3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide

Endpoint summary

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)
		(10^3 cells/µL)	(10^6 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)
		(10^3 cells/µL)	(fL)	(%)	(%)	(%)	(%)	(%)	(%)	(10^9 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)
		(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 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)
		(10^3 cells/µL)	(10^6 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)
		(10^3 cells/µL)	(fL)	(%)	(%)	(%)	(%)	(%)	(%)	(10^9 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)
		(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 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)
		(10^3 cells/µL)	(10^6 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)
		(10^3 cells/µL)	(fL)	(%)	(%)	(%)	(%)	(%)	(%)	(10^9 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)
		(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 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)
		(10^3 cells/µL)	(%)	(%)	(%)	(%)	(%)	(10^3 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)
		(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 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)
		(10^3 cells/µL)	(%)	(%)	(%)	(%)	(%)	(10^3 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)
		(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 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)
		(10^3 cells/µL)	(%)	(%)	(%)	(%)	(%)	(10^3 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)
		(10^3 cells/µL)	(10^3 cells/µL)	(10^3 cells/µL)	(10^3 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
	±SD