Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Repeated oral toxicity:
The toxicity of Pigment Red 112 when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination).


Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent a sign of toxicity. No correlating histopathological abnormalities were noted.


On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No-Observed-Adverse-Effect Level (NOAEL) for Pigment Red 112.



Repeated dermal toxicicty:
The dermal route was waived; substance is not classified for this endpoint. The substance is considered not to exert any local or systemic adverse effects.
Repeated inhalation toxicicty:
The inhalation route was waived; substance is not classified for this endpoint. When aerosolized in respirable form the substance is considered likely to behave like an inert


dust.


 


Inhalation:


The objective of this study was to determine the toxic potential of the test item, Agrocer Red 112 when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC).


A total of 200 (100 males + 100 females) healthy young Sprague Dawley rats were distributed to five groups viz.,


0 mg/m³ (control (G1)),


0.001 mg/L (low dose (G2))


0.003 mg/L. (mid dose- I (G3))


0.01 mg/L (mid dose- II (G4))


0.03 mg/L (high dose (G5))


and five recovery groups [(G1R - S1 & G1R - S2 (Air only), G2R - S1 & G2R - S2 (Low Dose), G3R - S1 & G3R - S2 (Mid Dose – I), G4R - S1 & G4R - S2 (Mid Dose – II) and G5R - S1 & G5R - S2 (High dose)].


The data recorded for all exposure days relating to the chamber conditions like particle size, temperature, relative humidity, oxygen, and carbon dioxide concentrations determined during the exposure period were found within the specified range.


Salient findings of the study are as follows,



  • No clinical signs or mortality/morbidity was noted throughout the experiment.

  • No treatment-related changes in body weight, percent change in body weight with respect to day 1, feed consumption was noted.

  • No ocular abnormalities were noted during ophthalmoscopic examination

  • No adverse effects were observed during neurological/functional examination tests.

  • No adverse effects were observed in haematology, clinical chemistry, coagulation, BALF analysis or urinalysis parameters.

  • No adverse changes were noted in fasting body weights, organ weights and its rations.

  • There were no test item related gross pathological changes.


There were no test item-related microscopic findings in the study.


The NOAEC was 30 mg/m³ (0,03 mg/L) after 90 days of exposure.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 January 2008 to 30 January 2008
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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Limit test:
no
Species:
rat
Strain:
other: Crl:WI(Han)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Approximately 6 weeks
- Weight at study initiation: males: 148-184 grams; females: 122-141 grams
- Fasting period before study: none
- Housing: Group housing of 5 animals per sex in Macrolon cages (MIV type, height 18 cm; during overnight activity monitoring individual housing in MIII type; height 15 cm.) with sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lilico & Son (Wonham Mill Ltd), Surrey, United Kingdom). No cage-enrichment was provided during overnight activity monitoring. Certificates of analysis were examined and then retained in the NOTOX archives.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 °C (actual range: 19.9 – 21.5C),
- Humidity (%): 30-70% (actual range: 26 - 63%)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 02 January 2008 to: 30 January 2008
Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS: Formulations (w/w) were prepared daily within 4 hours prior to dosing and were homogenised to a visually acceptable level.
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Test substance formulations in propylene glycol formed a homogeneous suspension at the concentrations tested (coefficient of variation <10%). Analysis of the accuracy of dose preparations revealed values within the range of 102-106% of nominal, which was considered to represent an acceptable level of accuracy for formulations of this type.
Duration of treatment / exposure:
28 days
Frequency of treatment:
Once daily for 28 days, 7 days per week, approximately the same time each day with a maximum of 4 hours difference between the earliest and latest dose. Animals were dosed up to the day prior to necropsy.
Remarks:
Doses / Concentrations:
0 mg/kg bw/day
Basis:
actual ingested
Remarks:
Doses / Concentrations:
100 mg/kg bw/day
Basis:
actual ingested
Remarks:
Doses / Concentrations:
300 mg/kg bw/day
Basis:
actual ingested
Remarks:
Doses / Concentrations:
1000 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: Dose levels were selected on the basis of a 5-day dose range finding study.
Positive control:
not applicable
Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least twice daily
- Cage side observations included: mortality, viability
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once daily after dosing
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not applicable
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: subjective appraisal
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of treatment
- Anaesthetic used for blood collection: Yes (iso-flurane anaesthesia)
- Animals fasted: Yes
- How many animals: 40
- Parameters examined: White blood cells, Differential leucocyte count (neutrophils, lymphocytes, monocytes, eosinophils, basophils), Red blood cells, Reticulocytes, Red blood cell distribution width, Haemoglobin, Haematocrit, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular haemoglobin concentration, Platelets,
Clotting potential (Prothrombin time, Activated Partial thromboplastin time)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of treatment
- Animals fasted: Yes
- How many animals: 40
- Parameters examined: Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase, Total Protein, Albumin, Total Bilirubin, Urea, Creatinine,
Glucose, Cholesterol, Sodium, Potassium, Chloride, Calcium, Inorganic Phosphate
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes:
At the end of week 1, 2, 3 and 4 of treatment, the following tests were performed on all animals:
- hearing ability, pupillary reflex, static righting reflex and grip strength.
- motor activity test (recording period: 12 hours during overnight for individual animals, using a computerized monitoring system, Pearson Technical Services, Debenham, Stowmarket, England).
Sacrifice and pathology:
GROSS PATHOLOGY: Yes. All animals were necropsied and descriptions of all macroscopic abnormalities recorded.
Samples of the following tissues and organs were collected from all animals at necropsy and fixed in 10% buffered formalin (neutral phosphate buffered 4% formaldehyde solution):
Identification marks: not processed
Ovaries, Adrenal glands, Pancreas, Aorta, Peyer's patches [jejunum, ileum] if detectable, Brain [cerebellum, mid-brain, cortex], Pituitary gland, Caecum,
(Preputial gland), Cervix, Prostate gland, (Clitoral gland), Rectum, Colon, (Salivary glands - mandibular, sublingual), Duodenum, Sciatic nerve, Epididymides, Seminal vesicles, (Eyes with optic nerve [if detectable] and (Skeletal muscle), Harderian gland), (Skin) , (Female mammary gland area), Spinal cord -cervical, midthoracic, lumbar, (Femur including joint), Spleen, Heart, Sternum with bone marrow, Ileum, Stomach, Jejunum, Testes, Kidneys, Thymus, (Larynx), Thyroid including parathyroid [if detectable], (Lacrimal gland, exorbital), (Tongue), Liver, Trachea, Lung, infused with formalin, Urinary bladder, Lymph nodes - mandibular, mesenteric, Uterus, (Nasopharynx), Vagina, Oesophagus, All gross lesions

Tissues/organs mentioned in parentheses were not examined by the pathologist since there were no changes in macroscopic appearance indicative of (potential) toxicity.

The following organ weights (and terminal body weight) were recorded from the animals on the scheduled day of necropsy: Adrenal glands, Brain, Epididymides, Heart, Kidneys, Liver, Spleen, Testes, Thymus

HISTOPATHOLOGY:
- all tissues collected at the scheduled sacrifice from all group 1 and 4 animals,
- all gross lesions.

Other examinations:
None
Statistics:
- If the variables could be assumed to follow a normal distribution, the Dunnett-test1 (many-to-one t-test) based on a pooled variance estimate was applied for the comparison of the treated groups and the control groups for each sex.
- The Steel-test2 (many-to-one rank test) was applied when the data could not be assumed to follow a normal distribution.
- The exact Fisher-test3 was applied to frequency data.

All tests were two-sided and in all cases p < 0.05 was accepted as the lowest level of significance. Group means were calculated for continuous data and medians were calculated for discrete data (scores) in the summary tables. Test statistics were calculated on the basis of exact values for means and pooled variances.
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not examined
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
Red staining of various body parts (shoulder, head, flank, back, neck, cervical region, chest
and/or generalized staining) and red faeces were noted among all groups treated with the test
substance.
Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract
noted among all groups treated with the test substance was considered to be related to staining
properties of the test substance, and not to represent signs of systemic toxicity. No correlation
histopathological abnormalities were noted.

No toxicologically relevant changes occurred in haematological parameters of treated rats.

No toxicologically relevant changes occurredin clinical biochemistry parameters of treated rats.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day (actual dose received)
Sex:
male/female
Basis for effect level:
other: No toxicologically significant changes were noted in any of the parameters investigated in this study.
Key result
Critical effects observed:
no
Conclusions:
The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week has been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance.
Executive summary:

The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week has been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
reliable

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 July 2021 to 09 June 2022
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 413 (90-Day (Subchronic) Inhalation Toxicity Study
GLP compliance:
yes (incl. QA statement)
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
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: 7-8 weeks at the time of randomization
- Weight at study initiation: Males: 140.05 g to 158.83 g
Females: 132.98 g to 139.96 g
- Fasting period before study: 16 to 18 hours
- Housing: polysulphonate cage (size: L 430 × B 280 × H 210 mm)
- Diet: Altromin Maintenance diet for rats and mice (manufactured by Altromin Spezialfutter GmbH & Co. KG) (except during restraining and exposure period)
- Water (e.g. ad libitum): yes, Deep bore-well water passed through a reverse osmosis unit
- Acclimation period: Males: 05 July 2021 to 11 July 2021
Females: 12 July 2021 to 18 July 2021



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6°C to 23.0°C
- Humidity (%): 44% to 67%
- 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: 05 July 2021 To: 14 April 2022
Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
> 1.8 - <= 2.01 µm
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow-past, nose-only dynamic inhalation exposure system supplied by CH Technologies, USA
- Method of holding animals in test chamber: restrainer
- Source and rate of air: compressed air, 20 lt/min
- Method of conditioning air: filtered air through filters
- System of generating particulates/aerosols: dust generator
- Temperature, humidity, pressure in air chamber: 21.5 to 23.6 °C, 51.2% to 59.2%, 20 lt/min
- Air flow rate: 20 lt/min
- Air change rate: 12 to 15 air changes per hour
- Method of particle size determination: gravimetric
- Treatment of exhaust air: NaOH

TEST ATMOSPHERE
- Brief description of analytical method used: no
- Samples taken from breathing zone: yes

Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
Actual aerosol concentration was determined by gravimetric method i.e. dividing the mass of test item collected on the filter paper by the volume of air passed through the filter paper and time. The 2.40 L/min critical orifice was used to draw the air from the inhalation chamber for five minutes at animal breathing zone. It was carried out for four times during exposure, initially before putting the animals into the chambers to ensure the chamber concentration and every two hours [i.e. 120 minutes (±15 minutes), 240 minutes (±15 minutes) and 360 minutes (±15 minutes)] after equilibration period for each exposure day.
Duration of treatment / exposure:
Animals were exposed to the test item by inhalation continuously for 6 hours per day, 5 days per week, for a total of 65 actual exposures, after equilibration period of the chamber concentration.
Following the 90 days exposure period, the animals in the recovery groups (Satellite 1 - G1R – S1, G2R – S1, G3R- S1, G4R – S1 and G5R – S1) and (Satellite 2 - G1R- S2, G2R – S2, G3R – S2 G4R – S2 and G5R – S2) were not given any treatment and maintained for 90 days (Satellite 1) and 180 days (Satellite 2) post treatment period and observed for reversibility or persistence of toxic effects
Frequency of treatment:
6 hours per day, 5 days per week
Dose / conc.:
0.03 mg/L air
Remarks:
G5 & G5R
Dose / conc.:
0.01 mg/L air
Remarks:
G4 & G4R
Dose / conc.:
0.003 mg/L air
Remarks:
G3
Dose / conc.:
0.001 mg/L air
Remarks:
G2 &G2R
Dose / conc.:
0 mg/L air
Remarks:
G1 & G1R
No. of animals per sex per dose:
10 M and 10 F
Control animals:
yes, sham-exposed
Details on study design:
- Dose selection rationale: As per sponsor provided doses
- Rationale for animal assignment (if not random): randomisation
- Fasting period before blood sampling for clinical biochemistry: yes, overnight
- Rationale for selecting satellite groups: to observe delayed toxic of test item and recovery
- Post-exposure recovery period in satellite groups: yes
Positive control:
No
Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily once
- Cage side observations checked in table [No.1] were included.

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly once

BODY WEIGHT: Yes
- Time schedule for examinations: weekly once

OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: week 13 for G1 and G5, week 26 and 39 for recovery group animals G1R, G5R Satelite-I and G1R, G5R Satelite-II
- Dose groups that were examined: G1, G1R, G5, G5R

HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 90 for main group, day 180 and 270 for recovery group
- Anaesthetic used for blood collection: Yes, isoflurane
- Animals fasted: Yes
- How many animals: 100 animals in main group, 100 animals in recovery group
- Parameters checked in table [No.10] were examined.

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 90 for main group, day 180 and 270 for recovery group
- Animals fasted: Yes
- How many animals: 100 animals in main group, 100 animals in recovery group
- Parameters checked in table [No.11] were examined.

URINALYSIS: Yes
- Time schedule for collection of urine: day 90 for main group, day 180 and 270 for recovery group
- 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 13 for main group, week 26 for satellite 1 group, week 39 for satellite 2 group
- Dose groups that were examined: G1, G1R, G5, G5R
- Battery of functions tested: sensory activity / grip strength / motor activity

BRONCHOALVEOLAR LAVAGE FLUID (BALF): Yes
- Time schedule for analysis: day 90 for main group, day 180 and 270 for recovery group
- Dose groups that were examined: all groups including recovery
- Number of animals: 200
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Statistics:
SPSS Software version 22
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
No toxicologically significant treatment-related variations were observed in all the tested dose groups when compared with control group. However, the following statistically significant variations were noted.
In main group males, increase in body weight was noted in G5 from day 71 to day 89 which is considered incidental as no concomitant variation was noted in feed consumption
Food consumption and compound intake (if feeding study):
effects observed, non-treatment-related
Description (incidence and severity):
No statistically significant treatment-related variations were observed in all the tested dose groups when compared with control group. However, the following statistically significant variations were noted.
In main group females, decrease in feed consumption was noted in G4 during week 10. The observed change in feed consumption was not accompanied by any changes in mean body weight and hence considered to be incidental
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
no effects observed
Haematological findings:
effects observed, non-treatment-related
Description (incidence and severity):
No toxicologically significant treatment related changes in haematology parameters were noted. However, the following statistically significant variations were noted.
In main group males, increase in WBC (G2), RBC (G3, G4 and G5), PT (G2, G3, G4 and G5) and absolute neutrophils (G2, G3, G4 and G5); decrease in MCH (G2, G3, G4 and G5), percent lymphocytes (G3 and G4) and percent basophils (G4) were noted. In main group females, increase in MCV and APTT (G4); decrease in WBC (G3, G4 and G5), Haemoglobin (G4), MCHC (G3, G4 and G5), absolute lymphocytes (G3, G4 and G5) and absolute monocytes (G3) was noted.
In recovery group (S1) males, decrease in Haematocrit (G4R-S1), percent basophils and absolute basolphils (G2R-S1 to G5R-S1), percent lymphocytes (G5R-S1), absolute lymphocytes (G3R-S1 and G5R-S1); increase in percent neutrophils (G3R-S1 and G5R-S1) noted. In females decrease in PT (G4R-S1 and G5R-S1) was noted.
In recovery group (S2) males, decrease in PT (G5R-S2) was noted. In females, increase in WBC and absolute lymphocytes (G2R-S2); decrease in PT (G5R-S2) and APTT (G2R-S2) was noted.
Main: The observed variations in WBC and differential counts at the end of treatment period could be secondary due to exposure of test item and was not associated in any microscopic changes in the marrow and hence considered incidental. Variations noted in MCH and MCHC is also considered incidental in the absence of associated variation in haemoglobin concentration (except haemoglobin concentration of G4F which lacks dose dependency). Increase in PT in main group males was minimal in nature and also in the absence of variation in other coagulation parameter, the noted change in considered incidental. All other changes noted in main groups are considered incidental in the absence of dose dependency anddue to random biological response.
Recovery: At the end of recovery period, few variations in differential counts in males (90-day recovery groups) still persisted which were minimal in nature. All other variations noted at the end of recovery period lacked dose dependency, were random in nature, or were not noted in other sex
Clinical biochemistry findings:
effects observed, non-treatment-related
Description (incidence and severity):
No toxicologically significant changes were observed in clinical chemistry parameters when compared to the vehicle control group. However, the following statistically significant variations were noted.
In main group, males increase in glucose (G4), creatinine (G3 and G4), albumin (G2, G3, G4 and G5), ALT (G2 and G5), calcium (G3, G4 and G5), chloride (G3, G4 and G5) as well as decrease in ALP and phosphorous (G2, G3, G4 and G5) were noted.
In main group females, increase in creatinine (G2, G3 and G4), triglycerides (G2), albumin (G2, G3, G4 and G5), total bilirubin (G4), sodium (G4 and G5) and Chloride (G3, G4 and G5); decrease in phosphorous (G2, G3, G4 and G5) and Globulin (G2 and G3) was noted.
The noted variations in albumin, ALP, ALT, calcium, chloride were not associated with any macroscopic changes at all the dose levels and no microscopic changes were noted at the high dose group in associated organs. All the other changes noted are considred incidental in the absence of dose dependency and the changes could be due to random physiological variation.
In recovery group (S1) males, increase in triglycerides (G5R-S1), sodium (G2R-S1 to G5R-S1), chloride (G4R-S1 and G5R-S1) were noted; in females increase in glucose and BUN (G2R-S1 and G4R-S1) were noted.
In recovery group (S2) males, increase in potassium (G4R-S2) was noted; in females decrease in urea and BUN (G3R-S2) and increase in ALT (G2R-S2), glucose and potassium (G3R-S2) were noted.
Variations in the recovery group were also considered incidental as they lacked dose dependency patterns
Endocrine findings:
not examined
Urinalysis findings:
effects observed, non-treatment-related
Description (incidence and severity):
No adverse treatment-related effects were observed in urinalysis parameters when compared to the control group. However, in main group females, increase in urine volume (G3) was noted. The noted variation is considered incidental due to its isolated occurance and also lacked dose dependency
Behaviour (functional findings):
effects observed, non-treatment-related
Description (incidence and severity):
There were no adverse effects observed during neurological/functional examination. However, in main group females (G5), decrease in movement counts was noted. This variation is considered incidental due to lack of dose responsiveness and also none of the other neuromuscular parameters were affected
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
effects observed, non-treatment-related
Description (incidence and severity):
No adverse changes were noted in fasting body weights, organ weights and its ratios. However, the following statistically significant variations were noted in organ weights and their ratios.
In main group males, increase in absolute weight of adrenals and kidneys (G5), epididymides and heart (G3, G4 and G5), brain (G3 and G5); decrease in absolute weight of thymus (G5), spleen (G4 and G5); increase in relative weight of heart (G3 and G5), epididymides (G3); decrease in relative weight of thymus (G2, G4 and G5), and spleen (G4 and G5) was noted. In females increase in absolute weight of adrenals and spleen (G5), uterus (G3 and G4), decrease in heart (G3), kidneys (G2 and G3), brain (G3), liver (G3 and G5); increase in realative weight of adrenals and spleen (G5), uterus (G3 and G4); decrease in kidneys (G2) and liver (G5) were noted.
In recovery group (S1) males, increase in relative weight of epididymides (G5R-S1) noted. In females decrease in absolute weight of adrenals (G3R-S1) and liver (G2R-S1) were noted.
In recovery group (S2) males, decrease in absolute weight of adrenals and relative weight of adrenals (G2R-S2) were noted.
All the variations noted in the groups were dose-independent, and were not associated with any macroscopic findings, hence the observed changes in absolute organ weights were considered incidental.
Relative weight changes (relative to brain weight)
In main group males, decrease in relative weight of thymus (G2, G4 and G5), spleen (G4 and G5), testies (G5) and lungs (G2 and G5), decrease in epididymides (G3 and G4) and heart (G4 and G5); in females increase in relative weight of adrenal and spleen (G5) and uterus (G3 and G4); decrease in relative weight of kidneys (G2) and Liver (G2 and G5) was noted.
In recovery group (S1) males, increase in relative weight of epididymides (G5R-S1) was noted. In females decrease in relative weight of adrenals (G3R-S1) and liver (G2R-S1) was noted.
In recovery group (S2) females, decrease in relative weight of kidneys (G3R-S2) was noted.
All variations noted in organ weights were not associated with any macroscopic examination and also no microscopic changes were noted in the high dose main group animals and hence considered incidental
Gross pathological findings:
no effects observed
Neuropathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
There were no test item-related, microscopic findings in the study.
Few of the microscopic findings observed in this study such as ultimobranchial cyst(s) in thyroid gland, epithelial cyst(s)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
Histopathological findings: neoplastic:
no effects observed
Key result
Dose descriptor:
NOAEC
Effect level:
> 30 mg/m³ air (analytical)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
behaviour (functional findings)
body weight and weight gain
clinical biochemistry
clinical signs
food consumption and compound intake
food efficiency
gross pathology
haematology
histopathology: non-neoplastic
immunology
mortality
ophthalmological examination
organ weights and organ / body weight ratios
serum/plasma biochemistry
urinalysis
Key result
Critical effects observed:
no

