Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
OECD 407 (28d, rat): NOAEL: 250 mg/kg bw/day
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 March 2021 to 23 June 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- adopted on 03 October 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: S148866
- Expiration date of the batch: 30.09.2022
- Purity test date: -
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (21 to 29°C)
- Stability under test conditions: 5 mg/mL and 50 mg/mL are stable up to 48 hours at room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: formulation - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- Rat is one of the recommended species by regulatory agencies for conducting preclinical toxicological studies among rodent species
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred animals
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: Male: 130.18g and 143.80g; Female: 120.31g and 130.77g
- Fasting period before study: No
- Housing: polypropylene cage (size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 24 March 2021 to 28 March 2021
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4ºC to 23.0ºC
- Humidity (%): 47% to 66%
- 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: Main Group From: 29 March 2021 To: 25 April 2021
Recovery group From: 29 March 2021 To: 09 May 2021
- Route of administration:
- oral: gavage
- Details on route of administration:
- The test item was administered through oral route using stainless steel (gavage) cannula as it is the probable route in human
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Formulation analysis for dose concentration verification was done by Analytical Chemistry Department of Bioneeds India Private Limited, as per validated analytical methods detailed in the Study No. BIO-ANM 1689.
For dose concentration verification analysis, the prepared formulations were sampled in duplicate sets (2 × 5 mL each) from middle layer from all the dose groups.
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 analysed. The second aliquot was stored as a backup purpose at established stability conditions and discarded after confirmation of results of first set of samples. Formulations were acceptable, as mean results were within the range of 90 to 110% of the nominal concentration and the relative standard deviation (% RSD) was <10.0% - Duration of treatment / exposure:
- 28 consecutive days
- Frequency of treatment:
- 28 consecutive days
- No. of animals per sex per dose:
- 5 Males + 5 Females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses of 100, 250 and 500 mg/kg body weight was selected as low (G2), mid (G3) and high dose (G4/G4R) levels for test item Cyclic Glucamide C12-C14 based on the results obtained from the dose range finding study (Bioneeds Study Number:
BIO-CTX 279) and as per the sponsor suggestion
- Rationale for animal assignment : Grouping and Randomisation
- Post-exposure recovery period in satellite groups: 14 day recovery period - Positive control:
- No
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once daily for clinical signs of toxicity and twice daily for mortality and morbidity
- Cage side observations checked in table [No.1] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: before initiation of the treatment and at weekly intervals thereafter during the experiment
BODY WEIGHT: Yes
- Time schedule for examinations: recorded on the Day 1, before test item administration and at weekly intervals thereafter. Fasting body weight of all the animals were recorded at terminal sacrifice
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: before start of the treatment and during week 4 of treatment for G1 and G4 group animals and during week 6 for recovery group animals G1R and G4R
- Dose groups that were examined: G1, G4, G1R and G4R
HAEMATOLOGY: Yes
- Time schedule for collection of blood: main groups on day 29 and from recovery group animals on day 43
- Anaesthetic used for blood collection: Yes (mild isoflurane anesthesia)
- Animals fasted: Yes
- Parameters checked in table [No.10] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: main groups on day 29 and from recovery group animals on day 43
- Animals fasted: Yes
- Parameters checked in table [No.11] were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: main groups on day 29 and from recovery group animals on day 43
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked in table [No.12] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Week 4 for G1 and G4; Week 6 for G1R and G4R
- Dose groups that were examined: G1, G4, G1R and G4R
- Battery of functions tested: sensory, neuromuscular, physiological, grip strength and locomotory activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see Appendix 16)
HISTOPATHOLOGY: Yes (see Appendix 16) - Statistics:
- After verification, the data was subjected to statistical analysis using SPSS software version 22. Body weight, body weight gain (percent change in body weight with respect to Day 1 body weight), feed consumption, organ weights and ratios, haematological and clinical chemistry estimations and urine analysis parameters (urobilinogen, pH, specific gravity and urine volume), FOB parameters (rearing, urination, defecation, excessive grooming, body temperature, grip strength, motor activity and hind limb foot splay) were subjected to statistical analysis. One-way ANOVA followed by Dunnett’s post test was done for different treatment groups comparing with the control group data.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- However, statistically significant higher body weight gain (percent change in body weight with respect to Day 1) were observed during days 1-8, 1-22, 1-28 to 1-42 (G4RF). In the absence of associated variation in feed consumption, the noted variations are considered incidental
- Food consumption and compound intake (if feeding study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In main group, statistically significant decrease in red blood cells in G4 (-10.11%) in males; in females, increase in Mean platelet volume in G4 (+10.4%) and decrease in haematocrit value in G3 (-8.42%) was noted. These changes are considered as incidental in the absence of dose responsiveness and also because of the minimal magnitude.
In recovery groups, statistically significant increase in white blood cells G4RM
(-40.9%) and increase in APTT in G4RF (+9.2%) and decrease in percent monocytes in G4RF (-20.65%), absolute monocytes in G4RF (-39.05%) and absolute basophils in G4RF (-64.6%) was noted. Variations noted in few differential leukocyte counts in recovery females was not associated with any changes in WBC. All other changes noted are considered as incidental and not related to test item in the absence of such changes at the end of treatment period and also, all the changes could be due to random biological variation - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In main group, increase in total bilirubin in G4 (+157.1%), phosphorous in G4 (+16.4%) and potassium in G4 (+23.8%) in males; in females, increase in total cholesterol in G4 (+36.3%), calcium in G4 (+9.60%) and decrease in chloride in G2
(-2.7%) were noted. The increase in total bilirubin in G4 male was not associated with any microscopic changes in kidneys. All other changes noted are considered incidental in the absence of dose responsiveness and also, all the values were within the historical range of the species.
In recovery group males, decrease in total protein (-5.9%), and glucose (-7.9%), and increase in Phosphorous (+5.44%) was noted. All these changes are considered as incidental because of their minimal magnitude and also absence of such changes at the end of treatment period or in other sex-recovery females - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- However the statistically significant increase in specific gravity in G4M and decrease in pH in G4M and in females decrease in urine volume was noted in G4F. The noted variations are considered incidental and not related to test item in the absence of dose responsiveness
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test item related changes were observed in neurological/functional examination test in any of the test item treated groups. However there was decreased average hind limb grip strength in recovery groups of either sex in G4R.
The decrease in hind limb grip strength in G4R is considered to be incidental in the absence of variations in any of the other neuro-muscular parameters assessed - Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No adverse test item related changes in fasting body weights, organ weights (absolute and relative) were noted. However, the following statistically significant changes were noted in organ weights and its ratios.
Increase in absolute weight of spleen in G4M, decrease in relative weights of kidney in G3M, G4M and liver in G4M; increase in absolute weight of thymus in G3F, spleen in G3F and brain in G2F was noted. In recovery groups, decrease in relative weight of ovaries in G4RF was noted.
Increase in spleen weight is considered incidental in the absence of dose responsiveness and without any associated macroscopic and microscopic changes in spleen - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Grossly, test item-related, thickening of non-glandular region of stomach was observed in high dose rats (G4, Male: 5/5; Female: 5/5) and was microscopically correlated to hyperplasia of squamous cells in non-glandular stomach
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Microscopically, test item-related changes were observed in non-glandular region of stomach.
Incidences of Microscopic findings in non-glandular region of stomach
Sex Males Females
Group G1 G2 G3 G4 G1R G4R G1 G2 G3 G4 G1R G4R
Dose (mg/kg body weight/day) 0 100 250 500 0 500 0 100 250 500 0 500
Number of Animals Examined 5 5 5 5 5 5 5 5 5 5 5 5
Stomach: Hyperplasia, squamous cell, non-glandular - 2 2 5 - 3 - - 3 5 - 3
G: Group; - : No incidence
In non-glandular region of stomach, minimal to marked, diffuse hyperplasia of squamous cell was observed from low dose group of male rats and from mid dose group of female rats. Histologically, it was characterized by proliferation and thickening of stratum spinosum layer comprising of squamous epithelium with occasional increased keratin. Similar changes were also observed in recovery high dose group of rats but with decreased severity (minimal to moderate) and reduced incidences (3/5) indicating a trend towards recovery. Considering the recovery trend, magnitude of severity of lesion and relevance of this change to humans, this finding could be considered as non-adverse at 250 mg/kg body weight/day dose level (Nolte T et.al., 2016).
Few microscopic findings observed in this study such as ultimobranchial cyst in thyroid, epithelial cysts in thymus and all other findings were considered incidental as they occurred randomly across the dose groups including concurrent controls and/or were expected for laboratory rats of this age - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- histopathology: non-neoplastic
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 500 mg/kg bw/day (nominal)
- System:
- gastrointestinal tract
- Organ:
- stomach
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- Based on the results discussed, the No Observed Adverse Effect Level (NOAEL) of the test item, Cyclic Glucamide C12-C14 was found to be 250 mg/kg body weight/day, (mid dose) when administered for a period of 28 consecutive days repeatedly by oral (gavage) route to Sprague Dawley rats under the experimental conditions and the doses employed.
- Executive summary:
The objective of this study was to assess the toxic potential of the test itemCyclic Glucamide C12-C14when administered for a period of 28 consecutive days repeatedly by oral (gavage) to Sprague Dawley rats. This studyprovidesinformation on major toxic effects, target organs, possibility of cumulative effects and also the reversibility of effects (after 14 days recovery period) and an estimate of the No Observed Adverse Effect Level (NOAEL).
A total of60Sprague Dawley rats (30males +30females) were distributed to4main(G1, G2, G3 & G4)and2recovery groups(G1R & G4R). Each group consisted of 5 rats/sex. Theratsallocated to groups G2, G3 and G4/G4R were administeredwith testitem,Cyclic Glucamide C12-C14at the doses of100,250and500mg/kg body weight/dayrespectively andG1/G1Rgroup animals received vehicle(distilled water)alone. The vehicle/test item formulations were administered byoral (gavage) routeat an equivolume of 10 mL/kgbody weight.
The test item formulations at the concentrations of 5 mg/mL and 50 mg/mLwere stable up to 48 hours at room temperature.Formulation analysis fordoseconcentration verification was performed for all the dose formulations prior to first treatment and during week 4 of the study.The dose formulation samples of Cyclic Glucamide C12-C14wereanalyzed for dose concentration analysis byUV-Vis methodand the results were found to be within the range ± 10% recovery to the nominal concentration with ˂10% RSD.
All theratswere observed once daily for clinical signs and twice daily for mortality and morbidity, weekly for detailed clinical examination, body weight and feed consumption; ophthalmoscopic examination was performed during acclimatizationperiodfor all the ratsand duringweek 4 ofdosingperiod for G1 and G4groups and duringweek 6 for G1R and G4R groups. Functional observational battery was performed during week 4 ofdosingperiod for G1and G4groups and duringweek 6 for G1Rand G4R groups.
