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EC number: 276-817-3 | CAS number: 72749-80-5
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From: 31 May 2017; To: 23 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- OECD Guideline for Testing of Chemicals, Number 422, “Combined Repeated Dose Toxicity Study
with the Reproduction/Developmental Toxicity Screening Test” adopted on 29 July 2016 - Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Hydrogen 9-amino-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, disodium salt
- EC Number:
- 276-817-3
- EC Name:
- Hydrogen 9-amino-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, disodium salt
- Cas Number:
- 72749-80-5
- Molecular formula:
- C28H20N4O6S2.2Na
- IUPAC Name:
- Benzo[a]phenazinium, 9-amino-7-phenyl-5-(phenylamino)-4,10-disulfo-, inner salt, sodium salt (1:2)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- 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: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: Males: 231.73 g to 259.15 g; Females: 210.13 g to 231.58 g
- Housing: 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
- Diet (ad libitum): Altromin maintenance diet for rats and mice; type: 1324 (manufactured by Altromin Spezialfutter GmbH & Co. KG)
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter
- Acclimation period: nineteen days (including five days of acclimatizion and 14 days of screening for oestrous cycles) From: 31 May 2017; To: 19 June 2017
DETAILS OF FOOD AND WATER QUALITY:
Altromin maintenance diet for rats and mice; type: 1324 (manufactured by Altromin Spezialfutter GmbH & Co. KG); batch no./lot no. 030118//0838
Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier (contaminant free)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.1 to 23.9
- Humidity (%): 40 to 69
- 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: 31 May 2017; To: 31 May 2017;
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- The vehicle and test item formulations were administered through oral (gavage) route as it is the most appropriate route for substances to focus on the detection of hazardous properties on reproduction
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle: The test item is in-soluble in distilled water and forms uniform suspension in corn oil at the concentration of 100 mg/mL (highest dose concentration) as evidenced by the in-house solubility/suspendibility test results. Hence, corn oil was selected for the test item formulation preparation
- Concentration in vehicle: Low Dose: 11 mg/mL; Mid Dose: 33 mg/mL; High Dose: 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Lot/batch no: MR02081
- Purity: 100% - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Formulation analysis for homogeneity and dose concentration verification of Acid Violet 50 was done by Analytical Chemistry department of Bioneeds India Private Limited. The analysis was done as per methods detailed in the Study Plan No. BIO-ANM 440. Sampling and analysis of formulations was performed during first week of treatment and during week 5 of the treatment. The samples were collected in duplicates (5 mL each) from top, middle and bottom layer in duplicate sets from each concentration.
The collected samples were transferred to Analytical Chemistry department of Bioneeds India Private Limited for dose concentration analysis. One set of aliquot of each formulation was analyzed. The second aliquot was stored as a backup purpose at established storage conditions. The second set of samples was discarded, as the analysis results of first set of samples were within the limits. Formulations were considered acceptable, and the results are found to be within the acceptable range of 85 to 115 % the nominal concentration and the % RSD is less than 10.0%. - Duration of treatment / exposure:
- The males were treated for two weeks pre-mating, during mating and up to the day before sacrifice during post-mating period (total of 37 days of treatment).
The females were treated for two weeks pre-mating period, during mating, pregnancy (gestation) and up to lactation day 13.
The recovery group animals were treated until the first scheduled sacrifice of dams (total of 50 days) and kept without treatment for a further 21 days observation - Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 110 mg/kg bw/day (actual dose received)
- Remarks:
- Low Dose
- Dose / conc.:
- 330 mg/kg bw/day (actual dose received)
- Remarks:
- 330.0
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- High Dose
- No. of animals per sex per dose:
- Main Group: 12 males and 12 females per dose
Recoery Group: 5 males and 5 females per dose - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses of 0, 110, 330 and 1000 mg/kg body weight for vehicle control/vehicle control recovery, low dose, mid dose and high dose/high dose recovery groups respectively were selected in consultation with the sponsor based on the results of dose range finding study of test item Acid Violet 50 when administered through oral gavage for a period of 14 consecutive days to Sprague Dawley Rats (Bioneeds Study No.: BIO-TX 2461).
Comparable doses were selected as the test item Acid Violet 50 when administered orally to Sprague Dawley rats once daily for 14 consecutive days did not reveal any treatment related effects at all the tested doses (100, 300 and 1000 mg/kg body weight).
- Rationale for animal assignment: The animals were weighed and arranged in ascending order of their body weights. These body weight stratified animals were distributed to all the groups using Microsoft Excel Spreadsheet, such that body weight variation of animals selected for the study did not exceed ± 20% (+7.71% and -13.12% for males and +8.45% and -7.67% for females) of the mean body weight of each sex.
- Rationale for selecting satellite groups: To observe delayed effects
- Post-exposure recovery period in satellite groups: The recovery group animals were treated until the first scheduled sacrifice of dams (total of 50 days) and kept without treatment for a further 21 days observation. - Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly once
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly once
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: all animals during acclimatization;
during end of the dosing period for males (shortly prior to scheduled sacrifice) of vehicle control and high dose main group animals
during lactation period for females (shortly prior to scheduled sacrifice) of vehicle control and high dose main group animals;
during last week for recovery group animals
- Dose groups that were examined:
vehicle control/vehicle control recovery and high dose/high dose recovery group animals
HAEMATOLOGY: Yes
- Time schedule for collection of blood:
five males and five females randomly selected from each main group and from all recovery group animals on the day of scheduled terminal sacrifice (for main group males after completion of 37 days of treatment; for main group females on lactation day 14 and for recovry at sacrifice).
- Anaesthetic used for blood collection: Yes (mild isoflurane)
- Animals fasted: Yes
- How many animals: five males and five females randomly selected from each main group and from all recovery group animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: five males and five females randomly selected from each main group and from all recovery group animals on the day of scheduled terminal sacrifice (for main group males after completion of 37 days of treatment; for main group females on lactation day 14 and for recovry at sacrifice).
- Animals fasted: Yes
- How many animals: five males and five females randomly selected from each main group and from all recovery group animals
URINALYSIS: Yes
- Time schedule for collection of urine: five males and five females randomly selected from each main group males and from all recovery group animals on the day of scheduled terminal sacrifice.
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: five males and five females, randomly selected from each group towards the end of the dosing period for males, during lactation period for females (shortly prior to scheduled sacrifice) and from the recovery group animals towards the end of the recovery period (shortly prior to scheduled sacrifice).
- Dose groups that were examined: from all the dose groups
- Battery of functions tested: sensory activity / grip strength / motor activity / hind limb foot splay - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- not applicable
- Statistics:
- The data was subjected to various statistical analyses using SPSS software version 22. All analysis
and comparisons were evaluated at the 95% level of confidence (P<0.05).
Note: Data of non-pregnant females, females mated but not littered were excluded from statistical a
nalysis.
The statistical analysis was followed to the parameters as mentioned below:
Body weight, Change in body weight,Feed consumption, Copulatory interval, Gestation length,
Hematology, Clinical chemistry, Absolute organ weights, Relative organ weights, FOB (Body t
emperature, Defecation, Urination, Rearing, Grip strength), Pup weight and Ano-genital distance: P
arametric - One-way ANOVA with Dunnett’s post test.
Pre implantation loss, Pre natal loss, Post natal loss, Total No. of early/late resorptions/dam, Corpora
lutea/dam, Implantations/dam, No. of pups/dam, Sex ratio, Mean litter size, Mean pup weight: Non
Parametric - Kruskal-Wallis
Pregnancy rate, Dams with/without live pups, Dams with/without dead pups, No. of litters with/without
resorptions: Cross Tabs -Chi-square test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no clinical signs of toxicity observed at any of the tested dose groups of either sex. However, the faecal matter of all the test dose group animals of either sex was found violet coloured. This observation was due to the colour of the test item.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no mortality/morbidity observed at any of the tested main and recovery groups of either sex
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related changes in mean body weight and percent change in body weight with respect to day 1 at any of the main and recovery group animals of either sex. However, statistical significant decrease in percent change in body weight with respect to day 1 during week 1 was noted in G4 and G4R females when compared with vehicle control group females. These changes are considered as incidental but not treatment related as there were no effects were observed in feed
consumption during this period and the changes were inconsistent. - Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related changes noted in feed consumption at any of the doses of both the main and recovery group animals of either sex. However, statistical significant increase in feed consumption during week 2 was noted in G3 females when compared with vehicle control group females. This change is considered as incidental but not treatment related as there were no effects were observed in mean body weight and percent change in body weight during this period and due to lack
of dose dependency. - Food efficiency:
- not examined
- Description (incidence and severity):
- not applicable
