2, F & 111 |
Mean |
6.00 |
4.80 |
10.80 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.37 |
100.00 |
||||
±SD |
1.94 |
1.23 |
2.20 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.62 |
0.00 |
|||||
n |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
|||||
G3, F & 333 |
Mean |
5.30 |
4.80 |
10.10 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
1.21 |
100.00 |
||||
±SD |
2.00 |
1.03 |
1.73 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.67 |
0.00 |
|||||
n |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
|||||
G4, F & 1000 |
Mean |
6.36 |
4.45 |
10.82 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
2.07 |
100.00 |
||||
±SD |
2.11 |
1.57 |
1.99 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
2.39 |
0.00 |
|||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
F: Female; SD: Standard Deviation; n: Number of Dams; LD: Lactation Day; m/f: Male/Female; %: Percentage.
TABLE 21. SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
Group, Sex & Dose |
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) |
100.0 |
11 (12) |
91.7 |
|
G2, M & 111 |
12 (12) |
100.0 |
10 (12) |
83.3 |
|
G3, M & 333 |
12 (12) |
100.0 |
10 (12) |
83.3 |
|
G4, M & 1000 |
12 (12) |
100.0 |
11 (12) |
91.7 |
M: Male.
TABLE 21 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
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 |
3.58 |
n |
8 |
4 |
22.55 |
|
SD |
3.80 |
% |
66.67 |
33.33 |
0.52 |
||
N |
12 |
11 |
|||||
G2, F & 111 |
Mean |
3.75 |
n |
9 |
3 |
22.20 |
|
SD |
4.45 |
% |
75 |
25 |
0.63 |
||
N |
12 |
10 |
|||||
G3, F & 333 |
Mean |
4.58 |
n |
8 |
4 |
22.50 |
|
SD |
5.00 |
% |
66.67 |
33.33 |
0.53 |
||
N |
12 |
10 |
|||||
G4, F & 1000 |
Mean |
4.67 |
n |
8 |
4 |
22.36 |
|
SD |
5.50 |
% |
66.67 |
33.33 |
0.50 |
||
N |
12 |
11 |
F: Female; SD: Standard Deviation; n: Number of females with evidence of mating (pre-coital interval); n: Number of pregnant females (gestation length).
TABLE 21 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
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) |
100.0 |
11 (12) |
91.7 |
|
G2, F & 111 |
12 (12) |
100.0 |
10 (12) |
83.3 |
|
G3, F & 333 |
12 (12) |
100.0 |
10 (12) |
83.3 |
|
G4, F & 1000 |
12 (12) |
100.0 |
11 (12) |
91.7 |
F: Female.
TABLE 21 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
Group, Sex & Dose mg/kg body weight/day) |
Female Fecundity or Pregnancy Index (%) |
Gestation Index (%) |
|||||
No. of Pregnant Females |
No. of Females Confirmed with Mating |
Female Fecundity or Pregnancy Index (%) |
Females with Live Born Pups at Parturition |
No. of Females with Evidence of Pregnancy |
Gestation Index (%) |
||
G1, F & 0 |
11 |
12 |
91.7 |
11 |
11 |
100.0 |
|
G2, F & 111 |
10 |
12 |
83.3 |
10 |
10 |
100.0 |
|
G3, F & 333 |
10 |
12 |
83.3 |
10 |
10 |
100.0 |
|
G4, F & 1000 |
11 |
12 |
91.7 |
11 |
11 |
100.0 |
F: Female.
TABLE 21 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
Group, Sex & Dose (mg/kg body weight/day) |
Parturition index (%) |
||
No. of Females Littered |
No. of Females with evidence of pregnancy |
Parturition index (%) |
|
G1, F & 0 |
11 |
11 |
100.0 |
G2, F & 111 |
10 |
10 |
100.0 |
G3, F & 333 |
10 |
10 |
100.0 |
G4, F & 1000 |
11 |
11 |
100.0 |
F: Female.
TABLE 21 (Contd…). SUMMARY RECORD OF REPRODUCTIVE PERFORMANCE
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 |
12.45 |
12.00 |
0.45 |
3.70 |
|
0.00 |
0.00 |
±SD |
2.42 |
2.41 |
0.52 |
4.40 |
|
0.00 |
0.00 |
|
n |
11 |
11 |
11 |
11 |
|
11 |
11 |
|
G2, F & 111 |
Mean |
12.70 |
12.00 |
0.70 |
6.02 |
|
0.00 |
0.00 |
±SD |
2.75 |
3.09 |
1.06 |
9.67 |
|
0.00 |
0.00 |
|
n |
10 |
10 |
10 |
10 |
|
10 |
10 |
|
G3, F & 333 |
Mean |
11.00 |
10.80 |
0.20 |
1.50 |
|
0.00 |
0.00 |
±SD |
2.75 |
2.53 |
0.42 |
3.25 |
|
0.00 |
0.00 |
|
n |
10 |
10 |
10 |
10 |
|
10 |
10 |
|
G4, F & 1000 |
Mean |
13.27 |
12.45 |
0.82 |
6.72 |
|
0.00 |
0.00 |
±SD |
1.74 |
2.54 |
1.40 |
11.56 |
|
0.00 |
0.00 |
|
n |
11 |
11 |
11 |
11 |
|
11 |
11 |
F: Female; n: Number of Dams.