At the end oftreatmentand recovery period, i.e., Day 29 andDay43, respectively, blood and urine sampleswerecollected and analyzed from overnight fastedrats. Subsequently, theratswere sacrificed using CO2asphyxiationfollowed by exsanguinationand subjected to gross pathological examination. Thestudy plan specified organs/tissueswere collected, weighedand preserved for histopathological examination.Histopathology examination was performed on organs of vehicle control and high dose group (G1 and G4).
No mortality and clinical signswere noted up to mid dose (250 mg/kg/day) group.However, ‘wetness around oral region after dose administration (approximately within 5 to 10 minutes post treatment) and found dried later during evening observation’ was observed in G4/G4R(high-dose-500 mg/kg/day) treated group of either sex from day 04 until the end of treatment period and was found normal during recovery period. The wetness could be secondary due to irritant nature of administration of test item which is evident from thehistopathology changesin stomachand considered adverse.
Notest item-related changes in body weight, percent change in body weight and feed consumptionwere observedthroughout the experimental period. Notest item-related neurological/functional abnormalitiesand no ocular changes were observed during examination.
No toxicologically significant changes were noted in haematology, coagulation, clinical chemistry and urinalysis parameters.There were no test item-related effects inabsolute and relative organ weightsin all the tested dose groups in both the sexes.
Grossly, test item-related, thickening of non-glandular region of stomach was observed in high dose rats (G4, Male: 5/5; Female: 5/5) and was microscopically correlated to hyperplasia of squamous cells in non-glandular stomach.
Microscopically, test item-related changes were observed in non-glandular region of stomach and the incidences are as follows.
Sex
Males
Females
Group
G1
G2
G3
G4
G1R
G4R
G1
G2
G3
G4
G1R
G4R
Dose(mg/kg body weight/day)
0
100
250
500
0
500
0
100
250
500
0
500
Number of Animals Examined
5
5
5
5
5
5
5
5
5
5
5
5
Stomach:Hyperplasia, squamous cell, non-glandular
-
2
2
5
-
3
-
-
3
5
-
3
G: Group; - : No incidence
In non-glandular region of stomach, minimal to marked, diffuse hyperplasia of squamous cell was observed from low dose group of male rats and from mid dose group of female rats. Histologically, itwas characterized by proliferation and thickening ofstratum spinosumlayer comprising of squamous epithelium with occasional increased keratin. Similar changes were also observed in recovery high dose group of rats but with decreased severity (minimal to moderate) and reduced incidences (3/5) indicating a trend towards recovery. Considering the recovery trend, magnitude of severity of lesion and relevance of this change to humans, this finding could be considered as non-adverse at 250 mg/kg body weight/day dose level (Nolte Tet.al.,2016)
Reference
TABLE 1. SUMMARY OF CLINICAL SIGNS OF TOXICITY, DETAILED CLINICAL EXAMINATION AND MORTALITY RECORD
Refer Appendix 1
Group, Sex & Dose (mg/kg body weight/day) |
No. of Animals |
Clinical Signs of Toxicity |
Mortality (No. of Incidences/ No. of Animals) |
G1, M & 0 |
5 |
N |
0/5 |
G2, M & 100 |
5 |
N |
0/5 |
G3, M & 250 |
5 |
N |
0/5 |
G4, M & 500 |
5 |
N |
0/5 |
G1, F & 0 |
5 |
N |
0/5 |
G2, F & 100 |
5 |
N |
0/5 |
G3, F & 250 |
5 |
N |
0/5 |
G4, F & 500 |
5 |
N |
0/5 |
G1R, M & 0 |
5 |
N |
0/5 |
G4R, M & 500 |
5 |
N |
0/5 |
G1R, F & 0 |
5 |
N |
0/5 |
G4R, F & 500 |
5 |
N |
0/5 |
M: Male; F: Female; R: Recovery; N: Normal.
TABLE 2. SUMMARY OF BODY WEIGHTS (g)RECORD
Refer Appendix 2
Group, Sex & Dose (mg/kg body weight/day) |
Body Weight (g) on Days |
||||||
1 |
8 |
15 |
22 |
28 |
|||
G1, M & 0 |
Mean |
157.29 |
188.16 |
219.07 |
254.82 |
276.01 |
|
±SD |
4.42 |
9.01 |
13.26 |
10.77 |
13.18 |
||
n |
5 |
5 |
5 |
5 |
5 |
||
G2, M & 100 |
Mean |
162.71 |
192.42 |
221.61 |
258.27 |
287.83 |
|
±SD |
10.71 |
16.04 |
22.05 |
25.61 |
34.39 |
||
n |
5 |
5 |
5 |
5 |
5 |
||
G3, M & 250 |
Mean |
159.88 |
187.48 |
215.36 |
249.01 |
275.89 |
|
±SD |
7.33 |
2.81 |
15.11 |
18.99 |
21.59 |
||
n |
5 |
5 |
5 |
5 |
5 |
||
G4, M & 500 |
Mean |
159.20 |
194.87 |
228.31 |
258.41 |
277.62 |
|
±SD |
8.66 |
15.25 |
16.14 |
15.79 |
21.40 |
||
n |
5 |
5 |
5 |
5 |
5 |
||
G1, F & 0 |
Mean |
143.81 |
162.65 |
178.79 |
200.33 |
215.84 |
|
±SD |
6.63 |
9.97 |
8.20 |
13.26 |
9.87 |
||
n |
5 |
5 |
5 |
5 |
5 |
||
G2, F & 100 |
Mean |
144.90 |
163.77 |
184.24 |
211.49 |
229.71 |
|
±SD |
4.81 |
4.89 |
8.68 |
10.98 |
9.70 |
||
n |
5 |
5 |
5 |
5 |
5 |
||
G3, F & 250 |
Mean |
147.35 |
167.58 |
189.21 |
213.38 |
235.85 |
|
±SD |
8.16 |
11.92 |
16.44 |
22.53 |
20.01 |
||
n |
5 |
5 |
5 |
5 |
5 |
||
G4, F & 500 |
Mean |
141.38 |
162.56 |
181.08 |
208.77 |
223.21 |
|
±SD |
4.35 |
3.22 |
7.22 |
11.31 |
7.81 |
||
n |
5 |
5 |
5 |
5 |
5 |
||
M: Male; F: Female; 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 |
8 |
15 |
22 |
28 |
35 |
42 |
||
G1R, M & 0 |
Mean |
155.41 |
185.53 |
212.85 |
243.54 |
266.66 |
290.53 |
308.44 |
±SD |
6.93 |
8.56 |
15.70 |
19.91 |
20.95 |
17.96 |
16.45 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 500 |
Mean |
160.06 |
189.79 |
229.18 |
260.57 |
281.54 |
311.37 |
326.66 |
±SD |
2.79 |
4.72 |
12.98 |
26.64 |
26.88 |
24.26 |
24.37 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
145.37 |
160.25 |
184.73 |
212.73 |
227.10 |
247.72 |
266.95 |
±SD |
3.82 |
5.62 |
5.28 |
8.30 |
5.97 |
3.83 |
5.77 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 500 |
Mean |
141.22 |
165.12 |
190.00 |
221.93 |
237.43 |
258.38 |
276.14 |
±SD |
7.23 |
10.09 |
14.61 |
14.15 |
12.44 |
13.09 |
12.02 |
|
n |
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 1RECORD
Refer Appendix 3
Group, Sex & Dose (mg/kg body weight/day) |
Percent Change in Body Weight (%) during Days |
|||||||||||
1 to 8 |
1 to 15 |
1 to 22 |
1 to 28 |
|||||||||
G1, M & 0 |
Mean |
19.58 |
39.22 |
61.98 |
75.45 |
|||||||
±SD |
3.15 |
6.22 |
4.26 |
6.02 |
||||||||
n |
5 |
5 |
5 |
5 |
||||||||
G2, M & 100 |
Mean |
18.16 |
35.98 |
58.49 |
76.45 |
|||||||
±SD |
2.62 |
4.63 |
6.14 |
10.10 |
||||||||
n |
5 |
5 |
5 |
5 |
||||||||
G3, M & 250 |
Mean |
17.41 |
34.66 |
55.71 |
72.60 |
|||||||
±SD |
3.88 |
6.29 |
8.84 |
11.66 |
||||||||
n |
5 |
5 |
5 |
5 |
||||||||
G4, M & 500 |
Mean |
22.33 |
43.33 |
62.34 |
74.27 |
|||||||
±SD |
4.42 |
3.80 |
5.55 |
6.53 |
||||||||
n |
5 |
5 |
5 |
5 |
||||||||
G1, F & 0 |
Mean |
13.04 |
24.34 |
39.34 |
50.21 |
|||||||
±SD |
2.03 |
2.08 |
7.51 |
6.68 |
||||||||
n |
5 |
5 |
5 |
5 |
||||||||
G2, F & 100 |
Mean |
13.04 |
27.11 |
45.92 |
58.52 |
|||||||
±SD |
1.68 |
2.48 |
4.49 |
3.39 |
||||||||
n |
5 |
5 |
5 |
5 |
||||||||
G3, F & 250 |
Mean |
13.72 |
28.63 |
44.92 |
60.15 |
|||||||
±SD |
4.64 |
12.33 |
14.40 |
11.66 |
||||||||
n |
5 |
5 |
5 |
5 |
||||||||
G4, F & 500 |
Mean |
15.03 |
28.28 |
47.87 |
57.99 |
|||||||
±SD |
2.85 |
8.67 |
10.80 |
7.26 |
||||||||
n |
5 |
5 |
5 |
5 |
||||||||
M: Male; F: Female; SD: Standard Deviation; n: Number of animals.
TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT (%) WITH RESPECT TO DAY 1 RECORD
Refer Appendix 3
Group, Sex & Dose (mg/kg body weight/day) |
Percent Change in Body Weight (%) during Days |
||||||||||||||
1 to 8 |
1 to 15 |
1 to 22 |
1 to 28 |
1 to 35 |
1 to 42 |
||||||||||
G1R, M & 0 |
Mean |
19.44 |
36.99 |
56.67 |
71.58 |
86.98 |
98.45 |
||||||||
±SD |
4.38 |
8.55 |
10.13 |
11.16 |
9.07 |
5.28 |
|||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||
G4R, M & 500 |
Mean |
18.58 |
43.11 |
62.61 |
75.72 |
94.38 |
103.93 |
||||||||
±SD |
2.38 |
5.78 |
13.89 |
13.81 |
11.79 |
11.75 |
|||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||
G1R, F & 0 |
Mean |
10.22 |
27.11 |
46.35 |
56.26 |
70.47 |
83.66 |
||||||||
±SD |
1.19 |
3.50 |
4.73 |
3.98 |
3.46 |
1.98 |
|||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||
G4R, F & 500 |
Mean |
16.90* |
34.49 |
57.23* |
68.27* |
83.11* |
95.77* |
||||||||
±SD |
2.69 |
6.56 |
8.05 |
8.01 |
8.12 |
8.97 |
|||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05).