- Water consumption and compound intake (if drinking water study):
- not examined
- Description (incidence and severity):
- not applicable
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- no ocular changes observed in vehicle control/vehicle control recovery and high dose/high dose recovery group animals of both the sex
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related changes observed in haematology parameters at any of the tested doses of either sex. However, statistically significant decrease in absolute reticulocytes and statistically significant increase in absolute neutrophils at G2 males; statistically significant increase in absolute monocytes and statistically significant increase in activated prothrombin time at G4 males;statistically significant decrease in haemoglobin at G4R males; statistically significant increase in activated prothrombin time at G4R females were noted when compared with concurrent vehicle control group animals. These changes are considered as incidental and not treatment related, due to lack of dose dependency and /or due to biological variation.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related changes observed in clinical chemistry parameters at any of the tested doses of either sex. However, statistically significant increase in alkaline phosphatase at G2 and G3 males; statistically significant increase in potassium at G4 males; statistically significant increase in chloride at G3 males; statistically significant increase in potassium at G4R males; statistically significant decrease in total bilirubin at G4R females; statistically significant increase in phosphorous and statistically significant decrease in sodium at G4R females; statistically significant decrease in total protein at G4R females were noted when compared with concurrent vehicle control group animals. These changes are considered as incidental and not treatment related, due to lack of dose dependency
and /or due to biological variation. - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related changes observed in urinalysis parameters at any of the tested doses of main group males and either sex of recovery groups. However, statistically significant decrease in urine pH at G4R females was noted when compared with concurrent vehicle control group. This change is considered as incidental and not treatment related as the value is within historical control data.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There were no changes observed in the neurological/functional examination in both main and recovery group animals of either sex.
- Immunological findings:
- not examined
- Description (incidence and severity):
- not applicable
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related changes observed in the absolute and relative organ weights at any of the doses tested of both the sex in main and recovery group animals.However, statistically significant decrease in absolute Prostate + Seminal vesicles with coagulating glands at G4R males when compared with concurrent vehicle control group. This change can be considered as incidental and not treatment related, as there were no gross and microscopic findings were noted in this organ.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no gross pathological changes (both external and internal) observed at any of the doses tested in both the sex of adults and pups (110, 330 and 1000 mg/kg body weight). However there is slight reduction in size of testes and epididymis in one animal from G3 was observed. This observation is considered as incidental but not treatment related as there were no changes noted during microscopic examination of these organs
- Neuropathological findings:
- not examined
- Description (incidence and severity):
- not applicable
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No treatment related histopathological findings noticed in this study. Testes, which were screened with special emphasis on stages of spermatogenesis and interstitial testicular cell structure, revealed normal progression of the spermatogenic cycle and presence of all expected associations. One female in the high dose group showed MNC infiltration in liver. Similar finding was also observed in the concurrent control. Hence considered as background lesion.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- not applicable
- Other effects:
- not specified
- Description (incidence and severity):
- not applicable
- Details on results:
- there were no treatment related systemic and reproductive toxicity effects observed upto 1000 mg/kg body weight
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
TABLE 1. SUMMARY OF CLINICAL SIGNS OF TOXICITY, DETAILED CLINICAL EXAMINATION
AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
No. of Animals |
Clinical Signs of Toxicity/Detailed Clinical Examination |
Mortality (No. of Mortality / No. of Animals dosed) |
G1, M & 0 |
12 |
N |
0/12 |
G2, M & 110 |
12 |
N |
0/12 |
G3, M & 330 |
12 |
N |
0/12 |
G4, M & 1000 |
12 |
N |
0/12 |
M: Male; N: Normal
TABLE 1 (Contd..,). SUMMARYOF CLINICAL SIGNS OF TOXICITY, DETAILED CLINICAL
EXAMINATION AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
No. of Animals |
Clinical Signs of Toxicity/Detailed Clinical Examination |
Mortality (No. of Mortality / No. of Animals dosed) |
G1, F & 0 |
12 |
N |
0/12 |
G2, F & 110 |
12 |
N |
0/12 |
G3, F & 330 |
12 |
N |
0/12 |
G4, F & 1000 |
12 |
N |
0/12 |
F: Female; N: Normal
TABLE 1 (Contd..,). SUMMARYOF CLINICAL SIGNS OF TOXICITY, DETAILED CLINICAL
EXAMINATION AND MORTALITY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
No. of Animals |
Clinical Signs of Toxicity/Detailed Clinical Examination |
Mortality (No. of Mortality / No. of Animals dosed) |
G1R, M & 0 |
5 |
N |
0/5 |
G4R, M & 1000 |
5 |
N |
0/5 |
G1R, F & 0 |
5 |
N |
0/5 |
G4R, F & 1000 |
5 |
N |
0/5 |
M:Male; F: Female; R: Recovery; N: Normal
TABLE 2. SUMMARY OF BODY WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Body Weight (g) on Days |
|||||||
1 |
7 |
14 |
21 |
28 |
35 |
|||
G1, M & 0 |
Mean |
352.93 |
371.41 |
386.55 |
405.28 |
414.94 |
433.65 |
|
±SD |
21.25 |
23.51 |
31.94 |
36.07 |
35.12 |
39.96 |
||
n |
12 |
12 |
12 |
12 |
12 |
12 |
||
G2, M & 110 |
Mean |
351.38 |
368.93 |
384.28 |
404.17 |
411.24 |
426.96 |
|
±SD |
18.68 |
20.54 |
31.02 |
35.02 |
36.44 |
41.92 |
||
n |
12 |
12 |
12 |
12 |
12 |
12 |
||
G3, M & 330 |
Mean |
351.68 |
368.20 |
390.51 |
408.92 |
420.95 |
434.24 |
|
±SD |
18.71 |
17.64 |
24.36 |
27.46 |
30.71 |
35.96 |
||
n |
12 |
12 |
12 |
12 |
12 |
12 |
||
G4, M & 1000 |
Mean |
353.73 |
372.45 |
389.32 |
406.59 |
416.81 |
430.27 |
|
±SD |
24.02 |
26.05 |
32.45 |
31.24 |
30.14 |
35.17 |
||
n |
12 |
12 |
12 |
12 |
12 |
12 |
M: Male; SD: Standard Deviation; n: Number of Animals
TABLE 2 (Contd..,). SUMMARY OF BODY WEIGHT (g) RECORD
Refer Appendix 2
Group, Sex & Dose (mg/kg body weight/day) |
Body Weight (g) on Days |
|||
1 |
7 |
14 |
||
G1, F & 0 |
Mean |
250.53 |
261.85 |
267.25 |
±SD |
11.11 |
10.38 |
11.57 |
|
n |
12 |
12 |
12 |
|
G2, F & 110 |
Mean |
250.20 |
259.54 |
270.27 |
±SD |
10.01 |
10.20 |
11.81 |
|
n |
12 |
12 |
12 |
|
G3, F & 330 |
Mean |
250.85 |
260.47 |
270.76 |
±SD |
9.33 |
12.20 |
14.12 |
|
n |
12 |
12 |
12 |
|
G4, F & 1000 |
Mean |
250.07 |
257.83 |
269.25 |
±SD |
9.89 |
9.67 |
11.45 |
|
n |
12 |
12 |
12 |
F: Female; 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 Days |
|||||||||||
1 |
7 |
14 |
21 |
28 |
35 |
42 |
49 |
56 |
63 |
70 |
||
G1R, M & 0 |
Mean |
344.42 |
360.82 |
368.75 |
392.73 |
405.74 |
426.68 |
434.53 |
444.52 |
455.90 |
462.71 |
475.86 |
±SD |
14.18 |
15.26 |
16.88 |
23.90 |
28.80 |
34.74 |
35.53 |
36.14 |
39.61 |
40.98 |
34.72 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
345.71 |
365.03 |
368.49 |
392.05 |
413.81 |
431.45 |
433.86 |
437.33 |
445.82 |
451.97 |
462.97 |
±SD |
15.98 |
15.44 |
21.31 |
23.33 |
25.04 |
37.54 |
35.63 |
38.45 |
38.41 |
40.84 |
42.91 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
245.09 |
256.63 |
259.51 |
267.64 |
272.80 |
280.41 |
282.00 |
284.32 |
296.39 |
298.81 |
300.29 |
±SD |
6.00 |
6.08 |
8.76 |
11.40 |
10.54 |
12.84 |
12.28 |
12.23 |
12.10 |
12.26 |
10.26 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
245.40 |
253.40 |
258.77 |
266.14 |
269.14 |
282.61 |
284.82 |
286.81 |
292.64 |
297.05 |
300.28 |
±SD |
6.68 |
7.06 |
12.31 |
11.79 |
16.01 |
17.50 |
18.82 |
18.69 |
19.18 |
18.74 |
18.22 |
|
n |
5 |
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 OF PERCENT CHANGE IN BODY WEIGHT (%) WITH RESPECT TO DAY 1 RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Percent Change in Body Weight (%) with respect to Day 1 during Days |
||||||
1 to 7 |
1 to 14 |
1 to 21 |
1 to 28 |
1 to 35 |
|||
G1, M & 0 |
Mean |
5.23 |
9.42 |
14.68 |
17.45 |
22.71 |
|
±SD |
1.19 |
3.35 |
4.17 |
4.04 |
5.42 |
||
n |
12 |
12 |
12 |
12 |
12 |
||
G2, M & 110 |
Mean |
4.98 |
9.24 |
14.86 |
16.86 |
21.28 |
|
±SD |
0.76 |
3.74 |
4.52 |
5.10 |
6.40 |
||
n |
12 |
12 |
12 |
12 |
12 |
||
G3, M & 330 |
Mean |
4.73 |
11.02 |
16.25 |
19.69 |
23.45 |
|
±SD |
1.27 |
2.97 |
4.36 |
6.20 |
7.79 |
||
n |
12 |
12 |
12 |
12 |
12 |
||
G4, M & 1000 |
Mean |
5.28 |
9.98 |
14.91 |
17.85 |
21.60 |
|
±SD |
0.76 |
3.05 |
3.00 |
4.01 |
5.06 |
||
n |
12 |
12 |
12 |
12 |
12 |
M: Male; SD: Standard Deviation; n: Number of Animals
TABLE 3 (Contd..,). SUMMARY OF PERCENTCHANGE IN BODY WEIGHT (%) WITH RESPECT TO DAY 1 RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Change in Body Weight (%) during Days |
|||
1 to 7 |
1 to 14 |
|||
G1, F & 0 |
Mean |
4.54 |
6.71 |
|
±SD |
1.15 |
2.76 |
||
n |
12 |
12 |
||
G2, F & 110 |
Mean |
3.74 |
8.02 |
|
±SD |
1.29 |
2.16 |
||
n |
12 |
12 |
||
G3, F & 330 |
Mean |
3.81 |
7.92 |
|
±SD |
1.84 |
3.52 |
||
n |
12 |
12 |
||
G4, F & 1000 |
Mean |
3.12* |
7.71 |
|
±SD |
0.86 |
3.45 |
||
n |
12 |
12 |
F: Female; SD: Standard Deviation; n: Number of Animals
*: Statistically significant than the control group (p<0.05)
TABLE 3 (Contd..,). SUMMARY OF PERCENTCHANGE IN BODY WEIGHT (%) WITH RESPECT TO DAY 1 RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Change in Body Weight (%) during Days |
||||||||||
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 |
1 to 70 |
||
G1R, M & 0 |
Mean |
4.76 |
7.08 |
13.99 |
17.73 |
23.75 |
26.03 |
28.93 |
32.21 |
34.17 |
38.09 |
±SD |
0.45 |
2.91 |
4.10 |
5.20 |
5.89 |
6.31 |
6.20 |
7.16 |
7.41 |
6.81 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
5.61 |
6.61 |
13.45 |
19.74 |
24.85 |
25.59 |
26.57 |
29.01 |
30.77 |
33.93 |
±SD |
1.70 |
4.54 |
5.75 |
6.05 |
10.06 |
10.13 |
10.62 |
10.26 |
10.50 |
10.80 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
4.72 |
5.88 |
9.17 |
11.28 |
14.38 |
15.03 |
15.98 |
20.93 |
21.92 |
22.53 |
±SD |
1.38 |
2.15 |
2.46 |
2.03 |
3.31 |
3.00 |
2.90 |
4.01 |
4.13 |
3.35 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
3.26* |
5.41 |
8.41 |
9.60 |
15.09 |
15.97 |
16.79 |
19.16 |
20.96 |
22.28 |
±SD |
0.27 |
2.47 |
2.00 |
3.67 |
4.34 |
4.76 |
4.72 |
4.83 |
4.66 |
4.28 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of Animals
*: Statistically significant than the control group (p<0.05)
TABLE 4. SUMMARY OF FEED CONSUMPTION (g/rat/day) RECORD
Group & Dose |
Feed Consumption (g) |
||||
Week 1Feed Consumption |
Week 2 Feed Consumption |
Post Mating Feed Consumption |
|||