  • SUMMARY OF CLINICAL SIGNS AND MORTALITY RECORD


                                                                                                                          Refer Appendix 1
































































































































































































Group, Sex & Dose


(mg/L)



No. of


Animals



Clinical Signs of Toxicity



Mortality                                (No. of Incidences/


No. of Animals)



G1, M & 0



10



N



0/10



G2, M & 0.001



10



N



0/10



G3, M & 0.003



10



N



0/10



G4, M & 0.01



10



N



0/10



G5, M & 0.03



10



N



0/10



G1, F & 0



10



N



0/10



G2, F & 0.001



10



N



0/10



G3, F & 0.003



10



N



0/10



G4, F & 0.01



10



N



0/10



G5, F & 0.03



10



N



0/10



G1R - S1, M & 0



05



N



0/05



G2R - S1, M& 0.001



05



N



0/05



G3R - S1, M & 0.003



05



N



0/05



G4R - S1, M & 0.01



05



N



0/05



G5R - S1, M & 0.03



05



N



0/05



G1R - S1, F & 0



05



N



0/05



G2R - S1, F & 0.001



05



N



0/05



G3R - S1, F & 0.003



05



N



0/05



G4R - S1, F & 0.01



05



N



0/05



G5R - S1, F & 0.03



05



N



0/05



G1R – S2, M & 0



05



N



0/05



G2R – S2, M& 0.001



05



N



0/05



G3R – S2, M & 0.003



05



N



0/05



G4R – S2, M & 0.01



05



N



0/05



G5R – S2, M & 0.03



05



N



0/05



G1R – S2, F & 0



05



N



0/05



G2R – S2, F & 0.001



05



N



0/05



G3R – S2, F & 0.003



05



N



0/05



G4R – S2, F & 0.01



05



N



0/05



G5R – S2, F & 0.03



05



N



0/05



M: Male; F: Female; N: Normal; R: Recovery; S1: Satellite 1; S2: Satellite 2.


 


 



  • SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2








































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



1



5



8



12



15



19



22



26



29



G1, M & 0



Mean



175.96



181.61



193.88



204.16



215.88



225.54



237.96



248.86



257.86



±SD



8.76



9.75



11.15



11.52



12.06



12.44



13.92



14.93



14.76



n



10



10



10



10



10



10



10



10



10



G2, M & 0.001



Mean



178.67



185.75



199.35



210.00



222.44



233.11



247.09



257.79



267.58



±SD



9.57



9.28



9.79



9.57



9.18



9.16



10.14



9.28



9.62



n



10



10



10



10



10



10



10



10



10



G3, M & 0.003



Mean



179.30



185.56



196.82



206.48



217.41



227.67



241.18



252.16



261.28



±SD



9.05



8.71



10.45



10.61



12.95



13.88



15.10



16.73



18.34



n



10



10



10



10



10



10



10



10



10



G4, M & 0.01



Mean



179.76



186.47



200.04



210.60



225.07



234.63



248.74



260.15



269.78



±SD



10.27



9.91



10.79



10.96



10.20



10.24



10.49



11.25



11.58



n



10



10



10



10



10



10



10



10



10



G5, M & 0.03



Mean



178.42



184.59



199.02



209.71



222.87



232.04



246.51



257.09



266.58



±SD



8.24



9.02



8.82



8.17



9.39



9.26



10.45



10.73



10.62



n



10



10



10



10



10



10



10



10



10



G1, F & 0



Mean



169.17



172.82



178.30



183.68



190.80



195.57



200.33



203.64



208.25



±SD



7.40



7.37



8.53



10.28



10.01



10.66



11.55



11.27



11.07



n



10



10



10



10



10



10



10



10



10



G2, F & 0.001



Mean



167.60



171.44



178.13



183.92



191.08



195.60



200.77



204.55



209.39



±SD



6.08



6.53



6.93



8.15



10.18



10.96



13.55



15.67



16.01



n



10



10



10



10



10



10



10



10



10



G3, F & 0.003



Mean



168.11



171.34



176.54



182.06



188.93



193.63



198.66



202.57



207.79



±SD



4.20



3.78



5.14



5.78



7.08



8.92



9.67



9.91



9.97



n



10



10



10



10



10



10



10



10



10



G4, F & 0.01



Mean



168.05



171.50



176.61



181.97



189.28



194.60



199.69



203.74



209.20



±SD



4.80



5.82



7.47



7.77



10.19



12.28



13.18



12.47



12.39



n



10



10



10



10



10



10



10



10



10



G5, F & 0.03



Mean



169.10



172.54



177.88



183.21



190.25



194.49



200.14



204.40



209.04



±SD



5.71



6.05



7.45



8.76



10.94



12.19



11.43



13.49



13.71



n



10



10



10



10



10



10



10



10



10



 M: Male; F: Female; SD: Standard Deviation; n: Number of animals.


 



  • TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2








































































































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



36



43



50



57



64



71



78



85



89



G1, M & 0



Mean



268.53



286.06



302.17



316.94



329.47



358.31



373.62



389.40



396.27



±SD



17.53



18.93



20.67



23.41



23.63



21.47



20.30



21.73



22.30



n



10



10



10



10



10



10



10



10



10



G2, M & 0.001



Mean



278.37



295.90



312.50



329.74



343.41



373.68



388.80



405.15



412.39



±SD



11.14



14.06



19.56



24.75



24.33



22.30



21.11



25.46



24.24



n



10



10



10



10



10



10



10



10



10



G3, M & 0.003



Mean



271.47



290.02



308.39



321.40



335.17



366.09



381.88



396.39



404.29



±SD



18.38



22.47



27.82



30.11



30.68



27.66



27.61



27.22



27.46



n



10



10



10



10



10



10



10



10



10



G4, M & 0.01



Mean



281.18



298.07



318.69



332.01



346.44



374.79



390.05



404.33



413.99



±SD



11.75



9.43



11.62



12.58



12.54



13.61



13.45



13.47



12.21



n



10



10



10



10



10



10



10



10



10



G5, M & 0.03



Mean



278.20



297.51



320.45



329.47



353.83



386.35*



402.21*



418.61*



425.77*



±SD



11.15



13.63



21.28



37.61



22.13



21.27



20.72



20.80



20.70



n



10



10



10



10



10



10



10



10



10



G1, F & 0



Mean



218.52



225.49



231.32



238.59



244.95



255.28



261.20



267.37



272.80



±SD



11.93



11.81



11.31



11.02



11.48



10.91



10.77



11.29



11.18



n



10



10



10



10



10



10



10



10



10



G2, F & 0.001



Mean



217.34



223.70



231.65



237.65



243.84



259.86



262.49



269.14



275.20



±SD



17.44



17.52



16.72



16.55



16.70



18.52



18.70



18.25



18.22



n



10



10



10



10



10



10



10



10



10



G3, F & 0.003



Mean



216.66



222.43



228.13



235.11



242.70



253.07



259.73



266.14



271.06



±SD



9.56



7.55



7.43



8.08



7.95



7.31



6.65



6.53



6.32



n



10



10



10



10



10



10



10



10



10



G4, F & 0.01



Mean



216.09



223.02



230.72



236.68



243.51



256.30



262.37



269.03



274.17



±SD



13.00



12.51



9.24



8.99



8.51



7.94



8.25



8.34



8.89



n



10



10



10



10



10



10



10



10



10



G5, F & 0.03



Mean



216.56



222.52



228.31



234.70



241.05



253.04



259.25



265.37



271.24



±SD



13.13



14.26



14.61



14.74



14.71



14.90



14.12



13.77



13.56



n



10



10



10



10



10



10



10



10



10



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05)


 



  • TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2








































































































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



1



5



8



12



15



19



22



26



29



G1R-S1, M & 0



Mean



180.49



186.10



200.07



209.29



221.44



228.07



234.45



246.19



255.57



±SD



11.74



12.27



13.20



12.69



14.60



14.81



15.23



16.35



16.17



n



5



5



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



183.70



189.91



201.46



211.27



224.05



230.11



237.14



247.06



255.80



±SD



12.15



11.37



14.70



14.31



15.65



16.19



18.23



16.75



16.10



n



5



5



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



180.10



184.76



199.54



209.36



222.04



228.01



235.83



248.19



258.70



±SD



11.20



10.73



12.74



12.85



11.64



12.09



11.36



11.80



13.12



n



5



5



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



180.66



185.81



199.74



210.55



222.34



229.16



236.95



248.76



257.32



±SD



10.73



10.15



11.18



10.43



9.48



9.72



10.40



10.42



8.85



n



5



5



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



179.27



184.58



198.95



209.56



222.12



228.07



235.87



247.43



258.14



±SD



7.75



8.46



10.09



10.20



10.71



10.22



10.63



11.52



11.85



n



5



5



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



168.63



171.56



179.12



185.86



190.92



195.58



199.96



203.83



207.77



±SD



6.77



7.43



5.63



4.87



5.07



3.05



3.52



3.80



4.42



n



5



5



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



170.49



173.82



178.83



186.21



191.46



196.17



200.47



204.66



208.77



±SD



5.57



5.31



3.64



4.82



5.68



5.74



6.69



7.92



9.24



n



5



5



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



170.52



174.16



182.18



188.83



194.93



199.80



204.01



208.62



212.99



±SD



4.84



3.77



6.41



6.40



7.12



6.18



5.34



6.03



6.53



n



5



5



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



171.44



174.65



181.56



188.18



193.92



198.51



202.72



207.83



212.28



±SD



2.54



1.34



3.37



4.83



4.32



4.17



3.62



2.40



2.51



n



5



5



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



169.40



172.28



179.83



186.50



192.10



196.72



200.83



205.26



209.72



±SD



4.89



5.44



6.96



6.96



7.93



7.21



7.16



8.33



8.20



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 


TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2








































































































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



36



43



50



57



64



71



78



85



92



G1R-S1, M & 0



Mean



264.87



286.34



306.62



322.94



338.25



365.89



383.08



396.56



409.85



±SD



16.21



28.24



31.99



29.52



29.47



27.26



27.40



25.86



26.26



n



5



5



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



269.43



296.61



316.47



332.01



343.98



373.31



389.80



399.77



413.69



±SD



15.79



13.30



18.81



18.05



18.05



18.09



17.03



18.25



18.56



n



5



5



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



270.43



295.54



315.92



327.24



338.40



350.72



368.98



379.32



392.67



±SD



11.78



11.05



11.82



11.54



11.97



17.00



16.56



17.10



16.91



n



5



5



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



269.80



300.31



316.79



333.06



345.53



372.37



388.88



402.30



416.82



±SD



7.59



7.68



11.90



15.79



14.94



16.34



16.15



16.51



15.85



n



5



5



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



269.00



290.70



310.63



325.42



335.57



349.87



366.79



378.04



392.66



±SD



11.59



15.42



22.82



27.49



27.47



29.94



29.20



29.37



29.72



n



5



5



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



224.93



230.83



238.35



244.45



251.05



262.76



269.60



276.36



283.29



±SD



4.12



6.60



8.08



7.70



7.70



8.42



9.34



8.56



8.91



n



5



5



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



223.06



231.28



237.06



243.33



249.34



260.60



263.09



268.95



276.30



±SD



12.00



14.27



13.83



14.49



14.36



13.26



11.28



11.06



11.09



n



5



5



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



231.78



239.41



244.42



250.87



256.61



266.80



274.51



280.77



287.53



±SD



7.57



11.30



10.87



10.81



12.00



10.48



11.42



11.80



11.31



n



5



5



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



228.32



237.20



243.45



250.89



258.14



267.74



274.22



279.59



286.74



±SD



7.52



8.52



11.13



11.08



10.54



10.23



10.63



11.01



10.88



n



5



5



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



227.06



231.11



237.22



245.44



250.61



261.49



267.84



274.99



280.89



±SD



11.68



12.14



13.11



12.88



12.71



11.19



11.71



11.25



11.26



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 



  • TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2










































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



99



106



113



120



127



134



141



G1R-S1, M & 0



Mean



428.38



440.04



451.46



464.13



477.22



490.12



494.91



±SD



23.46



23.34



24.54



23.33



23.46



23.29



23.41



n



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



435.01



447.84



461.87



475.58



488.78



503.18



510.14



±SD



18.84



19.63



18.25



15.23



14.35



13.34



13.86



n



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



407.88



422.83



438.00



452.07



466.09



478.19



485.48



±SD



18.47



19.48



19.71



19.64



19.96



19.26



18.59



n



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



431.07



443.59



457.47



471.96



487.87



500.52



507.79



±SD



16.26



17.26



18.86



17.56



17.52



16.97



17.29



n



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



408.47



422.87



437.51



451.83



466.70



479.05



486.15



±SD



29.71



32.00



31.65



32.07



32.41



33.18



32.74



n



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



294.00



302.68



311.54



324.00



331.18



335.15



343.13



±SD



8.12



6.73



7.86



7.70



8.03



8.23



8.89



n



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



284.60



291.16



302.64



314.60



321.71



326.46



334.08



±SD



12.04



12.46



11.99



11.89



11.80



12.00



11.89



n



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



294.63



302.31



311.20



321.97



329.55



334.45



342.66



±SD



12.55



12.56



11.48



11.54



11.23



11.35



11.99



n



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



292.87



301.44



311.19



323.52



330.79



335.44



343.69



±SD



10.81



10.20



9.38



9.43



10.12



10.48



10.51



n



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



286.63



293.80



304.53



315.66



322.10



327.35



334.75



±SD



10.95



10.78



12.14



12.22



11.42



11.44



11.39



n



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 


 



  • TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2











































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



148



155



162



169



176



179



G1R-S1, M & 0



Mean



508.67



520.05



534.27



547.45



560.67



571.20



±SD



23.03



24.29



23.96



23.92



23.93



22.03



n



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



523.17



536.93



550.74



564.28



577.34



587.83



±SD



13.22



13.43



13.92



12.96



12.20



10.38



n



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



499.32



512.50



527.45



541.63



554.86



562.77



±SD



18.88



18.71



18.40



17.76



17.72



18.01



n



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



520.35



533.83



547.51



561.61



574.97



582.76



±SD



17.26



16.85



16.14



16.13



16.50



16.13



n



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



500.18



514.24



527.48



540.70



555.07



565.03



±SD



32.55



32.16



32.20



31.75



31.85



31.18



n



5



5



5



5



5



5



G1R-S1, F & 0



Mean



352.93



363.40



371.02



380.84



410.27



416.00



±SD



9.71



9.84



9.80



10.06



48.80



47.80



n



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



346.20



357.36



367.19



377.39



386.46



391.64



±SD



12.20



14.50



15.75



15.18



15.55



15.56



n



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



353.41



363.06



372.31



382.28



390.97



397.44



±SD



11.96



12.02



12.62



11.93



12.32



11.38



n



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



355.56



368.54



378.84



388.56



397.86



403.29



±SD



10.01



10.61



10.93



10.76



9.98



9.82



n



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



345.09



355.32



365.84



372.00



381.19



386.60



±SD



11.40



11.45



11.03



14.69



14.07



13.06



n



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 


 



  • TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2








































































































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



1



5



8



12



15



19



22



26



29



G1R-S2, M & 0



Mean



179.28



184.72



201.17



211.04



223.26



229.24



236.49



247.31



257.85



±SD



8.30



8.16



7.99



7.33



8.42



10.16



8.91



8.45



9.23



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



179.04



187.53



202.01



212.11



227.04



233.64



240.58



252.43



260.78



±SD



7.16



7.00



8.03



7.35



5.35



5.16



6.53



9.25



5.66



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



179.63



185.00



200.25



211.05



224.21



230.41



237.83



249.15



259.06



±SD



7.12



5.75



6.92



6.62



8.53



8.79



9.29



10.06



10.75



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



179.33



186.27



200.91



210.55



225.22



229.65



236.76



247.95



257.97



±SD



7.66



7.32



8.86



8.68



9.79



10.36



8.99



10.54



11.36



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



182.11



188.27



203.61



214.95



227.25



233.52



241.09



253.24



263.84



±SD



4.03



3.47



5.55



4.80



5.78



5.44



4.53



3.81



3.66



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



172.09



175.16



181.36



188.23



192.40



196.98



201.73



206.82



211.16



±SD



6.13



4.64



2.84



3.98



5.27



6.71



6.63



7.21



5.89



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



172.84



176.09



182.08



188.73



194.03



199.21



203.67



208.56



212.37



±SD



2.60



2.16



4.23



7.83



7.42



6.90



6.82



7.24



8.26



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



173.23



176.14



182.70



190.49



196.51



201.58



207.96



212.86



216.96



±SD



7.10



7.72



7.66



6.73



6.92



6.61



8.67



9.70



9.74



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



171.19



174.51



181.38



188.55



193.67



198.94



203.39



208.43



213.14



±SD



8.21



7.43



7.38



11.71



12.25



11.75



11.25



11.74



12.13



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



171.08



174.81



180.97



188.31



193.60



198.63



203.09



208.28



213.56



±SD



2.71



3.76



5.37



7.42



8.19



7.46



6.90



6.51



6.72



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


 



  • TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2








































































































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



36



43



50



57



64



71



78



85



92



G1R-S2, M & 0



Mean



271.10



301.04



320.25



334.60



346.29



373.49



388.79



402.28



416.22



±SD



6.83



9.34



16.13



19.17



19.48



21.32



20.64



19.74



19.73



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



272.03



299.98



322.31



333.61



349.06



381.25



395.57



409.07



423.55



±SD



5.76



11.90



18.93



20.97



23.19



19.09



18.00



16.77



16.16



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



270.06



298.66



323.79



342.98



354.24



365.11



378.52



391.07



405.72



±SD



10.09



13.52



20.88



27.14



27.43



26.92



26.27



28.80



28.41



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



268.54



300.05



324.75



342.32



356.01



387.11



400.56



412.72



426.71



±SD



10.94



14.96



21.93



27.34



27.59



24.40



24.02



25.69



25.77



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



273.21



305.37



329.30



344.09



355.54



370.77



382.32



393.97



408.71



±SD



4.66



8.26



18.34



21.55



21.20



26.02



24.94



26.24



27.03



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



224.14



230.23



237.04



242.91



249.50



261.98



268.45



274.38



282.37



±SD



14.02



16.35



17.25



16.17



15.94



16.18



15.91



15.85



15.63



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



228.70



238.88



245.11



250.03



257.49



267.56



272.58



278.59



284.99



±SD



9.05



12.60



14.47



14.99



14.01



14.74



14.81



15.33



15.38



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



236.89



244.50



250.17



257.48



263.56



274.86



282.38



288.94



294.92



±SD



7.90



5.28



5.89



4.45



4.49



5.00



4.97



4.73



5.00



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



227.39



236.81



246.57



253.58



259.49



270.85



277.65



283.32



290.04



±SD



14.34



17.01



19.32



18.15



17.74



18.25



18.41



18.74



18.84



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



228.77



236.80



241.70



249.02



254.43



264.79



270.83



277.88



285.58



±SD



13.34



17.64



17.78



18.75



18.72



18.51



18.39



18.40



17.45



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2








































































































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



99



106



113



120



127



134



141



148



155



G1R-S2, M & 0



Mean



432.45



446.43



464.36



479.38



494.05



506.55



511.83



525.83



539.87



±SD



19.55



19.88



17.67



16.90



17.35



17.34



17.52



16.55



16.96



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



441.48



456.80



474.38



488.89



502.38



515.51



522.52



537.36



550.70



±SD



12.04



15.20



13.60



13.26



12.87



12.02



13.11



10.09



10.49



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



422.25



436.54



454.46



470.10



485.35



497.74



503.93



517.69



531.64



±SD



28.22



28.56



28.97



25.64



26.43



27.01



26.30



26.86



26.84



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



442.57



459.75



474.48



489.33



503.09



515.98



522.97



537.06



551.99



±SD



25.77



26.82



24.92



22.45



22.15



21.28



21.02



19.75



20.81



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



427.54



443.78



460.74



475.19



489.32



501.46



508.99



521.90



536.69



±SD



26.94



26.19



25.30



22.35



22.95



22.95



23.10



23.12



22.40



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



288.53



296.49



306.59



319.45



326.87



331.56



339.05



351.14



362.65



±SD



15.42



14.16



15.03



15.61



15.02



14.71



14.31



14.16



13.91



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



292.47



298.98



308.76



320.40



328.06



332.62



339.90



351.74



364.02



±SD



14.81



14.42



13.49



12.87



13.13



13.74



13.45



12.82



13.69



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



301.18



308.09



318.45



329.46



336.54



341.12



348.84



359.40



371.43



±SD



5.87



5.65



5.63



5.31



6.02



5.66



6.14



7.45



8.07



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



296.12



303.00



313.06



325.23



332.03



336.93



343.85



356.74



366.91



±SD



19.21



18.75



17.74



18.84



19.23



19.39



18.70



19.28



19.22



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



294.01



301.29



311.23



323.82



329.99



334.97



341.24



354.07



366.58



±SD



16.61



16.74



14.76



14.14



13.78



13.98



14.38



13.79



13.49



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2








































































































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



162



169



176



183



190



197



204



211



218



G1R-S2, M & 0



Mean



554.40



569.11



582.97



597.28



610.38



623.56



636.28



649.14



661.36



±SD



16.56



16.18



14.38



14.48



13.39



13.06



13.43



13.52



12.83



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



565.04



578.61



594.12



608.48



620.84



632.69



646.26



656.02



667.31



±SD



10.21



10.55



11.30



9.97



9.65



9.14



9.50



8.48



8.55



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



545.49



558.03



571.33



584.94



597.66



609.25



622.76



633.09



645.43



±SD



26.94



26.46



26.44



27.16



27.34



27.18



27.06



30.11



30.15



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



565.14



578.49



592.92



606.93



620.12



632.13



645.17



658.33



669.94



±SD



20.14



19.34



21.01



20.68



19.43



19.29



19.52



19.20



19.54



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



550.21



564.08



579.68



595.29



607.01



619.28



630.20



643.30



655.39



±SD



22.23



22.46



21.69



23.05



22.40



22.66



22.04



21.58



22.70



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



373.29



381.72



390.40



398.88



408.60



416.14



423.65



431.03



437.52



±SD



12.62



12.15



11.78



11.65



12.03



11.52



11.26



11.38



11.69



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



359.58



383.56



393.27



401.36



409.62



417.01



425.21



433.01



438.99



±SD



35.96



14.40



13.63



14.28



13.50



13.57



12.76



12.74



13.56



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



382.10



390.46



398.54



406.48



415.37



422.73



430.36



437.84



444.17



±SD



8.59



9.21



9.14



8.75



8.69



8.51



8.29



8.48



8.60



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



374.54



382.74



391.05



399.53



407.99



414.07



422.13



429.85



435.78



±SD



19.37



19.42



18.44



18.79



19.18



18.90



18.86



18.78



19.09



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



374.22



382.08



391.36



399.68



408.14



414.69



421.72



429.76



436.57



±SD



13.31



13.39



13.46



13.74



14.31



13.99



13.68



13.13



12.85



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


TABLE 2 (Contd...). SUMMARY OF BODY WEIGHTS (g) RECORD


  Refer Appendix 2









































































































































































































































































































































































 Group, Sex & Dose (mg/L)


 

Body Weight (g) on Days



225



232



239



246



253



260



267



269



G1R-S2, M & 0



Mean



670.16



676.42



682.13



690.05



698.99



705.18



711.46



714.99



±SD



12.52



13.26



12.29



8.91



8.51



9.41



8.61



8.63



n



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



676.95



683.22



686.79



694.51



705.64



713.39



718.98



722.65



±SD



8.31



8.47



7.72



6.80



7.25



7.35



7.99



8.50



n



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



649.71



655.47



660.17



674.95



683.29



690.89



696.75



700.28



±SD



32.62



31.85



30.68



32.39



32.89



32.26



32.00



31.66



n



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



678.39



683.60



688.38



699.77



709.67



717.38



723.64



727.23



±SD



18.40



17.93



18.27



21.94



20.36



19.38



20.52



20.56



n



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



663.55



669.06



672.69



687.85



694.80



703.04



708.51



711.55



±SD



22.88



22.48



22.56



22.59



23.60



23.69



23.78



23.51



n



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



441.23



444.52



453.91



458.56



463.20



467.56



472.74



475.05



±SD



11.83



11.70



13.20



13.38



13.83



13.86



13.38



13.52



n



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



443.15



447.97



457.44



462.94



467.80



471.36



476.93



480.06



±SD



13.66



13.98



14.92



14.97



14.69



14.34



13.57



13.32



n



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



447.35



452.66



468.23



473.10



477.21



480.62



485.62



488.14



±SD



8.85



9.04



13.02



13.42



13.35



13.79



13.69



13.98



n



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



439.44



443.30



461.63



467.92



472.64



476.62



481.05



483.40



±SD



19.28



18.97



17.70



16.50



17.00



17.18



16.87



16.38



n



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



440.20



444.66



458.80



462.97



468.78



472.67



477.51



480.03



±SD



12.50



12.69



12.04



11.63



10.96



10.94



11.16



11.64



n



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


 



  • SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3









































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to 5



1 to 8



1 to 12



1 to 15



1 to 19



1 to 22



1 to 26



1 to 29



G1, M & 0



Mean



3.20



10.16



16.01



22.69



28.18



35.23



41.46



46.62



±SD



1.17



1.98



2.46



3.08



3.26



4.16



5.70



6.59



n



10



10



10



10



10



10



10



10



G2, M & 0.001



Mean



3.98



11.60



17.59



24.58



30.58



38.41



44.47



49.98



±SD



0.71



0.82



1.45



2.11



2.66



3.52



5.13



6.03



n



10



10



10



10



10



10



10



10



G3, M & 0.003



Mean



3.52



9.77



15.17



21.23



26.95



34.49



40.59



45.67



±SD



1.13



1.48



1.82



2.69



3.42



4.18



4.73



5.92



n



10



10



10



10



10



10



10



10



G4, M & 0.01



Mean



3.76



11.31



17.20



25.31



30.65



38.52



44.90



50.27



±SD



1.03



1.72



2.07



3.44



3.97



4.29



5.37



5.71



n



10



10



10



10



10



10



10



10



G5, M & 0.03



Mean



3.46



11.58



17.60



24.98



30.14



38.28



44.23



49.58



±SD



1.38



2.37



2.53



3.59



3.87



5.28



5.92



6.75



n



10



10



10



10



10



10



10



10



G1, F & 0



Mean



2.16



5.39



8.55



12.78



15.62



18.41



20.39



23.13



±SD



0.76



1.77



2.64



3.15



4.14



4.18



4.43



4.49



n



10



10



10



10



10



10



10



10



G2, F & 0.001



Mean



2.29



6.28



9.74



14.01



16.73



19.81



22.06



24.94



±SD



1.11



1.34



2.83



4.48



5.77



7.38



8.53



8.66



n



10



10



10



10



10



10



10



10



G3, F & 0.003



Mean



1.94



5.02



8.32



12.40



15.20



18.19



20.54



23.65



±SD



1.17



1.99



2.94



3.60



4.97



5.30



6.10



6.10



n



10



10



10



10



10



10



10



10



G4, F & 0.01



Mean



2.04



5.07



8.26



12.61



15.77



18.78



21.19



24.44



±SD



0.98



2.05



2.61



4.64



6.02



6.16



5.57



5.44



n



10



10



10



10



10



10



10



10



G5, F & 0.03



Mean



2.03



5.19



8.34



12.51



15.00



18.35



20.86



23.62



±SD



1.21



2.72



3.84



5.27



5.91



5.46



6.80



7.11



n



10



10



10



10



10



10



10



10



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/L)


 

Percent Change in Body Weight (%) during Days



1 to 36



1 to 43



1 to 50



1 to 57



1 to 64



1 to 71



1 to 78



1 to 85



1 to 89



G1, M & 0



Mean



52.65



62.62



71.78



80.23



87.35



103.80



112.51



121.47



125.37



±SD



7.48



7.99



8.77



11.33



11.28



10.83



10.09



10.45



10.59



n



10



10



10



10



10



10



10



10



10



G2, M & 0.001



Mean



56.00



65.85



75.17



84.88



92.55



109.59



118.07



127.25



131.29



±SD



6.03



8.27



11.68



15.21



15.23



15.49



15.07



17.35



16.63



n



10



10



10



10



10



10



10



10



10



G3, M & 0.003



Mean



51.39



61.76



71.99



79.28



86.97



104.27



113.07



121.19



125.60



±SD



6.63



9.56



12.79



14.58



14.78



13.17



12.84



12.86



12.78



n



10



10



10



10



10



10



10



10



10



G4, M & 0.01



Mean



56.63



66.22



77.72



85.16



93.21



108.95



117.44



125.41



130.88



±SD



6.09



9.46



10.52



11.35



11.67



11.24



11.12



11.40



13.02



n



10



10



10



10



10



10



10



10



10



G5, M & 0.03



Mean



56.07



66.93



79.77



85.20



98.50



116.82



125.71



134.92



138.94



±SD



6.19



8.27



11.81



23.48



12.35



13.43



13.17



13.43



13.46



n



10



10



10



10



10



10



10



10



10



G1, F & 0



Mean



29.22



33.33



36.79



41.10



44.87



50.99



54.50



58.14



61.35



±SD



5.34



4.94



4.78



4.82



5.49



5.22



5.12



5.31



5.14



n



10



10



10



10



10



10



10



10



10



G2, F & 0.001



Mean



29.74



33.55



38.28



41.88



45.57



55.12



56.70



60.67



64.29



±SD



10.31



10.70



9.95



10.06



10.13



11.05



11.27



10.99



10.96



n



10



10



10



10



10



10



10



10



10



G3, F & 0.003



Mean



28.92



32.36



35.76



39.91



44.44



50.61



54.58



58.39



61.33



±SD



5.83



4.74



4.78



5.30



5.66



5.45



5.25



5.11



5.27



n



10



10



10



10



10



10



10



10



10



G4, F & 0.01



Mean



28.54



32.69



37.35



40.89



44.95



52.58



56.18



60.17



63.21



±SD



5.79



5.92



5.53



5.34



4.97



4.90



4.86



5.68



5.42



n



10



10



10



10



10



10



10



10



10



G5, F & 0.03



Mean



28.09



31.63



35.05



38.83



42.59



49.69



53.37



56.99



60.45



±SD



6.99



8.11



8.12



8.34



8.19



8.48



8.07



7.80



7.42



n



10



10



10



10



10



10



10



10



10



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/L)


 