TABLE 22. SUMMARY OF ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Adrenals |
Thymus |
Spleen |
Testes |
Epididymides |
Heart |
Kidneys |
Brain |
|
G1, M & 0 |
Mean |
0.0667 |
0.2891 |
0.7915 |
3.3315 |
1.4198 |
1.3943 |
2.9537 |
2.1193 |
±SD |
0.0045 |
0.0466 |
0.2701 |
0.3035 |
0.1420 |
0.2048 |
0.2510 |
0.0321 |
|
n |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
|
G2, M & 111 |
Mean |
0.0719 |
0.3589 |
0.8023 |
3.4284 |
1.4112 |
1.5033 |
2.8196 |
2.1336 |
±SD |
0.0094 |
0.0292 |
0.0928 |
0.1782 |
0.1365 |
0.1061 |
0.1723 |
0.0957 |
|
n |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
|
G3, M & 333 |
Mean |
0.0709 |
0.4450* |
0.8041 |
3.3728 |
1.4195 |
1.4754 |
2.8317 |
2.1467 |
±SD |
0.0060 |
0.0665 |
0.1455 |
0.2771 |
0.1776 |
0.1560 |
0.1507 |
0.0446 |
|
n |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
0.0716 |
0.4129* |
0.8155 |
3.3454 |
1.5221 |
1.5218 |
3.0082 |
2.2033 |
±SD |
0.0115 |
0.1013 |
0.1404 |
0.2101 |
0.1812 |
0.3979 |
0.7565 |
0.1355 |
|
n |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
M: Male; SD: Standard Deviation; n: Number of Animals; *: Statistically significant (P<0.05) change than the vehicle control group.
TABLE 22 (Contd…). SUMMARY OF ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Liver |
Prostate |
Seminal vesicles with coagulating glands |
Lungs |
Pituitary |
Thyroid along with parathyroid# |
G1, M & 0 |
Mean |
10.0491 |
1.1499 |
1.6300 |
1.9467 |
0.0208 |
0.0296 |
±SD |
1.6192 |
0.1975 |
0.4468 |
0.1258 |
0.0014 |
0.0017 |
|
n |
5 |
12 |
12 |
5 |
5 |
12 |
|
G2, M & 111 |
Mean |
10.3930 |
1.1988 |
1.6027 |
2.0659 |
0.0197 |
0.0290 |
±SD |
0.4389 |
0.2552 |
0.3454 |
0.1175 |
0.0013 |
0.0020 |
|
n |
5 |
12 |
12 |
5 |
5 |
12 |
|
G3, M & 333 |
Mean |
10.6576 |
1.3430 |
1.7846 |
2.0478 |
0.0203 |
0.0301 |
±SD |
0.7376 |
0.3501 |
0.3700 |
0.1024 |
0.0009 |
0.0013 |
|
n |
5 |
12 |
12 |
5 |
5 |
12 |
|
G4, M & 1000 |
Mean |
10.8065 |
1.2209 |
1.9124 |
2.0837 |
0.0205 |
0.0305 |
±SD |
2.8155 |
0.3931 |
0.5906 |
0.1492 |
0.0015 |
0.0023 |
|
n |
5 |
12 |
12 |
5 |
5 |
12 |
M: Male; SD: Standard Deviation; n: Number of Animals; #: Weighed post fixation.
TABLE 22 (Contd…). SUMMARY OF ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Adrenals |
Thymus |
Spleen |
Ovaries |
Uterus with Cervix |
Heart |
|
G1, F & 0 |
Mean |
0.0741 |
0.2781 |
0.7048 |
0.1738 |
0.5901 |
1.1848 |
±SD |
0.0083 |
0.0317 |
0.0646 |
0.0299 |
0.1167 |
0.1262 |
|
n |
5 |
5 |
5 |
12 |
11@ |
5 |
|
G2, F & 111 |
Mean |
0.0884 |
0.2632 |
0.7503 |
0.1432* |
0.5097 |
1.1940 |
±SD |
0.0110 |
0.0345 |
0.1289 |
0.0332 |
0.1138 |
0.0729 |
|
n |
5 |
5 |
5 |
12 |
11@ |
5 |
|
G3, F & 333 |
Mean |
0.0728 |
0.2267* |
0.6584 |
0.1291* |
0.5413 |
1.2001 |
±SD |
0.0094 |
0.0282 |
0.1051 |