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

Repeated dose toxicity: inhalation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 413 (90-Day (Subchronic) Inhalation Toxicity Study

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Test material

Test material information

1

Reference substance name:

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

EC Number:

229-440-3

EC Name:

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

Cas Number:

6535-46-2

Molecular formula:

C24H16Cl3N3O2

IUPAC Name:

3-hydroxy-N-(2-methylphenyl)-4-[(2,4,5-trichlorophenyl)diazenyl]-2-naphthamide

Test material form:

solid: nanoform, no surface treatment

Details on test material:

- Density: 1.48 g/cm3 (20 degree celcius)

Test animals

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

Administration / exposure

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

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0.03 mg/L air

Remarks:

G5 & G5R

Doses / concentrations 2

Dose / conc.:

0.01 mg/L air

Remarks:

G4 & G4R

Doses / concentrations 3

Dose / conc.:

0.003 mg/L air

Remarks:

G3

Doses / concentrations 4

Dose / conc.:

0.001 mg/L air

Remarks:

G2 &G2R

Doses / concentrations 5

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

Examinations

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

Results and discussion

Results of examinations

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

Effect levels

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

Target system / organ toxicity

Key result

Critical effects observed:

no

Any other information on results incl. tables

• 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	47.61	0.02	0.35	0.52	0.27	2.02	0.83	0.22	0.36
	n	5	5	5	5	5	5	5	5	5
G3R-S2, F & 0.003	Mean	56.20	0.03	10.64	2.98	3.74	14.60*	141.30	3.74*	105.60
	±SD	20.44	0.03	0.54	0.28	0.57	1.80	1.44	0.19	1.76
	n	5	5	5	5	5	5	5	5	5
G4R-S2, F & 0.01	Mean	48.40	0.05	10.62	2.82	3.63	15.27	142.50	3.40	107.36
	±SD	31.00	0.03	0.28	0.26	0.18	1.67	1.91	0.30	1.83
	n	5	5	5	5	5	5	5	5	5
G5R-S2, F & 0.03	Mean	65.00	0.07	10.60	3.36	3.53	16.42	142.66	3.70	108.44
	±SD	39.67	0.01	0.41	0.77	0.38	2.31	2.72	0.51	2.03
	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)

                                                    

 

• SUMMARY OF URINALYSIS

          Refer Appendix 13

Examination	Group, Sex & Dose (mg/L)		G1, M & 0	G2, M & 0.001	G3, M & 0.003	G4, M & 0.01	G5, M & 0.03
	Number of Animals		10	10	10	10	10
Physical	Colour	Pale Yellow	6	6	6	4	3
		Yellow	4	4	4	6	7
	Appearance	Clear	2	-	-	4	2
		Turbid	8	10	10	6	8
	Volume (mL)	Mean	3.7	3.7	3.4	3.6	3.6
		±SD	0.9	0.8	0.3	0.6	0.6
Chemical	pH	Mean	7.9	8.1	8.0	7.8	8.0
		±SD	0.3	0.4	0.4	0.3	0.3
	Specific Gravity	Mean	1.008	1.006	1.006	1.008	1.007
		±SD	0.003	0.002	0.002	0.003	0.003
	Urobilinogen (mg/dL)	Mean	1.0	0.9	0.7	0.4	1.2
		±SD	0.7	0.5	0.6	0.4	0.8
	Bilirubin (mg/dL)	Neg	2	-	-	4	3
		1	8	10	10	6	7
	Ketones (mg/dL)	Neg	3	2	1	3	-
		5	7	8	9	7	10
	Blood (Ery/µL)	Neg	9	9	10	10	10
		Ca10	-	1	-	-	-
		Ca25	1	-	-	-	-
	Proteins (mg/dL)	Neg	1	-	-	2	1
		Trace	1	-	-	2	1
		30	3	2	3	4	3
		100	3	2	3	2	2
		>=300	2	6	4	-	3
	Nitrite	Neg	1	-	3	3	1
		Pos	9	10	7	7	9
	Leucocytes (Leu/µL)	Ca15	-	-	-	1	-
		Ca70	2	2	3	6	1
		Ca125	8	8	7	3	9
	Glucose (mg/dL)	Neg	10	10	10	10	10
	Micro albumin (MALB) (mg/dL)	>15	9	10	10	8	9
		15	1	-	-	2	1
Microscopic	Epithelial cells	0	6	9	7	9	8
		0-1	3	-	1	-	2
		1-2	1	1	2	1	-
	Casts	Absent	9	9	10	10	10
		Present	1	1	-	-	-
	Crystals	Absent	-	-	-	2	-
		Present	10	10	10	8	10