G1, M & 0 |
Mean |
24.93 |
25.52 |
33.18 |
|
±SD |
0.77 |
0.58 |
0.51 |
||
n |
12 |
12 |
12 |
||
G2, M & 110 |
Mean |
25.27 |
26.32 |
32.71 |
|
±SD |
0.53 |
0.74 |
1.29 |
||
n |
12 |
12 |
12 |
||
G3, M & 330 |
Mean |
24.93 |
25.43 |
32.99 |
|
±SD |
0.84 |
0.84 |
0.94 |
||
n |
12 |
12 |
12 |
||
G4, M & 1000 |
Mean |
25.10 |
26.05 |
32.85 |
|
±SD |
0.95 |
0.65 |
0.90 |
||
n |
12 |
12 |
12 |
M: Male;SD: Standard Deviation; n: Number ofanimals
TABLE 4 (Contd..,). SUMMARY OF FEED CONSUMPTION (g/rat/day) RECORD
Group, Sex & Dose |
Feed Consumption (g) |
|||
Week 1 Feed Consumption |
Week 2 Feed Consumption |
|||
G1, F & 0 |
Mean |
22.53 |
22.11 |
|
±SD |
0.52 |
0.69 |
||
n |
12 |
12 |
||
G2, F & 110 |
Mean |
22.58 |
22.80 |
|
±SD |
0.80 |
0.40 |
||
n |
12 |
12 |
||
G3, F & 330 |
Mean |
22.38 |
23.05* |
|
±SD |
0.67 |
0.74 |
||
n |
12 |
12 |
||
G4, F & 1000 |
Mean |
22.41 |
22.12 |
|
±SD |
1.33 |
0.68 |
||
n |
12 |
12 |
F: Female; SD: Standard Deviation; n: Number of animals
*: Statistically significant than the control group (p<0.05)
TABLE 4 (Contd..,). SUMMARY OF FFED CONSUMPTION (g/rat/day) RECORD
Refer Appendix 4
Group, Sex & Dose |
Feed Consumption (g) |
|||||||||||
Week 1 |
Week 2 |
Week 3 |
Week 4 |
Week 5 |
Week 6 |
Week 7 |
Week 8 |
Week 9 |
Week 10 |
Week 11 |
||
G1R, M & 0 |
Mean |
21.05 |
22.89 |
24.48 |
25.46 |
25.16 |
25.36 |
26.54 |
27.75 |
29.12 |
31.75 |
30.20 |
±SD |
6.17 |
5.69 |
6.29 |
3.60 |
1.94 |
2.71 |
2.38 |
1.77 |
1.43 |
1.00 |
0.28 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
20.63 |
22.14 |
24.01 |
25.77 |
25.71 |
25.95 |
26.82 |
27.97 |
29.63 |
31.74 |
32.61 |
±SD |
4.37 |
6.29 |
5.86 |
2.45 |
2.11 |
3.07 |
2.53 |
2.51 |
1.34 |
1.46 |
1.36 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
2 |
2 |
2 |
2 |
2 |
|
G1R, F & 0 |
Mean |
17.82 |
18.70 |
20.16 |
23.82 |
24.69 |
23.90 |
24.44 |
25.79 |
26.76 |
28.54 |
27.97 |
±SD |
4.54 |
5.32 |
3.39 |
2.36 |
1.20 |
0.69 |
1.04 |
0.94 |
0.76 |
0.30 |
0.61 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
18.41 |
18.00 |
22.26 |
24.08 |
24.75 |
23.60 |
24.98 |
25.94 |
27.19 |
28.03 |
26.86 |
±SD |
4.70 |
5.22 |
6.28 |
2.60 |
1.86 |
1.06 |
1.12 |
0.31 |
0.75 |
0.22 |
0.41 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of animals
TABLE 5 . SUMMARY OF OPHTHALMOSCOPIC EXAMINATION RECORD
Day 37 |
|||||
Group, Sex & Dose |
G1, M & 0 |
G4, M & 1000 |
|||
Number of Animals |
12 |
12 |
|||
Parameters |
Observations |
||||
Eye |
L |
R |
L |
R |
|
Adnexa |
Lids |
N |
N |
N |
N |
Ducts |
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 |
Vessels |
N |
N |
N |
N |
Macula |
N |
N |
N |
N |
|
Optic disc |
N |
N |
N |
N |
|
Tapetum lucidum |
N |
N |
N |
N |
|
Tapetum nigrum |
N |
N |
N |
N |
N: No Abnormality Detected; L: Left; R: Right; M: Male
TABLE 5 (Contd..,). SUMMARY OFOPHTHALMOLOGICALEXAMINATIONRECORD
During Lactation Day 13 |
|||||
Group, Sex & Dose |
G1, F & 0 |
G4, F & 1000 |
|||
Number of Animals |
12 |
11 |
|||
Parameters |
Observations |
||||
Eye |
L |
R |
L |
R |
|
Adnexa |
Lids |
N |
N |
N |
N |
Ducts |
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 |
Vessels |
N |
N |
N |
N |
Macula |
N |
N |
N |
N |
|
Optic disc |
N |
N |
N |
N |
|
Tapetum lucidum |
N |
N |
N |
N |
|
Tapetum nigrum |
N |
N |
N |
N |
N: No Abnormality Detected; L: Left; R: Right; F: Female
TABLE 5 (Contd..,). SUMMARY OFOPHTHALMOLOGICAL EXAMINATION RECORD
Day 71 |
|||||||||
Group, Sex & Dose |
G1R, M & 0 |
G4R, M & 1000 |
G1R, F & 0 |
G4R, F & 1000 |
|||||
Number of Animals |
5 |
5 |
5 |
5 |
|||||
Parameters |
Observations |
||||||||
Eye |
L |
R |
L |
R |
L |
R |
L |
R |
|
Adnexa |
Lids |
N |
N |
N |
N |
N |
N |
N |
N |
Ducts |
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 |
Vessels |
N |
N |
N |
N |
N |
N |
N |
N |
Macula |
N |
N |
N |
N |
N |
N |
N |
N |
|
Optic disc |
N |
N |
N |
N |
N |
N |
N |
N |
|
Tapetum lucidum |
N |
N |
N |
N |
N |
N |
N |
N |
|
Tapetum nigrum |
N |
N |
N |
N |
N |
N |
N |
N |
N: No Abnormality Detected; L: Left; R: Right; M: Male; F: Female
TABLE 6. SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERATION BATTERY (FOB) RECORD
Day 37 |
||||||
Parameters↓ |
Group, Sex & Dose |
G1, M & 0 |
G2, M & 110 |
G3, M & 330 |
G4, M & 1000 |
|
Number of Animals (Randomly selected)→ |
5 |
5 |
5 |
5 |
||
Home cage observations |
||||||
a. Convulsions |
1 |
1 |
1 |
1 |
||
b. Tremors |
1 |
1 |
1 |
1 |
||
c. Palpebral closure |
1 |
1 |
1 |
1 |
||
Handling observation |
||||||
a. Ease of removal from the cage |
2 |
2 |
2 |
2 |
||
b. Ease of handling animal in hand |
2 |
2 |
2 |
2 |
||
c. Lacrimation |
1 |
1 |
1 |
1 |
||
d. Red deposits around |
Eyes |
1 |
1 |
1 |
1 |
|
Nose |
1 |
1 |
1 |
1 |
||
Mouth |
1 |
1 |
1 |
1 |
||
e. Crusty deposits around |
Eyes |
1 |
1 |
1 |
1 |
|
Nose |
1 |
1 |
1 |
1 |
||
Mouth |
1 |
1 |
1 |
1 |
||
f. Salivation |
1 |
1 |
1 |
1 |
||
g. Fur appearance |
1 |
1 |
1 |
1 |
||
h. Piloerection |
1 |
1 |
1 |
1 |
||
i. Palpebral closure |
1 |
1 |
1 |
1 |
||
j. Respiratory character |
1 |
1 |
1 |
1 |
||
k. Eye prominence |
1 |
1 |
1 |
1 |
||
l. Muscle tone |
1 |
1 |
1 |
1 |
||
Home cage observations: a. Convulsions - 1=Absent, 2=Present, b. Tremors- 1=Absent, 2=Present, c. Palpebral closure - 1=Normal, Handling observation : a. Ease of removal from the cage - 2=Normal, b. Ease of handling animal in hand - 2=Normal, c. Lacrimation - 1=None, 2=Slight, 3=Severe, d. Red deposits around - 1=Absent, 2=Present, e. Crusty deposits around - 1=Absent, 2=Present , f. Salivation- 1=Normal , g. Fur Appearance - 1=Normal, h. Piloerection - 1=None, 2=Slight 3=Severe, i. Palpebral Closure - 1=Normal, j. Respiratory character 1=Normal, k. Eye Prominence - 1=Normal, l. Muscle tone - 1=Normal |
||||||
: Male; R: Recovery;SD: Standard Deviation |
TABLE 6 (Contd..,). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
Day 37 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameters↓ |
Group, Sex & Dose |
G1, M & 0 |
G2, M & 110 |
G3, M & 330 |
G4, M & 1000 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of Animals (Randomly selected)→ |
5 |
5 |
5 |
5 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Open field Observation |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
a. Mobility |
1 |
1 |
1 |
1 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
b. Gait |
1 |
1 |
1 |
1 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
c. Arousal |
3 |
3 |
3 |
3 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
d. Rearing |
Mean |
6.00 |
6.20 |
5.80 |
5.20 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
±SD |
0.71 |
1.30 |
0.84 |
1.48 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
e. Urination Numbers of pools of urine |
Mean |
4.20 |
3.80 |
4.00 |
4.80 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
±SD |
2.49 |
2.59 |
2.55 |
0.84 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
f. Defecation Number of fecal pellets |
Mean |
1.80 |
1.20 |
1.60 |
1.40 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
±SD |
1.30 |
1.30 |
1.14 |
0.89 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
g. Stereotypies- repetitive circling |
1 |
1 |
1 |
1 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
h. Excessive grooming |
Mean |
2.40 |
2.80 |
2.00 |
2.00 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
±SD |
0.89 |
0.84 |
1.00 |
0.71 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sensory observations |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
a.Startle response |
2 |
2 |
2 |
2 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
b. Touch response |
2 |
2 |
2 |
2 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
c. Pupil response |
2 |
2 |
2 |
2 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
d. Response to nociceptive stimuli |
2 |
2 |
2 |
2 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
e. Righting reflex |
1 |
1 |
1 |
1 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Physiological observation Body temperature (°F) |
Mean |
100.24 |
99.94 |
100.00 |
99.84 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
±SD |
0.91 |
0.56 |
0.38 |
0.74 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Open field Observation: a. Mobility - 1=Normal, b. Gait - 1=Normal, c. Arousal - 3=Normal, g. Stereotypies - repetitive circling- 1=Absent, 2=Present,Sensory Observations: a.Startle Response -2=Normal,b. Touch Response -2=Normal,c. Pupil Response 2=Normal,d. Response to Nociceptive stimuli - 2=Normal,e. Righting Reflex - 1=Present, 2=Slow, 3=Absent. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
M: Male; R: Recovery;SD: Standard Deviation TABLE 6 (Contd..,). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
TABLE 6 (Contd..,). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
M: Male; F: Female; R: Recovery;SD: Standard Deviation |
TABLE 6 (Contd..,). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
Day 71 |
||||||
Parameters↓ |
Group, Sex & Dose |
G1R, M & 0 |
G4R, M & 1000 |
G1R, F & 0 |
G4R, F & 1000 |
|
Number of Animals→ |
5 |
5 |
5 |
5 |
||
Home cage observations |
||||||
a. Convulsions |
1 |
1 |
1 |
1 |
||
b. Tremors |
1 |
1 |
1 |
1 |
||
c. Palpebral closure |
1 |
1 |
1 |
1 |
||
Handling observation |
||||||
a. Ease of removal from the cage |
2 |
2 |
2 |
2 |
||
b. Ease of handling animal in hand |
2 |
2 |
2 |
2 |
||
c. Lacrimation |
1 |
1 |
1 |
1 |
||
d. Red deposits around |
Eyes |
1 |
1 |
1 |
1 |
|
Nose |
1 |
1 |
1 |
1 |
||
Mouth |
1 |
1 |
1 |
1 |
||
e. Crusty deposits around |
Eyes |
1 |
1 |
1 |
1 |
|
Nose |
1 |
1 |
1 |
1 |
||
Mouth |
1 |
1 |
1 |
1 |
||
f. Salivation |
1 |
1 |
1 |
1 |
||
g. Fur appearance |
1 |
1 |
1 |
1 |
||
h. Piloerection |
1 |
1 |
1 |
1 |
||
i. Palpebral closure |
1 |
1 |
1 |
1 |
||
j. Respiratory character |
1 |
1 |
1 |
1 |
||
k. Eye prominence |
1 |
1 |
1 |
1 |
||
l. Muscle tone |
1 |
1 |
1 |
1 |
||
Home cage observations: a. Convulsions - 1=Absent, 2=Present, b. Tremors- 1=Absent, 2=Present, c. Palpebral closure - 1=Normal, Handling observation : a. Ease of removal from the cage - 2=Normal, b. Ease of handling animal in hand - 2=Normal, c. Lacrimation - 1=None, 2=Slight, 3=Severe, d. Red deposits around - 1=Absent, 2=Present, e. Crusty deposits around - 1=Absent, 2=Present , f. Salivation- 1=Normal , g. Fur Appearance - 1=Normal, h. Piloerection - 1=None, 2=Slight, 3=Severe, i. Palpebral Closure - 1=Normal, j. Respiratory character 1=Normal, k. Eye Prominence - 1=Normal, l. Muscle tone - 1=Normal |
||||||
M: Male; F: Female; R: Recovery;SD: Standard Deviation
TABLE 6 (Contd..,). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
Day 71 |
|||||
Parameters↓ |
Group, Sex & Dose |
G1R, M & 0 |
G4R, M & 1000 |
G1R, F & 0 |
G4R, F & 1000 |
Number of Animals→ |
5 |
5 |
5 |
5 |
|
Open field Observation a. Mobility |
1 |
1 |
1 |
1 |
|
b. Gait |
1 |
1 |
1 |
1 |
|
c. Arousal |
3 |
3 |
3 |
3 |
|
d. Rearing |
Mean |
5.80 |
5.40 |
5.60 |
6.00 |
±SD |
0.84 |
1.14 |
1.14 |
0.71 |
|
e. Urination Numbers of pools of urine |
Mean |
4.20 |
4.00 |
4.40 |
4.00 |
±SD |
2.49 |
2.74 |
3.05 |
2.35 |
|
f. Defecation Number of fecal pellets |
Mean |
1.60 |
1.40 |
1.40 |
1.40 |
±SD |
1.14 |
1.14 |
1.34 |
1.34 |
|
g. Stereotypies- repetitive circling |
|
1 |
1 |
1 |
1 |
h. Excessive grooming |
Mean |
2.60 |
3.20 |
3.00 |
3.00 |
±SD |
0.55 |
1.10 |
0.71 |
0.71 |
|
Sensory observations |
|||||
a.Startle response |
2 |
2 |
2 |
2 |
|
b. Touch response |