TABLE 4. SUMMARY OF FEED CONSUMPTION (g/rat/day)RECORD
Refer Appendix 4
Group, Sex & Dose (mg/kg body weight/day) |
Week 1 |
Week 2 |
Week 3 |
Week 4 |
||
G1, M & 0 |
Mean |
17.31 |
20.29 |
22.79 |
25.65 |
|
±SD |
0.37 |
0.80 |
0.58 |
1.21 |
||
n |
3 |
3 |
3 |
3 |
||
G2, M & 100 |
Mean |
18.23 |
21.46 |
23.09 |
25.55 |
|
±SD |
2.05 |
3.24 |
1.63 |
2.23 |
||
n |
3 |
3 |
3 |
3 |
||
G3, M & 250 |
Mean |
17.20 |
18.59 |
22.40 |
24.76 |
|
±SD |
1.37 |
1.68 |
1.73 |
0.90 |
||
n |
3 |
3 |
3 |
3 |
||
G4, M & 500 |
Mean |
19.04 |
21.09 |
23.40 |
25.36 |
|
±SD |
2.95 |
2.30 |
2.70 |
2.03 |
||
n |
3 |
3 |
3 |
3 |
||
G1, F & 0 |
Mean |
15.86 |
15.76 |
17.71 |
20.26 |
|
±SD |
1.22 |
1.74 |
3.49 |
1.42 |
||
n |
3 |
3 |
3 |
3 |
||
G2, F & 100 |
Mean |
14.28 |
17.79 |
19.34 |
20.91 |
|
±SD |
0.27 |
0.50 |
1.26 |
0.48 |
||
n |
3 |
3 |
3 |
3 |
||
G3, F & 250 |
Mean |
15.49 |
17.58 |
19.27 |
20.94 |
|
±SD |
1.96 |
2.10 |
2.40 |
1.58 |
||
n |
3 |
3 |
3 |
3 |
||
G4, F & 500 |
Mean |
14.30 |
15.22 |
17.42 |
18.42 |
|
±SD |
0.40 |
1.46 |
1.66 |
1.96 |
||
n |
3 |
3 |
3 |
3 |
M: Male; F: Female; SD: Standard Deviation;n: Number of cages.
TABLE 4 (Contd...). SUMMARY OF FEED CONSUMPTION (g/rat/day) RECORD
Refer Appendix 4
Group, Sex & Dose (mg/kg body weight/day) |
Week 1 |
Week 2 |
Week 3 |
Week 4 |
Week 5 |
Week 6 |
|||||||||
G1R, M & 0 |
Mean |
16.86 |
20.32 |
21.56 |
23.32 |
24.30 |
24.52 |
||||||||
±SD |
1.00 |
1.60 |
0.75 |
2.39 |
1.29 |
1.77 |
|||||||||
n |
3 |
3 |
3 |
3 |
3 |
3 |
|||||||||
G4R, M & 500 |
Mean |
18.71 |
20.86 |
21.70 |
21.75 |
22.03 |
23.06 |
||||||||
±SD |
1.64 |
2.24 |
0.42 |
1.06 |
1.91 |
2.89 |
|||||||||
n |
3 |
3 |
3 |
3 |
3 |
3 |
|||||||||
G1R, F & 0 |
Mean |
14.16 |
17.97 |
19.83 |
20.16 |
21.46 |
21.68 |
||||||||
±SD |
1.59 |
0.12 |
1.03 |
1.72 |
1.20 |
1.18 |
|||||||||
n |
3 |
3 |
3 |
3 |
3 |
3 |
|||||||||
G4R, F & 500 |
Mean |
15.65 |
18.51 |
20.21 |
21.27 |
22.22 |
22.73 |
||||||||
±SD |
1.45 |
1.10 |
2.36 |
1.96 |
3.50 |
3.57 |
|||||||||
n |
3 |
3 |
3 |
3 |
3 |
3 |
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: Numberof cages.
TABLE 5. SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB)RECORD
Refer Appendix 5
Week 4 |
||||||||||||
Parameters↓ |
Group & Sex |
G1 & M |
G4 & M |
G1 & F |
G4 & F |
|||||||
Dose (mg/kg body weight/day) |
0 |
500 |
0 |
500 |
||||||||
Number of Animals |
5 |
5 |
5 |
5 |
||||||||
Home cage observations |
||||||||||||
Home Cage posture |
1 |
1 |
1 |
1 |
||||||||
Respiratory pattern |
1 |
1 |
1 |
1 |
||||||||
Clonic involuntary movements |
1 |
1 |
1 |
1 |
||||||||
Tonic involuntary movements |
1 |
1 |
1 |
1 |
||||||||
Vocalization |
1 |
1 |
1 |
1 |
||||||||
Palpebral Closure |
1 |
1 |
1 |
1 |
||||||||
Handling observation |
|
|||||||||||
Ease of removal from the cage |
2 |
2 |
2 |
2 |
||||||||
Ease of handling animal in hand |
2 |
2 |
2 |
2 |
||||||||
Red or crusty deposits |
Eyes |
1 |
1 |
1 |
1 |
|||||||
Nose |
1 |
1 |
1 |
1 |
||||||||
Mouth |
1 |
1 |
1 |
1 |
||||||||
Lacrimation |
1 |
1 |
1 |
1 |
||||||||
Salivation |
1 |
1 |
1 |
1 |
||||||||
Fur Appearance |
1 |
1 |
1 |
1 |
||||||||
Piloerection |
1 |
1 |
1 |
1 |
||||||||
Eye Prominence |
1 |
1 |
1 |
1 |
||||||||
Muscle Tone |
1 |
1 |
1 |
1 |
||||||||
Home cage observations: Home cage posture- 1=Normal,Respiratory Pattern -1=Normal,Clonic involuntary movements -1=None/Normal,Tonic involuntary movements -1=None/Normal,Vocalization -1=Absent (Normal),Palpebral closure -1=Eyelids wide open (Normal),Handling observation : Ease of removal from the cage -2=Normal,Ease of handling animal in hand -2=Normal,Red/Crusty deposits -1=Absent,Lacrimation- 1=None,Salivation-1=Absent (Normal),Fur Appearance -1=Normal,Piloerection -1=None, Eye Prominence -1=Normal,Muscle tone -1=Normal |
||||||||||||
M: Male; F: Female
TABLE 5 (Contd...). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
Refer Appendix 5
Week 4 |
|||||||||||
Parameters↓ |
Group & Sex |
G1 & M |
G4 & M |
G1 & F |
G4 & F |
||||||
Dose (mg/kg body weight/day) |
0 |
500 |
0 |
500 |
|||||||
Number of Animals |
5 |
5 |
5 |
5 |
|||||||
Open field Observation |
|||||||||||
Mobility |
1 |
1 |
1 |
1 |
|||||||
Gait |
1 |
1 |
1 |
1 |
|||||||
Arousal |
3 |
3 |
3 |
3 |
|||||||
Number of Rearing |
Mean |
8.0 |
8.2 |
8.6 |
8.6 |
||||||
±SD |
1.0 |
0.8 |
1.1 |
0.5 |
|||||||
Numbers of Urination |
Mean |
1.0 |
1.4 |
1.2 |
1.2 |
||||||
±SD |
0.0 |
0.5 |
0.4 |
0.4 |
|||||||
Number of Defecation |
Mean |
1.2 |
1.2 |
1.2 |
1.2 |
||||||
±SD |
0.4 |
0.4 |
0.4 |
0.4 |
|||||||
Clonic involuntary movement |
1 |
1 |
1 |
1 |
|||||||
Tonic involuntary movement |
1 |
1 |
1 |
1 |
|||||||
Stereotype Behaviour |
1 |
1 |
1 |
1 |
|||||||
Excessive Grooming |
Mean |
3.8 |
4.0 |
4.2 |
4.2 |
||||||
±SD |
0.8 |
0.7 |
0.8 |
0.8 |
|||||||
Sensory Observations |
|||||||||||
Approach Response |
2 |
2 |
2 |
2 |
|||||||
Auditory Response |
2 |
2 |
2 |
2 |
|||||||
Touch Response |
2 |
2 |
2 |
2 |
|||||||
Pupil Reflex |
2 |
2 |
2 |
2 |
|||||||
Tail Pinch Response |
2 |
2 |
2 |
2 |
|||||||
Righting Reflex |
1 |
1 |
1 |
1 |
|||||||
Physiological observation |
|||||||||||
Body temperature (°F) |
Mean |
98.0 |
98.0 |
98.4 |
98.4 |
||||||
±SD |
0.1 |
0.2 |
0.1 |
0.2 |
|||||||
Open field Observation: Mobility -1=Normal,Gait -1=Normal,Arousal -3=Normal,Clonic involuntary movements -1=None/Normal,Tonic involuntary movements -1=None/Normal,Stereotype Behaviour -1=Absent, Sensory Observations: Approach response -2=Normal, Auditory Response -2=Normal,Touch Response -2=Normal,Pupil Reflex -2=Normal,Tail Pinch Response -2=Normal,Righting Reflex -1=Present |
|||||||||||
M: Male; F: Female
TABLE 5 (Contd...). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
Refer Appendix 5
Week 6 |
||||||||||||
Parameters↓ |
Group & Sex |
G1R & M |
G4R & M |
G1R & F |
G4R & F |
|||||||
Dose (mg/kg body weight/day) |
0 |
500 |
0 |
500 |
||||||||
Number of Animals |
5 |
5 |
5 |
5 |
||||||||
Home cage observations |
||||||||||||
Home Cage posture |
1 |
1 |
1 |
1 |
||||||||
Respiratory pattern |
1 |
1 |
1 |
1 |
||||||||
Clonic involuntary movements |
1 |
1 |
1 |
1 |
||||||||
Tonic involuntary movements |
1 |
1 |
1 |
1 |
||||||||
Vocalization |
1 |
1 |
1 |
1 |
||||||||
Palpebral Closure |
1 |
1 |
1 |
1 |
||||||||
Handling observation |
|
|||||||||||
Ease of removal from the cage |
2 |
2 |
2 |
2 |
||||||||
Ease of handling animal in hand |
2 |
2 |
2 |
2 |
||||||||
Red or crusty deposits |
Eyes |
1 |
1 |
1 |
1 |
|||||||
Nose |
1 |
1 |
1 |
1 |
||||||||
Mouth |
1 |
1 |
1 |
1 |
||||||||
Lacrimation |
1 |
1 |
1 |
1 |
||||||||
Salivation |
1 |
1 |
1 |
1 |
||||||||
Fur Appearance |
1 |
1 |
1 |
1 |
||||||||
Piloerection |
1 |
1 |
1 |
1 |
||||||||
Eye Prominence |
1 |
1 |
1 |
1 |
||||||||
Muscle Tone |
1 |
1 |
1 |
1 |
||||||||