        M: Male; Neg: Negative; Ca: Calculated Approximately; Pos: Positive; SD: Standard Deviation;

          -: Not Applicable

 

 

 

 

 

TABLE 13 (Contd…). SUMMARY OF URINALYSIS

Refer Appendix 13

Examination	Group, Sex & Dose (mg/L)		G1, F & 0	G2, F & 0.001	G3, F & 0.003	G4, F & 0.01	G5, F & 0.03
	Number of Animals		10	10	10	10	10
Physical	Colour	Pale Yellow	10	10	8	10	10
		Yellow	-	-	2	-	-
	Appearance	Clear	10	10	8	10	10
		Turbid	-	-	2	-	-
	Volume (mL)	Mean	3.0	2.9	4.3*	3.6	3.4
		±SD	0.7	0.5	0.9	1.3	0.6
Chemical	pH	Mean	6.4	6.3	6.3	6.8	6.3
		±SD	0.8	0.3	0.5	0.8	0.7
	Specific Gravity	Mean	1.019	1.019	1.020	1.019	1.022
		±SD	0.005	0.006	0.005	0.008	0.005
	Urobilinogen (mg/dL)	Mean	0.3	0.2	0.2	0.2	0.3
		±SD	0.3	0.0	0.0	0.0	0.3
	Bilirubin (mg/dL)	Neg	8	8	7	6	8
		1	2	2	3	4	2
	Ketones (mg/dL)	Neg	9	10	8	9	9
		5	1	-	2	1	1
	Blood (Ery/µL)	Neg	8	10	10	10	9
		Ca10	1	-	-	-	-
		Ca25	1	-	-	-	-
		Ca80	-	-	-	-	1
	Proteins (mg/dL)	Neg	6	8	5	5	7
		Trace	3	2	3	5	3
		30	-	-	2	-	-
		100	1	-	-	-	-
	Nitrite	Neg	2	2	8	7	9
		Pos	8	8	2	3	1
	Leucocytes (Leu/µL)	Neg	-	4	4	4	3
		Ca15	6	4	3	5	7
		Ca70	4	1	2	1	-
		Ca125	-	1	1	-	-
	Glucose (mg/dL)	Neg	10	10	10	10	10
	Micro albumin (MALB) (mg/dL)	Neg	-	2	-	-	-
		>15	4	2	5	5	3
		15	6	6	5	5	7
Microscopic	Epithelial cells	0	7	7	6	9	6
		0-1	2	2	2	1	3
		1-2	1	1	2	-	1
	Casts	Absent	10	10	10	10	10
	Crystals	Absent	-	-	-	1	-
		Present	10	10	10	9	10

F: Female; Neg: Negative; Ca: Calculated Approximately; Pos: Positive; SD: Standard Deviation;

 -: Not Applicable; *: Statistically significant (p<0.05)

 

 

 

 

 