Percent Change in Body Weight (%) during Days



1 to


5



1 to


8



1 to 12



1 to 15



1 to 19



1 to 22



1 to 26



1 to 29



1 to 36



G1R-S1, M & 0



Mean



3.11



10.85



15.99



22.69



26.37



29.90



36.44



41.66



46.88



±SD



1.04



1.26



1.34



1.63



1.90



2.16



4.30



4.16



6.15



n



5



5



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



3.42



9.64



15.01



21.97



25.28



29.06



34.53



39.34



46.79



±SD



1.04



2.16



2.21



2.98



3.87



4.31



4.63



5.35



5.25



n



5



5



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



2.61



10.82



16.30



23.42



26.71



31.07



37.94



43.77



50.37



±SD



1.41



3.12



3.81



5.10



4.27



4.26



4.19



4.68



6.23



n



5



5



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



2.88



10.58



16.61



23.17



26.94



31.26



37.83



42.66



49.62



±SD



1.40



1.42



2.48



2.13



2.28



2.72



3.58



5.73



6.59



n



5



5



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



2.95



10.95



16.87



23.88



27.22



31.57



38.03



44.01



50.08



±SD



0.94



0.88



0.86



1.46



1.36



1.54



2.73



2.98



3.17



n



5



5



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



1.73



6.25



10.28



13.28



16.11



18.70



20.99



23.32



33.54



±SD



1.21



0.98



2.35



2.25



4.34



4.34



4.12



4.12



5.31



n



5



5



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



1.97



4.94



9.25



12.31



15.09



17.59



20.03



22.43



30.79



±SD



1.20



1.97



1.56



0.65



1.55



1.71



1.55



2.52



4.03



n



5



5



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



2.16



6.82



10.74



14.32



17.19



19.66



22.36



24.92



36.04



±SD



1.27



0.83



2.17



2.73



2.59



2.26



2.06



2.13



6.54



n



5



5



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



1.88



5.93



9.81



13.15



15.84



18.28



21.25



23.85



33.17



±SD



1.05



2.82



4.26



3.89



4.02



3.50



2.80



2.87



3.37



n



5



5



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



1.69



6.14



10.09



13.38



16.12



18.56



21.16



23.80



34.09



±SD



1.27



2.06



2.20



2.56



2.49



2.95



3.31



3.54



7.17



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 



  • TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3








































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to 43



1 to 50



1 to 57



1 to 64



1 to 71



1 to 78



1 to 85



1 to 92



1 to 99



G1R-S1, M & 0



Mean



58.46



69.63



78.87



87.47



102.89



112.46



119.99



127.39



137.82



±SD



8.79



9.87



10.67



12.32



12.18



12.77



12.68



13.32



14.67



n



5



5



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



61.83



72.89



81.45



87.98



103.98



112.98



118.31



125.90



137.55



±SD



9.33



15.38



16.38



16.67



17.15



17.21



16.01



16.13



16.96



n



5



5



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



64.34



75.75



82.07



88.28



95.17



105.32



111.11



118.57



127.01



±SD



5.86



8.70



9.23



9.63



12.70



12.55



13.73



14.42



14.87



n



5



5



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



66.50



75.77



84.72



91.65



106.55



115.75



123.15



131.22



139.14



±SD



5.88



10.85



11.39



11.31



12.73



13.65



13.20



13.57



14.33



n



5



5



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



62.28



73.49



81.73



87.42



95.33



104.76



111.08



119.24



128.07



±SD



8.58



14.26



16.38



16.61



17.02



16.48



17.04



17.26



17.40



n



5



5



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



37.08



41.62



45.22



49.14



56.11



60.18



64.19



68.30



74.63



±SD



7.04



9.36



8.96



9.28



9.93



10.63



10.26



10.55



9.92



n



5



5



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



35.60



39.00



42.68



46.20



52.82



54.32



57.76



62.07



66.92



±SD



5.44



5.24



5.65



5.35



4.34



4.12



4.08



3.89



3.46



n



5



5



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



40.58



43.52



47.31



50.68



56.66



61.17



64.86



68.82



72.98



±SD



9.57



9.41



9.43



10.10



9.59



9.91



10.39



10.26



10.70



n



5



5



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



38.33



41.96



46.30



50.53



56.13



59.91



63.04



67.21



70.79



±SD



3.16



4.65



4.44



4.13



3.80



4.00



4.22



4.11



4.02



n



5



5



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



36.49



40.06



44.92



47.98



54.40



58.15



62.36



65.85



69.27



±SD



7.45



7.29



7.26



7.31



6.37



6.65



6.08



6.20



6.87



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 



  • TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3











































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to 106



1 to 113



1 to 120



1 to 127



1 to 134



1 to 141



G1R-S1, M & 0



Mean



144.25



150.49



157.52



164.81



171.98



174.63



±SD



13.89



12.39



11.43



12.17



12.36



12.06



n



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



144.55



152.23



159.73



166.93



174.79



178.59



±SD



17.49



17.65



17.51



17.50



17.63



18.08



n



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



135.33



143.72



151.54



159.34



166.09



170.17



±SD



15.65



14.93



14.80



15.14



15.31



15.72



n



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



146.04



153.73



161.80



170.66



177.67



181.71



±SD



13.82



14.62



14.87



16.03



15.83



16.17



n



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



136.14



144.30



152.32



160.62



167.52



171.47



±SD



19.07



18.85



19.43



19.69



20.17



19.67



n



5



5



5



5



5



5



G1R-S1, F & 0



Mean



79.79



85.05



92.43



96.69



99.04



103.79



±SD



9.91



10.29



10.09



10.22



10.30



10.88



n



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



70.76



77.51



84.53



88.71



91.49



95.97



±SD



3.49



3.23



3.31



3.60



3.58



3.64



n



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



77.48



82.70



89.02



93.47



96.34



101.15



±SD



10.49



10.31



10.61



10.56



10.57



10.82



n



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



75.80



81.49



88.68



92.92



95.63



100.44



±SD



3.72



3.20



3.13



3.53



3.75



3.71



n



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



73.49



79.80



86.37



90.18



93.30



97.67



±SD



6.23



6.20



6.13



5.88



6.52



6.61



n



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 


TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3











































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to 148



1 to 155



1 to 162



1 to 169



1 to 176



1 to 179



G1R-S1, M & 0



Mean



182.30



188.57



196.47



203.81



211.17



217.07



±SD



12.73



12.14



12.21



12.92



13.55



13.97



n



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



185.72



193.23



200.77



208.18



215.30



220.97



±SD



18.64



18.94



19.37



19.87



19.87



18.77



n



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



177.86



185.22



193.56



201.45



208.81



213.18



±SD



15.92



16.57



17.27



17.17



17.37



16.93



n



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



188.66



196.15



203.74



211.57



218.98



223.27



±SD



16.17



16.56



16.66



17.08



17.55



16.76



n



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



179.30



187.15



194.53



201.93



209.94



215.48



±SD



19.65



19.60



19.45



19.69



19.52



18.87



n



5



5



5



5



5



5



G1R-S1, F & 0



Mean



109.60



115.79



120.30



126.19



143.45



146.85



±SD



10.95



10.63



10.49



12.09



28.41



27.84



n



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



103.09



109.61



115.36



121.35



126.68



129.73



±SD



4.06



4.82



4.86



4.35



4.80



5.29



n



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



107.45



113.12



118.56



124.38



129.49



133.28



±SD



10.56



10.94



11.56



10.73



11.32



10.91



n



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



107.37



114.94



120.95



126.61



132.05



135.21



±SD



3.43



3.50



3.63



3.42



2.90



2.68



n



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



103.75



109.79



116.00



119.70



125.13



128.35



±SD



5.89



5.39



5.38



9.65



9.43



9.55



n



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 



  • TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3








































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to


5



1 to


8



1 to 12



1 to 15



1 to 19



1 to 22



1 to 26



1 to 29



1 to 36



G1R-S2, M & 0



Mean



3.04



12.24



17.77



24.57



27.88



31.96



38.04



43.91



51.34



±SD



0.94



1.06



1.63



1.64



1.24



1.99



3.67



3.83



3.74



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



4.76



12.84



18.51



26.90



30.62



34.51



41.12



45.82



52.13



±SD



1.94



1.64



2.39



3.55



4.50



5.45



6.14



6.04



6.79



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



3.03



11.52



17.54



24.85



28.30



32.45



38.74



44.27



50.40



±SD



1.72



2.42



1.98



2.87



2.85



3.91



4.01



4.37



4.17



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



3.89



12.04



17.43



25.61



28.08



32.06



38.29



43.87



49.81



±SD



1.28



1.67



1.60



2.46



2.88



2.13



2.74



3.08



4.30



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



3.40



11.80



18.04



24.79



28.24



32.41



39.08



44.91



50.05



±SD



1.42



1.01



1.72



1.35



2.13



2.52



1.35



1.87



2.28



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



1.82



5.46



9.48



11.92



14.61



17.36



20.32



22.85



30.45



±SD



1.30



2.91



4.22



5.24



6.31



6.22



6.41



6.09



10.43



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



1.89



5.36



9.22



12.28



15.28



17.86



20.68



22.88



32.29



±SD



1.23



2.66



4.86



4.67



4.43



4.38



4.34



4.84



3.88



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



1.68



5.48



10.00



13.47



16.40



20.06



22.88



25.24



36.84



±SD



1.25



2.39



2.14



1.22



1.52



1.85



2.62



1.94



4.53



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



1.97



5.99



10.10



13.09



16.18



18.79



21.73



24.48



32.79



±SD



1.29



1.83



2.38



2.83



2.32



2.16



2.18



2.38



4.13



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



2.17



5.79



10.08



13.18



16.12



18.73



21.76



24.84



33.71



±SD



1.29



3.15



4.45



4.85



4.52



4.30



3.93



3.80



7.37



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.
TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3








































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to 43



1 to 50



1 to 57



1 to 64



1 to 71



1 to 78



1 to 85



1 to 92



1 to 99



G1R-S2, M & 0



Mean



68.07



78.75



86.77



93.31



108.46



117.01



124.56



132.34



141.43



±SD



5.59



8.04



10.32



10.54



10.93



10.74



10.71



10.68



11.04



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



67.57



79.96



86.24



94.84



112.93



120.97



128.52



136.64



146.73



±SD



2.89



5.68



6.11



7.05



5.90



5.92



5.12



5.51



6.06



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



66.29



80.27



90.80



97.07



103.28



110.76



117.74



125.89



135.13



±SD



4.80



9.48



10.21



10.16



12.88



12.69



13.79



13.19



13.81



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



67.36



81.13



90.89



98.57



115.96



123.47



130.25



138.06



146.91



±SD



6.20



10.46



13.20



14.14



12.57



12.39



13.26



13.27



13.14



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



67.76



80.86



88.96



95.26



103.61



109.97



116.35



124.45



134.81



±SD



6.04



10.12



11.34



11.27



13.90



13.49



13.92



14.32



14.70



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



34.00



37.96



41.34



45.17



52.41



56.17



59.62



64.27



67.84



±SD



11.70



12.17



11.35



11.14



11.15



11.02



11.03



11.09



10.85



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



38.16



41.75



44.59



48.91



54.73



57.64



61.12



64.82



69.15



±SD



5.76



6.57



6.63



6.02



6.46



6.41



6.66



6.65



6.21



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



41.27



44.55



48.80



52.31



58.84



63.19



66.98



70.43



74.04



±SD



4.71



4.88



5.51



5.74



5.78



6.06



6.03



6.07



6.27



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



38.30



44.03



48.14



51.60



58.23



62.21



65.53



69.46



73.02



±SD



6.93



9.06



8.27



8.07



8.00



8.19



8.39



8.51



8.75



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



38.41



41.27



45.55



48.71



54.77



58.30



62.43



66.91



71.85



±SD



10.02



10.08



10.66



10.62



10.52



10.47



10.54



9.63



9.26



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3








































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to 106



1 to 113



1 to 120



1 to 127



1 to 134



1 to 141



1 to 148



1 to 155



1 to 162



G1R-S2, M & 0



Mean



149.24



159.34



167.74



175.94



182.93



185.88



193.68



201.52



209.64



±SD



11.49



12.91



13.03



13.52



13.84



14.02



13.52



13.73



13.86



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



155.24



165.07



173.19



180.75



188.11



192.01



200.38



207.83



215.86



±SD



5.48



4.62



4.90



5.55



6.25



5.85



8.13



8.23



9.01



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



143.07



153.05



161.81



170.31



177.22



180.68



188.33



196.10



203.84



±SD



13.48



13.54



12.50



13.20



13.68



13.52



13.54



13.39



13.91



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



156.48



164.72



173.04



180.73



187.94



191.83



199.70



208.04



215.39



±SD



13.40



12.53



11.79



12.02



11.87



11.60



10.94



11.84



11.88



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



143.72



153.05



160.99



168.74



175.41



179.55



186.65



194.76



202.19



±SD



14.02



13.86



12.29



12.53



12.39



12.64



12.77



12.19



12.30



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



72.48



78.35



85.82



90.13



92.85



97.21



104.24



110.95



117.15



±SD



10.54



10.97



11.20



10.87



10.63



10.52



10.60



10.79



10.90



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



72.92



78.59



85.32



89.76



92.39



96.60



103.46



110.56



108.05



±SD



6.00



5.49



5.07



5.21



5.45



5.20



4.79



5.28



20.49



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



78.04



84.02



90.40



94.50



97.14



101.61



107.70



114.65



120.82



±SD



6.50



6.54



7.08



7.49



7.33



7.71



7.94



8.45



8.89



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



77.04



82.94



90.04



94.01



96.87



100.93



108.45



114.41



118.88



±SD



8.24



7.96



8.33



8.36



8.33



7.93



8.03



8.15



8.38



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



76.10



81.91



89.28



92.88



95.80



99.46



106.97



114.28



118.75



±SD



9.20



8.01



7.79



7.58



7.69



7.86



7.66



7.55



7.49



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3








































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to 169



1 to 176



1 to 183



1 to 90



1 to 97



1 to 204



1 to 211



1 to 218



1 to 225



G1R-S2, M & 0



Mean



217.84



225.58



233.56



240.86



248.23



255.33



262.52



269.36



274.27



±SD



13.51



13.09



12.82



12.33



12.61



13.02



13.15



13.84



13.86



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



223.45



232.13



240.16



247.08



253.72



261.29



266.76



273.07



278.48



±SD



9.59



10.01



10.27



10.61



11.04



10.94



11.20



11.45



12.33



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



210.84



218.25



225.83



232.90



239.37



246.91



252.65



259.52



261.86



±SD



14.01



14.31



14.62



14.31



14.46



14.78



16.32



16.17



16.53



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



222.85



230.87



238.73



246.10



252.81



260.08



267.45



273.91



278.66



±SD



11.95



11.83



12.83



12.51



13.04



13.00



13.75



13.33



13.88



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



209.81



218.38



226.96



233.39



240.12



246.12



253.32



259.95



264.44



±SD



12.42



12.06



13.02



12.19



12.36



12.04



11.81



12.30



12.43



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



122.05



127.08



132.02



137.67



142.06



146.42



150.71



154.49



156.65



±SD



10.65



10.11



10.40



10.62



10.55



10.45



10.65



11.07



11.16



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



121.87



127.50



132.17



136.96



141.24



145.98



150.50



153.96



156.37



±SD



5.71



5.35



5.71



5.26



5.39



4.95



4.95



5.39



5.50



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



125.66



130.33



134.92



140.07



144.32



148.73



153.05



156.71



158.56



±SD



9.47



9.45



9.59



10.01



9.97



10.37



10.24



10.60



10.89



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



123.67



128.53



133.49



138.45



142.00



146.72



151.24



154.70



156.83



±SD



8.25



7.66



7.89



8.46



8.17



8.21



8.22



8.27



8.25



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



123.35



128.77



133.63



138.58



142.40



146.52



151.22



155.20



157.33



±SD



7.61



7.52



7.70



7.87



7.59



7.64



7.28



7.35



7.40



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


TABLE 3 (Contd...). SUMMARY OF PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1 RECORD


Refer Appendix 3










































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Percent Change in Body Weight (%) during Days



1 to 232



1 to 239



1 to 246



1 to 253



1 to 260



1 to 267



1 to 269



G1R-S2, M & 0



Mean



277.77



280.97



285.49



290.47



293.91



297.43



299.41



±SD



14.22



14.45



16.69



16.42



16.14



16.51



16.84



n



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



281.98



283.99



288.32



294.54



298.86



301.98



304.02



±SD



12.23



12.49



13.17



13.08



12.80



12.71



12.69



n



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



265.08



267.71



275.93



280.58



284.81



288.09



290.05



±SD



16.14



15.84



16.55



16.71



16.43



16.48



16.20



n



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



281.57



284.22



290.55



296.09



300.41



303.90



305.91



±SD



13.83



13.40



14.07



13.88



13.91



14.41



14.75



n



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



267.46



269.45



277.75



281.55



286.07



289.08



290.75



±SD



11.98



11.90



10.65



10.61



10.51



10.75



10.81



n



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



158.55



163.97



166.66



169.35



171.89



174.91



176.25



±SD



10.81



10.31



10.14



9.95



10.06



10.01



10.19



n



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



159.15



164.62



167.81



170.62



172.68



175.92



177.73



±SD



5.52



5.93



6.12



5.87



5.57



5.36



5.24



n



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



161.63



170.66



173.44



175.82



177.78



180.66



182.11



±SD



11.08



13.48



12.84



13.03



12.97



12.59



12.53



n



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



159.10



169.88



173.59



176.34



178.67



181.26



182.65



±SD



8.31



9.52



9.86



9.72



9.96



9.95



10.02



n



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



159.93



168.24



170.68



174.07



176.35



179.17



180.65



±SD



7.21



8.59



8.54



8.20



8.19



8.10



8.19



n



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.



  • SUMMARY OF AVERAGE FEED CONSUMPTION (g/rat/day) RECORD


  Refer Appendix 4

































































































































































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Week 1



Week 2



Week 3



Week 4



Week 5



Week 6



Week 7



Week 8



Week 9



Week 10



Week 11



Week 12



Week 13



G1, M & 0



Mean



20.56



20.47



20.31



20.33



22.09



22.19



24.74



24.63



24.66



24.43



24.26



24.49



27.25



±SD



0.28



0.06



0.15



0.04



0.20



0.10



0.49



0.43



0.26



0.25



0.32



0.16



0.82



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G2, M & 0.001



Mean



20.51



20.48



20.14



20.16



22.10



22.17



25.00



25.01



25.01



24.84



24.62



24.54



27.25



±SD



0.11



0.07



0.10



0.11



0.17



0.18



0.33



0.15



0.11



0.25



0.30



0.24



1.06



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G3, M & 0.003



Mean



20.60



20.44



20.36



20.25



22.20



22.26



24.89



24.73



24.60



24.42



24.40



24.78



27.02



±SD



0.15



0.15



0.15



0.19



0.25



0.20



0.29



0.25



0.26



0.27



0.15



0.22



0.98



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G4, M & 0.01



Mean



20.39



20.36



20.17



20.25



22.24



22.35



25.07



24.71



24.83



24.61



24.48



24.62



27.04



±SD



0.13



0.08



0.11



0.18



0.10



0.17



0.27



0.23



0.19



0.39



0.29



0.31



0.71



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G5, M & 0.03



Mean



20.64



20.51



20.33



20.28



22.22



22.41



25.02



24.67



24.56



24.34



24.12



24.25



27.47



±SD



0.18



0.06



0.14



0.18



0.23



0.23



0.32



0.46



0.21



0.18



0.21



0.24



0.37



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G1, F & 0



Mean



15.84



15.64



15.59



15.93



15.81



17.02



17.03



17.02



17.23



17.09



17.20



17.14



26.99



±SD



0.15



0.15



0.18



0.28



0.12



0.24



0.11



0.13



0.28



0.20



0.29



0.16



0.44



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G2, F & 0.001



Mean



15.80



15.65



15.79



15.83



15.82



17.02



17.18



17.00



17.03



17.27



17.26



17.14



27.66



±SD



0.08



0.23



0.44



0.25



0.09



0.27



0.29



0.11



0.17



0.16



0.26



0.26



0.42



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G3, F & 0.003



Mean



15.84



15.72



15.88



15.93



15.86



16.95



17.03



16.86



17.07



16.77



16.94



17.00



27.02



±SD



0.17



0.23



0.23



0.30



0.18



0.42



0.26



0.31



0.43



0.31



0.23



0.27



0.46



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G4, F & 0.01



Mean



15.84



15.73



15.69



15.80



15.73



17.04



17.10



16.97



16.96



16.53*



16.99



16.87



26.93



±SD



0.17



0.23



0.30



0.31



0.17



0.34



0.30



0.17



0.33



0.24



0.24



0.26



0.75



n



5



5



5



5



5



5



5



5



5



5



5



5



5



G5, F & 0.03



Mean



15.87



15.69



15.59



15.75



15.95



17.11



17.17



17.06



16.92



16.81



17.08



17.13



27.47



±SD



0.19



0.22



0.15



0.36



0.33



0.32



0.19



0.22



0.38



0.23



0.40



0.44



1.09



n



5



5



5



5



5



5



5



5



5



5



5



5



5



 M: Male; F: Female; SD: Standard Deviation; n: number of cages.


 



  • TABLE 4 (Contd...). SUMMARY OF AVERAGE FEED CONSUMPTION (g/rat/day) RECORD


  Refer Appendix 4

































































































































































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Week 1



Week 2



Week 3



Week 4



Week 5



Week 6



Week 7



Week 8



Week 9



Week 10



Week 11



Week 12



Week 13



G1R-S1, M & 0



Mean



24.27



24.35



24.16



24.20



26.37



26.18



29.30



29.07



28.75



28.46



28.26



28.59



28.28



±SD



7.03



6.84



6.76



6.72



7.06



7.02



7.31



7.08



7.03



6.92



6.64



6.79



6.71



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S1, M & 0.001



Mean



24.72



24.50



24.25



24.26



26.40



26.29



28.61



28.05



28.94



28.27



28.22



28.58



28.51



±SD



7.13



6.94



6.99



6.85



7.39



7.12



7.14



6.52



6.97



6.74



6.49



6.92



6.80



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S1, M & 0.003



Mean



24.35



24.12



24.15



24.01



26.15



26.34



28.42



28.62



28.41



28.23



28.34



28.70



28.17



±SD



6.74



6.59



6.86



6.60



6.98



7.10



6.40



7.48



7.18



7.04



7.00



7.31



6.77



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S1, M & 0.01



Mean



24.41



24.32



24.16



24.08



26.54



26.46



28.21



28.66



28.58



28.69



28.25



28.46



28.63



±SD



7.14



6.89



6.82



6.59



7.47



6.97



6.38



7.47



7.36



7.62



7.40



6.97



7.40



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S1, M & 0.03



Mean



24.45



24.10



24.12



24.14



26.49



26.70



28.51



28.57



28.59



28.45



28.10



28.20



28.51



±SD



6.74



6.60



6.86



6.79



7.57



7.74



6.37



7.35



7.14



7.67



7.14



6.79



7.49



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G1R-S1, F & 0



Mean



17.20



16.78



16.72



16.26



16.30



17.03



17.45



18.21



17.87



17.92



17.74



18.15



18.03



±SD



1.89



1.68



1.59



0.73



0.94



0.40



0.74



1.54



1.42



0.95



1.18



1.62



1.85



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S1, F & 0.001



Mean



16.85



16.72



16.89



16.75



16.62



17.37



17.73



17.76



17.95



18.10



18.01



18.37



18.42



±SD



1.82



1.54



1.52



1.76



1.39



1.57



1.85



1.43



1.23



1.60



1.69



2.24



2.04



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S1, F & 0.003



Mean



16.83



16.62



16.71



16.87



17.05



17.73



17.98



17.96



17.90



17.69



18.00



17.70



17.56



±SD



1.57



1.46



1.67



1.88



1.87



1.81



1.77



1.36



1.29



1.28



1.39



1.10



1.14



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S1, F & 0.01



Mean



16.87



16.64



16.71



16.33



16.52



17.34



17.57



18.03



17.56



17.47



17.78



17.37



17.34



±SD



1.54



1.52



1.43



1.64



1.75



1.56



1.66



1.14



1.00



0.77



0.62



1.12



1.18



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S1, F & 0.03



Mean



16.94



16.71



16.71



16.71



16.84



17.60



17.74



18.03



17.96



17.97



18.16



17.73



17.60



±SD



1.84



1.59



1.69



1.31



1.84



0.75



0.77



1.53



1.06



1.45



1.60



1.25



1.12



n



3



3



3



3



3



3



3



3



3



3



3



3



3



 M: Male; F: Female; SD: Standard Deviation; n: number of cages; R: Recovery; S1: Satellite 1.