Home cage observations: Home cage posture- 1=Normal,Respiratory Pattern -1=Normal,Clonic involuntary movements -1=None/Normal,Tonic involuntary movements -1=None/Normal,Vocalization -1=Absent (Normal),Palpebral closure -1=Eyelids wide open (Normal),Handling observation : Ease of removal from the cage -2=Normal,Ease of handling animal in hand -2=Normal,Red/Crusty deposits -1=Absent,Lacrimation- 1=None,Salivation-1=Absent (Normal),Fur Appearance -1=Normal,Piloerection -1=None, Eye Prominence -1=Normal,Muscle tone -1=Normal |
||||||||||||
M: Male; F: Female; R: Recovery
TABLE 5 (Contd...). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD
Refer Appendix 5
Week 6 |
|||||||||||
Parameters↓ |
Group & Sex |
G1R & M |
G4R & M |
G1R & F |
G4R & F |
||||||
Dose (mg/kg body weight/day) |
0 |
500 |
0 |
500 |
|||||||
Number of Animals |
5 |
5 |
5 |
5 |
|||||||
Open field Observation |
|||||||||||
Mobility |
1 |
1 |
1 |
1 |
|||||||
Gait |
1 |
1 |
1 |
1 |
|||||||
Arousal |
3 |
3 |
3 |
3 |
|||||||
Number of Rearing |
Mean |
6.4 |
6.0 |
8.2 |
8.2 |
||||||
±SD |
1.3 |
1.4 |
1.3 |
1.3 |
|||||||
Numbers of Urination |
Mean |
1.2 |
1.4 |
1.4 |
1.4 |
||||||
±SD |
0.4 |
0.5 |
0.5 |
0.5 |
|||||||
Number of Defecation |
Mean |
1.0 |
1.2 |
1.0 |
1.0 |
||||||
±SD |
0.0 |
0.4 |
0.7 |
0.7 |
|||||||
Clonic involuntary movement |
1 |
1 |
1 |
1 |
|||||||
Tonic involuntary movement |
1 |
1 |
1 |
1 |
|||||||
Stereotype Behaviour |
1 |
1 |
1 |
1 |
|||||||
Excessive Grooming |
Mean |
4.4 |
4.4 |
5.2 |
5.2 |
||||||
±SD |
0.5 |
1.1 |
1.3 |
0.8 |
|||||||
Sensory Observations |
|||||||||||
Approach Response |
2 |
2 |
2 |
2 |
|||||||
Auditory Response |
2 |
2 |
2 |
2 |
|||||||
Touch Response |
2 |
2 |
2 |
2 |
|||||||
Pupil Reflex |
2 |
2 |
2 |
2 |
|||||||
Tail Pinch Response |
2 |
2 |
2 |
2 |
|||||||
Righting Reflex |
1 |
1 |
1 |
1 |
|||||||
Physiological observation |
|||||||||||
Body temperature (°F) |
Mean |
97.9 |
98.0 |
98.6 |
98.6 |
||||||
±SD |
0.2 |
0.1 |
0.2 |
0.1 |
|||||||
Open field Observation: Mobility -1=Normal,Gait -1=Normal,Arousal -3=Normal,Clonic involuntary movements -1=None/Normal,Tonic involuntary movements -1=None/Normal,Stereotype Behaviour -1=Absent, Sensory Observations: Approach response -2=Normal, Auditory Response -2=Normal,Touch Response -2=Normal,Pupil Reflex -2=Normal,Tail Pinch Response -2=Normal,Righting Reflex -1=Present |
|||||||||||
M: Male; F: Female; R: Recovery.
TABLE 6. SUMMARY OF LANDING FOOT SPLAY (cm)RECORD
Refer Appendix 6
#Week 4 & 6 |
||||||
Group, Sex & Dose (mg/kg body weight/day) |
Hind Limb Foot Splay (cm) |
|||||
G1, M & 0 |
Mean |
5.7 |
||||
±SD |
0.5 |
|||||
n |
5 |
|||||
G4, M & 500 |
Mean |
6.0 |
||||
±SD |
0.6 |
|||||
n |
5 |
|||||
G1, F & 0 |
Mean |
7.2 |
||||
±SD |
1.0 |
|||||
n |
5 |
|||||
G4, F & 500 |
Mean |
6.3 |
||||
±SD |
0.6 |
|||||
n |
5 |
|||||
G1R, M & 0 |
Mean |
6.9 |
||||
±SD |
0.9 |
|||||
n |
5 |
|||||
G4R, M & 500 |
Mean |
7.8 |
||||
±SD |
0.5 |
|||||
n |
5 |
|||||
G1R, F & 0 |
Mean |
6.4 |
||||
±SD |
1.2 |
|||||
n |
5 |
|||||
G4R, F & 500 |
Mean |
6.0 |
||||
±SD |
0.7 |
|||||
n |
5 |
|||||
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: number of animals.
#: Week 4 for main group animals and week 6 for recovery group animals.
TABLE 7. SUMMARY OF ACTIMETER READING RECORD
Refer Appendix 7
#Week 4 & 6 |
||||||
Group, Sex & Dose (mg/kg body weight/day) |
Actimeter Readings |
|||||
Movement Counts (no.) |
||||||
G1, M & 0 |
Mean |
1949.6 |
||||
±SD |
84.9 |
|||||
n |
5 |
|||||
G4, M & 500 |
Mean |
1969.4 |
||||
±SD |
26.2 |
|||||
n |
5 |
|||||
G1, F & 0 |
Mean |
2093.6 |
||||
±SD |
39.5 |
|||||
n |
5 |
|||||
G4, F & 500 |
Mean |
2110.8 |
||||
±SD |
33.1 |
|||||
n |
5 |
|||||
G1R, M & 0 |
Mean |
1923.4 |
||||
±SD |
35.6 |
|||||
n |
5 |
|||||
G4R, M & 500 |
Mean |
1931.2 |
||||
±SD |
38.1 |
|||||
n |
5 |
|||||
G1R, F & 0 |
Mean |
2125.6 |
||||
±SD |
39.8 |
|||||
n |
5 |
|||||
G4R, F & 500 |
Mean |
2098.8 |
||||
±SD |
30.3 |
|||||
n |
5 |
|||||
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: number of animals.
#: Week 4 for main group animals and week 6 for recovery group animals.
TABLE 8. SUMMARY OF GRIP STRENGTH (kgf) MEASUREMENT RECORD
Refer Appendix 8
#Week 4 & 6 |
||||||||
Group, Sex & Dose (mg/kg body weight/day) |
Grip Strength (kgf) |
|||||||
Fore limb |
Hind limb |
|||||||
G1, M & 0 |
Mean |
1.548 |
0.541 |
|||||
±SD |
0.037 |
0.029 |
||||||
n |
5 |
5 |
||||||
G4, M & 500 |
Mean |
1.534 |
0.517 |
|||||
±SD |
0.036 |
0.024 |
||||||
n |
5 |
5 |
||||||
G1, F & 0 |
Mean |
1.441 |
0.420 |
|||||
±SD |
0.026 |
0.052 |
||||||
n |
5 |
5 |
||||||
G4, F & 500 |
Mean |
1.432 |
0.407 |
|||||
±SD |
0.024 |
0.042 |
||||||
n |
5 |
5 |
||||||
G1R, M & 0 |
Mean |
1.561 |
0.541 |
|||||
±SD |
0.030 |
0.018 |
||||||
n |
5 |
5 |
||||||
G4R, M & 500 |
Mean |
1.532 |
0.394* |
|||||
±SD |
0.044 |
0.027 |
||||||
n |
5 |
5 |
||||||
G1R, F & 0 |
Mean |
1.423 |
0.530 |
|||||
±SD |
0.032 |
0.030 |
||||||
n |
5 |
5 |
||||||
G4R, F & 500 |
Mean |
1.375 |
0.350* |
|||||
±SD |
0.042 |
0.018 |
||||||
n |
5 |
5 |
||||||
M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: number of animals.
#: Week 4 for main group animals and week 6 for recovery group animals; *: Statistically significant (p<0.05).
TABLE 9. SUMMARY OF OPHTHALMOSCOPIC EXAMINATION RECORD
Refer Appendix 9
Week 4 |
|||||||||||||||||
Group, Sex & Dose (mg/kg body weight/day) |
G1, M & 0 |
G4, M & 500 |
G1, F & 0 |
G4, F & 500 |
|||||||||||||
Number of Animals |
5 |
5 |
5 |
5 |
|||||||||||||
Eye Parameters ↓ |
Observations |
||||||||||||||||
Eye |
L |
R |
L |
R |
L |
R |
L |
R |
|||||||||
Eye Lids |
N |
N |
N |
N |
N |
N |
N |
N |
|||||||||
Cornea |
N |
N |
N |
N |
N |
N |
N |
N |
|||||||||
Iris |
N |
N |
N |
N |
N |
N |
N |
N |
|||||||||
Aqueous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
|||||||||
Lens |
N |
N |
N |
N |
N |
N |
N |
N |
|||||||||
Vitreous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
|||||||||
Retina/Optic disc |
N |
N |
N |
N |
N |
N |
N |
N |
|||||||||
N: No Abnormality Detected; L: Left; R: Right; M: Male; F: Female.
TABLE 9 (Contd...). SUMMARY OF OPHTHALMOSCOPIC EXAMINATION RECORD
Refer Appendix 9
Week 6 |
||||||||
Group, Sex & Dose (mg/kg body weight/day) |
G1R, M & 0 |
G4R, M & 500 |
G1R, F & 0 |
G4R, F & 500 |
||||
Number of Animals |
5 |
5 |
5 |
5 |
||||
Eye Parameters ↓ |
Observations |
|||||||
Eye |
L |
R |
L |
R |
L |
R |
L |
R |
Eye Lids |
N |
N |
N |
N |
N |
N |
N |
N |
Cornea |
N |
N |
N |
N |
N |
N |
N |
N |
Iris |
N |
N |
N |
N |
N |
N |
N |
N |
Aqueous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Lens |
N |
N |
N |
N |
N |
N |
N |
N |
Vitreous Humour |
N |
N |
N |
N |
N |
N |
N |
N |
Retina/Optic disc |
N |
N |
N |
N |
N |
N |
N |
N |
N: No Abnormality Detected; L: Left; R: Right; M: Male; F: Female.