TABLE 13 (Contd…). SUMMARY OF URINALYSIS

Refer Appendix 13

Examination	Group, Sex & Dose (mg/L)		G1R-S1, M & 0	G2R-S1, M & 0.001	G3R-S1, M & 0.003	G4R-S1, M & 0.01	G5R- S1, M & 0.03
	Number of Animals		5	5	5	5	5
Physical Examination	Color	Pale Yellow	4	2	4	2	2
		Yellow	1	3	1	3	3
	Appearance	Clear	1	-	2	1	1
		Turbid	4	5	3	4	4
	Volume (mL)	Mean	5.2	4.4	5.5	5.3	6.1
		±SD	2.0	1.0	0.4	1.0	1.3
Chemical Examination	pH	Mean	6.7	7.0	7.2	7.4	7.1
		±SD	0.3	0.5	0.3	0.9	1.0
	Specific gravity (SG)	Mean	1.019	1.021	1.014	1.015	1.019
		±SD	0.004	0.005	0.002	0.006	0.008
	Urobilinogen (UBG)           (mg/dL)	Mean	0.2	0.4	0.2	0.2	0.2
		±SD	0.0	0.4	0.0	0.0	0.0
	Bilirubin (BIL) (mg/dL)	Neg	5	5	5	5	5
	Ketones (KET) (mg/dL)	Neg	-	-	1	-	2
		5	5	4	4	5	3
		15	-	1	-	-	-
	Blood (BLD) (Ery/µL)	Neg	-	-	1	4	5
		Ca10	1	1	-	-	-
		Ca25	1	-	1	-	-
		Ca80	1	-	1	1	-
		>=Ca200	2	4	2	-	-
	Protein (PRO) (mg/dL)	Neg	-	-	1	-	-
		Trace	1	-	1	1	1
		30	2	3	2	2	3
		100	2	1	1	2	1
		>=300	-	1	-	-	-
	Nitrite (NIT)	Neg	4	4	-	1	1
		Pos	1	1	5	4	4
	Leucocytes (LEU) (Leu/µL)	Ca15	-	-	2	1	2
		Ca70	4	4	2	3	2
		Ca125	1	1	1	1	1
	Glucose (GLU) (mg/dL)	Neg	5	5	5	5	5
	Micro Albumin (MALB) (mg/dL)	>15	5	5	4	5	5
		15	-	-	1	-	-
Microscopic Examination	Epi Cells	0	3	3	3	3	2
		0-1	2	2	1	2	3
		1-2	-	-	1	-	-
	Casts	Absent	4	4	4	4	5
		Present	1	1	1	1	-
	Crystals	Absent	-	2	-	1	1
		Present	5	3	5	4	4

M: Male; R: Recovery; Neg: Negative; Ca: Calculated Approximately; Pos: Positive; SD: Standard Deviation;

 -: Not Applicable; R: Recovery; S1: Satellite 1.

 

TABLE 13 (Contd…). SUMMARY OF URINALYSIS

Refer Appendix 13

Examination	Group, Sex & Dose (mg/L)		G1R-S1, F & 0	G2R-S1, F & 0.001	G3R-S1, F & 0.003	G4R-S1, F & 0.01	G5R- S1, F & 0.03
	Number of Animals		5	5	5	5	5
Physical Examination	Color	Pale Yellow	5	5	4	4	4
		Yellow	-	-	1	1	1
	Appearance	Clear	3	5	4	2	3
		Turbid	2	-	1	3	2
	Volume (mL)	Mean	4.2	3.5	4.8	3.6	4.7
		±SD	1.4	0.8	1.8	3.0	1.7
Chemical Examination	pH	Mean	6.9	7.5	7.1	7.0	7.3
		±SD	0.5	0.6	1.0	0.4	0.6
	Specific gravity (SG)	Mean	1.014	1.011	1.014	1.012	1.010
		±SD	0.004	0.004	0.004	0.004	0.000
	Urobilinogen (UBG)           (mg/dL)	Mean	0.2	0.2	0.2	0.2	0.2
		±SD	0.0	0.0	0.0	0.0	0.0
	Bilirubin (BIL) (mg/dL)	Neg	5	5	5	5	5
	Ketones (KET) (mg/dL)	Neg	5	5	5	5	5
	Blood (BLD) (Ery/µL)	Neg	-	1	2	1	-
		Ca10	2	3	1	1	2
		Ca25	3	1	2	2	3
		Ca80	-	-	-	1	-
	Protein (PRO) (mg/dL)	Neg	-	2	-	1	2
		Trace	3	3	4	1	2
		30	1	-	1	2	-
		100	1	-	-	1	1
	Nitrite (NIT)	Neg	3	1	2	2	-
		Pos	2	4	3	3	5
	Leucocytes (LEU) (Leu/µL)	Neg	1	2	3	1	2
		Ca15	2	1	2	3	3
		Ca70	-	2	-	1	-
		Ca125	2	-	-	-	-
	Glucose (GLU) (mg/dL)	Neg	5	5	5	5	5
	Micro Albumin (MALB) (mg/dL)	Neg	-	-	-	1	1
		>15	5	3	5	4	3
		15	-	2	-	-	1
Microscopic Examination	Epi Cells	0	3	3	3	3	3
		0-1	2	1	2	2	2
		1-2	-	1	-	-	-
	Casts	Absent	5	4	4	3	5
		Present	-	1	1	2	-
	Crystals	Absent	1	-	1	-	1
		Present	4	5	4	5	4