 



  • TABLE 4 (Contd...). SUMMARY OF AVERAGE FEED CONSUMPTION (g/rat/day) RECORD


  Refer Appendix 4

































































































































































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Week 14



Week 15



Week 16



Week 17



Week 18



Week 19



Week 20



Week 21



Week 22



Week 23



Week 24



Week 25



Week 26



G1R-S1, M & 0



Mean



27.77



27.85



27.34



27.14



27.26



27.05



26.10



25.96



26.02



25.74



26.10



25.86



34.78



±SD



6.56



6.15



6.20



6.01



6.11



5.83



5.37



5.16



5.30



4.86



5.22



4.84



1.73



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S1, M & 0.001



Mean



27.83



28.25



26.87



26.57



26.77



26.68



25.91



25.87



25.85



25.90



26.60



26.56



33.28



±SD



6.50



6.92



6.82



6.30



6.50



6.15



5.09



4.92



4.84



4.43



5.56



4.83



1.75



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S1, M & 0.003



Mean



27.57



28.43



26.94



26.51



26.66



26.54



26.03



25.77



25.74



25.81



26.06



26.24



33.91



±SD



6.23



7.17



5.91



5.53



5.53



5.95



5.48



5.01



4.81



5.11



5.31



4.68



0.76



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S1, M & 0.01



Mean



28.05



28.52



26.63



26.42



26.65



26.29



25.92



25.73



25.96



25.83



26.74



26.45



33.64



±SD



6.69



6.65



6.51



5.98



6.26



5.84



5.53



5.12



4.91



5.24



5.21



5.09



0.46



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S1, M & 0.03



Mean



27.96



28.04



26.66



26.20



26.44



26.42



26.20



26.05



25.91



25.64



26.80



26.29



33.29



±SD



6.85



6.32



6.46



5.86



6.06



6.20



5.51



5.31



5.03



4.29



5.67



4.67



1.67



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G1R-S1, F & 0



Mean



18.39



17.50



16.45



16.50



16.65



16.35



16.55



16.53



16.29



15.85



16.64



17.11



23.22



±SD



2.24



1.82



0.48



0.76



1.11



1.10



1.12



0.91



0.69



0.44



0.86



0.61



1.06



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S1, F & 0.001



Mean



18.32



17.74



16.82



16.48



16.37



16.24



16.54



16.66



16.83



16.43



17.05



16.79



21.02



±SD



1.65



1.62



0.77



0.59



0.74



0.61



0.77



1.02



1.01



0.82



1.07



0.55



2.96



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S1, F & 0.003



Mean



17.73



16.33



17.14



17.16



17.22



16.91



16.75



16.50



16.48



16.90



16.86



17.42



22.79



±SD



1.24



0.70



1.39



1.37



1.80



1.58



1.49



1.14



1.20



0.23



1.17



1.75



1.12



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S1, F & 0.01



Mean



17.74



16.44



16.57



16.45



16.65



16.54



16.54



16.45



16.35



16.53



17.19



17.30



21.91



±SD



1.52



0.26



0.43



0.81



1.22



0.65



1.18



0.95



0.64



0.11



0.33



1.12



1.59



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S1, F & 0.03



Mean



17.44



16.58



16.86



17.00



17.20



16.41



16.74



16.19



16.49



16.52



17.36



17.75



24.27



±SD



0.85



0.64



0.84



0.93



1.24



0.91



1.01



0.33



1.00



0.58



1.02



1.32



0.95



n



3



3



3



3



3



3



3



3



3



3



3



3



3



 M: Male; F: Female; SD: Standard Deviation; n: number of cages; R: Recovery; S1: Satellite 1.


 


TABLE 4 (Contd...). SUMMARY OF AVERAGE FEED CONSUMPTION (g/rat/day) RECORD


  Refer Appendix 4

































































































































































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Week 1



Week 2



Week 3



Week 4



Week 5



Week 6



Week 7



Week 8



Week 9



Week 10



Week 11



Week 12



Week 13



G1R-S2, M & 0



Mean



24.74



24.43



24.33



24.33



26.63



26.62



28.60



28.59



28.47



28.22



28.10



28.61



28.44



±SD



7.42



7.25



7.17



7.13



7.09



7.38



6.65



7.16



6.97



6.60



6.46



7.39



6.94



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S2, M & 0.001



Mean



24.63



24.47



24.27



24.49



26.43



26.35



27.83



28.74



28.63



28.92



28.62



28.62



28.58



±SD



7.15



6.93



6.84



7.29



7.40



7.18



5.90



7.65



7.40



7.74



7.48



7.52



7.22



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S2, M & 0.003



Mean



24.70



24.44



24.06



23.97



26.11



26.23



28.10



28.77



28.58



28.78



28.58



28.56



28.38



±SD



6.79



6.64



6.63



6.42



6.80



7.01



6.03



7.52



7.32



7.50



7.47



7.37



7.15



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S2, M & 0.01



Mean



24.95



24.63



24.41



26.95



26.64



26.45



28.06



28.33



27.97



27.83



27.63



28.86



28.60



±SD



7.53



7.24



7.17



11.46



7.73



7.42



5.50



6.37



6.12



5.70



5.70



7.70



7.59



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S2, M & 0.03



Mean



24.67



24.68



24.24



24.16



26.15



26.23



28.40



28.96



28.79



28.80



28.55



28.61



28.41



±SD



7.41



7.44



6.66



6.52



7.01



7.21



6.11



7.34



7.19



7.06



6.95



7.48



7.28



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G1R-S2, F & 0



Mean



17.05



16.66



16.70



16.67



17.03



18.32



18.41



18.12



18.07



17.69



17.80



17.48



17.32



±SD



1.75



1.57



1.62



1.42



1.98



1.88



1.71



1.53



1.77



1.26



1.31



1.14



1.08



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S2, F & 0.001



Mean



16.88



16.64



17.00



16.57



16.75



17.61



17.78



18.15



18.05



18.24



18.11



18.14



18.00



±SD



1.83



1.39



1.48



1.52



1.75



1.64



1.66



1.43



1.16



1.38



0.92



1.51



1.59



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S2, F & 0.003



Mean



16.71



16.77



16.74



17.12



17.09



18.22



17.90



17.81



17.85



17.90



18.03



17.41



17.17



±SD



1.66



1.44



1.56



2.37



2.15



1.99



1.93



1.50



1.60



1.16



1.64



1.08



1.03



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S2, F & 0.01



Mean



16.77



16.84



17.11



16.53



16.50



17.54



17.88



18.05



17.87



17.52



18.05



17.61



17.45



±SD



1.55



1.95



1.87



1.26



1.04



1.08



1.29



1.86



1.48



0.88



1.46



1.72



1.63



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S2, F & 0.03



Mean



16.90



16.67



16.68



16.69



16.60



17.77



17.94



17.89



17.77



18.11



17.80



17.89



17.84



±SD



1.53



1.52



1.66



1.60



1.21



1.43



1.74



1.44



1.12



1.74



1.24



1.13



1.21



n



3



3



3



3



3



3



3



3



3



3



3



3



3



 M: Male; F: Female; SD: Standard Deviation; n: number of cages; R: Recovery; S2: Satellite 2.


 


TABLE 4 (Contd...). SUMMARY OF AVERAGE FEED CONSUMPTION (g/rat/day) RECORD


  Refer Appendix 4

































































































































































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Week 14



Week 15



Week 16



Week 17



Week 18



Week 19



Week 20



Week 21



Week 22



Week 23



Week 24



Week 25



Week 26



G1R-S2, M & 0



Mean



27.82



28.12



27.14



27.02



26.73



26.45



26.07



25.98



25.88



25.77



26.03



26.30



26.65



±SD



6.51



6.78



6.47



5.90



5.90



5.87



4.83



4.84



4.97



4.75



5.49



5.56



5.41



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S2, M & 0.001



Mean



27.86



28.09



26.74



26.47



26.54



26.18



26.15



25.93



25.85



25.68



26.33



25.72



26.49



±SD



6.88



6.26



6.72



6.41



6.52



6.46



5.36



4.94



5.00



4.86



5.21



4.90



5.39



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S2, M & 0.003



Mean



27.80



28.31



26.20



26.66



26.86



26.91



25.99



25.94



25.95



25.44



26.69



26.24



27.42



±SD



6.60



6.68



4.60



5.49



5.64



6.14



5.06



4.96



5.22



4.60



4.46



4.09



5.85



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S2, M & 0.01



Mean



28.28



28.31



26.85



26.73



26.49



26.35



25.80



25.85



25.70



25.50



26.36



26.30



26.67



±SD



7.33



7.05



6.71



6.04



5.99



5.76



5.02



5.07



4.70



4.75



5.29



5.21



5.30



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S2, M & 0.03



Mean



27.93



28.15



27.02



26.88



26.65



26.47



25.77



25.85



25.78



25.56



26.65



26.84



27.05



±SD



6.86



6.42



7.03



5.95



5.50



5.85



5.15



4.85



5.01



4.80



5.33



5.73



5.80



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G1R-S2, F & 0



Mean



17.31



16.64



16.98



17.04



17.02



16.46



16.48



16.45



16.28



17.32



16.49



17.17



17.03



±SD



1.39



1.01



1.08



1.26



1.83



1.06



1.09



0.82



0.85



1.04



0.90



1.86



1.27



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S2, F & 0.001



Mean



17.84



17.13



16.68



16.85



16.53



16.54



16.40



16.35



16.58



17.11



17.14



17.31



17.50



±SD



1.51



0.92



0.64



1.15



0.92



0.73



0.78



0.66



1.19



1.42



0.74



1.28



1.45



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S2, F & 0.003



Mean



17.45



16.63



16.49



16.49



16.60



16.41



16.50



16.39



16.01



16.61



16.37



16.52



17.61



±SD



1.13



0.61



0.49



0.78



1.12



0.78



0.95



0.32



0.63



0.90



0.83



0.89



1.79



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S2, F & 0.01



Mean



17.31



16.65



16.75



16.44



16.45



16.17



16.18



16.36



16.35



17.20



16.56



16.81



16.89



±SD



1.48



0.97



0.88



0.62



0.63



0.52



0.51



0.75



1.23



1.34



0.17



0.26



0.42



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S2, F & 0.03



Mean



17.75



17.24



16.42



16.48



16.65



16.36



16.41



16.20



16.10



16.97



15.93



16.52



16.85



±SD



1.12



0.88



0.26



0.60



1.07



0.82



0.62



0.49



1.01



1.09



0.29



0.62



0.96



n



3



3



3



3



3



3



3



3



3



3



3



3



3



 M: Male; F: Female; SD: Standard Deviation; n: number of cages; R: Recovery; S2: Satellite 2.


 


TABLE 4 (Contd...). SUMMARY OF AVERAGE FEED CONSUMPTION (g/rat/day) RECORD


  Refer Appendix 4

































































































































































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Week 27



Week 28



Week 29



Week 30



Week 31



Week 32



Week 33



Week 34



Week 35



Week 36



Week 37



Week 38



Week 39



G1R-S2, M & 0



Mean



27.13



26.88



27.55



28.29



28.16



27.90



28.56



27.58



25.68



26.71



27.05



27.52



56.68



±SD



5.31



5.65



6.01



6.32



6.55



6.96



7.62



6.60



5.84



6.73



5.64



7.28



20.86



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S2, M & 0.001



Mean



26.01



26.73



27.70



28.00



28.23



28.01



28.13



27.34



25.10



26.45



26.47



27.27



61.79



±SD



5.03



4.96



5.55



5.52



6.08



6.05



6.10



5.46



5.49



6.02



5.16



6.49



10.39



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S2, M & 0.003



Mean



26.86



26.74



27.39



28.34



28.55



28.09



28.62



27.69



27.04



26.27



26.62



27.55



61.53



±SD



5.37



5.47



5.73



6.07



6.29



6.57



6.89



6.68



5.87



5.84



5.96



6.66



12.82



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S2, M & 0.01



Mean



26.21



26.24



27.70



27.28



27.51



28.04



28.34



27.54



25.53



26.45



26.47



27.10



59.96



±SD



5.32



5.08



5.89



4.59



5.13



6.40



6.31



5.81



4.45



5.72



5.75



5.79



13.40



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S2, M & 0.03



Mean



26.54



26.87



26.95



27.61



27.57



27.85



28.61



27.83



26.83



27.14



27.08



27.10



42.14



±SD



5.29



5.35



5.78



6.70



6.29



7.10



7.18



6.81



4.60



7.23



7.26



5.77



6.27



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G1R-S2, F & 0



Mean



17.69



18.54



18.94



19.07



19.61



18.89



18.14



16.37



16.37



17.55



17.95



17.67



11.42



±SD



1.83



1.36



2.17



2.08



2.69



2.22



2.08



3.04



2.17



1.40



2.94



2.86



1.15



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G2R-S2, F & 0.001



Mean



17.38



18.65



18.55



18.82



19.85



18.89



17.36



16.62



16.97



16.60



17.29



17.09



11.61



±SD



1.03



2.58



1.90



2.36



3.20



2.17



0.84



0.22



1.49



1.01



1.46



1.41



0.73



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G3R-S2, F & 0.003



Mean



17.71



18.91



19.01



19.23



19.74



19.51



18.45



19.44



18.76



17.74



18.13



18.35



10.75



±SD



1.56



1.84



2.25



2.10



3.51



2.22



1.62



2.61



2.29



2.06



1.77



2.35



1.44



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G4R-S2, F & 0.01



Mean



17.09



18.27



18.45



18.72



19.19



19.54



18.43



19.08



18.46



17.38



17.97



18.94



12.24



±SD



0.68



2.19



2.26



2.25



2.54



3.70



2.77



3.37



3.14



1.72



2.01



2.62



1.78



n



3



3



3



3



3



3



3



3



3



3



3



3



3



G5R-S2, F & 0.03



Mean



17.32



18.38



19.21



19.34



19.60



19.42



18.66



19.12



18.78



17.40



17.92



17.81



12.15



±SD



0.87



2.17



2.69



2.93



2.76



3.26



2.62



2.91



2.26



1.13



1.82



1.50



0.83



n



3



3



3



3



3



3



3



3



3



3



3



3



3



 M: Male; F: Female; SD: Standard Deviation; n: number of cages; R: Recovery; S2: Satellite 2.


 


 



  • SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB)

    • Refer Appendix 5













































































































































































Week 13



Parameters↓



Group & Sex



G1 & M



G5 & M



G1 & F



G5 & F



Dose (mg/L)



0



0.03



0



0.03



Number of Animals



10



10



10



10



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 13



Parameters↓



Group & Sex



G1 & M



G5 & M



G1 & F



G5 & F



Dose (mg/L)



0



0.03



0



0.03



Number of Animals



10



10



10



10



Open field Observation



Mobility



1



1



1



1



Gait



1



1



1



1



Arousal



3



3



3



3



Number of Rearing



Mean



6.3



6.6



8.6



8.3



±SD



1.1



1.8



1.1



1.3



Numbers of Urination



Mean



1.1



1.1



1.2



1.2



±SD



0.3



0.3



0.4



0.4



Number of Defecation



Mean



1.1



1.1



1.1



1.1



±SD



0.3



0.6



0.6



0.6



Clonic involuntary movement



1



1



1



1



Tonic involuntary movement



1



1



1



1



Stereotype Behaviour



1



1



1



1



Excessive Grooming



Mean



4.8



5.0



4.7



4.6



±SD



0.6



0.7



0.7



0.5



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



96.9



96.7



98.8



98.7



±SD



0.2



0.3



0.3



0.4



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











































































































































































Day 177



Parameters↓



Group & Sex



G1R-S1 & M



G5R-S1 & M



G1R-S1 & F



G5R-S1 & F



Dose (mg/L)



0



0.03



0



0.03



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; S1: Satellite 1.


 


TABLE 5 (Contd...). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD


Refer Appendix 5













































































































































































































Day 177



Parameters↓



Group & Sex



G1R-S1 & M



G5R-S1 & M



G1R-S1 & F



G5R-S1 & F



Dose (mg/L)



0



0.03



0



0.03



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



6.0



5.4



5.8



6.0



±SD



1.0



1.1



0.8



0.7



Numbers of Urination



Mean



1.2



1.2



1.2



1.2



±SD



0.4



0.4



0.4



0.4



Number of Defecation



Mean



1.0



1.2



1.0



1.0



±SD



0.7



0.8



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



4.0



4.8



4.0



4.0



±SD



0.7



0.8



0.7



0.7



Sensory Observations



 



Approach Response



2



2



2



2



Auditory Response



2



2



2



2



Touch Response



2



2



2



2



Pupil Reflex



2



2



2



2



Tail Pinch Response



2



2



2



2



Righting Reflex



1



1



1



1



Physiological observation


 

 



Body temperature (°F)



Mean



96.8



96.8



97.2



97.2



±SD



0.3



0.2



0.2



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; R: Recovery; S1: Satellite 1.


 


TABLE 5 (Contd...). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD


Refer Appendix 5











































































































































































Day 267



Parameters↓



Group & Sex



G1R-S2 & M



G5R-S2 & M



G1R-S2 & F



G5R-S2 & F



Dose (mg/L)



0



0.03



0



0.03



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; S2: Satellite 2.


 


TABLE 5 (Contd...). SUMMARY OF NEUROLOGICAL/FUNCTIONAL OBSERVATION BATTERY (FOB) RECORD


Refer Appendix 5













































































































































































































Day 267



Parameters↓



Group & Sex



G1R-S2 & M



G5R-S2 & M



G1R-S2 & F



G5R-S2 & F



Dose (mg/L)



0



0.03



0



0.03



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



6.4



7.2



7.2



±SD



0.9



1.3



1.8



2.3



Numbers of Urination



Mean



1.2



1.2



1.4



1.4



±SD



0.4



0.4



0.9



0.5



Number of Defecation



Mean



1.0



1.0



1.2



1.2



±SD



0.7



0.7



0.4



0.8



Clonic involuntary movement



1



1



1



1



Tonic involuntary movement



1



1



1



1



Stereotype Behaviour



1



1



1



1



Excessive Grooming



Mean



4.0



4.0



4.4



4.2



±SD



0.7



1.0



1.1



0.4



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



97.1



97.1



98.4



98.5



±SD



0.5



0.4



0.4



0.4



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; S2: Satellite 2.


 



  • SUMMARY OF HIND LIMB FOOT SPLAY (cm) RECORD


                                                                                                                                                         Refer Appendix 6










































































































































































# Week 13, Day 177 & 267



Group, Sex & Dose (mg/L)



 



Hind Limb Foot Splay (cm)



G1, M & 0



Mean



7.3



±SD



1.9



n



10



G5, M & 0.03



Mean



6.7



±SD



0.8



n



10



G1, F & 0



Mean



8.4



±SD



2.1



n



10



G5, F & 0.03



Mean



6.8



±SD



1.4



n



10



G1R-S1, M & 0



Mean



7.3



±SD



0.7



n



5



G5R-S1, M & 0.03



Mean



7.1



±SD



0.6



n



5



G1R-S1, F & 0



Mean



6.8



±SD



0.8



n



5



G5R-S1, F & 0.03



Mean



6.8



±SD



0.8



n



5



G1R-S2, M & 0



Mean



5.9



±SD



0.2



n



5



G5R-S2, M & 0.03



Mean



5.9



±SD



0.2



n



5



G1R-S2, F & 0



Mean



6.7



±SD



0.5



n



5



G5R-S2, F & 0.03



Mean



7.0



±SD



0.6



n



5



M: Male; F: Female; R: Recovery; SD: Standard Deviation; n: number of animals; R: Recovery; S1: Satellite 1; S2: Satellite 2. # Week 13 for main group animals, Day 177 & 267 for Recovery Groups


 


 



  • SUMMARY OF ACTIMETER READING RECORD


                                                                                                                                                         Refer Appendix 7










































































































































































# Week 13, Day 177 & 267



Group, Sex & Dose (mg/L)


 

Movement Counts (no.)