TABLE 10. SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 10
Group, Sex & Dose (mg/kg body weight/day) |
|
Total Leucocyte Count |
Total Erythrocyte Count |
Hemoglobin |
Haematocrit |
Mean Corpuscular Volume |
Mean Corpuscular Hemoglobin |
Mean Corpuscular Hemoglobin Concentration |
Platelet Count |
(WBC) |
(RBC) |
(HGB) |
(HCT) |
(MCV) |
(MCH) |
(MCHC) |
(PLT) |
||
(103cells/µL) |
(106cells/µL) |
(g/dL) |
(%) |
(fL) |
(pg) |
(g/dL) |
(103cells/µL) |
||
G1, M & 0 |
Mean |
10.85 |
8.35 |
16.42 |
50.06 |
59.96 |
19.70 |
32.82 |
812.60 |
±SD |
1.93 |
0.44 |
1.28 |
3.70 |
3.57 |
1.33 |
0.30 |
154.57 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 100 |
Mean |
11.20 |
8.42 |
16.60 |
50.88 |
60.62 |
19.76 |
32.64 |
966.80 |
±SD |
1.37 |
0.48 |
0.29 |
1.28 |
3.98 |
1.03 |
0.74 |
191.45 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 250 |
Mean |
10.11 |
8.54 |
16.70 |
50.56 |
59.24 |
19.58 |
33.06 |
776.20 |
±SD |
1.97 |
0.22 |
0.58 |
0.97 |
1.44 |
0.65 |
1.05 |
230.42 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 500 |
Mean |
8.86 |
7.51* |
15.06 |
47.24 |
63.38 |
20.16 |
31.86 |
921.60 |
±SD |
2.10 |
0.76 |
0.90 |
2.27 |
6.53 |
1.40 |
0.96 |
191.02 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, M & 0 |
Mean |
8.82 |
8.64 |
16.38 |
48.24 |
55.80 |
18.96 |
33.96 |
835.60 |
±SD |
1.68 |
0.39 |
1.09 |
2.83 |
1.22 |
0.63 |
0.95 |
136.73 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 500 |
Mean |
12.49* |
8.50 |
16.56 |
47.10 |
55.34 |
19.56 |
35.40 |
894.20 |
±SD |
3.07 |
0.68 |
0.89 |
5.17 |
1.91 |
0.78 |
2.53 |
98.41 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: number of animals; *: Statistically significant (p<0.05).
TABLE 10 (Contd...). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 10
Group, Sex & Dose (mg/kg body weight/day) |
|
Mean Platelet Volume |
Reticulocyte Count |
Neutrophils |
Lymphocytes |
Monocytes |
Eosinophils |
Basophils |
Absolute Reticulocyte Count |
(MPV) |
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
(Retic) |
||
(fL) |
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
(109cells/L) |
||
G1, M & 0 |
Mean |
6.36 |
3.36 |
17.76 |
76.14 |
3.24 |
0.72 |
0.66 |
280.36 |
±SD |
0.27 |
0.35 |
3.29 |
2.78 |
0.99 |
0.36 |
0.25 |
34.49 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 100 |
Mean |
6.42 |
4.93 |
18.44 |
75.12 |
3.42 |
1.02 |
0.64 |
412.80 |
±SD |
0.39 |
1.61 |
2.98 |
3.67 |
1.08 |
0.47 |
0.17 |
124.66 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 250 |
Mean |
6.58 |
4.21 |
19.84 |
73.52 |
3.46 |
1.18 |
0.68 |
357.78 |
±SD |
0.36 |
1.92 |
3.62 |
2.85 |
0.98 |
0.41 |
0.22 |
156.62 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 500 |
Mean |
6.70 |
6.50 |
18.38 |
75.58 |
3.36 |
0.88 |
0.62 |
473.06 |
±SD |
0.32 |
3.18 |
4.77 |
4.59 |
0.82 |
0.46 |
0.19 |
174.30 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, M & 0 |
Mean |
6.46 |
2.53 |
24.28 |
69.42 |
3.62 |
1.14 |
0.46 |
217.82 |
±SD |
0.30 |
0.49 |
3.49 |
3.52 |
1.56 |
0.67 |
0.15 |
34.76 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 500 |
Mean |
6.54 |
1.94 |
20.36 |
71.06 |
5.48 |
1.30 |
0.52 |
161.84 |
±SD |
0.17 |
0.72 |
3.99 |
6.90 |
2.03 |
0.48 |
0.08 |
46.06 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: Number of animals.
TABLE 10 (Contd...). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 10
Group, Sex & Dose (mg/kg body weight/day) |
|
Absolute Neutrophils |
Absolute Lymphocytes |
Absolute Monocytes |
Absolute Eosinophils |
Absolute Basophils |
Prothrombin Time |
Activated Prothrombin Time |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
(PT) |
(APTT) |
||
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(Seconds) |
(Seconds) |
||
G1, M & 0 |
Mean |
1.91 |
8.27 |
0.36 |
0.08 |
0.07 |
15.70 |
28.14 |
±SD |
0.42 |
1.55 |
0.14 |
0.04 |
0.04 |
0.98 |
7.15 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 100 |
Mean |
2.07 |
8.39 |
0.39 |
0.12 |
0.07 |
15.02 |
24.84 |
±SD |
0.46 |
0.89 |
0.14 |
0.07 |
0.03 |
3.59 |
3.87 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 250 |
Mean |
1.97 |
7.46 |
0.36 |
0.12 |
0.07 |
16.18 |
24.04 |
±SD |
0.33 |
1.67 |
0.15 |
0.04 |
0.03 |
0.94 |
2.27 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 500 |
Mean |
1.65 |
6.67 |
0.30 |
0.08 |
0.06 |
16.50 |
26.20 |
±SD |
0.65 |
1.51 |
0.10 |
0.04 |
0.03 |
2.55 |
2.67 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, M & 0 |
Mean |
2.11 |
6.17 |
0.31 |
0.10 |
0.04 |
15.34 |
23.40 |
±SD |
0.32 |
1.45 |
0.10 |
0.06 |
0.02 |
0.86 |
1.74 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 500 |
Mean |
2.57 |
8.82 |
0.70 |
0.17 |
0.07 |
14.56 |
23.22 |
±SD |
0.90 |
2.21 |
0.34 |
0.09 |
0.02 |
1.42 |
2.74 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: Number of animals.
TABLE 10 (Contd...). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 10
Group, Sex & Dose (mg/kg body weight/day) |
|
Total Leucocyte Count |
Total Erythrocyte Count |
Hemoglobin |
Haematocrit |
Mean Corpuscular Volume |
Mean Corpuscular Hemoglobin |
Mean Corpuscular Hemoglobin Concentration |
Platelet Count |
||||||||||
(WBC) |
(RBC) |
(HGB) |
(HCT) |
(MCV) |
(MCH) |
(MCHC) |
(PLT) |
||||||||||||
(103cells/µL) |
(106cells/µL) |
(g/dL) |
(%) |
(fL) |
(pg) |
(g/dL) |
(103cells/µL) |
||||||||||||
G1, F & 0 |
Mean |
9.41 |
7.94 |
16.06 |
48.48 |
61.06 |
20.24 |
33.14 |
935.00 |
||||||||||
±SD |
2.28 |
0.27 |
0.64 |
2.00 |
2.62 |
1.02 |
0.53 |
172.53 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G2, F & 100 |
Mean |
8.59 |
8.15 |
16.12 |
47.74 |
58.62 |
19.78 |
33.78 |
819.00 |
||||||||||
±SD |
1.78 |
0.35 |
0.51 |
1.08 |
2.10 |
0.87 |
0.48 |
61.81 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G3, F & 250 |
Mean |
9.74 |
7.52 |
15.24 |
44.40* |
59.18 |
20.24 |
34.26 |
894.60 |
||||||||||
±SD |
4.60 |
0.73 |
1.50 |
3.50 |
1.70 |
0.94 |
1.46 |
134.46 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G4, F & 500 |
Mean |
11.33 |
7.87 |
15.76 |
47.96 |
61.00 |
20.06 |
32.88 |
915.80 |
||||||||||
±SD |
2.14 |
0.51 |
1.00 |
2.60 |
1.39 |
0.52 |
0.38 |
237.06 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G1R, F & 0 |
Mean |
9.28 |
7.82 |
15.52 |
45.04 |
58.08 |
19.92 |
34.38 |
813.00 |
||||||||||
±SD |
0.39 |
1.11 |
1.77 |
3.62 |
4.79 |
0.77 |
1.47 |
358.27 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G4R, F & 500 |
Mean |
8.44 |
7.82 |
15.76 |
45.36 |
58.14 |
20.16 |
34.72 |
815.20 |
||||||||||
±SD |
0.90 |
0.62 |
0.97 |
2.60 |
2.10 |
0.70 |
0.25 |
354.10 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05).
TABLE 10 (Contd...). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 10
Group, Sex & Dose (mg/kg body weight/day) |
|
Mean Platelet Volume |
Reticulocyte Count |
Neutrophils |
Lymphocytes |
Monocytes |
Eosinophils |
Basophils |
Absolute Reticulocyte Count |
||||||||||
(MPV) |
(Retic) |
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
(Retic) |
||||||||||||
(fL) |
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
(109cells/L) |
||||||||||||
G1, F & 0 |
Mean |
6.34 |
4.64 |
20.36 |
74.40 |
2.60 |
1.04 |
0.62 |
367.32 |
||||||||||
±SD |
0.30 |
0.96 |
4.69 |
5.63 |
0.89 |
0.46 |
0.18 |
70.20 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G2, F & 100 |
Mean |
6.58 |
3.39 |
20.96 |
72.34 |
3.40 |
1.40 |
0.86 |
276.86 |
||||||||||
±SD |
0.23 |
0.64 |
3.95 |
3.56 |
0.90 |
0.44 |
0.17 |
56.06 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G3, F & 250 |
Mean |
6.68 |
4.61 |
18.78 |
75.16 |
3.12 |
1.14 |
0.58 |
338.04 |
||||||||||
±SD |
0.16 |
1.70 |
4.22 |
4.21 |
0.97 |
0.43 |
0.22 |
84.83 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G4, F & 500 |
Mean |
7.00* |
4.30 |
16.88 |
76.90 |
3.10 |
1.06 |
0.82 |
339.20 |
||||||||||
±SD |
0.51 |
1.52 |
4.42 |
5.33 |
0.91 |
0.34 |
0.25 |
123.38 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G1R, F & 0 |
Mean |
6.74 |
4.06 |
24.34 |
67.82 |
4.58 |
1.46 |
0.52 |
287.30 |
||||||||||
±SD |
0.50 |
3.52 |
6.85 |
6.68 |
1.15 |
0.71 |
0.13 |
188.83 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|||||||||||
G4R, F & 500 |
Mean |
6.78 |
2.34 |
18.58 |
75.72 |
2.46* |
1.68 |
0.44 |
178.74 |
||||||||||
±SD |
0.19 |
0.87 |
4.59 |
4.75 |
0.55 |
0.83 |
0.09 |
54.50 |
|||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05).