2 |
2 |
2 |
2 |
|
c. Pupil response |
2 |
2 |
2 |
2 |
|
d. Response to nociceptive stimuli |
2 |
2 |
2 |
2 |
|
e. Righting reflex |
1 |
1 |
1 |
1 |
|
Physiological observation Body temperature (°F) |
Mean |
100.34 |
99.78 |
100.08 |
100.22 |
±SD |
0.77 |
0.71 |
0.47 |
0.53 |
|
Open field Observation: a. Mobility - 1=Normal, b. Gait - 1=Normal, c. Arousal - 3=Normal, g. Stereotypies - repetitive circling- 1=Absent, 2=Present,Sensory Observations: a.Startle Response -2=Normal,b. Touch Response -2=Normal,c. Pupil Response 2=Normal,d. Response to Nociceptive stimuli - 2=Normal,e. Righting Reflex -1=Present, 2=Slow, 3=Absent. |
M: Male; F: Female; R: Recovery;SD: Standard Deviation
TABLE 7. SUMMARYOF PHOTOACTOMETER READIGS (MOVEMENTS) RECORD
Day 37 |
||
Group, Sex & Dose |
Movement Counts (no.) |
|
G1, M & 0 |
Mean |
616.40 |
±SD |
53.43 |
|
n |
5 |
|
G2, M & 110 |
Mean |
583.60 |
±SD |
82.76 |
|
n |
5 |
|
G3, M & 330 |
Mean |
592.80 |
±SD |
84.49 |
|
n |
5 |
|
G4, M & 1000 |
Mean |
608.00 |
±SD |
66.27 |
|
n |
5 |
M: Male;SD: Standard Deviation; n: Number of Animals (Randomly selected)
M: Male;SD: Standard Deviation; n: Number of Animals (Randomly selected)
TABLE 7 (Contd..,). SUMMARYOF PHOTOACTOMETER READIGS (MOVEMENTS) RECORD
During Lactation |
||
Group, Sex & Dose |
Movement Counts (no.) |
|
G1, F & 0 |
Mean |
629.00 |
±SD |
27.62 |
|
n |
5 |
|
G2, F & 110 |
Mean |
613.60 |
±SD |
32.91 |
|
n |
5 |
|
G3, F & 330 |
Mean |
623.40 |
±SD |
60.31 |
|
n |
5 |
|
G4, F & 1000 |
Mean |
620.40 |
±SD |
60.41 |
|
n |
5 |
F: Female;SD: Standard Deviation; n: Number of Animals (Randomly selected)
TABLE 7 (Contd..,). SUMMARYOF PHOTOACTOMETER READIGS (MOVEMENTS) RECORD
Day 71 |
|||
Group, Sex & Dose (mg/kg body weight/day) |
Movement Counts (no.) |
||
G1R, M & 0 |
Mean |
621.80 |
|
±SD |
21.87 |
||
n |
5 |
||
G4R, M & 1000 |
Mean |
610.60 |
|
±SD |
15.13 |
||
n |
5 |
||
G1R, F & 0 |
Mean |
598.20 |
|
±SD |
64.27 |
||
n |
5 |
||
G4R, F & 1000 |
Mean |
627.40 |
|
±SD |
48.97 |
||
n |
5 |
M: Male; F: Female; R: Recovery;SD: Standard Deviation; n: Number of Animals
TABLE 8. SUMMARYOF GRIP STREGTH (kgf) MEASUREMENT RECORD
Day 37 |
|||
Group, Sex & Dose |
|
Average Fore limb Grip Strength |
Average Hind limb Grip Strength |
G1, M & 0 |
Mean |
1.537 |
0.535 |
±SD |
0.023 |
0.039 |
|
n |
5 |
5 |
|
G2, M & 110 |
Mean |
1.568 |
0.563 |
±SD |
0.020 |
0.041 |
|
n |
5 |
5 |
|
G3, M & 330 |
Mean |
1.552 |
0.546 |
±SD |
0.043 |
0.028 |
|
n |
5 |
5 |
|
G4, M & 1000 |
Mean |
1.541 |
0.561 |
±SD |
0.049 |
0.029 |
|
n |
5 |
5 |
M: Male;SD: Standard Deviation; n: Number of Animals (Randomly selected)
TABLE 8 (Contd..,). SUMMARYOF GRIP STREGTH (kgf) MEASUREMENT RECORD
During Lactation |
||||
Group, Sex & Dose |
Average Fore limb Grip Strength |
Average Hind limb Grip Strength |
||
G1, F & 0 |
Mean |
1.643 |
0.621 |
|
±SD |
0.037 |
0.048 |
||
n |
5 |
5 |
||
G2, F & 110 |
Mean |
1.637 |
0.622 |
|
±SD |
0.050 |
0.046 |
||
n |
5 |
5 |
||
G3, F & 330 |
Mean |
1.641 |
0.628 |
|
±SD |
0.069 |
0.030 |
||
n |
5 |
5 |
||
G4, F & 1000 |
Mean |
1.634 |
0.619 |
|
±SD |
0.089 |
0.030 |
||
n |
5 |
5 |
F: Female;SD: Standard Deviation; n: Number of Animals (Randomly selected)
TABLE 8 (Contd..,). SUMMARYOF GRIP STREGTH (kgf) MEASUREMENT RECORD
Day 71 |
|||
Group, Sex & Dose |
Average Fore limb Grip Strength |
Average Hind limb Grip Strength |
|
G1R, M & 0 |
Mean |
1.603 |
0.533 |
±SD |
0.019 |
0.042 |
|
n |
5 |
5 |
|
G4R, M & 1000 |
Mean |
1.607 |
0.544 |
±SD |
0.033 |
0.031 |
|
n |
5 |
5 |
|
G1R, F & 0 |
Mean |
1.562 |
0.545 |
±SD |
0.038 |
0.046 |
|
n |
5 |
5 |
|
G4R, F & 1000 |
Mean |
1.558 |
0.548 |
±SD |
0.047 |
0.037 |
|
n |
5 |
5 |
M: Male; F: Female; R: Recovery;SD: Standard Deviation; n: Number of Animals
TABLE 9. SUMMARY OF HIND LIMB FOOT SPLAY (cm) RECORD
Day 37 |
||
Group, Sex & Dose |
Average Landing Foot Splay (cm) |
|
G1, M & 0 |
Mean |
10.45 |
±SD |
1.59 |
|
n |
5 |
|
G2, M & 110 |
Mean |
9.69 |
±SD |
1.02 |
|
n |
5 |
|
G3, M & 330 |
Mean |
10.56 |
±SD |
1.93 |
|
n |
5 |
|
G4, M & 1000 |
Mean |
9.52 |
±SD |
1.11 |
|
n |
5 |
M: Male;SD: Standard Deviation; n: Number of Animals (Randomly selected)
TABLE 9 (Contd..,).SUMMARY OF HIND LIMB FOOT SPLAY (cm) RECORD
During lactation |
||
Group, Sex & Dose |
Average Landing Foot Splay (cm) |
|
G1, F & 0 |
Mean |
6.65 |
±SD |
0.60 |
|
n |
5 |
|
G2, F & 110 |
Mean |
7.28 |
±SD |
0.71 |
|
n |
5 |
|
G3, F & 330 |
Mean |
6.52 |
±SD |
0.70 |
|
n |
5 |
|
G4, F & 1000 |
Mean |
7.13 |
±SD |
1.08 |
|
n |
5 |
F: Female;SD: Standard Deviation; n: Number of Animals (Randomly selected)
TABLE 9 (Contd..,).SUMMARY OF HIND LIMB FOOT SPLAY (cm) RECORD
Day 71 |
||
Group, Sex & Dose |
Average Landing Foot Splay (cm) |
|
G1R, M & 0 |
Mean |
10.36 |
±SD |
1.66 |
|
n |
5 |
|
G4R, M & 1000 |
Mean |
9.60 |
±SD |
0.71 |
|
n |
5 |
|
G1R, F & 0 |
Mean |
8.22 |
±SD |
0.76 |
|
n |
5 |
|
G4R, F & 1000 |
Mean |
8.32 |
±SD |
0.55 |
|
n |
5 |
M: Male; F: Female; R: Recovery;SD: Standard Deviation; n: Number of Animals
TABLE 10. SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Leucocyte Count |
Total Erythrocyte Count |
Haemoglobin |
Haematocrit |
Platelet Count |
Reticulocyte Count |
Neutrophils |
Lymphocytes |
Monocytes |
Eosinophils |
Basophils |
|
(WBC) |
(RBC) |
(HGB) |
(HCT) |
(PLT) |
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
||
(103cells/µL) |
(106cells/µL) |
(g/dL) |
(%) |
(103cells/µL) |
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
||
G1, M & 0 |
Mean |
6.85 |
7.00 |
12.38 |
42.34 |
822.80 |
3.63 |
23.46 |
71.44 |
2.76 |
1.00 |
0.10 |
±SD |
1.31 |
0.80 |
1.91 |
2.13 |
69.12 |
2.39 |
2.54 |
2.95 |
0.46 |
0.47 |
0.07 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 110 |
Mean |
10.59 |
7.36 |
13.50 |
41.26 |
810.80 |
1.66 |
25.40 |
69.68 |
2.92 |
0.68 |
0.14 |
±SD |
2.65 |
0.40 |
0.74 |
1.78 |
36.38 |
0.45 |
4.61 |
4.75 |
1.22 |
0.19 |
0.05 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 330 |
Mean |
7.84 |
6.73 |
13.76 |
43.28 |
758.40 |
1.95 |
26.96 |
67.46 |
3.36 |
0.92 |
0.10 |
±SD |
2.33 |
0.51 |
0.22 |
0.51 |
122.36 |
0.36 |
6.11 |
7.40 |
1.26 |
0.36 |
0.07 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
10.56 |
7.81 |
13.80 |
42.72 |
774.60 |
1.67 |
22.52 |
71.62 |
3.72 |
1.14 |
0.12 |
±SD |
2.76 |
0.79 |
1.03 |
2.64 |
110.53 |
0.62 |
2.63 |
2.65 |
0.40 |
0.40 |
0.04 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male;SD: Standard Deviation; n: Number of animals (Randomly Selected)
TABLE 10 (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 |
243.72 |
1.62 |
4.87 |
0.19 |
0.07 |
0.01 |
15.86 |
16.88 |
±SD |
141.28 |
0.45 |
0.74 |
0.06 |
0.05 |
0.01 |
0.90 |
1.55 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 110 |
Mean |
121.16* |
2.66* |
7.42 |
0.30 |
0.07 |
0.02 |
17.08 |
20.24 |
±SD |
29.26 |
0.74 |
2.24 |
0.10 |
0.02 |
0.01 |
1.87 |
3.77 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 330 |
Mean |
130.74 |
2.09 |
5.31 |
0.26 |
0.07 |
0.01 |
15.48 |
22.50 |
±SD |
19.49 |
0.63 |
1.88 |
0.11 |
0.03 |
0.01 |
1.45 |
4.19 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
126.56 |
2.33 |
7.60 |
0.40* |
0.12 |
0.01 |
15.36 |
27.92* |
±SD |
30.47 |
0.40 |
2.15 |
0.13 |
0.08 |
0.01 |
1.70 |
8.26 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male;SD: Standard Deviation; n: Number of animals (Randomly Selected)
*: Statistically significant than the control group (p<0.05)
TABLE 10 (Contd..,).SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Leucocyte Count |
Total Erythrocyte Count |
Haemoglobin |
Haemato-crit |
Platelet Count |
Reticulocyte Count |
Neutrophils |
Lymphocytes |
Mono-cytes |
Eosino-phils |
Basophils |
|
(WBC) |
(RBC) |
(HGB) |
(HCT) |
(PLT) |
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
||
(103cells/µL) |
(106cells/µL) |
(g/dL) |
(%) |
(103cells/ µL) |
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
||
G1, F & 0 |
Mean |
10.23 |
6.99 |
13.10 |
40.24 |
873.60 |
3.35 |
37.76 |
56.00 |
3.96 |
1.30 |
0.14 |
±SD |
4.44 |
0.40 |
0.57 |
2.07 |
192.17 |
0.77 |
3.86 |
4.32 |
0.72 |
0.94 |
0.11 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 110 |
Mean |
13.06 |
6.70 |
12.88 |
39.32 |
886.60 |
2.80 |
38.20 |
54.88 |
4.34 |
1.34 |
0.12 |
±SD |
2.56 |
0.46 |
0.54 |
1.57 |
376.63 |
0.61 |
5.19 |
6.19 |
0.87 |
0.69 |
0.08 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 330 |
Mean |
8.53 |
6.44 |
12.76 |
39.66 |
883.60 |
4.09 |
29.52 |
63.54 |
4.26 |
1.30 |
0.22 |
±SD |
4.19 |
0.66 |
1.35 |
3.51 |
638.76 |
2.21 |
10.75 |
9.44 |
1.58 |
0.83 |
0.16 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
11.04 |
6.55 |
12.68 |
39.36 |
784.80 |
2.86 |
29.86 |
62.52 |
4.86 |
1.32 |
0.18 |
±SD |
6.57 |
0.49 |
0.82 |
2.16 |
187.91 |
1.40 |
11.87 |
11.36 |
0.96 |
0.38 |
0.08 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female;SD: Standard Deviation; n: Number of animals (Randomly Selected)
TABLE 10 (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 |
233.88 |
3.82 |
5.74 |
0.42 |
0.16 |
0.02 |
17.36 |
13.74 |
±SD |
54.79 |
1.53 |
2.65 |
0.19 |
0.16 |
0.02 |
2.01 |
3.40 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 110 |
Mean |
188.90 |
4.99 |
7.14 |
0.58 |
0.17 |
0.02 |
20.48 |
16.98 |
±SD |
48.05 |
1.27 |
1.51 |
0.23 |
0.08 |
0.01 |
7.73 |
7.54 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 330 |
Mean |
253.54 |
2.52 |
5.38 |
0.39 |
0.12 |
0.02 |
17.64 |
16.82 |
±SD |
101.81 |
1.76 |
2.48 |
0.26 |
0.12 |
0.01 |
2.58 |
2.40 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
183.90 |
3.88 |
6.35 |
0.53 |
0.14 |
0.02 |
20.08 |
19.22 |
±SD |
82.17 |
3.34 |
2.77 |
0.35 |
0.10 |
0.01 |
4.09 |
9.19 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female;SD: Standard Deviation; n: Number of animals (Randomly Selected)
TABLE 10 (Contd..,).SUMMARY OF HAEMATOLOGY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Leucocyte Count |
Total Erythrocyte Count |
Haemoglobin |
Haematocrit |
Platelet Count |
Reticulocyte Count |
Neutro-phils |
Lympho-cytes |
Monocytes |
Eosinophils |
Basophils |
|
(WBC) |
(RBC) |
(HGB) |
(HCT) |
(PLT) |
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
||
(103cells/µL) |
(106cells/µL) |
(g/dL) |
(%) |
(103cells/µL) |
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
||
G1R, M & 0 |
Mean |
9.19 |
7.92 |
14.50 |
42.76 |
845.20 |
1.26 |
20.16 |
74.30 |
3.02 |
1.68 |
0.16 |
±SD |
1.08 |
0.40 |
0.35 |
3.03 |
239.96 |
0.21 |
2.01 |
2.04 |
0.59 |
0.42 |
0.05 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
9.61 |
7.70 |
13.20* |
40.48 |
897.80 |
1.60 |
25.96 |
67.56 |
3.74 |
1.64 |
0.16 |
±SD |
1.86 |
0.26 |
0.22 |
0.73 |
46.69 |
0.35 |
7.13 |
6.85 |
0.61 |
0.27 |
0.05 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
7.11 |
7.50 |
13.48 |
40.22 |
875.20 |
1.46 |
25.08 |
68.30 |
3.96 |
1.62 |
0.10 |
±SD |
1.94 |
0.37 |
0.47 |
1.24 |
133.85 |
0.41 |
6.76 |
8.28 |
1.81 |
0.38 |
0.00 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
8.63 |
7.59 |
13.62 |
41.38 |
815.60 |
1.47 |
28.02 |
66.64 |
2.86 |
1.52 |
0.14 |
±SD |
2.04 |
0.67 |
0.66 |
2.91 |
135.75 |
0.50 |
10.17 |
10.11 |
0.36 |
0.33 |
0.05 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female;SD: Standard Deviation; n: Number of animals (Randomly Selected)
TABLE 10 (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 |
99.06 |
1.86 |
6.83 |
0.28 |
0.15 |
0.02 |
19.02 |
23.38 |
±SD |
12.65 |
0.32 |
0.82 |
0.06 |