F: Female; R: Recovery; Neg: Negative; Ca: Calculated Approximately; Pos: Positive; SD: Standard Deviation;

 -: Not Applicable; R: Recovery; S1: Satellite 1.

 

TABLE 13 (Contd…). SUMMARY OF URINALYSIS

Refer Appendix 13

Examination	Group, Sex & Dose (mg/L)		G1R-S2, M & 0	G2R-S2, M & 0.001	G3R-S2, M & 0.003	G4R-S2, M & 0.01	G5R- S2, M & 0.03
	Number of Animals		5	5	5	5	5
Physical Examination	Color	Pale Yellow	4	4	3	3	5
		Yellow	1	1	2	2	-
	Appearance	Clear	4	4	3	4	4
		Turbid	1	1	2	1	1
	Volume (mL)	Mean	6.7	7.6	5.5	4.7	4.4
		±SD	1.4	1.7	1.8	1.9	0.8
Chemical Examination	pH	Mean	7.3	6.6	6.6	7.6	6.9
		±SD	0.4	0.2	0.7	1.2	0.5
	Specific gravity (SG)	Mean	1.018	1.014	1.021	1.018	1.022
		±SD	0.003	0.007	0.005	0.008	0.008
	Urobilinogen (UBG)          (mg/dL)	Mean	0.2	0.2	0.4	0.2	0.4
		±SD	0.0	0.0	0.4	0.0	0.4
	Bilirubin (BIL) (mg/dL)	Neg	5	5	5	5	5
	Ketones (KET) (mg/dL)	5	5	5	4	5	5
		15	-	-	1	-	-
	Blood (BLD) (Ery/µL)	Neg	-	-	-	-	2
		Ca10	-	-	1	1	-
		Ca25	-	1	-	-	-
		Ca80	-	2	-	2	1
		>=Ca200	5	2	4	2	2
	Protein (PRO) (mg/dL)	Trace	1	4	1	-	-
		30	2	-	3	2	1
		100	2	1	-	2	3
		>=300	-	-	1	1	1
	Nitrite (NIT)	Neg	4	4	4	2	5
		Pos	1	1	1	3	-
	Leucocytes (LEU) (Leu/µL)	Neg	1	-	-	-	-
		Ca15	-	3	-	2	1
		Ca70	3	1	4	1	2
		Ca125	1	1	1	1	1
		>=Ca500	-	-	-	1	1
	Glucose (GLU) (mg/dL)	Neg	5	5	5	5	5
	Micro Albumin (MALB) (mg/dL)	>15	5	5	5	5	5
Microscopic Examination	Epi Cells	0	3	3	4	3	4
		0-1	2	1	1	1	-
		1-2	-	1	-	1	1
	Casts	Absent	4	4	5	5	4
		Present	1	1	-	-	1
	Crystals	Absent	1	-	2	1	1
		Present	4	5	3	4	4

M: Male; R: Recovery; Neg: Negative; Ca: Calculated Approximately; Pos: Positive; SD: Standard Deviation;

 -: Not Applicable; R: Recovery; S2: Satellite 2.