TABLE 10 (Contd...). SUMMARY OF HAEMATOLOGY RECORD
Refer Appendix 10
Group, Sex & Dose (mg/kg body weight/day) |
|
Absolute Neutrophils |
Absolute Lymphocytes |
Absolute Monocytes |
Absolute Eosinophils |
Absolute Basophils |
Prothrombin Time |
Activated Prothrombin Time |
|||||||||
(Neut) |
(Lymph) |
(Mono) |
(Eos) |
(Baso) |
(PT) |
(APTT) |
|||||||||||
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(103cells/µL) |
(Seconds) |
(Seconds) |
|||||||||||
G1, F & 0 |
Mean |
1.86 |
7.05 |
0.25 |
0.10 |
0.06 |
16.60 |
23.02 |
|||||||||
±SD |
0.36 |
2.06 |
0.11 |
0.05 |
0.02 |
0.47 |
6.28 |
||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||||||||||
G2, F & 100 |
Mean |
1.75 |
6.25 |
0.29 |
0.13 |
0.07 |
18.34 |
26.72 |
|||||||||
±SD |
0.18 |
1.50 |
0.10 |
0.06 |
0.03 |
2.54 |
1.98 |
||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||||||||||
G3, F & 250 |
Mean |
1.82 |
7.34 |
0.31 |
0.09 |
0.06 |
17.50 |
26.46 |
|||||||||
±SD |
0.84 |
3.63 |
0.14 |
0.02 |
0.03 |
2.55 |
5.48 |
||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||||||||||
G4, F & 500 |
Mean |
1.86 |
8.78 |
0.34 |
0.11 |
0.10 |
17.36 |
22.44 |
|||||||||
±SD |
0.38 |
2.09 |
0.06 |
0.04 |
0.04 |
1.51 |
0.76 |
||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||||||||||
G1R, F & 0 |
Mean |
2.25 |
6.30 |
0.42 |
0.14 |
0.05 |
14.98 |
21.96 |
|||||||||
±SD |
0.62 |
0.77 |
0.12 |
0.07 |
0.01 |
0.83 |
1.07 |
||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||||||||||
G4R, F & 500 |
Mean |
1.56 |
6.40 |
0.21* |
0.14 |
0.03* |
17.10 |
24.50* |
|||||||||
±SD |
0.39 |
0.88 |
0.05 |
0.07 |
0.01 |
2.43 |
1.83 |
||||||||||
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05).
TABLE 11.SUMMARY OF CLINICAL CHEMISTRYRECORD
Refer Appendix 11
Group, Sex & Dose (mg/kg body weight/day) |
|
Glucose |
Urea |
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) |
(mg/dL) |
(g/dL) |
(g/dL) |
(U/L) |
(U/L) |
(U/L) |
||
G1, M & 0 |
Mean |
106.80 |
35.06 |
0.48 |
52.40 |
47.00 |
6.60 |
3.25 |
62.80 |
100.00 |
238.40 |
±SD |
17.34 |
2.43 |
0.02 |
10.92 |
19.89 |
0.39 |
0.12 |
14.34 |
20.38 |
27.78 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 100 |
Mean |
107.60 |
31.26 |
0.46 |
50.80 |
62.60 |
6.46 |
3.31 |
48.60 |
88.00 |
261.20 |
±SD |
17.87 |
2.51 |
0.01 |
7.60 |
17.36 |
0.26 |
0.06 |
2.30 |
6.00 |
52.75 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 250 |
Mean |
103.80 |
36.98 |
0.49 |
52.60 |
34.20 |
6.84 |
3.29 |
70.60 |
108.20 |
244.00 |
±SD |
14.75 |
5.20 |
0.01 |
9.13 |
7.60 |
0.24 |
0.18 |
11.41 |
9.18 |
33.76 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 500 |
Mean |
92.60 |
39.08 |
0.50 |
49.00 |
35.00 |
6.62 |
3.16 |
60.80 |
119.20 |
292.80 |
±SD |
5.98 |
2.98 |
0.03 |
7.75 |
7.07 |
0.41 |
0.20 |
6.18 |
21.98 |
61.24 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, M & 0 |
Mean |
106.20 |
37.04 |
0.57 |
47.80 |
33.60 |
7.42 |
3.33 |
73.00 |
131.00 |
217.60 |
±SD |
9.63 |
3.94 |
0.02 |
2.59 |
13.16 |
0.08 |
0.18 |
7.81 |
9.27 |
66.98 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 500 |
Mean |
99.00 |
40.54 |
0.53 |
53.20 |
45.60 |
6.98* |
3.22 |
72.40 |
136.60 |
209.20 |
±SD |
7.18 |
7.76 |
0.05 |
8.41 |
16.09 |
0.22 |
0.10 |
11.67 |
38.45 |
38.68 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: number of animals; *: Statistically significant (p<0.05).
TABLE 11 (Contd...). SUMMARY OF CLINICAL CHEMISTRY RECORD
Refer Appendix 11
Group, Sex & Dose (mg/kg body weight/day) |
|
Total Bilirubin |
Calcium |
Phosphorous |
Cholinesterase |
Globulin |
Albumin/ Globulin ratio |
Blood Urea Nitrogen |
Sodium |
Potassium |
Chloride |
(BIT) |
(CAL) |
(PHO) |
(CHE) |
(GLO) |
(A/G Ratio) |
(BUN) |
(Na) |
(K) |
(CLO) |
||
(mg/dL) |
(mg/dL) |
(mg/dL) |
(U/L) |
(g/dL) |
|
(mg/dL) |
(mmol/L) |
(mmol/L) |
(mmol/L) |
||
G1, M & 0 |
Mean |
0.03 |
9.84 |
6.36 |
77.40 |
3.35 |
0.98 |
16.36 |
142.44 |
3.50 |
110.16 |
±SD |
0.02 |
0.27 |
0.15 |
42.05 |
0.41 |
0.13 |
1.13 |
1.46 |
0.17 |
1.33 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 100 |
Mean |
0.03 |
9.98 |
6.78 |
77.80 |
3.15 |
1.05 |
14.59 |
142.80 |
3.66 |
111.18 |
±SD |
0.02 |
0.16 |
0.42 |
15.74 |
0.23 |
0.08 |
1.17 |
0.45 |
0.32 |
1.13 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 250 |
Mean |
0.04 |
10.00 |
6.52 |
89.80 |
3.55 |
0.93 |
17.26 |
143.12 |
3.90 |
111.42 |
±SD |
0.01 |
0.19 |
0.52 |
13.52 |
0.22 |
0.09 |
2.43 |
0.63 |
0.31 |
0.85 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 500 |
Mean |
0.07* |
10.06 |
7.40* |
96.00 |
3.46 |
0.94 |
18.24 |
142.36 |
4.34* |
111.42 |
±SD |
0.03 |
0.30 |
0.80 |
35.67 |
0.54 |
0.17 |
1.39 |
1.52 |
0.44 |
1.45 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, M & 0 |
Mean |
0.41 |
9.92 |
6.12 |
185.40 |
4.09 |
0.82 |
17.28 |
142.14 |
3.54 |
103.04 |
±SD |
0.06 |
0.36 |
0.41 |
16.01 |
0.16 |
0.08 |
1.84 |
1.09 |
0.25 |
1.61 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 500 |
Mean |
0.45 |
10.22 |
6.96* |
170.00 |
3.76* |
0.86 |
18.92 |
141.28 |
3.88 |
103.66 |
±SD |
0.02 |
0.46 |
0.69 |
26.05 |
0.17 |
0.04 |
3.62 |
1.67 |
0.37 |
1.82 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05).
TABLE 11 (Contd...). SUMMARY OF CLINICAL CHEMISTRY RECORD
Refer Appendix 11
Group, Sex & Dose (mg/kg body weight/day) |
|
Glucose |
Urea |
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) |
(mg/dL) |
(g/dL) |
(g/dL) |
(U/L) |
(U/L) |
(U/L) |
||
G1, F & 0 |
Mean |
117.40 |
36.74 |
0.49 |
51.20 |
37.00 |
6.90 |
3.41 |
45.00 |
101.60 |
129.20 |
±SD |
19.71 |
5.45 |
0.05 |
11.56 |
22.93 |
0.48 |
0.22 |
4.64 |
31.48 |
26.99 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 100 |
Mean |
107.60 |
38.30 |
0.47 |
57.80 |
39.40 |
6.78 |
3.50 |
38.80 |
94.80 |
147.80 |
±SD |
6.19 |
7.83 |
0.02 |
4.87 |
10.31 |
0.19 |
0.20 |
6.98 |
11.08 |
29.06 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 250 |
Mean |
120.40 |
37.22 |
0.48 |
55.60 |
37.40 |
6.54 |
3.39 |
47.20 |
87.20 |
118.60 |
±SD |
7.83 |
2.61 |
0.05 |
6.88 |
9.13 |
0.36 |
0.15 |
16.15 |
13.66 |
27.41 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 500 |
Mean |
109.40 |
37.34 |
0.49 |
69.80* |
43.60 |
6.96 |
3.65 |
46.40 |
97.40 |
154.20 |
±SD |
8.44 |
2.55 |
0.02 |
6.22 |
4.34 |
0.34 |
0.16 |
6.91 |
5.03 |
37.44 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
119.00 |
41.16 |
0.58 |
59.60 |
40.20 |
7.40 |
3.48 |
52.40 |
108.80 |
90.80 |
±SD |
29.67 |
3.22 |
0.03 |
8.02 |
11.48 |
0.37 |
0.20 |
3.29 |
14.52 |
19.69 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 500 |
Mean |
113.60 |
39.04 |
0.58 |
59.00 |
44.40 |
7.28 |
3.37 |
52.80 |
99.40 |
97.60 |
±SD |
7.16 |
2.03 |
0.02 |
5.70 |
8.26 |
0.08 |
0.11 |
3.70 |
8.56 |
20.12 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery; SD: Standard Deviation; n: number of animals; *: Statistically significant (p<0.05).