0.03 |
0.01 |
2.79 |
5.66 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
122.94 |
2.54 |
6.45 |
0.35 |
0.16 |
0.01 |
16.82 |
23.36 |
±SD |
26.24 |
1.02 |
1.22 |
0.05 |
0.05 |
0.00 |
0.69 |
1.27 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
108.98 |
1.75 |
4.91 |
0.26 |
0.12 |
0.01 |
16.28 |
11.62 |
±SD |
28.05 |
0.59 |
1.61 |
0.07 |
0.04 |
0.01 |
0.70 |
3.70 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
112.48 |
2.51 |
5.66 |
0.25 |
0.13 |
0.01 |
16.26 |
25.76* |
±SD |
43.28 |
1.38 |
1.15 |
0.07 |
0.02 |
0.00 |
0.65 |
5.22 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery;SD: Standard Deviation; n: Number of animals
*: Statistically significant than the control group (p<0.05)
TABLE 11.SUMMARY OF CLIICAL CHEMISRTY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Glucose |
Creatinine |
Total Cholesterol |
Triglycerides |
Total Protein |
Albumin |
Alanine aminotransferase |
Aspartate aminotransferase |
Alkaline phosphatase |
|
(GLU) |
(CRE) |
(CHO) |
(TRI) |
(TPR) |
(ALB) |
(ALT) |
(AST) |
(ALP) |
||
mg/dL |
mg/dL |
mg/dL |
mg/dL |
g/dL |
g/dL |
U/L |
U/L |
U/L |
||
G1, M & 0 |
Mean |
94.00 |
0.54 |
47.20 |
59.80 |
6.32 |
3.13 |
56.80 |
106.20 |
136.40 |
±SD |
12.73 |
0.05 |
6.38 |
24.73 |
0.24 |
0.16 |
11.37 |
23.16 |
42.09 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 110 |
Mean |
96.00 |
0.53 |
53.40 |
81.20 |
6.40 |
3.06 |
60.00 |
102.00 |
338.40* |
±SD |
7.25 |
0.03 |
6.35 |
35.70 |
0.31 |
0.13 |
4.85 |
20.45 |
130.16 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 330 |
Mean |
103.60 |
0.59 |
50.80 |
70.80 |
6.32 |
3.12 |
66.20 |
119.60 |
342.60* |
±SD |
13.69 |
0.03 |
7.22 |
27.64 |
0.38 |
0.19 |
16.08 |
19.48 |
165.35 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
101.40 |
0.56 |
47.20 |
77.20 |
6.38 |
3.00 |
68.60 |
123.80 |
268.60 |
±SD |
22.21 |
0.02 |
6.98 |
26.70 |
0.24 |
0.33 |
10.45 |
29.83 |
69.88 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male;SD: Standard Deviation; n: Number of Animals (Randomly Selected)
*: Statistically significant than the control group (p<0.05)
TABLE 11 (Contd..,).SUMMARY OF CLIICAL CHEMISRTY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Bilirubin |
Calcium |
Phosphorous |
Globulin |
Blood Urea Nitrogen |
Sodium |
Potassium |
Chloride |
|
(BIT) |
(CAL) |
(PHO) |
(GLO) |
(BUN) |
(Na) |
(K) |
(CLO) |
||
mg/dL |
mg/dL |
mg/dL |
g/dL |
mg/dL |
mmol/L |
mmol/L |
mmol/L |
||
G1, M & 0 |
Mean |
0.03 |
9.04 |
5.26 |
3.19 |
10.13 |
143.84 |
3.36 |
104.36 |
±SD |
0.04 |
0.23 |
0.58 |
0.21 |
2.14 |
0.38 |
0.16 |
0.50 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 110 |
Mean |
0.01 |
8.96 |
4.74 |
3.34 |
7.44 |
144.12 |
3.51 |
105.72 |
±SD |
0.03 |
0.22 |
0.31 |
0.29 |
1.92 |
0.65 |
0.16 |
1.88 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 330 |
Mean |
0.02 |
9.04 |
5.74 |
3.20 |
11.73 |
144.46 |
3.62 |
106.40* |
±SD |
0.04 |
0.25 |
0.29 |
0.29 |
3.71 |
0.71 |
0.28 |
1.05 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 1000 |
Mean |
0.00 |
9.00 |
5.20 |
3.38 |
8.48 |
144.48 |
3.99* |
106.28 |
±SD |
0.01 |
0.46 |
0.85 |
0.35 |
2.20 |
1.66 |
0.48 |
0.89 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male;SD: Standard Deviation; n: Number of Animals (Randomly Selected)
*: Statistically significant than the control group (p<0.05)
TABLE 11 (Contd..,).SUMMARY OF CLIICAL CHEMISRTY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Glucose |
Creatinine |
Total Cholesterol |
Triglycerides |
Total Protein |
Albumin |
Alanine aminotransferase |
Aspartate aminotransferase |
Alkaline phosphatase |
|
(GLU) |
(CRE) |
(CHO) |
(TRI) |
(TPR) |
(ALB) |
(ALT) |
(AST) |
(ALP) |
||
mg/dL |
mg/dL |
mg/dL |
mg/dL |
g/dL |
g/dL |
U/L |
U/L |
U/L |
||
G1, F & 0 |
Mean |
94.40 |
0.58 |
73.00 |
96.20 |
6.16 |
3.19 |
100.20 |
105.40 |
323.20 |
±SD |
9.61 |
0.07 |
14.23 |
54.83 |
0.27 |
0.23 |
18.19 |
14.94 |
130.02 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 110 |
Mean |
95.80 |
0.57 |
75.00 |
114.00 |
6.33 |
3.29 |
116.40 |
116.80 |
305.80 |
±SD |
5.67 |
0.06 |
7.35 |
27.16 |
0.46 |
0.17 |
13.09 |
14.92 |
93.31 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 330 |
Mean |
99.80 |
0.56 |
65.40 |
120.00 |
5.88 |
3.08 |
113.20 |
121.00 |
318.00 |
±SD |
24.35 |
0.10 |
20.67 |
55.03 |
0.36 |
0.26 |
26.83 |
19.60 |
116.12 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
116.60 |
0.52 |
68.40 |
92.80 |
6.14 |
3.24 |
104.20 |
123.60 |
315.40 |
±SD |
25.30 |
0.05 |
4.51 |
23.12 |
0.30 |
0.11 |
33.73 |
31.83 |
64.40 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female;SD: Standard Deviation; n: Number of Animals (Randomly Selected)
TABLE 11 (Contd..,).SUMMARY OF CLIICAL CHEMISRTY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Bilirubin |
Calcium |
Phosphorous |
Globulin |
Blood Urea Nitrogen |
Sodium |
Potassium |
Chloride |
|
(BIT) |
(CAL) |
(PHO) |
(GLO) |
(BUN) |
(Na) |
(K) |
(CLO) |
||
mg/dL |
mg/dL |
mg/dL |
g/dL |
mg/dL |
mmol/L |
mmol/L |
mmol/L |
||
G1, F & 0 |
Mean |
0.00 |
9.94 |
8.32 |
2.97 |
24.16 |
139.10 |
3.88 |
102.38 |
±SD |
0.00 |
0.17 |
0.58 |
0.17 |
2.78 |
2.09 |
0.25 |
1.25 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 110 |
Mean |
0.00 |
10.46 |
8.24 |
3.03 |
21.34 |
140.36 |
3.74 |
103.08 |
±SD |
0.00 |
0.34 |
1.88 |
0.29 |
3.14 |
2.14 |
0.13 |
1.20 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 330 |
Mean |
0.00 |
9.74 |
8.90 |
2.80 |
23.26 |
140.80 |
4.08 |
102.36 |
±SD |
0.00 |
0.76 |
1.54 |
0.40 |
9.80 |
2.99 |
0.74 |
2.77 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 1000 |
Mean |
0.00 |
10.14 |
9.14 |
2.90 |
19.73 |
140.50 |
4.22 |
101.86 |
±SD |
0.00 |
0.77 |
1.26 |
0.28 |
4.97 |
1.79 |
0.46 |
1.25 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female;SD: Standard Deviation; n: Number of Animals (Randomly Selected)
TABLE 11 (Contd..,).SUMMARY OF CLIICAL CHEMISRTY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Glucose |
Creatinine |
Total Cholesterol |
Triglycerides |
Total Protein |
Albumin |
Alanine aminotransferase |
Aspartate aminotransferase |
Alkaline phosphatase |
|
(GLU) |
(CRE) |
(CHO) |
(TRI) |
(TPR) |
(ALB) |
(ALT) |
(AST) |
(ALP) |
||
mg/dL |
mg/dL |
mg/dL |
mg/dL |
g/dL |
g/dL |
U/L |
U/L |
U/L |
||
G1R, M & 0 |
Mean |
107.40 |
0.59 |
48.00 |
43.20 |
6.48 |
3.18 |
58.60 |
105.40 |
98.00 |
±SD |
5.18 |
0.03 |
6.48 |
11.26 |
0.30 |
0.21 |
13.59 |
18.99 |
15.30 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
103.20 |
0.58 |
50.80 |
56.40 |
6.66 |
3.18 |
57.60 |
111.00 |
92.60 |
±SD |
2.77 |
0.04 |
3.03 |
16.82 |
0.15 |
0.17 |
5.59 |
19.86 |
17.53 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
106.00 |
0.64 |
64.80 |
42.20 |
7.48 |
3.78 |
49.80 |
94.00 |
86.00 |
±SD |
13.96 |
0.03 |
16.84 |
8.56 |
0.27 |
0.15 |
11.69 |
12.69 |
32.53 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
107.00 |
0.60 |
69.60 |
45.60 |
7.16* |
3.52 |
63.60 |
116.40 |
74.80 |
±SD |
6.67 |
0.03 |
11.61 |
18.04 |
0.09 |
0.21 |
33.35 |
41.45 |
31.92 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery;SD: Standard Deviation; n: Number of Animals
*: Statistically significant than the control group (p<0.05)
TABLE 11 (Contd..,).SUMMARY OF CLIICAL CHEMISRTY RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Total Bilirubin |
Calcium |
Phosphorous |
Globulin |
Blood Urea Nitrogen |
Sodium |
Potassium |
Chloride |
|
(BIT) |
(CAL) |
(PHO) |
(GLO) |
(BUN) |
(Na) |
(K) |
(CLO) |
||
mg/dL |
mg/dL |
mg/dL |
g/dL |
mg/dL |
mmol/L |
mmol/L |
mmol/L |
||
G1R, M & 0 |
Mean |
0.01 |
9.88 |
4.60 |
3.30 |
13.37 |
144.20 |
3.48 |
105.74 |
±SD |
0.02 |
0.51 |
0.22 |
0.18 |
1.68 |
0.68 |
0.15 |
1.30 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
0.00 |
10.28 |
4.62 |
3.48 |
11.41 |
144.66 |
3.82* |
105.84 |
±SD |
0.00 |
0.36 |
0.64 |
0.09 |
1.60 |
0.67 |
0.19 |
0.83 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
0.05 |
10.72 |
3.46 |
3.70 |
13.43 |
144.54 |
3.50 |
107.18 |
±SD |
0.03 |
0.31 |
0.50 |
0.19 |
1.71 |
0.79 |
0.29 |
0.76 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
0.01* |
10.78 |
4.24* |
3.64 |
14.77 |
143.00* |
3.74 |
106.16 |
±SD |
0.01 |
0.23 |
0.23 |
0.21 |
2.06 |
1.15 |
0.18 |
0.95 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; F: Female; R: Recovery;SD: Standard Deviation; n:Number of Animals (Randomly Selected)
*: Statistically significant than the control group (p<0.05)
TABLE 12.SUMMARY OF URINALSIS RECORD
Examination |
Group, Sex & Dose (mg/kg body weight/day) |
G1, M & 0 |
G2, M & 110 |
G3, M & 330 |
G4, M & 1000 |
|
Number of Animals (Randomly selected) |
5 |
5 |
5 |
5 |
||
Physical Examination |
Colour |
Pale Yellow |
5 |
5 |
5 |
4 |
Yellow |
- |
- |
- |
1 |
||
Appearance |
Clear |
4 |
4 |
5 |
5 |
|
Turbidity |
1 |
1 |
- |
- |
||
Volume (mL) |
Mean |
4.80 |
5.90 |
6.10 |
5.90 |
|
±SD |
1.89 |
1.08 |
1.29 |
2.16 |
||
Chemical Examination |
pH |
Mean |
7.20 |
7.10 |
7.30 |
7.20 |
±SD |
0.45 |
0.96 |
0.76 |
0.67 |
||
Specific Gravity (SG) |
Mean |
1.015 |
1.011 |
1.015 |
1.017 |
|
±SD |
0.006 |
0.004 |
0.009 |
0.006 |
||
Urobilinogen (UBG) mg/dL |
Mean |
0.20 |
0.20 |
0.36 |
0.36 |
|
±SD |
0.00 |
0.00 |
0.36 |
0.36 |
||
Microalbumin (mg/dL) |
>15 |
5 |
5 |
5 |
5 |
|
Bilirubin (BIL) mg/dL |
Neg |
5 |
5 |
5 |
5 |
|
Ketones (KET) mg/dL |
15 |
- |
- |
- |
2 |
|
5 |
4 |
3 |
4 |
2 |
||
Neg |
1 |
2 |
1 |
1 |
||
Blood (BLD) Ery/µL |
Neg |
1 |
- |
1 |
2 |
|
Ca10 |
1 |
1 |
1 |
1 |
||
Ca25 |
1 |
- |
2 |
1 |
||
Ca80 |
1 |
3 |
1 |
1 |
||
>=Ca200 |
1 |
1 |
- |
- |
||
Protein (PRO) mg/dL |
Trace |
1 |
2 |
- |
- |
|
30 |
- |
1 |
3 |
1 |
||
100 |
4 |
2 |
1 |
2 |
||
>=300 |
- |
- |
1 |
2 |
||
Nitrite (NIT) |
Neg |
3 |
5 |
4 |
2 |
|
Pos |
2 |
- |
1 |
3 |
||
Leucocytes (LEU) Leu/µL |
Neg |
3 |
3 |
3 |
2 |
|
Ca15 |
2 |
1 |
1 |
3 |
||
Ca70 |
- |
1 |
1 |
- |
||
Glucose (GLU) mg/dL |
250 |
- |
1 |
- |
- |
|
Neg |
5 |
4 |
5 |
5 |
||
Microscopic Examination |
Epi Cells |
0 |
1 |
1 |
2 |
- |
0-1 |
3 |
2 |
3 |
4 |
||
1-2 |
1 |
2 |
- |
1 |
||
Casts |
Absent |
5 |
5 |
5 |
5 |
|
Crystals |
Present |
5 |
5 |
5 |
5 |
M: Male;SD: Standard Deviation; n: Number of Animals (Randomly selected)
Pos: Positive; Neg: Negative; Ca: Calculated; >=: Greater than or equal to.
TABLE 12 (Contd..,).SUMMARY OF URINALSIS 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 |
5 |
5 |
5 |
5 |
Appearance |
Clear |
5 |
5 |
4 |
4 |
|
Turbidity |
- |
- |
1 |
1 |
||
Volume (mL) |
Mean |
8.60 |
8.50 |
8.70 |
8.40 |
|
±SD |
1.34 |
0.79 |
1.35 |
1.02 |
||
Chemical Examination |
pH |
Mean |
7.20 |
7.40 |
7.10 |
6.50* |
±SD |
0.57 |
0.22 |
0.42 |
0.35 |
||
Specific gravity (SG) |
Mean |
1.014 |
1.011 |
1.015 |
1.015 |
|
±SD |
0.004 |
0.002 |
0.000 |
0.000 |
||
Urobilinogen (UBG) mg/dL |
Mean |
0.20 |
0.20 |
0.20 |
0.20 |
|
±SD |
0.00 |
0.00 |
0.00 |
0.00 |
||
Microalbumin (mg/dL) |
>15 |
5 |
5 |
4 |
- |
|
Neg |
- |
- |
1 |
5 |
||
Bilirubin (BIL) mg/dL |
Neg |
5 |
5 |
5 |
5 |
|
Ketones (KET) mg/dL |
5 |
4 |
4 |
- |
- |
|
Neg |
1 |
1 |
5 |
5 |
||
Blood (BLD) Ery/µL |
Ca10 |
- |
1 |
4 |
- |
|
Ca80 |
2 |
3 |
1 |
1 |
||
>=Ca200 |
3 |
1 |
- |
4 |
||
Protein (PRO) mg/dL |
Trace |
2 |
5 |
4 |
- |
|
30 |
3 |
- |
- |
- |
||
Neg |
- |
- |
1 |
5 |
||
Nitrite (NIT) |
Neg |
5 |
5 |
5 |
4 |
|
Pos |
- |
- |
- |
1 |
||
Leucocytes (LEU) Leu/µL |
Neg |
5 |
5 |
5 |
5 |
|
Glucose (GLU) mg/dL |
Neg |
5 |
5 |
5 |
5 |
|
Microscopic Examination |
Epi Cells |
0 |
2 |
3 |
2 |
1 |
0-1 |