G1, M & 0



Mean



1865.1



±SD



32.6



n



10



G5, M & 0.03



Mean



1878.6



±SD



11.9



n



10



G1, F & 0



Mean



2158.6



±SD



30.4



n



10



G5, F & 0.03



Mean



2116.2*



±SD



11.7



n



10



G1R-S1, M & 0



Mean



1879.8



±SD



11.2



n



5



G5R-S1, M & 0.03



Mean



1868.6



±SD



16.8



n



5



G1R-S1, F & 0



Mean



2259.2



±SD



11.3



n



5



G5R-S1, F & 0.03



Mean



2261.6



±SD



10.5



n



5



G1R-S2, M & 0



Mean



1848.0



±SD



12.5



n



5



G5R-S2, M & 0.03



Mean



1839.2



±SD



18.6



n



5



G1R-S2, F & 0



Mean



2264.4



±SD



9.7



n



5



G5R-S2, F & 0.03



Mean



2263.6



±SD



14.0



n



5



M: Male; F: Female; SD: Standard Deviation; n: number of animals; R: Recovery; S1: Satellite 1;  


S2: Satellite 2. # Week 13 for main group animals, Day 177 & 267 for Recovery Groups



  •  

  •  


 



  • SUMMARY OF GRIP STRENGTH (kgf) MEASUREMENT RECORD


Refer Appendix 8
























































































































































































































































# Week 13, Day 177 & 267


 

Group, Sex & Dose (mg/L)


 

Fore limb



Hind limb


 
 

G1, M & 0



Mean



1.486



0.505


 

±SD



0.044



0.051


 

n



10



10


 

G5, M & 0.03



Mean



1.515



0.507


 

±SD



0.033



0.043


 

n



10



10


 

G1, F & 0



Mean



1.370



0.452


 

±SD



0.021



0.024


 

n



10



10


 

G5, F & 0.03



Mean



1.387



0.421


 

±SD



0.038



0.041


 

n



10



10


 

G1R-S1, M & 0



Mean



1.547



0.499


 

±SD



0.017



0.035


 

n



5



5


 

G5R-S1, M & 0.03



Mean



1.525



0.489


 

±SD



0.014



0.036


 

n



5



5


 

G1R-S1, F & 0



Mean



1.432



0.426


 

±SD



0.027



0.049


 

n



5



5


 

G5R-S1, F & 0.03



Mean



1.424



0.421


 

±SD



0.029



0.038


 

n



5



5


 

G1R-S2, M & 0



Mean



1.537



0.478


 

±SD



0.069



0.034


 

n



5



5


 

G5R-S2, M & 0.03



Mean



1.523



0.469


 

±SD



0.023



0.023


 

n



5



5


 

G1R-S2, F & 0



Mean



1.362



0.421


 

±SD



0.045



0.064


 

n



5



5


 

G5R-S2, F & 0.03



Mean



1.420



0.417


 

±SD



0.034



0.036


 

n



5



5


 

M: Male; F: Female; SD: Standard Deviation; n: number of animals; R: Recovery; S1: Satellite 1;  


S2: Satellite 2. # Week 13 for main group animals, Day 177 & 267 for Recovery Groups.


 


 


 


 


 


 


 


 



  • SUMMARY OF OPHTHALMOSCOPIC EXAMINATION RECORD


                                                                                                                                                                                                                                                             Refer Appendix 9


































































































































































































































































Week 13, 26 and 39



Group, Sex & Dose


(mg/L)



G1, M & 0



G5, M & 0.03



G1, F & 0



G5, F & 0.03



G1R-S1, M & 0



G5R-S1, M & 0.03



G1R-S1, F & 0



G5R-S1, F & 0.03



G1R-S2, M & 0



G5R-S2, M & 0.03



G1R-S2, F & 0



G5R-S2, F & 0.03



Number of Animals



10



10



10



10



5



5



5



5



5



5



5



5



Observations


Eye Parameters ↓



Eye



L



R



L



R



L



R



L



R



L



R



L



R



L



R



L



R



L



R



L



R



L



R



L



R



Eye Lids



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Cornea



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Iris



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Aqueous Humour



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Lens



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Vitreous Humour



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



Retina/Optic disc



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N



N: No Abnormality Detected; L: Left; R: Right; M: Male; F: Female; R: Recovery; S1: Satellite 1; S2: Satellite 2.


 



  • SUMMARY OF HAEMATOLOGY RECORD


                                          Refer Appendix 10

























































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Total


Leucocyte Count



Total


Erythrocyte Count



Hemoglobin



Haematocrit



Mean Corpuscular Volume



Mean Corpuscular Hemoglobin



Mean Corpuscular Hemoglobin Concentration



(WBC)



(RBC)



(HGB)



(HCT)



(MCV)



(MCH)



(MCHC)



(103 cells/µL)



(106 cells/µL)



(g/dL)



(%)



(fL)



(pg)



(g/dL)



G1, M & 0



Mean



8.41



8.39



16.78



48.53



57.93



20.06



34.59



±SD



1.07



0.45



0.52



1.97



2.45



1.38



1.55



n



10



10



10



10



10



10



10



G2, M & 0.001



Mean



10.19*



8.93



16.60



48.62



54.77



18.60*



34.04



±SD



1.91



1.07



1.89



4.34



3.56



0.68



1.37



n



10



10



10



10



10



10



10



G3, M & 0.003



Mean



9.26



9.33*



16.89



50.04



54.74



18.29*



33.69



±SD



0.89



1.32



1.42



1.97



8.94



1.58



2.10



n



10



10



10



10



10



10



10



G4, M & 0.01



Mean



9.01



9.43*



16.89



49.70



52.71*



17.91*



34.00



±SD



1.23



0.36



0.53



1.24



1.56



0.49



0.46



n



10



10



10



10



10



10



10



G5, M & 0.03



Mean



9.29



9.47*



16.94



50.07



52.92



17.90*



33.83



±SD



1.96



0.28



0.47



1.65



1.81



0.49



0.55



n



10



10



10



10



10



10



10



G1, F & 0



Mean



9.67



8.56



16.94



46.28



54.17



19.93



36.73



±SD



1.77



0.64



0.56



3.03



1.78



1.79



2.48



n



10



10



10



10



10



10



10



G2, F & 0.001



Mean



8.41



8.58



16.34



46.07



53.46



19.01



35.59



±SD



1.16



0.34



0.40



0.98



1.86



0.55



0.50



n



10



10



10



9



10



10



10



G3, F & 0.003



Mean



7.37*



8.56



16.27



46.33



54.15



19.03



35.14*



±SD



1.45



0.34



0.46



1.12



1.63



0.87



0.62



n



10



10



10



10



10



10



10



G4, F & 0.01



Mean



7.78*



7.83



15.58*



44.98



58.40*



18.11



34.56*



±SD



1.41



1.27



1.75



3.39



6.89



6.54



1.54



n



10



10



10



10



10



10



10



G5, F & 0.03



Mean



7.68*



8.70



16.55



47.33



54.38



19.02



34.95*



±SD



1.85



0.36



0.64



1.80



1.45



0.43



0.59



n



10



10



10



10



10



10



10



M: Male; F: Female; 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/L)


 

Platelet Count



Mean Platelet Volume



Reticulocyte Count



Neutrophils



Lymphocytes



Monocytes



Eosinophils



Basophils



Absolute Reticulocyte Count



(PLT)



(MPV)



(Retic)



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(Retic)



(103 cells/µL)



(fL)



(%)



(%)



(%)



(%)



(%)



(%)



(109 cells/L)



G1, M & 0



Mean



992.00



6.13



3.96



22.50



71.11



3.14



1.83



0.26



329.92



±SD



144.45



0.39



1.07



3.27



5.01



0.90



1.59



0.12



80.64



n



10



10



10



10



10



10



10



10



10



G2, M & 0.001



Mean



916.20



6.16



3.13



28.48



66.10



2.97



1.39



0.20



251.70



±SD



135.95



0.38



3.00



3.15



3.36



0.72



0.45



0.07



158.55



n



10



10



10



10



10



10



10



10



10



G3, M & 0.003



Mean



992.50



6.23



4.29



30.76*



64.34*



2.69



1.20



0.19



305.20



±SD



192.54



0.71



8.44



6.06



6.57



0.72



0.56



0.06



470.60



n



10



10



10



10



10



10



10



10



10



G4, M & 0.01



Mean



991.60



5.97



2.26



31.77*



63.59*



2.57



1.27



0.16*



212.41



±SD



126.11



0.26



0.44



7.91



8.04



0.87



0.22



0.05



40.31



n



10



10



10



10



10



10



10



10



10



G5, M & 0.03



Mean



939.00



6.19



1.86



28.98*



66.06



2.54



1.58



0.21



176.10



±SD



224.60



0.28



0.34



5.33



5.14



0.81



0.49



0.09



32.10



n



10



10



10



10



10



10



10



10



10



G1, F & 0



Mean



939.60



5.63



2.35



26.54



68.11



2.79



1.30



0.22



199.91



±SD



238.96



0.29



0.53



6.16



6.16



0.67



0.43



0.11



42.79



n



10



10



10



10



10



10



10



10



10



G2, F & 0.001



Mean



980.80



5.71



1.68



25.34



68.66



3.46



1.41



0.20



143.95



±SD



190.68



0.15



0.34



3.17



3.55



0.85



0.44



0.05



27.61



n



10



10



10



10



10



10



10



10



10



G3, F & 0.003



Mean



874.30



5.92



1.54



26.92



68.14



2.43



1.62



0.21



131.63



±SD



186.83



0.25



0.29



5.90



6.13



0.64



0.53



0.07



21.51



n



10



10



10



10



10



10



10



10



10



G4, F & 0.01



Mean



945.20



6.71



4.94



27.77



67.14



2.50



1.53



0.23



311.88



±SD



309.29



2.30



7.15



6.06



6.33



0.77



1.16



0.21



368.27



n



10



10



10



10



10



10



10



10



10



G5, F & 0.03



Mean



959.00



5.92



1.51



28.79



65.11



2.71



2.34



0.23



131.38



±SD



275.55



0.53



0.21



6.17



7.84



0.70



1.81



0.11



17.65



n



10



10



10



10



10



10



10



10



10



M: Male; F: Female; 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/L)


 

Absolute Neutrophils



Absolute Lymphocytes



Absolute Monocytes



Absolute Eosinophils



Absolute Basophils



Prothrombin Time



Activated Prothrombin Time



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(PT)



(APTT)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(Seconds)



(Seconds)



G1, M & 0



Mean



1.91



5.95



0.27



0.16



0.02



12.19



21.50



±SD



0.46



0.70



0.08



0.15



0.01



1.37



2.28



n



10



10



10



10



10



10



10



G2, M & 0.001



Mean



2.92*



6.71



0.31



0.14



0.02



14.71*



20.76



±SD



0.70



1.20



0.12



0.04



0.01



0.66



4.00



n



10



10



10



10



10



10



10



G3, M & 0.003



Mean



2.85*



5.96



0.25



0.11



0.02



14.66*



23.16



±SD



0.62



0.85



0.07



0.06



0.00



1.04



3.93



n



10



10



10



10



10



10



10



G4, M & 0.01



Mean



2.85*



5.75



0.23



0.11



0.01



14.85*



22.48



±SD



0.74



1.09



0.08



0.03



0.01



0.45



4.75



n



10



10



10



10



10



10



10



G5, M & 0.03



Mean



2.62*



6.21



0.24



0.15



0.02



14.58*



24.08



±SD



0.37



1.70



0.09



0.05



0.01



1.02



1.97



n



10



10



10



10



10



10



10



G1, F & 0



Mean



2.48



6.68



0.27



0.13



0.02



16.78



20.98



±SD



0.25



1.77



0.08



0.05



0.01



1.14



4.05



n



10



10



10



10



10



10



10



G2, F & 0.001



Mean



2.13



5.79



0.29



0.12



0.02



15.84



23.24



±SD



0.39



0.92



0.06



0.03



0.01



0.82



4.31



n



10



10



10



10



10



10



10



G3, F & 0.003



Mean



2.00



5.01*



0.18*



0.12



0.02



16.83



23.07



±SD



0.62



1.02



0.07



0.05



0.01



2.03



3.00



n



10



10



10



10



10



10



10



G4, F & 0.01



Mean



2.19



5.20*



0.20



0.12



0.02



16.97



26.84*



±SD



0.76



0.87



0.08



0.10



0.02



1.25



6.04



n



10



10



10



10



10



10



10



G5, F & 0.03



Mean



2.15



5.07*



0.21



0.17



0.02



16.02



23.40



±SD



0.50



1.58



0.07



0.11



0.01



0.73



3.02



n



10



10



10



10



10



10



10



M: Male; F: Female; 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/L)


 

Total


Leucocyte Count



Total


Erythrocyte Count



Hemoglobin



Haematocrit



Mean Corpuscular Volume



Mean Corpuscular Hemoglobin



Mean Corpuscular Hemoglobin Concentration



(WBC)



(RBC)



(HGB)



(HCT)



(MCV)



(MCH)



(MCHC)



(103 cells/µL)



(106 cells/µL)



(g/dL)



(%)



(fL)



(pg)



(g/dL)



G1R-S1, M & 0



Mean



12.73



9.36



16.36



49.50



52.96



17.56



33.12



±SD



2.18



0.62



1.49



1.67



2.94



2.13



3.07



n



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



10.81



9.29



16.20



48.16



51.94



17.46



33.62



±SD



2.36



0.69



1.14



3.27



2.49



0.90



0.57



n



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



8.43



8.10



15.70



41.60



51.46



19.90



38.50



±SD



0.91



1.00



2.82



4.11



1.56



5.41



9.73



n



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



9.05



7.17



14.96



37.62*



52.76



22.42



42.38



±SD



2.17



2.22



1.27



11.03



2.35



6.94



12.54



n



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



9.02



7.47



14.28



39.98



53.54



19.78



37.10



±SD



4.37



1.58



2.69



8.60



1.92



5.16



10.50



n



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



8.67



8.54



16.06



46.36



54.26



18.86



34.72



±SD



1.14



0.49



0.80



3.04



1.33



1.10



1.51



n



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



10.33



8.55



15.90



45.62



53.38



18.64



34.88



±SD



1.64



0.44



0.70



2.67



1.36



0.36



0.45



n



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



9.24



8.60



16.48



48.10



55.94



19.22



34.34



±SD



1.00



0.45



0.87



2.87



2.27



0.82



0.30



n



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



8.07



8.29



15.92



46.18



55.76



19.24



34.50



±SD



1.26



0.54



0.83



2.97



1.85



0.34



0.77



n



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



10.21



8.71



16.18



47.52



54.58



18.58



34.04



±SD



4.76



0.43



0.66



1.89



0.92



0.23



0.49



n



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1; *: Statistically significant (p<0.05).


 


TABLE 10 (Contd…).  SUMMARY OF HAEMATOLOGY RECORD


                                                                                       Refer Appendix 10



























































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Platelet Count



Mean Platelet Volume



Reticulocyte Count



Neutrophils



Lymphocytes



Monocytes



Eosinophils



Basophils



Absolute Reticulocyte Count



(PLT)



(MPV)



(Retic)



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(Retic)



(103 cells/µL)



(fL)



(%)



(%)



(%)



(%)



(%)



(%)



(109 cells/L)



G1R-S1, M & 0



Mean



740.40



6.60



2.04



24.54



68.68



3.96



1.66



0.62



189.30



±SD



234.35



1.46



0.50



6.25



6.48



0.35



0.73



0.25



41.55



n



5



5



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



819.20



6.14



2.11



30.92



63.14



3.48



1.72



0.26*



192.50



±SD



211.84



0.38



0.60



5.83



6.26



0.98



0.51



0.09



42.17



n



5



5



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



906.20



6.32



1.69



33.28*



60.40



3.90



1.54



0.22*



136.88



±SD



130.90



0.54



0.17



3.28



3.15



1.01



0.21



0.11



25.25



n



5



5



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



689.60



6.52



2.65



25.36



68.96



3.42



1.28



0.34*



186.32



±SD



106.82



0.50



0.71



4.64



4.68



0.85



0.65



0.11



62.29



n



5



5



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



641.20



6.24



1.78



34.38*



59.38*



4.18



1.30



0.22*



131.18



±SD



99.92



0.26



0.54



5.29



5.66



1.29



0.68



0.08



37.90



n



5



5



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



1034.20



6.18



1.77



25.76



67.08



4.40



1.62



0.42



150.30



±SD



126.97



0.13



0.58



3.61



5.33



2.06



0.73



0.08



44.91



n



5



5



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



877.20



6.14



1.52



24.88



68.92



3.48



1.62



0.38



129.70



±SD



248.96



0.15



0.32



4.61



4.30



0.75



0.31



0.08



27.19



n



5



5



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



803.40



6.16



1.58



29.02



63.36



4.56



1.90



0.42



135.70



±SD



175.59



0.23



0.35



3.66



3.75



1.48



0.55



0.16



30.58



n



5



5



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



778.00



6.48



1.89



25.88



66.34



3.92



2.72



0.42



156.88



±SD



201.58



0.51



0.44



3.58



2.69



1.08



2.43



0.16



39.65



n



5



5



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



881.80



6.20



1.85



24.62



69.68



2.96



1.66



0.42



161.58



±SD



67.34



0.10



0.23



4.88



5.78



0.98



0.91



0.28



21.32



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1; *: Statistically significant (p<0.05).