TABLE 11 (Contd...). SUMMARY OF CLINICAL CHEMISTRY RECORD
Refer Appendix 11
Group, Sex & Dose (mg/kg body weight/day) |
|
Total Bilirubin |
Calcium |
Phosphorous |
Cholinesterase |
Globulin |
Albumin/Globulin ratio |
Blood Urea Nitrogen |
Sodium |
Potassium |
Chloride |
(BIT) |
(CAL) |
(PHO) |
(CHE) |
(GLO) |
(A/G Ratio) |
(BUN) |
(Na) |
(K) |
(CLO) |
||
(mg/dL) |
(mg/dL) |
(mg/dL) |
(U/L) |
(g/dL) |
|
(mg/dL) |
(mmol/L) |
(mmol/L) |
(mmol/L) |
||
G1, F & 0 |
Mean |
0.02 |
10.42 |
6.34 |
369.40 |
3.49 |
0.99 |
17.14 |
142.20 |
3.84 |
111.62 |
±SD |
0.02 |
0.36 |
1.08 |
55.17 |
0.47 |
0.16 |
2.54 |
0.68 |
0.23 |
1.92 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 100 |
Mean |
0.02 |
10.66 |
7.12 |
365.00 |
3.28 |
1.08 |
17.87 |
141.72 |
3.44 |
108.58* |
±SD |
0.02 |
0.32 |
0.60 |
75.82 |
0.23 |
0.12 |
3.65 |
0.65 |
0.20 |
1.40 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 250 |
Mean |
0.04 |
10.64 |
6.44 |
331.00 |
3.15 |
1.08 |
17.37 |
141.76 |
3.54 |
109.62 |
±SD |
0.01 |
0.26 |
0.43 |
119.65 |
0.26 |
0.08 |
1.22 |
0.78 |
0.30 |
1.94 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 500 |
Mean |
0.04 |
11.42* |
6.92 |
315.60 |
3.31 |
1.11 |
17.42 |
142.54 |
3.89 |
109.98 |
±SD |
0.02 |
0.30 |
0.54 |
149.86 |
0.32 |
0.13 |
1.19 |
1.43 |
0.28 |
1.05 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
0.45 |
10.16 |
6.20 |
458.20 |
3.92 |
0.89 |
19.21 |
140.92 |
3.55 |
103.40 |
±SD |
0.01 |
0.50 |
0.46 |
190.69 |
0.30 |
0.08 |
1.50 |
0.61 |
0.30 |
0.77 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 500 |
Mean |
0.33 |
10.00 |
5.72 |
630.80 |
3.91 |
0.86 |
18.22 |
141.08 |
3.71 |
103.24 |
±SD |
0.12 |
0.23 |
0.13 |
211.92 |
0.11 |
0.05 |
0.95 |
0.80 |
0.23 |
1.13 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05).
TABLE 12. SUMMARY OF URINALYSISRECORD
Refer Appendix 12
Examination
|
Group, Sex & Dose (mg/kg body weight/day) |
G1, M & 0 |
G2, M & 100 |
G3, M & 300 |
G4, M & 1000 |
G1R, M & 0 |
G4R, M & 1000 |
|
Number of Animals |
5 |
5 |
5 |
5 |
5 |
5 |
||
Physical Examination |
Colour |
Pale Yellow |
2 |
5 |
3 |
5 |
5 |
5 |
Yellow |
3 |
- |
2 |
- |
- |
- |
||
Appearance |
Clear |
2 |
5 |
3 |
4 |
5 |
5 |
|
Turbid |
3 |
- |
2 |
1 |
- |
- |
||
Volume (mL) |
Mean |
7.5 |
6.1 |
6.5 |
6.5 |
6.4 |
6.5 |
|
±SD |
1.8 |
2.0 |
1.7 |
0.8 |
1.1 |
1.3 |
||
Chemical Examination |
pH |
Mean |
8.5 |
8.5 |
8.5 |
8.0* |
7.5 |
7.4 |
±SD |
0.0 |
0.0 |
0.0 |
0.4 |
0.0 |
0.2 |
||
Specific gravity (SG) |
Mean |
1.005 |
1.005 |
1.009 |
1.012* |
1.010 |
1.011 |
|
±SD |
0.000 |
0.000 |
0.004 |
0.003 |
0.000 |
0.002 |
||
Urobilinogen (UBG) (mg/dL) |
Mean |
0.2 |
0.5 |
0.2 |
0.2 |
0.2 |
0.2 |
|
±SD |
0.0 |
0.4 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Bilirubin (BIL) (mg/dL) |
Neg |
3 |
2 |
5 |
5 |
5 |
5 |
|
1 |
2 |
3 |
- |
- |
- |
- |
||
Ketones (KET) (mg/dL) |
5 |
3 |
4 |
2 |
1 |
4 |
- |
|
Neg |
2 |
1 |
3 |
4 |
1 |
5 |
||
Blood (BLD) (Ery/µL) |
Neg |
2 |
3 |
- |
- |
1 |
5 |
|
Ca10 |
1 |
- |
1 |
- |
1 |
- |
||
Ca25 |
1 |
- |
3 |
- |
3 |
- |
||
Ca80 |
1 |
2 |
1 |
3 |
- |
- |
||
>=Ca200 |
- |
- |
- |
2 |
- |
- |
||
Protein (PRO) (mg/dL) |
Neg |
1 |
- |
1 |
- |
1 |
3 |
|
Trace |
1 |
1 |
1 |
4 |
4 |
2 |
||
100 |
1 |
- |
1 |
- |
- |
- |
||
30 |
- |
1 |
2 |
1 |
- |
- |
||
>=300 |
2 |
3 |
- |
- |
- |
- |
||
Nitrite (NIT) |
Neg |
3 |
4 |
3 |
2 |
3 |
- |
|
Pos |
2 |
1 |
2 |
3 |
2 |
5 |
||
Leucocytes (LEU) (Leu/µL) |
Neg |
1 |
- |
- |
2 |
2 |
1 |
|
Ca70 |
1 |
4 |
3 |
- |
- |
2 |
||
Ca15 |
3 |
1 |
2 |
3 |
3 |
2 |
||
Glucose (GLU) (mg/dL) |
Neg |
5 |
5 |
5 |
5 |
5 |
5 |
|
Microscopic Examination |
Epi Cells |
0 |
1 |
2 |
1 |
- |
1 |
2 |
0-1 |
2 |
3 |
3 |
3 |
3 |
2 |
||
1-2 |
2 |
- |
1 |
2 |
1 |
1 |
||
Casts |
Absent |
5 |
5 |
5 |
5 |
5 |
5 |
|
Crystals |
Present |
5 |
4 |
5 |
5 |
5 |
5 |
|
Absent |
- |
1 |
- |
- |
- |
- |
||
M: Male; Neg: Negative; Ca: Calculated Approximately; Pos: Positive; SD: Standard Deviation;
*: Statistically significant (p<0.05).
TABLE 12 (Contd...). SUMMARY OF URINALYSIS RECORD
Refer Appendix 12
Examination
|
Group, Sex & Dose (mg/kg body weight/day) |
G1, F & 0 |
G2, F & 100 |
G3, F & 300 |
G4, F & 1000 |
G1R, F & 0 |
G4R, F & 1000 |
|
Number of Animals |
5 |
5 |
5 |
5 |
5 |
5 |
||
Physical Examination |
Colour |
Pale Yellow |
5 |
4 |
4 |
3 |
2 |
4 |
Yellow |
- |
1 |
1 |
2 |
3 |
1 |
||
Appearance |
Clear |
4 |
3 |
4 |
3 |
2 |
4 |
|
Turbid |
1 |
2 |
1 |
2 |
3 |
1 |
||
Volume (mL) |
Mean |
7.2 |
7.6 |
6.4 |
5.5* |
5.2 |
6.3 |
|
±SD |
1.3 |
0.4 |
0.7 |
0.8 |
2.0 |
1.2 |
||
Chemical Examination |
pH |
Mean |
8.5 |
8.5 |
8.2 |
8.2 |
7.7 |
7.5 |
±SD |
0.0 |
0.0 |
0.4 |
0.8 |
0.6 |
0.6 |
||
Specific gravity (SG) |
Mean |
1.007 |
1.007 |
1.010 |
1.012 |
1.013 |
1.011 |
|
±SD |
0.003 |
0.003 |
0.004 |
0.008 |
0.003 |
0.004 |
||
Urobilinogen (UBG) (mg/dL) |
Mean |
0.2 |
0.2 |
0.2 |
0.2 |
0.2 |
0.2 |
|
±SD |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Bilirubin (BIL) (mg/dL) |
Neg |
5 |
5 |
5 |
5 |
5 |
5 |
|
Ketones (KET) (mg/dL) |
5 |
- |
- |
- |
1 |
3 |
- |
|
Neg |
5 |
5 |
5 |
4 |
2 |
5 |
||
Blood (BLD) (Ery/µL) |
Neg |
- |
1 |
2 |
2 |
1 |
5 |
|
Ca10 |
1 |
1 |
2 |
1 |
- |
- |
||
Ca25 |
2 |
1 |
1 |
2 |
1 |
- |
||
Ca80 |
1 |
2 |
- |
- |
3 |
- |
||
>=Ca200 |
1 |
- |
- |
- |
- |
- |
||
Protein (PRO) (mg/dL) |
Neg |
2 |
2 |
3 |
2 |
2 |
4 |
|
Trace |
3 |
3 |
1 |
2 |
1 |
1 |
||
30 |
- |
- |
1 |
- |
- |
- |
||
100 |
- |
- |
- |
1 |
2 |
- |
||
Nitrite (NIT) |
Neg |
4 |
5 |
4 |
4 |
2 |
- |
|
Pos |
1 |
- |
1 |
1 |
3 |
5 |
||
Leucocytes (LEU) (Leu/µL) |
Neg |
4 |
2 |
2 |
3 |
- |
1 |
|
Ca70 |
- |
- |
- |
1 |
- |
- |
||
Ca15 |
1 |
3 |
3 |
1 |
3 |
4 |
||
Ca125 |
- |
- |
- |
- |
2 |
- |
||
Glucose (GLU) (mg/dL) |
Neg |
5 |
5 |
5 |
5 |
5 |
5 |
|
Microscopic Examination |
Epi Cells |
0 |
1 |
- |
1 |
- |
1 |
2 |
0-1 |
3 |
4 |
2 |
3 |
2 |
2 |
||
1-2 |
1 |
1 |
2 |
2 |
2 |
1 |
||
Casts |
Absent |
5 |
5 |
5 |
5 |
5 |
5 |
|
Crystals |
Present |
5 |
4 |
5 |
5 |
5 |
5 |
|
Absent |
- |
1 |
- |
- |
- |
- |
||
F: Female; Neg: Negative; Ca: Calculated Approximately; Pos: Positive; SD: Standard Deviation;
>=; More than or equal to; *: Statistically significant (p<0.05).