2 |
2 |
1 |
3 |
||
1-2 |
1 |
- |
2 |
1 |
||
2-3 |
- |
- |
- |
- |
||
Casts |
Absent |
5 |
5 |
5 |
5 |
|
Crystals |
Present |
5 |
5 |
5 |
5 |
M: Male; F: Female;SD: Standard Deviation; n: Number of Animals; Pos: Positive; Neg: Negative; Ca: Calculated
*: Statistically significant than the control group (p<0.05)
TABLE 13 (Contd..,).SUMMARY OF ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Adrenals |
Thymus |
Spleen |
Epididymes |
Testes |
Heart |
Kidneys |
Brain |
Liver |
PSC |
Thyroid along with parathyroid# |
|
G1, M & 0 |
Mean |
0.0748 |
0.4083 |
1.4875 |
1.4644 |
3.2042 |
1.5285 |
2.9538 |
2.2363 |
12.4668 |
4.7458 |
0.0230 |
±SD |
0.0112 |
0.0686 |
0.7760 |
0.1628 |
0.3175 |
0.1467 |
0.4860 |
0.1587 |
2.4600 |
0.6170 |
0.0040 |
|
n |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
5 |
12 |
12 |
|
G2, M & 110 |
Mean |
0.0693 |
0.4236 |
1.3154 |
1.5012 |
3.3500 |
1.5301 |
3.0747 |
2.2646 |
11.6021 |
4.3578 |
0.0236 |
±SD |
0.0103 |
0.0489 |
0.4042 |
0.1499 |
0.2902 |
0.1276 |
0.4144 |
0.1684 |
1.4523 |
0.6411 |
0.0054 |
|
n |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
5 |
12 |
12 |
|
G3, M & 330 |
Mean |
0.0787 |
0.3932 |
1.4196 |
1.4830 |
3.1904 |
1.5830 |
3.4092 |
2.3726 |
12.6911 |
4.5579 |
0.0218 |
±SD |
0.0103 |
0.0854 |
0.2984 |
0.2442 |
0.7644 |
0.2104 |
0.1248 |
0.1261 |
1.3841 |
0.8952 |
0.0023 |
|
n |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
5 |
12 |
12 |
|
G4, M & 1000 |
Mean |
0.0710 |
0.3928 |
1.1159 |
1.5932 |
3.4803 |
1.4070 |
3.5326 |
2.4086 |
11.2318 |
5.0252 |
0.0221 |
±SD |
0.0093 |
0.0908 |
0.4592 |
0.2333 |
0.3318 |
0.1488 |
0.6437 |
0.0552 |
1.4246 |
0.7548 |
0.0054 |
|
n |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
5 |
12 |
12 |
M: Male;SD: Standard Deviation; n: Number of animals: #: Weighed post fixation: PSC:Prostate + Seminal vesicles with coagulating glands
TABLE 13 (Contd..,).SUMMARY OF ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
|
Adrenals |
Thymus |
Spleen |
Heart |
Kidneys |
Brain |
Liver |
Thyroid along with parathyroid# |
G1, F & 0 |
Mean |
0.0966 |
0.2964 |
0.5788 |
1.2573 |
2.1996 |
2.1245 |
11.8333 |
0.0219 |
±SD |
0.0199 |
0.0293 |
0.0401 |
0.0411 |
0.1216 |
0.1900 |
0.8625 |
0.0046 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
12 |
|
G2, F & 110 |
Mean |
0.0937 |
0.2753 |
0.9697 |
1.2310 |
2.5220 |
2.3099 |
12.3020 |
0.0240 |
±SD |
0.0086 |
0.0152 |
0.2926 |
0.1081 |
0.3362 |
0.1754 |
1.4895 |
0.0068 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
11 |
|
G3, F & 330 |
Mean |
0.0937 |
0.2864 |
0.8288 |
1.1555 |
2.1549 |
2.1199 |
11.5027 |
0.0206 |
±SD |
0.0136 |
0.0407 |
0.4319 |
0.0899 |
0.2358 |
0.0991 |
1.2154 |
0.0024 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
11 |
|
G4, F & 1000 |
Mean |
0.2680 |
0.3007 |
0.6806 |
1.3033 |
2.1556 |
2.1361 |
12.0178 |
0.0211 |
±SD |
0.4172 |
0.0308 |
0.0499 |
0.0607 |
0.0912 |
0.1073 |
1.0290 |
0.0026 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
11 |
F: Female;SD: Standard Deviation; n: Number of animals; #: Weighed post fixation (excluding non-pregnant animals)
TABLE 13 (Contd..,).SUMMARY OF ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Adrenals |
Thymus |
Spleen |
Epididymes |
Testes |
Heart |
Kidneys |
Brain |
Liver |
PSC |
Thyroid along with parathyroid# |
|
G1R, M & 0 |
Mean |
0.0540 |
0.2383 |
1.1859 |
1.4440 |
3.2241 |
1.4134 |
2.5498 |
2.0356 |
11.5613 |
3.4105 |
0.0260 |
±SD |
0.0071 |
0.0382 |
0.1382 |
0.0625 |
0.1891 |
0.1147 |
0.1590 |
0.1122 |
1.1807 |
0.3936 |
0.0044 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
0.0585 |
0.2403 |
1.0514 |
1.3748 |
3.2331 |
1.3274 |
2.5014 |
2.0688 |
12.1786 |
2.9304 |
0.0252* |
±SD |
0.0068 |
0.0268 |
0.1085 |
0.0244 |
0.1568 |
0.0511 |
0.1411 |
0.0768 |
1.0689 |
0.2115 |
0.0033 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery;SD: Standard Deviation; n: Number of animals; PSC:Prostate + Seminal vesicles with coagulating glands; #: Weighed post fixation
*: Statistically significant than the control group (p<0.05)
TABLE 13 (Contd..,).SUMMARY OF ABSOLUTE ORGAN WEIGHT (g) RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Adrenals |
Thymus |
Spleen |
Heart |
Kidneys |
Brain |
Liver |
Thyroid along with parathyroid# |
|
G1R, F & 0 |
Mean |
0.0627 |
0.2513 |
0.6045 |
0.9485 |
1.6102 |
1.9874 |
7.3470 |
0.0272 |
±SD |
0.0072 |
0.0190 |
0.0830 |
0.0625 |
0.0802 |
0.1058 |
0.5912 |
0.0030 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
0.0585 |
0.2312 |
0.6047 |
0.9361 |
1.6242 |
2.0209 |
7.7516 |
0.0276 |
±SD |
0.0035 |
0.0308 |
0.0664 |
0.0616 |
0.0614 |
0.0831 |
0.5586 |
0.0029 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery;SD: Standard Deviation; n: Number of animals; #: Weighed post fixation
TABLE 14.SUMMARY OF FASTING BODY WEIGHT (g) AND ORGAN WEIGHT (%) RELATIVE TO FASTING BODY WEIGHT RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Fasting Body Weight (g) |
Adrenals |
Thymus |
Spleen |
Epididymes |
Testes |
Heart |
Kidneys |
Brain |
Liver |
PSC |
Thyroid along with parathyroid |
|
G1, M & 0 |
Mean |
410.03 |
0.0183 |
0.1005 |
0.3675 |
0.3583 |
0.7834 |
0.3711 |
0.7155 |
0.5481 |
3.0055 |
1.1692 |
0.0056 |
±SD |
37.56 |
0.0034 |
0.0226 |
0.2037 |
0.0398 |
0.0687 |
0.0099 |
0.0821 |
0.0780 |
0.3359 |
0.1983 |
0.0009 |
|
n |
12 |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
5 |
12 |
12 |
|
G2, M & 110 |
Mean |
402.30 |
0.0176 |
0.1064 |
0.3240 |
0.3760 |
0.8390 |
0.3846 |
0.7789 |
0.5750 |
2.9049 |
1.0904 |
0.0059 |
±SD |
43.50 |
0.0038 |
0.0101 |
0.0732 |
0.0450 |
0.0901 |
0.0301 |
0.1573 |
0.1010 |
0.1895 |
0.1795 |
0.0016 |
|
n |
12 |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
5 |
12 |
12 |
|
G3, M & 330 |
Mean |
410.88 |
0.0192 |
0.0969 |
0.3501 |
0.3663 |
0.7832 |
0.3823 |
0.8280 |
0.5779 |
3.0611 |
1.1252 |
0.0053 |
±SD |
34.87 |
0.0034 |
0.0300 |
0.1115 |
0.0854 |
0.1962 |
0.0355 |
0.0725 |
0.0746 |
0.1318 |
0.2860 |
0.0006 |
|
n |
12 |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
5 |
12 |
12 |
|
G4, M & 1000 |
Mean |
403.88 |
0.0184 |
0.1020 |
0.2935 |
0.3956 |
0.8654 |
0.3633 |
0.9094 |
0.6240 |
2.9117 |
1.2476 |
0.0055 |
±SD |
35.72 |
0.0039 |
0.0296 |
0.1454 |
0.0534 |
0.0882 |
0.0566 |
0.1664 |
0.0899 |
0.5896 |
0.1804 |
0.0015 |
|
n |
12 |
5 |
5 |
5 |
12 |
12 |
5 |
5 |
5 |
5 |
12 |
12 |
M: Male;SD: Standard Deviation; n: Number of animals; PSC:Prostate + Seminal vesicles with coagulating glands
TABLE 14 (Contd..,).SUMMARY OF FASTING BODY WEIGHT (g) AND ORGAN WEIGHT (%) RELATIVE TO FASTING BODY WEIGHT RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Fasting Body Weight (g) |
Adrenals |
Thymus |
Spleen |
Heart |
Kidneys |
Brain |
Liver |
Thyroid along with parathyroid |
|
G1, F & 0 |
Mean |
293.81 |
0.0330 |
0.1012 |
0.1972 |
0.4288 |
0.7507 |
0.7254 |
4.0356 |
0.0074 |
±SD |
19.27 |
0.0072 |
0.0104 |
0.0076 |
0.0046 |
0.0456 |
0.0703 |
0.2574 |
0.0014 |
|
n |
12 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
12 |
|
G2, F & 110 |
Mean |
301.74 |
0.0307 |
0.0904 |
0.3183 |
0.4020 |
0.8219 |
0.7573 |
4.0189 |
0.0079 |
±SD |
15.26 |
0.0034 |
0.0091 |
0.0977 |
0.0165 |
0.0609 |
0.0726 |
0.3752 |
0.0021 |
|
n |
11 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
11 |
|
G3, F & 330 |
Mean |
296.91 |
0.0330 |
0.1015 |
0.3007 |
0.4078 |
0.7594 |
0.7513 |
4.0753 |
0.0070 |
±SD |
25.78 |
0.0037 |
0.0164 |
0.1590 |
0.0200 |
0.0515 |
0.0669 |
0.5067 |
0.0009 |
|
n |
11 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
11 |
|
G4, F & 1000 |
Mean |
302.66 |
0.0932 |
0.1029 |
0.2328 |
0.4457 |
0.7370 |
0.7293 |
4.1049 |
0.0070 |
±SD |
19.33 |
0.1467 |
0.0128 |
0.0229 |
0.0367 |
0.0557 |
0.0415 |
0.3896 |
0.0010 |
|
n |
11 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
11 |
F: Female;SD: Standard Deviation; n: Number of animals
TABLE 14 (Contd..,).SUMMARY OF FASTING BODY WEIGHT (g) AND ORGAN WEIGHT (%) RELATIVE TO FASTING BODY WEIGHT RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Fasting Body Weight (g) |
Adrenals |
Thymus |
Spleen |
Epididymes |
Testes |
Heart |
Kidneys |
Brain |
Liver |
PSC |
Thyroid along with parathyroid |
|
G1R, M & 0 |
Mean |
453.53 |
0.0119 |
0.0525 |
0.2612 |
0.3210 |
0.7146 |
0.3141 |
0.5650 |
0.4505 |
2.5559 |
0.7586 |
0.0058 |
±SD |
36.36 |
0.0013 |
0.0067 |
0.0186 |
0.0404 |
0.0716 |
0.0462 |
0.0560 |
0.0339 |
0.2477 |
0.1313 |
0.0011 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 1000 |
Mean |
434.34 |
0.0135 |
0.0555 |
0.2428 |
0.3188 |
0.7513 |
0.3088 |
0.5801 |
0.4795 |
2.8212 |
0.6797 |
0.0059 |
±SD |
43.79 |
0.0018 |
0.0056 |
0.0207 |
0.0284 |
0.0949 |
0.0411 |
0.0598 |
0.0418 |
0.3202 |
0.0769 |
0.0012 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery;SD: Standard Deviation; n: Number of animals; PSC:Prostate + Seminal vesicles with coagulating glands
TABLE 14 (Contd..,).SUMMARY OF FASTING BODY WEIGHT (g) AND ORGAN WEIGHT (%) RELATIVE TO FASTING BODY WEIGHT RECORD
Group, Sex & Dose (mg/kg body weight/day) |
Fasting Body Weight (g) |
Adrenals |
Thymus |
Spleen |
Heart |
Kidneys |
Brain |
Liver |
Thyroid along with parathyroid |
|
G1R, F & 0 |
Mean |
277.89 |
0.0225 |
0.0906 |
0.2176 |
0.3414 |
0.5798 |
0.7151 |
2.6452 |
0.0098 |
±SD |
8.40 |
0.0022 |
0.0086 |
0.0290 |
0.0208 |
0.0326 |
0.0297 |
0.2147 |
0.0010 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 1000 |
Mean |
275.98 |
0.0212 |
0.0838 |
0.2197 |
0.3397 |
0.5899 |
0.7336 |
2.8066 |
0.0100 |
±SD |
13.81 |
0.0013 |
0.0103 |
0.0274 |
0.0246 |
0.0405 |
0.0459 |
0.0818 |
0.0013 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery;SD: Standard Deviation; n: Number of animals
TABLE 15.SUMMARY RECORD OF VAGINAL SMEAR EXAMINATION FOR DETERMINATON OF OESTRUS CYCLICITY
Group & Dose |
No. of Females |
No. of Females with Regular Oestrus Cyclicity during Pre-mating, mating and on Lactation day 14 |
No. of Females with Irregular Oestrus Cyclicity during Pre-mating, mating and on Lactation day 14 |
G1 & 0 |
12 |
12 |
0 |
G2 & 110 |
12 |
12 |
0 |
G3 & 330 |
12 |
12 |
0 |
G4 & 1000 |
12 |
12 |
0 |
TABLE 16. SUMMARY OF COHABITATION RECORD
Group & Dose |
Copulatory Interval (Days) |
|
Conceiving Days (1 to 5) |
Conceiving Days (6 to 20) |
|
G1 & 0 |
Mean |
5.17 |
n |
10 |
2 |
±SD |
4.97 |
||||
n |
12 |
% |
83.3 |
16.7 |
|
G2 & 110 |
Mean |
3.83 |
n |
11 |
1 |
±SD |
3.79 |
||||
n |
11 |
% |
91.7 |
8.3 |
|
G3 & 330 |
Mean |
8.17 |
n |
6 |
6 |
±SD |
5.77 |
||||
n |
11 |
% |
50.0 |
50.0 |
|
G4 & 1000 |
Mean |
6.33 |
n |
7 |
5 |
±SD |
5.16 |
||||
n |
11 |
% |
58.3 |
41.7 |
SD: Standard Deviation; n: Number of animals; %: Percent
TABLE 17. SUMMARY RECORD OF BODY WEIGHT (g) DURING GESTATION PERIOD
Group & Dose |
Body weight (g) on Gestation Days |
||||
0 |
7 |
14 |
20 |
||
G1 & 0 |
Mean |
271.36 |
283.93 |
312.15 |
370.46 |
±SD |
12.65 |
12.11 |
17.64 |
24.09 |
|
n |
12 |
12 |
12 |
12 |
|
G2 & 110 |
Mean |
273.59 |
287.73 |
314.80 |
369.77 |
±SD |
13.40 |
18.89 |
20.86 |
32.89 |
|
n |
11 |
11 |
11 |
11 |
|
G3 & 330 |
Mean |
275.14 |
289.37 |
315.43 |
377.64 |
±SD |
14.90 |
17.01 |
19.06 |
32.03 |
|
n |
11 |
11 |
11 |
11 |
|
G4 & 1000 |
Mean |
276.17 |
291.09 |
319.92 |
377.45 |
±SD |
16.34 |
19.83 |
28.07 |
33.43 |
|
n |
11 |
11 |
11 |
11 |
SD: Standard Deviation; n: Number of dams
TABLE 18. SUMMARY RECORD OF CHANGE IN BODY WEIGHT (%) DURING GESTATION PERIOD
Group & Dose |
Change in body weight (%) during Gestation |