 


TABLE 10 (Contd…). SUMMARY OF HAEMATOLOGY RECORD


    Refer Appendix 10

























































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Absolute Neutrophils



Absolute Lymphocytes



Absolute Monocytes



Absolute Eosinophils



Absolute Basophils



Prothrombin Time



Activated Prothrombin Time



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(PT)



(APTT)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(Seconds)



(Seconds)



G1R-S1, M & 0



Mean



3.16



8.69



0.51



0.22



0.08



21.22



20.40



±SD



1.19



1.37



0.12



0.12



0.04



2.07



2.53



n



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



3.38



6.79



0.37



0.19



0.03*



20.48



21.02



±SD



1.07



1.48



0.13



0.07



0.02



1.40



5.12



n



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



2.80



5.08*



0.34



0.13



0.02*



21.36



22.54



±SD



0.36



0.51



0.12



0.03



0.01



0.65



3.78



n



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



2.29



6.24



0.31



0.13



0.03*



19.64



23.34



±SD



0.64



1.64



0.09



0.08



0.02



1.26



4.86



n



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



3.12



5.29*



0.42



0.11



0.02*



20.14



20.56



±SD



1.71



2.31



0.33



0.06



0.02



1.29



1.45



n



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



2.26



5.78



0.40



0.14



0.04



22.28



24.16



±SD



0.62



0.46



0.25



0.06



0.01



2.77



8.18



n



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



2.53



7.15



0.36



0.17



0.04



18.88



28.28



±SD



0.42



1.44



0.09



0.06



0.02



2.74



7.23



n



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



2.68



5.84



0.43



0.17



0.04



19.64



27.48



±SD



0.44



0.64



0.18



0.04



0.02



2.52



1.82



n



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



2.08



5.37



0.32



0.21



0.03



17.32*



21.16



±SD



0.36



0.95



0.13



0.16



0.02



1.97



6.80



n



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



2.48



7.13



0.33



0.14



0.05



17.44*



25.28



±SD



1.17



3.31



0.28



0.04



0.07



2.74



2.73



n



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1; *: Statistically significant (p<0.05)


 


 


TABLE 10 (Contd…).  SUMMARY OF HAEMATOLOGY RECORD


                                                                                       Refer Appendix 10

























































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Total


Leucocyte Count



Total


Erythrocyte Count



Hemoglobin



Haematocrit



Mean Corpuscular Volume



Mean Corpuscular Hemoglobin



Mean Corpuscular Hemoglobin Concentration



(WBC)



(RBC)



(HGB)



(HCT)



(MCV)



(MCH)



(MCHC)



(103 cells/µL)



(106 cells/µL)



(g/dL)



(%)



(fL)



(pg)



(g/dL)



G1R-S2, M & 0



Mean



10.12



8.94



15.38



45.86



51.36



17.18



33.46



±SD



3.50



0.84



1.58



4.30



1.76



0.75



0.43



n



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



8.21



9.28



16.56



48.54



52.32



17.84



34.08



±SD



1.21



0.25



0.23



1.69



0.90



0.35



0.86



n



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



9.34



8.78



15.98



46.76



53.30



18.20



34.18



±SD



0.95



0.37



0.04



0.88



3.01



0.77



0.66



n



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



9.82



9.18



16.26



47.42



51.66



17.74



34.34



±SD



1.92



0.38



0.69



2.35



1.47



0.59



0.65



n



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



8.31



9.18



16.52



48.86



53.26



18.02



33.80



±SD



1.52



0.49



0.41



1.83



1.77



0.90



0.65



n



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



6.18



8.28



15.94



45.04



54.42



19.28



35.38



±SD



0.42



0.31



0.43



2.22



1.60



0.34



0.82



n



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



8.84*



8.53



16.22



45.92



53.84



19.02



35.32



±SD



2.09



0.22



0.73



1.79



1.52



0.51



0.63



n



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



6.87



8.15



15.32



44.18



54.24



18.84



34.74



±SD



1.58



0.32



0.36



1.18



1.02



0.34



0.25



n



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



7.02



8.47



15.78



45.78



54.08



18.62



34.42



±SD



0.68



0.40



0.82



2.49



1.16



0.72



0.77



n



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



6.71



8.08



15.58



44.20



54.68



19.28



35.26



±SD



0.62



0.29



1.06



2.92



1.98



0.82



0.80



n



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group SD: Standard Deviation; n: Number of animals; R; Recovery: S2: Satellite 2; *: Statistically significant (p<0.05)


 


TABLE 10 (Contd…).  SUMMARY OF HAEMATOLOGY RECORD


                                                                                       Refer Appendix 10



























































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Platelet Count



Mean Platelet Volume



Reticulocyte Count



Neutrophils



Lymphocytes



Monocytes



Eosinophils



Basophils



Absolute Reticulocyte Count



(PLT)



(MPV)



(Retic)



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(Retic)



(103 cells/µL)



(fL)



(%)



(%)



(%)



(%)



(%)



(%)



(109 cells/L)



G1R-S2, M & 0



Mean



1028.00



7.22



2.61



28.52



63.52



3.98



2.88



0.26



230.08



±SD



129.94



0.30



0.84



2.97



1.45



1.47



0.44



0.09



64.54



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



982.20



7.26



1.83



31.78



60.88



4.20



2.06



0.32



170.62



±SD



224.15



0.44



0.46



7.04



6.91



1.05



0.69



0.13



47.20



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



1039.40



7.22



2.30



28.88



61.36



4.58



4.02



0.20



200.44



±SD



258.52



0.13



0.61



8.32



7.90



1.41



1.97



0.10



46.56



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



1198.80



7.30



2.24



35.12



56.86



4.08



2.88



0.24



205.74



±SD



247.11



0.10



0.30



6.73



6.15



0.61



0.78



0.09



30.44



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



985.80



7.22



1.87



31.04



60.86



4.08



2.84



0.24



172.20



±SD



236.52



0.28



0.79



5.91



5.79



1.07



0.99



0.05



76.37



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



848.00



7.46



2.09



33.12



59.26



4.30



2.24



0.20



173.46



±SD



210.18



0.18



0.46



8.08



8.13



0.82



0.72



0.07



39.98



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



963.00



7.32



1.89



28.90



62.82



4.80



2.30



0.24



161.26



±SD



188.85



0.35



0.17



7.23



7.61



0.63



0.89



0.09



17.93



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



1033.00



7.30



1.95



33.08



58.74



5.34



1.68



0.24



159.02



±SD



214.43



0.12



0.33



5.55



4.94



1.74



0.82



0.05



25.82



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



1014.40



7.40



1.94



31.28



61.94



3.90



1.94



0.16



163.24



±SD



147.21



0.28



0.47



6.29



5.09



1.33



0.29



0.05



35.86



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



951.20



7.56



2.07



31.78



60.54



4.44



1.98



0.24



168.48



±SD



162.41



0.15



0.74



7.59



6.65



1.91



0.39



0.09



64.86



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


 


TABLE 10 (Contd…). SUMMARY OF HAEMATOLOGY RECORD


    Refer Appendix 10

























































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Absolute Neutrophils



Absolute Lymphocytes



Absolute Monocytes



Absolute Eosinophils



Absolute Basophils



Prothrombin Time



Activated Prothrombin Time



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(PT)



(APTT)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(Seconds)



(Seconds)



G1R-S2, M & 0



Mean



2.84



6.46



0.42



0.28



0.03



23.42



24.82



±SD



0.93



2.31



0.21



0.09



0.02



1.28



9.26



n



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



2.58



5.01



0.35



0.17



0.03



21.16



18.84



±SD



0.54



1.08



0.11



0.07



0.01



1.42



3.31



n



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



2.71



5.71



0.43



0.38



0.02



22.64



21.20



±SD



0.82



0.74



0.17



0.20



0.01



2.05



4.39



n



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



3.38



5.64



0.40



0.28



0.02



22.82



22.44



±SD



0.59



1.61



0.12



0.08



0.02



2.08



8.71



n



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



2.52



5.11



0.34



0.25



0.02



20.36*



22.64



±SD



0.31



1.34



0.08



0.12



0.01



1.60



6.46



n



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



2.04



3.67



0.27



0.14



0.01



22.48



24.98



±SD



0.49



0.55



0.05



0.05



0.00



0.86



6.54



n



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



2.62



5.50*



0.43



0.19



0.02



21.04



18.10*



±SD



1.15



1.13



0.13



0.06



0.01



1.96



2.62



n



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



2.25



4.05



0.38



0.11



0.02



21.26



20.70



±SD



0.49



1.04



0.23



0.04



0.01



1.90



2.19



n



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



2.22



4.33



0.27



0.14



0.01



19.34



19.22



±SD



0.64



0.34



0.08



0.02



0.00



4.27



1.31



n



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



2.11



4.08



0.30



0.13



0.01



17.14*



21.26



±SD



0.42



0.71



0.14



0.02



0.00



4.53



1.89



n



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2; *: Statistically significant (p<0.05)


 



  • SUMMARY OF BALF RECORD


                                                                                                                                                                                             Refer Appendix 11

























































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Total Leucocyte Count



Neutrophils



Lymphocytes



Monocytes



Eosinophils



Basophils



Absolute Neutrophils



(WBC)



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(Neut)



(103 cells/µL)



(%)



(%)



(%)



(%)



(%)



(103 cells/µL)



G1, M & 0



Mean



0.88



21.73



59.78



2.67



3.54



3.02



0.24



±SD



0.95



10.33



12.31



1.92



8.94



4.13



0.41



n



10



10



10



10



10



10



10



G2, M & 0.001



Mean



0.36



25.22



64.44



2.22



1.65



4.22



0.09



±SD



0.19



8.23



11.95



1.83



1.48



2.60



0.03



n



10



10



10



10



10



10



10



G3, M & 0.003



Mean



0.51



34.81*



54.66



4.38



3.02



3.47



0.20



±SD



0.36



12.14



17.33



4.70



1.32



1.50



0.22



n



10



10



10



10



10



10



10



G4, M & 0.01



Mean



0.43



27.22



62.94



2.66



2.23



4.49



0.12



±SD



0.11



12.56



18.13



1.50



1.30



3.03



0.07



n



10



10



10



10



10



10



10



G5, M & 0.03



Mean



0.44



23.92



70.22



2.15



2.75



5.14



0.09



±SD



0.24



12.01



13.55



1.16



1.72



2.97



0.05



n



10



10



10



10



10



10



10



G1, F & 0



Mean



0.61



16.93



75.39



2.56



3.43



9.87



0.12



±SD



0.32



9.08



11.06



1.40



2.89



5.02



0.10



n



10



10



10



10



10



10



10



G2, F & 0.001



Mean



0.13*



21.33



62.58



0.35*



15.55*



12.95



0.02*



±SD



0.06



19.45



30.57



0.62



14.61



4.61



0.01



n



10



10



10



10



10



10



10



G3, F & 0.003



Mean



0.21*



8.86



83.92



0.34*



6.81



13.04



0.02*



±SD



0.10



4.16



7.77



0.58



3.96



3.52



0.01



n



10



10



10



10



10



10



10



G4, F & 0.01



Mean



0.21*



9.94



86.14



0.38*



3.50



13.86



0.02*



±SD



0.09



5.16



6.46



0.34



2.62



4.77



0.01



n



10



10



10



10



10



10



10



G5, F & 0.03



Mean



0.18*



14.98



78.18



0.42*



6.28



11.09



0.02*



±SD



0.11



8.26



9.85



0.48



3.30



4.69



0.01



n



10



10



10



10



10



10



10



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05)


TABLE 11 (Contd…). SUMMARY OF BALF RECORD


        Refer Appendix 11


























































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Absolute Lymphocytes



Absolute Monocytes



Absolute Eosinophils



Absolute Basophils



Lactate Dehydrogenase



Total


Protein



Alkaline phosphatase



Gamma-glutamyl transferase



(Lymph)



(Mono)



(Eos)



(Baso)



(LDH)



(TPR)



(ALP)



(GGT)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(u/L)



(g/dL)/(µg/ml)



(U/L)



(U/L)



G1, M & 0



Mean



0.50



0.04



0.03



0.02



68.50



0.43



10.80



3.45



±SD



0.47



0.07



0.07



0.02



47.49



0.26



2.53



2.46



n



10



10



10



10



10



10



10



10



G2, M & 0.001



Mean



0.24



0.01



0.01



0.02



59.83



0.24*



10.00



3.88



±SD



0.16



0.01



0.01



0.01



27.87



0.05



0.00



2.77



n



10



10



10



10



10



10



10



10



G3, M & 0.003



Mean



0.24



0.04



0.02



0.01



56.66



0.21*



11.30



2.21



±SD



0.08



0.07



0.02



0.01



49.34



0.09



4.11



0.76



n



10



10



10



10



10



10



10



10



G4, M & 0.01



Mean



0.27



0.01



0.01



0.02



38.12



0.30



10.00



1.58



±SD



0.12



0.01



0.01



0.02



9.74



0.10



0.00



1.06



n



10



10



10



10



10



10



10



10



G5, M & 0.03



Mean



0.33



0.01



0.01



0.02



61.19



0.32



10.00



3.19



±SD



0.23



0.01



0.01



0.02



35.37



0.13



0.00



2.16



n



10



10



10



10



10



10



10



10



G1, F & 0



Mean



0.45



0.02



0.02



0.07



207.67



294.00



20.80



3.62



±SD



0.24



0.01



0.01



0.05



200.35



136.52



20.51



1.64



n



10



10



10



10



10



10



10



10



G2, F & 0.001



Mean



0.09*



0.00*



0.02



0.02*



42.75*



272.37



10.00



2.58



±SD



0.07



0.00



0.01



0.01



30.45



61.71



0.00



0.72



n



10



10



10



10



10



10



10



10



G3, F & 0.003



Mean



0.18*



0.00*



0.01



0.03*



87.84



233.41



10.10



2.58



±SD



0.10



0.00



0.01



0.02



63.93



78.80



0.32



2.66



n



10



10



10



10



10



10



10



10



G4, F & 0.01



Mean



0.18*



0.00*



0.01



0.03*



140.33



290.17



14.90



9.73



±SD



0.08



0.00



0.01



0.02



84.92



151.87



10.46



20.03



n



10



10



10



10



10



10



10



10



G5, F & 0.03



Mean



0.14*



0.00*



0.01



0.02*



91.54



304.69



10.50



3.74



±SD



0.09



0.00



0.01



0.02



61.16



82.45



0.71



2.19



n



10



10



10



10



10



10



10



10



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05)


TABLE 11 (Contd…). SUMMARY OF BALF RECORD


        Refer Appendix 11

























































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Total Leucocyte Count



Neutrophils



Lymphocytes



Monocytes



Eosinophils



Basophils



Absolute Neutrophils



(WBC)



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(Neut)



(103 cells/µL)



(%)



(%)



(%)



(%)



(%)



(103 cells/µL)



G1R-S1, M & 0



Mean



1.15



34.48



50.78



3.66



3.32



1.72



0.51



±SD



1.34



17.34



18.00



2.99



3.45



1.14



0.78



n



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



0.91



24.16



68.50



2.72



0.92



3.02



0.27



±SD



0.70



19.70



19.58



3.40



0.54



1.22



0.34



n



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



0.73



26.20



67.46



2.04



1.18



4.42



0.19



±SD



0.18



15.92



17.29



1.07



0.71



4.11



0.11



n



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



1.09



21.50



62.64



11.56



2.78



7.80*



0.36



±SD



1.51



10.82



31.74



22.74



2.97



5.11



0.65



n



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



0.71



26.78



66.42



2.24



2.40



6.18



0.21



±SD



0.21



11.71



12.01



1.50



0.99



3.61



0.16



n



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



0.46



15.36



73.40



6.44



2.92



11.46



0.13



±SD



0.40



19.36



29.76



12.56



2.24



5.53



0.25



n



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



0.55



17.24



76.60



1.96



2.38



4.38*



0.10



±SD



0.26



16.00



18.12



1.52



2.23



2.81



0.12



n



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



0.35



12.76



81.82



1.14



2.68



8.64



0.04



±SD



0.16



3.92



6.56



0.63



1.73



1.02



0.02



n



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



0.25



14.66



77.64



1.64



3.80



5.42*



0.03



±SD



0.10



4.71



9.14



0.78



3.17



2.78



0.01



n



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



0.56



9.34



86.24



0.68



2.48



7.48



0.05



±SD



0.26



3.08



4.90



0.43



1.20



3.28



0.04



n



5



5



5



5



5



5



5



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1; *: Statistically significant (p<0.05)


TABLE 11 (Contd…). SUMMARY OF BALF RECORD


        Refer Appendix 11


























































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Absolute Lymphocytes



Absolute Monocytes



Absolute Eosinophils



Absolute Basophils



Lactate Dehydrogenase



Total


Protein



Alkaline phosphatase



Gamma-glutamyl transferase



(Lymph)



(Mono)



(Eos)



(Baso)



(LDH)



(TPR)



(ALP)



(GGT)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(u/L)



(g/dL)



(U/L)



(U/L)



G1R-S1, M & 0



Mean



0.50



0.07



0.02



0.02



146.40



0.92



12.20



3.71



±SD



0.43



0.12



0.01



0.02



113.31



1.19



4.92



1.44



n



5



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



0.56



0.04



0.01



0.03



106.30



0.36



16.60



2.69



±SD



0.35



0.08



0.00



0.02



67.47



0.08



10.48



0.81



n



5



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



0.49



0.01



0.01



0.04



73.86



0.26



10.80



3.15



±SD



0.17



0.01



0.01



0.05



21.60



0.10



1.79



1.48



n



5



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



0.31



0.40



0.01



0.04



131.90



0.53



13.40



4.02



±SD



0.13



0.88



0.01



0.01



122.12



0.39



5.98



1.44



n



5



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



0.45



0.02



0.01



0.04



96.10



0.32



17.60



4.64



±SD



0.08



0.02



0.01



0.03



50.22



0.14



11.28



2.74



n



5



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



0.24



0.07



0.01



0.05



67.24



0.29



19.00



1.65



±SD



0.06



0.15



0.00



0.04



68.82



0.15



19.03



1.11



n



5



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



0.43



0.01



0.01



0.02



57.12



0.34



13.40



1.32



±SD



0.25



0.01



0.00



0.02



35.09



0.18



5.46



0.31



n



5



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



0.30



0.00



0.01



0.03



44.38



0.28



10.60



2.69



±SD



0.15



0.01



0.00



0.01



16.75



0.19



0.89



1.37



n



5



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



0.20



0.00



0.01



0.02



37.94



0.22



10.40



1.75



±SD



0.10



0.00



0.01



0.01



16.45



0.09



0.89



0.62



n



5



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



0.48



0.00



0.01



0.04



60.96



0.20



10.40



2.14



±SD



0.22



0.00



0.01



0.03



22.41



0.05



0.89



0.96



n



5



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1.


 


TABLE 11 (Contd…). SUMMARY OF BALF RECORD


        Refer Appendix 11

























































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Total Leucocyte Count



Neutrophils



Lymphocytes



Monocytes



Eosinophils



Basophils



Absolute Neutrophils



(WBC)



(Neut)



(Lymph)



(Mono)



(Eos)



(Baso)



(Neut)



(103 cells/µL)



(%)



(%)



(%)



(%)



(%)



(103 cells/µL)



G1R-S2, M & 0



Mean



2.03



32.16



58.36



7.16



0.74



3.58



0.81



±SD



2.26



11.48



14.75



5.49



0.23



1.40



1.12



n



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



0.92



36.14



54.90



3.56



1.24



5.38



0.44



±SD



0.76



24.87



27.60



3.77



0.65



3.81



0.60



n



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



0.81



29.26



64.74



2.46



1.56



5.36



0.30



±SD



0.53



16.86



17.46



1.21



1.17



3.09



0.39



n



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



0.48



22.96



72.52



2.02



1.22



5.72



0.17



±SD



0.43



17.64



18.79



0.98



0.55



2.25



0.28



n



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



0.77



29.08



61.40



4.76



2.18



8.72



0.27



±SD



0.48



13.04



12.92



2.26



1.28



6.51



0.29



n



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



0.31



21.18



69.36



3.06



3.12



6.44



0.07



±SD



0.11



7.76



8.34



0.94



1.25



1.52



0.05



n



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



0.60



21.12



64.72



7.86



4.26



6.46



0.14



±SD



0.47



10.36



22.74



12.22



4.85



3.84



0.14



n



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



0.53



17.46



75.60



4.12



1.24



9.68



0.11



±SD



0.34



9.06



10.34



2.42



0.74



3.62



0.11



n



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



0.35



19.20



72.42



3.32



3.82



9.16



0.07



±SD



0.09



10.86



13.92



2.21



2.01



2.63



0.04



n



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



0.41



18.18



74.92



2.56



2.98



9.78



0.07



±SD



0.14



6.16



7.14



0.47



2.05



1.65



0.03



n



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2.