TABLE 13. SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g)RECORD
Refer Appendix 13
Group, Sex & Dose (mg/kg body weight/day) |
|
Adrenals |
Thymus |
Spleen |
Testes |
Epididymis |
Heart |
Kidneys |
Brain |
Liver |
Prostate+Seminal vesicles with coagulating glands (PSC) |
Lungs |
G1, M & 0 |
Mean |
0.0564 |
0.4008 |
1.2066 |
3.0142 |
0.9021 |
1.0784 |
2.1416 |
1.8576 |
8.8502 |
1.7639 |
1.7227 |
±SD |
0.0078 |
0.0628 |
0.1264 |
0.2739 |
0.0656 |
0.0607 |
0.0899 |
0.0876 |
0.5907 |
0.1936 |
0.1080 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 100 |
Mean |
0.0609 |
0.4612 |
1.2871 |
3.1388 |
0.9026 |
1.1312 |
2.2458 |
1.8099 |
9.1684 |
1.7620 |
1.7478 |
±SD |
0.0079 |
0.1084 |
0.0956 |
0.1047 |
0.0855 |
0.0719 |
0.3333 |
0.0594 |
1.5671 |
0.3830 |
0.2699 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 250 |
Mean |
0.0568 |
0.3303 |
1.0453 |
3.1250 |
0.9472 |
1.0031 |
1.8983 |
1.8531 |
8.1079 |
1.5733 |
1.7701 |
±SD |
0.0068 |
0.0597 |
0.0528 |
0.1654 |
0.0526 |
0.0895 |
0.1980 |
0.0660 |
0.8482 |
0.3514 |
0.2030 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 500 |
Mean |
0.0567 |
0.3086 |
1.4895* |
3.2044 |
0.8919 |
1.1026 |
1.9104 |
1.8042 |
8.3928 |
1.5983 |
2.0375 |
±SD |
0.0092 |
0.0978 |
0.1791 |
0.0375 |
0.0238 |
0.0813 |
0.3249 |
0.0868 |
1.0884 |
0.3214 |
0.5360 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, M & 0 |
Mean |
0.0528 |
0.3303 |
1.1610 |
3.2827 |
1.1655 |
1.1137 |
2.3275 |
1.9180 |
8.8810 |
2.0205 |
1.9618 |
±SD |
0.0074 |
0.0772 |
0.1578 |
0.3090 |
0.0544 |
0.1242 |
0.2906 |
0.1343 |
1.2445 |
0.2263 |
0.2557 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 500 |
Mean |
0.0561 |
0.2928 |
1.1915 |
3.2977 |
1.2130 |
1.2798 |
2.3140 |
1.9319 |
9.5308 |
2.2211 |
2.3093 |
±SD |
0.0072 |
0.0394 |
0.1239 |
0.1041 |
0.0699 |
0.1564 |
0.1589 |
0.0886 |
1.0133 |
0.1970 |
0.4472 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05).
TABLE 13 (Contd...). SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g) RECORD
Refer Appendix 13
Group, Sex & Dose (mg/kg body weight/day) |
|
Adrenals |
Thymus |
Spleen |
Ovaries |
Uterus with cervix |
Heart |
Kidneys |
Brain |
Liver |
Lungs |
G1, F & 0 |
Mean |
0.0706 |
0.3414 |
0.9134 |
0.1313 |
0.5102 |
0.9020 |
1.5984 |
1.7228 |
7.2885 |
1.5387 |
±SD |
0.0024 |
0.0441 |
0.0959 |
0.0087 |
0.1197 |
0.0725 |
0.1174 |
0.0848 |
0.6456 |
0.1387 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 100 |
Mean |
0.0731 |
0.3534 |
1.0056 |
0.1374 |
0.4911 |
0.9188 |
1.5387 |
1.8341* |
7.4323 |
1.6153 |
±SD |
0.0048 |
0.0417 |
0.1008 |
0.0141 |
0.1097 |
0.0907 |
0.0439 |
0.0581 |
0.7217 |
0.1510 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 250 |
Mean |
0.0728 |
0.4352* |
1.1379* |
0.1390 |
0.4605 |
0.9463 |
1.6586 |
1.7316 |
7.6430 |
1.5522 |
±SD |
0.0067 |
0.0789 |
0.1166 |
0.0079 |
0.0378 |
0.0653 |
0.0401 |
0.0477 |
0.2016 |
0.1398 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 500 |
Mean |
0.0741 |
0.3801 |
0.9047 |
0.1351 |
0.5351 |
0.8730 |
1.6999 |
1.7634 |
7.5322 |
1.4893 |
±SD |
0.0106 |
0.0463 |
0.0729 |
0.0220 |
0.0912 |
0.0602 |
0.1258 |
0.0644 |
0.4969 |
0.1058 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
0.0759 |
0.3214 |
0.9870 |
0.1481 |
0.4759 |
0.9912 |
1.6362 |
1.8662 |
7.6368 |
1.9055 |
±SD |
0.0090 |
0.0562 |
0.2147 |
0.0093 |
0.0685 |
0.0758 |
0.0269 |
0.0902 |
0.7581 |
0.3539 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 500 |
Mean |
0.0704 |
0.4111 |
0.9551 |
0.1323 |
0.4660 |
0.9685 |
1.6778 |
1.8497 |
7.4311 |
1.7021 |
±SD |
0.0100 |
0.0998 |
0.1442 |
0.0136 |
0.0504 |
0.1091 |
0.1610 |
0.0868 |
0.7299 |
0.1695 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05).
TABLE 14. SUMMARY OF ORGAN WEIGHT RELATIVE TO FASTING BODY WEIGHT(%)RECORD
Refer Appendix 14
Group, Sex & Dose (mg/kg body weight/day) |
|
Fasting Body Weight (g) |
Adrenals |
Thymus |
Spleen |
Testes |
Epididymis |
Heart |
Kidneys |
Brain |
Liver |
Prostate+Seminal vesicles with coagulating glands (PSC) |
Lungs |
G1, M & 0 |
Mean |
244.77 |
0.0231 |
0.1645 |
0.4950 |
1.2323 |
0.3690 |
0.4412 |
0.8763 |
0.7614 |
3.6189 |
0.7209 |
0.7062 |
±SD |
14.29 |
0.0036 |
0.0297 |
0.0644 |
0.1046 |
0.0264 |
0.0250 |
0.0401 |
0.0640 |
0.2066 |
0.0701 |
0.0691 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, M & 100 |
Mean |
259.62 |
0.0235 |
0.1770 |
0.5026 |
1.2222 |
0.3497 |
0.4398 |
0.8642 |
0.7042 |
3.5171 |
0.6740 |
0.6735 |
±SD |
32.63 |
0.0014 |
0.0288 |
0.0764 |
0.1377 |
0.0319 |
0.0496 |
0.0439 |
0.0743 |
0.1548 |
0.0705 |
0.0666 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, M & 250 |
Mean |
245.03 |
0.0234 |
0.1356 |
0.4280 |
1.2781 |
0.3890 |
0.4097 |
0.7736* |
0.7605 |
3.3039 |
0.6367 |
0.7236 |
±SD |
19.02 |
0.0039 |
0.0270 |
0.0292 |
0.0630 |
0.0445 |
0.0260 |
0.0279 |
0.0718 |
0.1175 |
0.0951 |
0.0778 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, M & 500 |
Mean |
256.09 |
0.0221 |
0.1203 |
0.5883 |
1.2582 |
0.3500 |
0.4313 |
0.7437* |
0.7061 |
3.2752* |
0.6213 |
0.7986 |
±SD |
20.69 |
0.0035 |
0.0362 |
0.1135 |
0.1080 |
0.0288 |
0.0237 |
0.0856 |
0.0263 |
0.2923 |
0.0885 |
0.2146 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, M & 0 |
Mean |
276.16 |
0.0191 |
0.1188 |
0.4200 |
1.1874 |
0.4230 |
0.4028 |
0.8402 |
0.6945 |
3.2042 |
0.7332 |
0.7091 |
±SD |
17.95 |
0.0022 |
0.0215 |
0.0468 |
0.0525 |
0.0244 |
0.0278 |
0.0552 |
0.0180 |
0.2613 |
0.0833 |
0.0665 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, M & 500 |
Mean |
297.44 |
0.0189 |
0.0982 |
0.4024 |
1.1145 |
0.4102 |
0.4311 |
0.7811 |
0.6518 |
3.2093 |
0.7503 |
0.7762 |
±SD |
21.35 |
0.0025 |
0.0075 |
0.0508 |
0.1031 |
0.0460 |
0.0510 |
0.0759 |
0.0473 |
0.3236 |
0.0868 |
0.1465 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
M: Male; R: Recovery; SD: Standard Deviation, n: Number of animals; *: Statistically significant (p<0.05).
TABLE 14 (Contd...). SUMMARY OF ORGAN WEIGHT RELATIVE TO FASTING BODY WEIGHT (%) RECORD
Refer Appendix 14
Group, Sex & Dose (mg/kg body weight/day) |
|
Fasting Body Weight (g) |
Adrenals |
Thymus |
Spleen |
Ovaries |
Uterus with cervix |
Heart |
Kidneys |
Brain |
Liver |
Lungs |
G1, F & 0 |
Mean |
195.53 |
0.0361 |
0.1742 |
0.4671 |
0.0672 |
0.2608 |
0.4609 |
0.8174 |
0.8827 |
3.7235 |
0.7875 |
±SD |
6.83 |
0.0014 |
0.0165 |
0.0455 |
0.0047 |
0.0595 |
0.0244 |
0.0520 |
0.0680 |
0.2318 |
0.0749 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G2, F & 100 |
Mean |
199.45 |
0.0367 |
0.1772 |
0.5050 |
0.0688 |
0.2472 |
0.4600 |
0.7725 |
0.9215 |
3.7247 |
0.8092 |
±SD |
10.56 |
0.0030 |
0.0183 |
0.0518 |
0.0051 |
0.0594 |
0.0272 |
0.0273 |
0.0549 |
0.2706 |
0.0491 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G3, F & 250 |
Mean |
220.38 |
0.0334 |
0.1993 |
0.5265 |
0.0638 |
0.2129 |
0.4322 |
0.7622 |
0.7952 |
3.5095 |
0.7094 |
±SD |
28.00 |
0.0048 |
0.0397 |
0.1100 |
0.0082 |
0.0391 |
0.0303 |
0.0971 |
0.0957 |
0.4113 |
0.0704 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4, F & 500 |
Mean |
198.35 |
0.0372 |
0.1915 |
0.4558 |
0.0679 |
0.2694 |
0.4404 |
0.8576 |
0.8901 |
3.7969 |
0.7529 |
±SD |
10.40 |
0.0038 |
0.0193 |
0.0197 |
0.0087 |
0.0398 |
0.0252 |
0.0539 |
0.0346 |
0.1336 |
0.0706 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G1R, F & 0 |
Mean |
245.35 |
0.0309 |
0.1312 |
0.4020 |
0.0604 |
0.1939 |
0.4042 |
0.6673 |
0.7610 |
3.1127 |
0.7770 |
±SD |
6.00 |
0.0036 |
0.0239 |
0.0856 |
0.0043 |
0.0277 |
0.0320 |
0.0240 |
0.0419 |
0.3072 |
0.1471 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
G4R, F & 500 |
Mean |
252.14 |
0.0279 |
0.1630 |
0.3785 |
0.0526* |
0.1853 |
0.3847 |
0.6647 |
0.7355 |
2.9438 |
0.6747 |
±SD |
13.70 |
0.0030 |
0.0400 |
0.0525 |
0.0063 |
0.0223 |
0.0454 |
0.0396 |
0.0550 |
0.1861 |
0.0502 |
|
n |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
F: Female; R: Recovery; SD: Standard Deviation, n: Number of animals; *: Statistically significant (p<0.05).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Guideline Study, high quality
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results from the available repeated dose toxicity data and given that no human relevance is deducible from the effects on the forestomach seen in rats, it is concluded that the registration substance is not subject to classification and labelling according to the criteria of GHS and /or EU CLP.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