|||
0 to 7 |
7 to 14 |
14 to 20 |
||
G1 & 0 |
Mean |
4.67 |
9.93 |
18.70 |
±SD |
1.92 |
3.89 |
4.69 |
|
n |
12 |
12 |
12 |
|
G2 & 110 |
Mean |
5.11 |
9.42 |
17.36 |
±SD |
2.68 |
2.43 |
4.85 |
|
n |
11 |
11 |
11 |
|
G3 & 330 |
Mean |
5.17 |
9.04 |
19.73 |
±SD |
2.23 |
3.57 |
7.02 |
|
n |
11 |
11 |
11 |
|
G4 & 1000 |
Mean |
5.39 |
9.83 |
18.18 |
±SD |
3.17 |
4.16 |
7.36 |
|
n |
11 |
11 |
11 |
SD: Standard Deviation; n: Number of dams
TABLE 19. SUMMARY RECORD OF CHANGE IN BODY WEIGHT (%) DURING GESTATION PERIOD
Group, Sex & Dose |
Feed Consumption (g) during Gestation |
||||
GD 0 to 7 |
GD 7 to 14 |
GD 14 to 20 |
|||
G1 & 0 |
Mean |
20.86 |
22.19 |
25.03 |
|
±SD |
1.23 |
1.93 |
2.43 |
||
n |
12 |
12 |
12 |
||
G2 & 110 |
Mean |
20.60 |
21.25 |
23.76 |
|
±SD |
2.65 |
1.80 |
1.58 |
||
n |
11 |
11 |
11 |
||
G3 & 330 |
Mean |
20.86 |
22.38 |
24.60 |
|
±SD |
1.84 |
2.34 |
3.16 |
||
n |
11 |
11 |
11 |
||
G4 & 1000 |
Mean |
20.13 |
20.87 |
23.14 |
|
±SD |
1.76 |
1.31 |
1.89 |
||
n |
11 |
11 |
11 |
SD: Standard Deviation; n: Number of dams
TABLE 20. SUMMARY RECORD OF BODY WEIGHT (g) DURING LACTATION PERIOD
Group, Sex & Dose |
Body Weight (g) on Lactation Day |
||||
1 |
4 |
7 |
13 |
||
G1 & 0 |
Mean |
278.44 |
294.08 |
298.24 |
314.94 |
±SD |
16.31 |
16.65 |
18.10 |
17.65 |
|
n |
12 |
12 |
12 |
12 |
|
G2 & 110 |
Mean |
281.82 |
292.91 |
300.97 |
322.16 |
±SD |
21.53 |
23.35 |
19.32 |
18.01 |
|
n |
11 |
11 |
11 |
11 |
|
G3 & 330 |
Mean |
281.39 |
288.04 |
298.27 |
316.03 |
±SD |
33.43 |
30.09 |
26.65 |
24.33 |
|
n |
11 |
11 |
11 |
11 |
|
G4 & 1000 |
Mean |
293.33 |
296.65 |
303.91 |
322.55 |
±SD |
17.02 |
19.39 |
21.63 |
17.91 |
|
n |
11 |
11 |
11 |
11 |
SD: Standard Deviation; n: Number of dams
TABLE 21. SUMMARY RECORD OF PERCENT CHANGE IN BODY WEIGHT (%) DURING LACTATION PERIOD
Group, Sex & Dose |
Change in body weight (%) during Lactation |
|||
1 to 4 |
4 to 7 |
7 to 13 |
||
G1 & 0 |
Mean |
5.65 |
1.43 |
5.68 |
±SD |
2.27 |
2.95 |
3.32 |
|
n |
12 |
12 |
12 |
|
G2 & 110 |
Mean |
3.98 |
2.90 |
7.15 |
±SD |
4.23 |
3.16 |
4.00 |
|
n |
11 |
11 |
11 |
|
G3 & 330 |
Mean |
2.55* |
3.75 |
6.07 |
±SD |
2.79 |
4.13 |
2.69 |
|
n |
11 |
11 |
11 |
|
G4 & 1000 |
Mean |
1.10* |
2.43 |
6.25 |
±SD |
1.20 |
2.21 |
2.55 |
|
n |
11 |
11 |
11 |
SD: Standard Deviation; n: Number of dams
*: Statistically significant than the control group (p<0.05)
TABLE 22. SUMMARY RECORD OF FEED CONSUMPTION (g/dam/day) DURING LACTATION PERIOD
Group & Dose |
Feed Consumption (g) during Lactation |
||||
LD 1 to 4 |
LD 4 to 7 |
LD 7 to 14 |
|||
G1 & 0 |
Mean |
25.34 |
35.64 |
36.01 |
|
±SD |
2.71 |
5.41 |
4.19 |
||
n |
12 |
12 |
12 |
||
G2 & 110 |
Mean |
25.22 |
38.92 |
37.93 |
|
±SD |
2.61 |
3.95 |
4.15 |
||
n |
11 |
11 |
11 |
||
G3 & 330 |
Mean |
26.02 |
32.38 |
35.29 |
|
±SD |
4.05 |
5.19 |
4.84 |
||
n |
11 |
11 |
11 |
||
G4 & 1000 |
Mean |
26.04 |
35.80 |
35.73 |
|
±SD |
4.47 |
6.61 |
5.59 |
||
n |
11 |
11 |
11 |
SD: Standard Deviation; n: Number of dams; LD: Lactation Day
TABLE 23. SUMMARY RECORD OF GESTATION LENGTH (DAYS) AND DELIVERY DATA
Group & Dose |
Gestation Length (Days) |
Litter Size (No.) |
Live Pups (No.) |
Dead Pups (No.) |
|
Sex Ratio (M/F) at Birth |
Live Birth Index |
|||||||
Total (No.) |
Male (No.) |
Female (No.) |
Total (No.) |
Male (No.) |
Female (No.) |
|||||||||
G1 & 0 |
Mean |
22.08 |
11.08 |
10.75 |
4.67 |
6.08 |
0.33 |
0.33 |
0.08 |
0.83 |
97.34 |
|||
±SD |
0.79 |
1.93 |
1.71 |
1.72 |
1.51 |
0.65 |
0.65 |
0.29 |
0.44 |
5.03 |
||||
n |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
||||
G2 & 110 |
Mean |
22.36 |
11.55 |
11.55 |
5.82 |
5.73 |
0.00* |
0.00 |
0.00 |
1.17 |
100.00 |
|||
±SD |
0.81 |
1.37 |
1.37 |
1.66 |
1.49 |
0.00 |
0.00 |
0.00 |
0.66 |
0.00 |
||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||||
G3 & 330 |
Mean |
22.55 |
10.73 |
10.73 |
5.55 |
5.18 |
0.00* |
0.00 |
0.00 |
1.31 |
100.00 |
|||
±SD |
0.69 |
1.79 |
1.79 |
1.97 |
2.04 |
0.00 |
0.00 |
0.00 |
0.82 |
0.00 |
||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||||
G4 & 1000 |
Mean |
22.55 |
10.91 |
10.64 |
5.45 |
5.18 |
0.27 |
0.18 |
0.09 |
1.29 |
97.27 |
|||
±SD |
0.82 |
2.43 |
4.00 |
2.34 |
2.09 |
0.90 |
0.60 |
0.30 |
0.82 |
9.05 |
||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
F: Female;SD: Standard Deviation; n: Number of dams; NAD: No abnormality detected; LD: Lactation Day
*: Statistically significant than the control group (p<0.05)
TABLE 24. SUMMARY OF LITTER OBSERVATION RECORD DURING LACTATION PERIOD
Group & Dose |
|
No. of Live Pups At Birth |
During LD 1-4 |
Sex Ratio (M/F) at LD 4 |
No. of Survived Pups during LD 1-4 |
Pup Survival Index |
||||||
Live Pups (No.) |
|
Dead Pups (No.) |
||||||||||
Total (No.) |
Male (No.) |
Female (No.) |
Total (No.) |
Male (No.) |
Female (No.) |
|||||||
G1 & 0 |
Mean |
10.75 |
10.75 |
4.67 |
6.08 |
0.00 |
0.00 |
0.00 |
0.83 |
10.75 |
100.00 |
|
±SD |
1.71 |
1.71 |
1.72 |
1.51 |
0.00 |
0.00 |
0.00 |
0.44 |
1.71 |
0.00 |
||
n |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
||
G2 & 110 |
Mean |
11.55 |
11.55 |
5.82 |
5.73 |
0.00 |
0.00 |
0.00 |
1.17 |
11.55 |
100.00 |
|
±SD |
1.37 |
1.37 |
1.66 |
1.49 |
0.00 |
0.00 |
0.00 |
0.66 |
1.37 |
0.00 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||
G3 & 330 |
Mean |
10.73 |
10.55 |
5.45 |
5.09 |
0.18 |
0.09 |
0.09 |
1.31 |
10.55 |
97.73 |
|
±SD |
1.79 |
2.16 |
2.07 |
2.12 |
0.60 |
0.30 |
0.30 |
0.82 |
2.16 |
7.54 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||
G4 & 1000 |
Mean |
10.64 |
10.64 |
5.45 |
5.18 |
0.00 |
0.00 |
0.00 |
1.29 |
10.64 |
100.00 |
|
±SD |
2.69 |
2.69 |
2.34 |
2.09 |
0.00 |
0.00 |
0.00 |
0.82 |
2.69 |
0.00 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
M: Male: F: Female;SD: Standard Deviation; n: Number of dams; LD: Lactation Day
TABLE 24 (Contd..,). SUMMARY OF LITTER OBSERVATION RECORD DURING LACTATION PERIOD
Group & Dose |
Pups Sacrificed for Blood Collection on LD 4 (No.) |
Pups Sacrificed for Blood Collection on LD 4 (No.) |
No. of Survived Pups during LD 1-4 |
No. of Live Pups on LD 4 |
During LD 4-7 |
Sex Ratio (M/F) at LD 7 |
No. of Survived Pups during LD 4-7 |
Pup Survival Index |
||||||||
Live Pups (No.) |
Dead Pups (No.) |
|||||||||||||||
Male (No.) |
Female (No.) |
Total (No.) |
Male (No.) |
Female (No.) |
Total (No.) |
Male (No.) |
Female (No.) |
|||||||||
G1 & 0 |
Mean |
0.00 |
0.92 |
0.92 |
10.75 |
9.83 |
9.83 |
4.67 |
5.17 |
0.00 |
0.00 |
0.00 |
1.12 |
9.83 |
100.00 |
|
±SD |
0.00 |
1.00 |
1.00 |
1.71 |
0.94 |
0.94 |
1.72 |
1.40 |
0.00 |
0.00 |
0.00 |
0.98 |
0.94 |
0.00 |
||
n |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
||
G2 & 110 |
Mean |
0.00 |
1.27 |
1.27 |
11.55 |
10.27 |
10.27 |
5.82 |
4.45 |
0.00 |
0.00 |
0.00 |
1.51 |
10.27 |
100.00 |
|
±SD |
0.00 |
1.01 |
1.01 |
1.37 |
0.65 |
0.65 |
1.66 |
1.44 |
0.00 |
0.00 |
0.00 |
0.72 |
0.65 |
0.00 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||
G3 & 330 |
Mean |
0.00 |
1.18 |
1.18 |
10.55 |
9.36 |
9.36 |
5.45 |
3.91 |
0.00 |
0.00 |
0.00 |
2.14 |
9.36 |
100.00 |
|
±SD |
0.00 |
0.98 |
0.98 |
2.16 |
1.43 |
1.43 |
2.07 |
1.87 |
0.00 |
0.00 |
0.00 |
2.40 |
1.43 |
0.00 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||
G4 & 1000 |
Mean |
0.00 |
0.82 |
0.82 |
10.64 |
9.82 |
9.82 |
5.45 |
4.36 |
0.00 |
0.00 |
0.00 |
1.63 |
9.82 |
100.00 |
|
±SD |
0.00 |
0.98 |
0.98 |
2.69 |
1.89 |
1.89 |
2.34 |
1.69 |
0.00 |
0.00 |
0.00 |
1.35 |
1.89 |
0.00 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
M: Male: F: Female;SD: Standard Deviation; n: Number of dams; LD: Lactation Day
TABLE 24 (Contd..,). SUMMARY OF LITTER OBSERVATION RECORD DURING LACTATION PERIOD
Group & Dose |
No. of Live Pups on LD 7 |
During LD 7-13 |
Sex Ratio (M/F) at LD 13 |
No. of Survived Pups during LD 7-13 |
Pup Survival Index |
|||||||
Live Pups (No.) |
Dead Pups (No.) |
|||||||||||
Total (No.) |
Male (No.) |
Female (No.) |
Total (No.) |
Male (No.) |
Female (No.) |
|||||||
G1 & 0 |
Mean |
9.83 |
9.83 |
4.67 |
5.17 |
0.00 |
0.00 |
0.00 |
1.12 |
9.83 |
100.00 |
|
±SD |
0.94 |
0.94 |
1.72 |
1.40 |
0.00 |
0.00 |
0.00 |
0.98 |
0.94 |
0.00 |
||
n |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
||
G2 & 110 |
Mean |
10.27 |
10.27 |
5.82 |
4.45 |
0.00 |
0.00 |
0.00 |
1.51 |
10.27 |
100.00 |
|
±SD |
0.65 |
0.65 |
1.66 |
1.44 |
0.00 |
0.00 |
0.00 |
0.72 |
0.65 |
0.00 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||
G3 & 330 |
Mean |
9.36 |
9.36 |
5.45 |
3.91 |
0.00 |
0.00 |
0.00 |
2.14 |
9.36 |
100.00 |
|
±SD |
1.43 |
1.43 |
2.07 |
1.87 |
0.00 |
0.00 |
0.00 |
2.40 |
1.43 |
0.00 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||
G4 & 1000 |
Mean |
9.82 |
9.82 |
5.45 |
4.36 |
0.00 |
0.00 |
0.00 |
1.63 |
9.82 |
100.00 |
|
±SD |
1.89 |
1.89 |
2.34 |
1.69 |
0.00 |
0.00 |
0.00 |
1.35 |
1.89 |
0.00 |
||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
M: Male: F: Female;SD: Standard Deviation; n: Number of dams; LD: Lactation Day
TABLE 25. SUMMARY OF PUP OBSERVATION RECORD DURING LACTATION PERIOD
Group & Dose (mg/kg body weight/day) |
Pup Observation on LD 1 |
Pup Observation on LD 4 |
Pup Observation on LD 7 |
Pup Observation on LD 13 |
|
G1 & 0 |
N |
N |
N |
N |
|
G2 & 110 |
N |
N |
N |
N |
|
G3 & 330 |
N |
N |
N |
N |
|
G4 & 1000 |
N |
N |
N |
N |
|
LD: Lactation Day
TABLE 26. SUMMARY OF PUP WEIGHT (g) DURING LACTATION PERIOD
Group& Dose |
Pup weight (g) on LD 1 |
|
Pup weight (g) on LD 4 |
Pup Weight (g) on |
Pup weight (g) on LD 13 |
|||||||
Male |
Female |
Male |
Female |
Male |
Female |
Male |
Female |
|||||
G1 & 0 |
Mean |
7.24 |
6.54 |
10.29 |
9.10 |
15.17 |
13.35 |
26.87 |
22.96 |
|||
±SD |
0.55 |
0.55 |
1.67 |
1.02 |
2.33 |
1.07 |
2.44 |
0.71 |
||||
n |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
||||
G2 & 110 |
Mean |
6.83 |
6.47 |
9.57 |
9.11 |
14.26 |
13.69 |
25.79 |
22.98 |
|||
±SD |
0.76 |
0.68 |
1.75 |
1.49 |
1.48 |
1.57 |
2.21 |
1.12 |
||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||||
G3 & 330 |
Mean |
6.83 |
6.28 |
9.82 |
9.41 |
15.42 |
13.65 |
27.17 |
22.96 |
|||
±SD |
0.66 |
0.47 |
1.87 |
1.11 |
1.63 |
1.77 |
0.74 |
3.27 |
||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
||||
G4 & 1000 |
Mean |
7.47 |
7.20 |
11.17 |
10.26 |
16.05 |
14.47 |
28.03 |
23.91 |
|||
±SD |
1.05 |
1.30 |
1.59 |
2.12 |
2.07 |
2.71 |
1.64 |
3.82 |
||||
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
LD: Lactation Day
TABLE 27. SUMMARY OF UTERI OBSERVATIONS RECORD
Group & Dose |
No. of Corpo raluetea |
No. of Implantations |
Implantation index (%) |
Pre-Implantation Loss (%) |
Post-Implantation Loss (%) |
Pre-natal Loss (No.) |
Pre-natal Loss (%) |
Post-natal Loss (No.) |
Post-natal Loss (%) |
No. of Early Resorptions |
No. of Late Resorptions |
|
G1 & 0 |
Mean |
11.08 |
11.08 |
100.00 |
0.00 |
2.66 |
0.33 |
97.34 |
0.00 |
0.00 |
0.00 |
0.00 |
±SD |
1.93 |
1.93 |
0.00 |
0.00 |
5.03 |
0.65 |
5.03 |
0.00 |
0.00 |
0.00 |
0.00 |
|
n |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
|
G2 & 110 |
Mean |
11.55 |
11.55 |
100.00 |
0.00 |
0.00 |
0.00 |
100.00 |
0.00 |
0.00 |
0.00 |
0.00 |
±SD |
1.37 |
1.37 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
|
G3 & 330 |
Mean |
10.73 |
10.73 |
100.00 |
0.00 |
0.00 |
0.00 |
100.00 |
0.18 |
2.27 |
0.00 |
0.00 |
±SD |
1.79 |
1.79 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.60 |
7.54 |
0.00 |
0.00 |
|
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
|
G4 & 1000 |
Mean |