TABLE 11 (Contd…). SUMMARY OF BALF RECORD


        Refer Appendix 11


























































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Absolute Lymphocytes



Absolute Monocytes



Absolute Eosinophils



Absolute Basophils



Lactate Dehydrogenase



Total


Protein



Alkaline phosphatase



Gamma-glutamyl transferase



(Lymph)



(Mono)



(Eos)



(Baso)



(LDH)



(TPR)



(ALP)



(GGT)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(103 cells/µL)



(u/L)



(µg/ml)



(U/L)



(U/L)



G1R-S2, M & 0



Mean



1.00



0.19



0.01



0.08



195.44



495.98



23.40



6.34



±SD



0.92



0.22



0.01



0.10



119.79



31.54



14.38



4.91



n



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



0.40



0.04



0.01



0.03



86.26



530.26



14.20



3.99



±SD



0.23



0.05



0.02



0.02



55.53



19.17



4.60



2.89



n



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



0.46



0.02



0.01



0.04



87.14



307.01*



18.20



4.17



±SD



0.12



0.03



0.01



0.04



71.73



81.32



14.57



2.79



n



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



0.29



0.01*



0.00



0.03



66.84*



622.15*



14.40



2.91



±SD



0.13



0.02



0.01



0.03



58.56



16.77



9.84



1.41



n



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



0.42



0.04



0.01



0.09



125.00



726.10*



23.00



6.38



±SD



0.16



0.04



0.00



0.10



52.05



58.29



9.41



5.24



n



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



0.22



0.01



0.01



0.02



147.98



472.31



14.20



9.00



±SD



0.07



0.01



0.01



0.01



189.81



30.47



19.06



5.03



n



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



0.36



0.07



0.02



0.05



98.06



443.81



10.20



9.05



±SD



0.34



0.13



0.01



0.06



51.83



4.91



7.79



9.28



n



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



0.38



0.03



0.01



0.05



99.06



455.36



14.20



7.22



±SD



0.21



0.03



0.01



0.03



104.25



12.89



20.68



7.90



n



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



0.26



0.01



0.01



0.03



89.02



438.12*



7.00



6.34



±SD



0.09



0.01



0.01



0.01



41.66



17.03



2.65



1.10



n



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



0.31



0.01



0.01



0.04



78.84



450.96



6.00



5.27



±SD



0.12



0.01



0.00



0.02



28.70



7.25



2.00



1.75



n



5



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group; SD: Standard Deviation; n: Number of animals; R: Recovery; S2: Satellite 2; *: Statistically significant (p<0.05)


 



  • SUMMARY OF CLINICAL CHEMISTRY RECORD


                                                                                                                                                                                                                                                                   Refer Appendix 12



























































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Glucose



Urea



Creatinine



Total Cholesterol



Triglycerides



Total Protein



Albumin



Alanine aminotransferase



Aspartate aminotransferase



(GLU)


 

(CRE)



(CHO)



(TRI)



(TPR)



(ALB)



(ALT)



(AST)



(mg/dL)



(mg/dL)



(mg/dL)



(mg/dL)



(mg/dL)



(g/dL)



(g/dL)



(U/L)



(U/L)



G1, M & 0



Mean



75.90



32.27



0.50



53.50



47.00



7.20



3.20



54.00



104.80



±SD



6.79



4.24



0.03



9.42



20.86



0.20



0.14



10.80



5.51



n



10



10



10



10



10



10



10



10



10



G2, M & 0.001



Mean



76.30



30.61



0.51



47.90



47.80



7.38



3.37*



69.80*



106.60



±SD



6.46



4.30



0.02



6.56



20.29



0.35



0.11



13.31



18.55



n



10



10



10



10



10



10



10



10



10



G3, M & 0.003



Mean



85.80



32.03



0.55*



45.60



44.50



7.46



3.56*



61.90



112.20



±SD



14.20



5.11



0.03



10.72



14.78



0.21



0.13



8.71



19.41



n



10



10



10



10



10



10



10



10



10



G4, M & 0.01



Mean



93.90*



32.36



0.53*



48.60



46.10



7.37



3.56*



66.10



113.60



±SD



8.05



3.89



0.03



9.71



10.70



0.29



0.16



9.29



21.37



n



10



10



10



10



10



10



10



10



10



G5, M & 0.03



Mean



83.80



33.10



0.51



49.60



46.00



7.50



3.60*



69.20*



113.90



±SD



9.10



4.57



0.02



8.24



13.43



0.29



0.12



15.60



24.36



n



10



10



10



10



10



10



10



10



10



G1, F & 0



Mean



95.50



38.64



0.59



57.90



37.80



8.06



3.59



47.60



95.30



±SD



6.50



5.69



0.03



9.57



6.76



0.34



0.12



7.57



7.73



n



10



10



10



10



10



10



10



10



10



G2, F & 0.001



Mean



95.60



37.45



0.65*



63.70



54.00*



7.97



3.88*



48.90



83.50



±SD



7.63



4.51



0.05



13.26



20.60



0.25



0.24



8.53



6.11



n



10



10



10



10



10



10



10



10



10



G3, F & 0.003



Mean



97.80



38.24



0.63*



67.20



39.80



8.04



3.93*



46.10



85.00



±SD



7.89



7.04



0.03



11.03



10.20



0.39



0.12



11.64



11.52



n



10



10



10



10



10



10



10



10



10



G4, F & 0.01



Mean



94.20



42.22



0.64*



61.40



40.20



7.99



3.79*



52.30



95.90



±SD



10.64



3.59



0.02



6.02



12.94



0.40



0.12



9.55



12.21



n



10



10



10



10



10



10



10



10



10



G5, F & 0.03



Mean



100.40



39.93



0.62



66.10



37.70



8.06



3.88*



44.60



87.10



±SD



10.00



4.63



0.02



10.77



9.94



0.20



0.14



11.74



16.56



n



10



10



10



10



10



10



10



10



10



M: Male; F: Female; SD: Standard Deviation; n: number of animals; *: Statistically significant (p<0.05).


TABLE 12 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD


Refer Appendix 12



























































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Alkaline phosphatase



Total Bilirubin



Calcium



Phosphorous



Globulin



Blood Urea Nitrogen



Sodium



Potassium



Chloride



(ALP)



(BIT)



(CAL)



(PHO)



(GLO)



(BUN)



(Na)



(K)



(CLO)



(U/L)



(mg/dL)



(mg/dL)



(mg/dL)



(g/dL)



(mg/dL)



(mmol/L)



(mmol/L)



(mmol/L)



G1, M & 0



Mean



200.40



0.07



9.00



7.25



4.00



15.06



143.50



3.57



106.68



±SD



48.17



0.02



0.35



0.75



0.18



1.98



0.58



0.38



0.97



n



10



10



10



10



10



10



10



10



10



G2, M & 0.001



Mean



153.40*



0.08



9.22



5.19*



4.01



14.29



144.06



3.57



108.40



±SD



31.27



0.06



0.27



0.61



0.32



2.01



1.35



0.21



1.95



n



10



10



10



10



10



10



10



10



10



G3, M & 0.003



Mean



158.30*



0.10



9.36*



5.54*



3.90



14.95



144.35



3.73



109.81*



±SD



37.09



0.06



0.24



0.65



0.19



2.39



1.35



0.39



1.86



n



10



10



10



10



10



10



10



10



10



G4, M & 0.01



Mean



149.40*



0.09



9.63*



5.33*



3.81



15.10



144.30



3.82



109.46*



±SD



24.36



0.02



0.21



0.33



0.23



1.82



0.90



0.32



1.88



n



10



10



10



10



10



10



10



10



10



G5, M & 0.03



Mean



147.20*



0.08



9.69*



5.59*



3.90



15.45



143.93



3.68



108.91*



±SD



29.97



0.02



0.19



0.49



0.22



2.13



1.18



0.28



1.62



n



10



10



10



10



10



10



10



10



10



G1, F & 0



Mean



104.00



0.06



10.60



5.08



4.47



18.03



140.25



3.45



104.06



±SD



41.09



0.01



0.36



0.43



0.31



2.65



1.11



0.17



1.87



n



10



10



10



10



10



10



10



10



10



G2, F & 0.001



Mean



85.30



0.07



10.66



4.42*



4.10*



17.48



140.00



3.50



105.27



±SD



31.83



0.04



0.33



0.49



0.22



2.10



1.16



0.33



1.59



n



10



10



10



10



10



10



10



10



10



G3, F & 0.003



Mean



71.20



0.07



10.75



4.25*



4.11*



17.85



140.75



3.34



105.87*



±SD



20.05



0.02



0.27



0.53



0.30



3.28



0.71



0.20



1.23



n



10



10



10



10



10



10



10



10



10



G4, F & 0.01



Mean



84.70



0.09*



10.58



4.57*



4.20



19.70



141.85*



3.39



106.76*



±SD



29.91



0.05



0.29



0.43



0.34



1.68



1.45



0.23



1.17



n



10



10



10



10



10



10



10



10



10



G5, F & 0.03



Mean



82.90



0.07



10.74



4.57*



4.18



18.63



142.31*



3.62



107.49*



±SD



24.88



0.02



0.25



0.29



0.25



2.16



1.19



0.19



1.15



n



10



10



10



10



10



10



10



10



10



M: Male; F: Female; SD: Standard Deviation; n: Number of animals; *: Statistically significant (p<0.05)


 


TABLE 12 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD


Refer Appendix 12



























































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Glucose



Urea



Creatinine



Total Cholesterol



Triglycerides



Total Protein



Albumin



Alanine aminotransferase



Aspartate aminotransferase



(GLU)


 

(CRE)



(CHO)



(TRI)



(TPR)



(ALB)



(ALT)



(AST)



(mg/dL)



(mg/dL)



(mg/dL)



(mg/dL)



(mg/dL)



(g/dL)



(g/dL)



(U/L)



(U/L)



G1R-S1, M & 0



Mean



115.40



32.12



0.55



43.00



25.60



6.84



3.22



58.40



102.60



±SD



10.60



3.77



0.04



14.51



10.99



0.40



0.16



11.13



17.76



n



5



5



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



107.40



33.98



0.55



47.40



39.60



6.78



3.40



72.00



116.40



±SD



7.99



5.29



0.02



12.44



15.04



0.41



0.22



13.66



38.66



n



5



5



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



103.20



30.72



0.56



40.40



40.00



6.56



3.32



67.80



81.00



±SD



6.61



5.35



0.03



6.11



11.68



0.30



0.19



9.36



10.51



n



5



5



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



111.40



30.66



0.54



57.80



50.40



6.58



3.39



62.20



88.80



±SD



13.01



2.47



0.05



8.07



13.54



0.33



0.23



9.73



12.21



n



5



5



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



110.60



32.92



0.54



59.80



64.00*



6.66



3.37



52.00



84.80



±SD



9.45



4.68



0.02



14.22



39.60



0.17



0.26



9.19



14.86



n



5



5



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



115.60



33.92



0.67



67.80



44.20



7.92



3.84



47.00



78.40



±SD



15.50



2.95



0.02



13.42



28.40



0.34



0.15



7.04



6.27



n



5



5



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



104.00



42.46*



0.71



65.60



37.80



7.74



3.60



50.20



91.20



±SD



14.18



5.75



0.07



16.47



11.84



0.36



0.26



12.36



15.56



n



5



5



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



107.00



37.12



0.66



69.00



42.40



8.02



4.04



44.40



83.80



±SD



8.34



2.79



0.02



6.82



5.37



0.27



0.08



6.11



12.44



n



5



5



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



116.80



45.18*



0.62



60.60



48.60



7.68



3.92



52.60



92.80



±SD



16.25



5.40



0.03



7.13



23.63



0.26



0.20



13.74



17.73



n



5



5



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



104.20



34.48



0.63



66.80



42.60



7.80



3.87



47.00



96.60



±SD



6.72



2.85



0.02



21.51



9.96



0.19



0.24



6.00



20.43



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1; *: Statistically significant (p<0.05)


 


 


TABLE 12 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD


Refer Appendix 12



























































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Alkaline phosphatase



Total Bilirubin



Calcium



Phosphorous



Globulin



Blood Urea Nitrogen



Sodium



Potassium



Chloride



(ALP)



(BIT)



(CAL)



(PHO)



(GLO)



(BUN)



(Na)



(K)



(CLO)



(U/L)



(mg/dL)



(mg/dL)



(mg/dL)



(g/dL)



(mg/dL)



(mmol/L)



(mmol/L)



(mmol/L)



G1R-S1, M & 0



Mean



139.00



0.03



9.94



5.08



3.62



14.99



144.00



3.79



109.76



±SD



48.66



0.03



0.30



0.90



0.52



1.76



0.85



0.19



1.76



n



5



5



5



5



5



5



5



5



5



G2R-S1, M & 0.001



Mean



149.80



0.04



10.02



4.76



3.38



15.86



145.68*



3.77



111.36



±SD



60.41



0.01



0.34



0.53



0.52



2.47



0.54



0.17



1.37



n



5



5



5



5



5



5



5



5



5



G3R-S1, M & 0.003



Mean



122.60



0.02



9.76



4.80



3.24



14.34



145.72*



3.65



111.72



±SD



20.89



0.01



0.50



0.31



0.33



2.50



0.40



0.15



0.96



n



5



5



5



5



5



5



5



5



5



G4R-S1, M & 0.01



Mean



158.80



0.04



9.84



5.08



3.19



14.31



145.66*



3.79



112.66*



±SD



106.14



0.02



0.30



0.36



0.51



1.15



1.02



0.22



1.64



n



5



5



5



5



5



5



5



5



5



G5R-S1, M & 0.03



Mean



108.40



0.02



10.10



4.78



3.29



15.36



146.48*



3.78



112.72*



±SD



12.42



0.01



0.19



0.33



0.31



2.19



0.61



0.18



0.73



n



5



5



5



5



5



5



5



5



5



G1R-S1, F & 0



Mean



82.80



0.05



10.48



4.52



4.08



15.83



147.40



3.42



114.18



±SD



45.55



0.04



0.22



0.48



0.29



1.38



1.07



0.57



1.86



n



5



5



5



5



5



5



5



5



5



G2R-S1, F & 0.001



Mean



124.00



0.06



10.36



4.92



4.14



19.81*



145.90



3.66



112.70



±SD



70.55



0.02



0.67



0.48



0.50



2.68



0.32



0.30



1.36



n



5



5



5



5



5



5



5



5



5



G3R-S1, F & 0.003



Mean



78.00



0.05



11.00



5.04



3.98



17.32



147.18



3.74



113.58



±SD



44.36



0.02



0.44



0.68



0.29



1.30



1.15



0.26



1.75



n



5



5



5



5



5



5



5



5



5



G4R-S1, F & 0.01



Mean



65.60



0.07



10.62



4.82



3.76



21.08*



146.66



3.72



111.98



±SD



17.49



0.04



0.44



0.47



0.10



2.52



1.35



0.18



1.89



n



5



5



5



5



5



5



5



5



5



G5R-S1, F & 0.03



Mean



77.40



0.05



10.54



5.36



3.93



16.09



147.06



3.47



114.78



±SD



45.61



0.03



0.51



0.34



0.26



1.33



1.72



0.28



3.56



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group; SD: Standard Deviation; n: Number of animals; R: Recovery; S1: Satellite 1; *: Statistically significant (p<0.05)


 


TABLE 12 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD


Refer Appendix 12



























































































































































































































































































































































































































Group, Sex & Dose (mg/L)


 

Glucose



Urea



Creatinine



Total Cholesterol



Triglycerides



Total Protein



Albumin



Alanine aminotransferase



Aspartate aminotransferase



(GLU)


 

(CRE)



(CHO)



(TRI)



(TPR)



(ALB)



(ALT)



(AST)



(mg/dL)



(mg/dL)



(mg/dL)



(mg/dL)



(mg/dL)



(g/dL)



(g/dL)



(U/L)



(U/L)



G1R-S2, M & 0



Mean



108.20



29.30



0.55



54.00



36.00



7.22



3.10



100.40



161.40



±SD



7.85



5.09



0.05



14.20



7.48



0.22



0.22



61.72



77.82



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



98.00



31.84



0.56



55.00



32.60



7.08



3.11



85.80



124.00



±SD



12.23



2.43



0.02



20.94



10.26



0.33



0.17



22.25



30.16



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



101.80



29.98



0.54



50.40



51.20



6.96



3.18



73.80



112.40



±SD



6.46



5.36



0.03



5.64



8.58



0.09



0.12



11.03



10.53



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



106.80



29.18



0.52



54.60



34.00



7.04



3.20



79.40



139.20



±SD



6.14



3.14



0.03



8.68



13.27



0.19



0.18



24.00



38.30



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



109.00



34.04



0.54



53.60



42.80



7.38



3.20



97.80



121.20



±SD



14.87



7.45



0.05



7.06



12.68



0.59



0.15



58.58



28.57



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



103.60



40.78



0.65



82.40



57.80



7.20



3.85



66.20



105.80



±SD



6.02



8.48



0.03



18.38



16.45



0.51



0.31



16.60



27.97



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



103.60



32.86



0.63



80.00



49.00



7.34



3.82



159.00*



355.20



±SD



4.39



4.32



0.02



21.15



20.09



0.23



0.30



104.16



350.44



n



5



5



5



5



5



5



5



5



5



G3R-S2, F & 0.003



Mean



118.80*



31.28*



0.66



89.60



65.60



7.74



4.00



72.60



126.60



±SD



13.88



3.86



0.03



13.52



28.33



0.54



0.19



37.56



39.11



n



5



5



5



5



5



5



5



5



5



G4R-S2, F & 0.01



Mean



110.00



32.72



0.67



101.80



68.00



7.80



4.17



54.00



100.20



±SD



5.10



3.58



0.04



25.21



21.42



0.28



0.27



25.40



34.33



n



5



5



5



5



5



5



5



5



5



G5R-S2, F & 0.03



Mean



107.40



35.18



0.65



88.80



42.20



7.60



4.07



55.80



124.00



±SD



8.73



4.95



0.01



34.88



10.85



0.46



0.27



9.68



59.15



n



5



5



5



5



5



5



5



5



5



M: Male; F: Female; R: Recovery Group; SD: Standard Deviation; n: Number of animals; R: Recovery; S2; Satellite 2; *: Statistically significant (p<0.05)


 


 


TABLE 12 (Contd…). SUMMARY OF CLINICAL CHEMISTRY RECORD


Refer Appendix 12




















































































































































































































































































Group, Sex & Dose (mg/L)


 

Alkaline phosphatase



Total Bilirubin



Calcium



Phosphorous



Globulin



Blood Urea Nitrogen



Sodium



Potassium



Chloride



(ALP)



(BIT)



(CAL)



(PHO)



(GLO)



(BUN)



(Na)



(K)



(CLO)



(U/L)



(mg/dL)



(mg/dL)



(mg/dL)



(g/dL)



(mg/dL)



(mmol/L)



(mmol/L)



(mmol/L)



G1R-S2, M & 0



Mean



129.20



0.04



9.80



4.24



4.12



13.67



141.78



3.43



105.12



±SD



40.71



0.02



0.31



0.36



0.25



2.38



1.96



0.29



2.72



n



5



5



5



5



5



5



5



5



5



G2R-S2, M & 0.001



Mean



148.00



0.05



9.68



4.04



3.97



14.86



142.24



3.72



106.68



±SD



87.36



0.01



0.57



0.35



0.43



1.14



1.11



0.16



1.52



n



5



5



5



5



5



5



5



5



5



G3R-S2, M & 0.003



Mean



92.40



0.05



9.90



3.94



3.78



13.99



142.20



3.60



107.00



±SD



21.47



0.01



0.42



0.40



0.12



2.50



0.88



0.23



0.39



n



5



5



5



5



5



5



5



5



5



G4R-S2, M & 0.01



Mean



104.80



0.05



9.84



3.86



3.84



13.62



142.16



3.86*



107.42



±SD



25.53



0.02



0.55



0.52



0.21



1.47



1.34



0.12



1.51



n



5



5



5



5



5



5



5



5



5



G5R-S2, M & 0.03



Mean



153.20



0.06



9.86



4.00



4.18



15.88



142.64



3.60



107.04



±SD



54.69



0.02



0.33



0.37



0.67



3.48



0.56



0.27



0.83



n



5



5



5



5



5



5



5



5



5



G1R-S2, F & 0



Mean



63.00



0.03



10.54



3.00



3.35



19.03



143.08



3.17



107.10



±SD



24.73



0.03



0.42



0.54



0.25



3.96



2.08



0.24



2.41



n



5



5



5



5



5



5



5



5



5



G2R-S2, F & 0.001



Mean



80.80



0.05



10.28



2.92



3.52



15.33



141.84



3.23



106.66