 

TABLE 13 (Contd…). SUMMARY OF URINALYSIS

Refer Appendix 13

Examination	Group, Sex & Dose (mg/L)		G1R-S2, F & 0	G2R-S2, F & 0.001	G3R-S2, F & 0.003	G4R-S2, F & 0.01	G5R- S2, F & 0.03
	Number of Animals		5	5	5	5	5
Physical Examination	Color	Pale Yellow	5	5	4	5	5
		Yellow	-	-	1	-	-
	Appearance	Clear	5	5	4	5	5
		Turbid	-	-	1	-	-
	Volume (mL)	Mean	5.1	6.7	4.8	5.3	5.2
		±SD	2.0	3.3	1.3	1.5	1.6
Chemical Examination	pH	Mean	6.6	6.6	6.9	6.9	6.7
		±SD	0.4	0.7	1.0	0.5	0.3
	Specific gravity (SG)	Mean	1.019	1.017	1.014	1.015	1.018
		±SD	0.004	0.006	0.007	0.005	0.003
	Urobilinogen (UBG)           (mg/dL)	Mean	0.2	0.2	0.6	0.2	0.2
		±SD	0.0	0.0	0.8	0.0	0.0
	Bilirubin (BIL) (mg/dL)	Neg	5	5	5	5	5
	Ketones (KET) (mg/dL)	Neg	5	4	5	5	5
		5	-	1	-	-	-
	Blood (BLD) (Ery/µL)	Neg	3	3	5	5	4
		Ca25	2	1	-	-	1
		>=Ca200	-	1	-	-	-
	Protein (PRO) (mg/dL)	Neg	-	2	2	-	1
		Trace	2	1	1	4	4
		30	3	2	1	-	-
		100	-	-	-	1	-
		>=300	-	-	1	-	-
	Nitrite (NIT)	Neg	4	3	3	3	4
		Pos	1	2	2	2	1
	Leucocytes (LEU) (Leu/µL)	Neg	1	-	-	1	2
		Ca15	2	5	5	3	3
		Ca70	-	-	-	1	-
		Ca125	2	-	-	-	-
	Glucose (GLU) (mg/dL)	Neg	5	5	5	5	5
	Micro Albumin (MALB) (mg/dL)	>15	5	3	3	5	4
		15	-	2	2	-	1
Microscopic Examination	Epi Cells	0	4	4	4	4	4
		0-1	1	1	1	1	1
	Casts	Absent	5	5	5	5	5
	Crystals	Absent	-	1	1	-	-
		Present	5	4	4	5	5

F: Female; R: Recovery; Neg: Negative; Ca: Calculated Approximately; Pos: Positive; SD: Standard Deviation;

 -: Not Applicable; R: Recovery; S2: Satellite 2.

      

 

• SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g)