10.91 |
10.91 |
100.00 |
0.00 |
2.73 |
0.27 |
97.27 |
0.00 |
0.00 |
0.00 |
0.00 |
±SD |
2.43 |
2.43 |
0.00 |
0.00 |
9.05 |
0.90 |
9.05 |
0.00 |
0.00 |
0.00 |
0.00 |
|
n |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
11 |
SD: Standard Deviation; n: Number of animals
TABLE 28. SUMMARY RECORD OF ANO-GENITAL DISTANCE (mm) OF PUPS ON LACTATION DAY 4
Group & Dose |
Male Mean AGD (mm) |
Female Mean AGD (mm) |
||
G1 & 0 |
Mean |
6.97 |
2.93 |
|
±SD |
0.76 |
0.36 |
||
n |
12 |
12 |
||
G2 & 110 |
Mean |
6.98 |
2.86 |
|
±SD |
0.97 |
0.29 |
||
n |
11 |
11 |
||
G3 & 330 |
Mean |
6.85 |
2.94 |
|
±SD |
0.53 |
0.27 |
||
n |
11 |
11 |
||
G4 & 1000 |
Mean |
7.42 |
2.95 |
|
±SD |
0.69 |
0.37 |
||
n |
11 |
11 |
SD: Standard Deviation; n: Number of animals; mm: milli meter
TABLE 29. SUMMARY RECORD OF MALE PUP NIPPLE RETENTION (No.) ON LACTATION DAY 13
Group & Dose |
No. of Nipples/Areolae |
||
G1 & 0 |
Mean |
0.00 |
|
±SD |
0.00 |
||
n |
12 |
||
G2 & 110 |
Mean |
0.00 |
|
±SD |
0.00 |
||
n |
11 |
||
G3 & 330 |
Mean |
0.00 |
|
±SD |
0.00 |
||
n |
11 |
||
G4 & 1000 |
Mean |
0.00 |
|
±SD |
0.00 |
||
n |
11 |
SD: Standard Deviation; n: Number of animals
TABLE 30. SUMMARY RECORD OF SERUM T4 LEVELS (ng/mL)
Group, Sex & Dose (mg/kg body weight/day) |
Serum T4 Levels (ng/mL) |
||
G1, M & 0 |
Mean |
81.773 |
|
±SD |
8.886 |
||
n |
12 |
||
G2, M & 110 |
Mean |
74.769 |
|
±SD |
5.861 |
||
n |
12 |
||
G3, M & 330 |
Mean |
74.183 |
|
±SD |
5.778 |
||
n |
12 |
||
G4, M & 1000 |
Mean |
81.428 |
|
±SD |
10.239 |
||
n |
12 |
M: Male; SD: Standard Deviation; n: Number of animals
TABLE 31. SUMMARY RECORD OF SERUM T4 LEVELS (ng/mL) IN LACATION DAY 13 PUPS
Group & Dose (mg/kg body weight/day) |
Serum T4 Levels (ng/mL) |
||
G1 & 0 |
Mean |
58.407 |
|
±SD |
4.208 |
||
n |
12 |
||
G2 & 110 |
Mean |
53.282 |
|
±SD |
6.297 |
||
n |
11 |
||
G3 & 330 |
Mean |
53.750 |
|
±SD |
4.964 |
||
n |
11 |
||
G4 & 1000 |
Mean |
49.324* |
|
±SD |
5.452 |
||
n |
11 |
SD: Standard Deviation; n: Number of dams (serum collected from two pups per dam pooled for analysis)
*: Statistically significant than the control group (p<0.05)
TABLE 32. SUMMARY OF GROSS PATHOLOGY FINDINGS RECORD
Organs/ Lesions |
Group |
G1 |
G2 |
G3 |
G4 |
||||
Dose (mg/kg body weight/day) |
0 |
110 |
330 |
1000 |
|||||
Sex |
M |
F |
M |
F |
M |
F |
M |
F |
|
No. of Animals |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
12 |
|
No Abnormality Detected |
12 |
12 |
12 |
12 |
11 |
12 |
12 |
12 |
|
Testes and Epididymis - reduced in size (bilateral) |
- |
- |
- |
- |
1 |
- |
- |
- |
Note: The numeral indicates number of animal/s without lesion. M: Male; F: Female
TABLE 32 (Contd..,). SUMMARY OF GROSS PATHOLOGY FINDINGS RECORD
Organs/ Lesions |
Group |
G1R |
G4R |
||
Dose (mg/kg body weight/day) |
0 |
1000 |
|||
Sex |
M |
F |
M |
F |
|
No. of Animals |
5 |
5 |
5 |
5 |
|
No Abnormality Detected |
5 |
5 |
5 |
5 |
The numeral indicates number of animal/s without lesion. M: Male; F: Female; R: Recovery
TABLE 33. SUMMARY OF PUP GROSS PATHOLOGY FINDINGS RECORD
Organs/ Lesions |
Group |
G1 |
G2 |
G3 |
G4 |
||||
Dose (mg/kg body weight/day) |
0 |
110 |
330 |
1000 |
|||||
Sex |
M |
F |
M |
F |
M |
F |
M |
F |
|
No. of Dead pups (At birth) |
4 |
- |
- |
- |
- |
- |
2 |
1 |
|
No Abnormality Detected |
4 |
- |
- |
- |
- |
- |
2 |
1 |
|
|
No. of Dead pups (Lactation Day 2) |
- |
- |
- |
- |
1 |
1 |
- |
- |
No Abnormality Detected |
- |
- |
- |
- |
1 |
1 |
- |
- |
|
|
No. of pups sacrificed on Lactation Day 4 |
- |
11 |
- |
14 |
- |
13 |
- |
9 |
No Abnormality Detected |
- |
11 |
- |
14 |
- |
13 |
- |
9 |
|
|
No. of pups sacrificed on Lactation Day 13 |
56 |
62 |
64 |
48 |
60 |
43 |
60 |
48 |
No Abnormality Detected |
56 |
62 |
64 |
48 |
60 |
43 |
60 |
48 |
Note: The numeral indicates number of animal/s without lesion. M: Male; F: Female
TABLE 34. SUMMARY OF HISTOPATHOLOGY FINDINGS RECORD
Group No. |
G1 |
G4 |
||
Dose (mg/kg body weight) |
0 |
1000 |
||
Sex |
M |
F |
M |
F |
No. of Animals (randomly selected) |
5 |
5 |
5 |
5 |
No. of Animals (not randomly selected) |
7 |
7 |
7 |
7 |
ORGANS AND OBSERVATIONS |
||||
LIVER |
|
|
|
|
MNC infiltration |
0 |
1 |
0 |
1 |
SPLEEN |
|
|
|
|
Red pulp; increased golden-brown pigment |
0 |
1 |
0 |
0 |
PROSTATE GLAND |
|
|
|
|
Neutrophils infiltration |
1 |
X |
0 |
X |
Note: The numeral indicates number of animal/s with lesion; M: Male; F: Female; X: Organs not subjected for histopathological examination due to sex difference.
Applicant's summary and conclusion
- Conclusions:
- Based on the results discussed, the No Observed Adverse Effect Level (NOAEL) of the test item Acid Violet 50 was found to be 1000 mg/kg body weight when administered to the males for two weeks pre-mating, during mating and up to the day before sacrifice during post-mating period (total of 37 days), to the females for two weeks pre-mating, during mating, pregnancy (gestation) and up to lactation day 13 and recovery group animals for 50 days, with a recovery period of 21 days observation under the experimental conditions employed in this study.
- Executive summary:
The test item, Acid Violet 50 was evaluated for possible adverse effects following repeated oral dosing to males for 37 days, to females for two weeks pre-mating period, during mating period, during pregnancy (gestation) and up to lactation day 13 to evaluate effects of test item on male and female reproductive performance such as gonadal function, mating behaviour, conception, development of the conceptus, parturition, and early neonatal development.
A total of 116 (58 males + 58 females) Sprague Dawley rats were distributed to four main groups and two recovery groups. Each main group (G1, G2, G3and G4) consisted of 12 males and 12 females and each recovery group (G1R and G4R) consisted of 5 males and 5 females. The animals in G1/G1R group were administered with vehicle[Corn oil], theanimals in G2, G3 and G4/G4Rgroups were administered
withtest itemat the dose levels of110, 330 and 1000 mg/kg body weight for low dose, mid dose and high dose/high dose recovery groups respectively.The vehicleand test item formulationswere administered orally by gavageat the dose volume of 10 mL/kg body weight.
The main group males were treated for two weeks pre-mating, during mating and up to the day before sacrifice during post-mating period (total of 37 days of treatment). The main group females were treated for two weeks pre-mating period, during mating, pregnancy (gestation) and up to lactation day 13 after which the pups were sacrificed on lactation Day 13 and females (dams) were sacrificed on lactation
day 14 after overnight fasting (water allowed). The recovery group males and females were treated until the first scheduled sacrifice of dams (total of 50 days) and kept without treatment for a further 21 days observation.
The dose formulation analysis for homogeneity and concentration verification was performed during weeks 1 and 5 of the treatment period and the results are found to be within the acceptable range of 85 to 115 % the nominal concentration and the % RSD is less than 10.0%.
All animals were observed for clinical signs once daily, mortality and morbidity twice daily, detailed clinical examination weekly once, body weight and feed consumption weekly once. Ophthalmological examination was carried out once before treatment for all animals, duringend of the dosing period for males (shortly prior to scheduled sacrifice) and during lactation period for females (shortly prior to scheduled sacrifice) for vehicle control and high dose group animals andduring last weekfor recovery group animals.Neurological/Functional examination was performed for five males and five females, randomly selected from each group towards the end of the dosing period for males (shortly prior to
scheduled sacrifice), during lactation period for females (shortly prior to scheduled sacrifice) and from both the recovery group animals towards the end of the recovery period (shortly prior to scheduled sacrifice).
The clinical pathology (hematological and clinical chemistry) examinations were conducted in five males and five females from each main group (randomly selected) andfor all recovery group animals. Urinalysis was performed from the five randomly selected males of each main group during the last week of the treatment period and for all recovery animals at termination. The serum from adult males of all the main
groups and from lactation day 13 pups representing two pups per litter was screened for T4 levels.
The main group females were observed for oestrus cyclicityduring pre-mating treatment and mating treatment period and the dams on lactation day 14 prior to sacrifice.The main group females were observed forcopulatory interval and all the adult animals of main groups were observed for mating and fertility index.
Each litter was examined after delivery (lactation day 1) and the number and sex of pups (litter size), stillbirths (dead pups born on day 1) and live births were recorded. The dams were observed for body weights and feed consumption during gestation and lactation periods, gestation length, live birth index,number of pups, sex ratio and pup survival indexthroughout the lactation period. The pups were observed forclinical signs and external anomalies once daily from PND 1 to 13. The both male and female pupweights were recorded separately on lactation days 1, 4, 7 and 13.The anogenital distance of each pup was measured on lactation day 4. The numbers of nipples/areolae in male pups were counted on lactation day 13.
Gross pathology and organ weighing were performed on day 38 for males, on lactation day 13 for pups, lactation day 14 for dams and on day 72 for recovery group animals. The number of corpora lutea and implantation sites for dams were recorded during necropsy.
All the animals did not reveal any clinical signs of toxicity except, violet colored fecal matter after dose administration from all the tested dose group animals of either sex which can be due to the colour of the test item. No mortality or morbidity was observed throughout the experimental period. No treatment related changes in body weight, percent change in body weight, feed consumption, ophthalmoscopic
examination, neurological/functional examination, haematology, clinical chemistry, urine analysis nor in organ weights (both absolute and relative) were observed in both the sex of main and recovery group animals. There were no treatment related changes observed in serum T4 levels of males and in serum T4 levels of lactation day 13 pups at any of the tested dose groups.
The dams did not reveal any treatment related changes in oestrus cyclicity, copulatory interval, body weights and feed consumption during gestation and lactation periods, gestation length, live birth index, number of pups, sex ratio and pup survival index throughout the lactation period, uteri observations.
All the pups did not reveal any clinical signs or external anomalies throughout the lactation period. No treatment related changes in pup weights, anogenital distance were noted. No occurrences of nipples in male pups at any of the tested dose groups and vehicle control group.
The animals did not reveal any treatment related gross pathological and histopathological findings.
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