                                                                                                                                                                                                                                                                        Refer Appendix 14

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Brain	Liver	Lungs
G1, M & 0	Mean	0.0526	0.3208	1.2857	3.2366	1.1929	1.1047	2.1140	1.8549	9.1028	0.6310
	±SD	0.0044	0.0429	0.1181	0.1212	0.0842	0.1059	0.1620	0.0834	0.7748	0.0353
	n	10	10	10	10	10	10	10	10	10	10
G2, M & 0.001	Mean	0.0522	0.2825	1.3134	3.2346	1.2859	1.1766	2.2836	1.9217	9.2714	0.5880
	±SD	0.0048	0.0384	0.1377	0.1180	0.0380	0.0552	0.1849	0.0714	0.6328	0.0525
	n	10	10	10	10	10	10	10	10	10	10
G3, M & 0.003	Mean	0.0548	0.2970	1.2863	3.2226	1.4318*	1.2637*	2.2580	1.9765*	9.0725	0.6137
	±SD	0.0032	0.0476	0.1663	0.1658	0.1679	0.0625	0.0855	0.0769	0.5406	0.0441
	n	10	10	10	10	10	10	10	10	10	10
G4, M & 0.01	Mean	0.0558	0.2827	1.0412*	3.4314	1.4151*	1.2415*	2.2719	1.9274	9.3101	0.6164
	±SD	0.0049	0.0387	0.1416	0.2323	0.0716	0.0462	0.0734	0.0885	0.6187	0.0652
	n	10	10	10	10	10	10	10	10	10	10
G5, M & 0.03	Mean	0.0638*	0.2469*	0.7630*	3.2182	1.3658*	1.3991*	2.4223*	2.0753*	9.7353	0.6295
	±SD	0.0073	0.0282	0.1160	0.2457	0.0908	0.0706	0.2391	0.0683	0.6317	0.0442
	n	10	10	10	10	10	10	10	10	10	10

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

.

 

 

 

 

TABLE 14 (Contd…). SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g)

Refer Appendix 14

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Brain	Liver	Lungs
G1, F & 0	Mean	0.0578	0.3197	0.5557	0.1612	0.5448	0.8665	1.5958	1.9304	8.5632	0.5947
	±SD	0.0041	0.0159	0.0486	0.0065	0.0558	0.0190	0.0498	0.0677	0.5632	0.0424
	n	10	10	10	10	10	10	10	10	10	10
G2, F & 0.001	Mean	0.0589	0.3283	0.5973	0.1613	0.5805	0.8581	1.4695*	1.9229	8.3710	0.5768
	±SD	0.0043	0.0332	0.0423	0.0069	0.0597	0.0201	0.0396	0.0537	0.8115	0.0684
	n	10	10	10	10	10	10	10	10	10	10
G3, F & 0.003	Mean	0.0537	0.3200	0.5803	0.1566	0.6122*	0.8251*	1.5149*	1.8669*	7.4185*	0.5880
	±SD	0.0053	0.0255	0.0343	0.0083	0.0129	0.0510	0.0732	0.0586	1.1355	0.0526
	n	10	10	10	10	10	10	10	10	10	10
G4, F & 0.01	Mean	0.0576	0.3098	0.5647	0.1581	0.6175	0.8648	1.5519	1.8932	7.9064	0.6003
	±SD	0.0045	0.0212	0.0432	0.0081	0.0299	0.0146	0.0867	0.0391	1.2389	0.0292
	n	10	10	10	10	10	10	10	10	10	10
G5, F & 0.03	Mean	0.0649*	0.3057	0.6659*	0.1630	0.5931*	0.8772	1.5387	1.9117	6.9971*	0.5469
	±SD	0.0043	0.0132	0.0436	0.0085	0.0916	0.0328	0.0884	0.0460	0.7054	0.0618
	n	10	10	10	10	10	10	10	10	10	10

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

 

TABLE 14 (Contd…). SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g)

Refer Appendix 14

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Brain	Liver	Lungs
G1R-S1, M & 0	Mean	0.0673	0.3126	1.0985	3.4158	1.3676	1.2912	2.5952	2.0390	11.2153	0.7918
	±SD	0.0152	0.0969	0.1522	0.3827	0.2298	0.1417	0.3926	0.0579	1.3002	0.0843
	n	5	5	5	5	5	5	5	5	5	5
G2R-S1, M & 0.001	Mean	0.0622	0.3084	1.0044	3.6368	1.5643	1.5114	2.8477	2.1600	11.4695	0.7682
	±SD	0.0059	0.0388	0.0338	0.3333	0.1455	0.2643	0.3916	0.1659	1.9777	0.0611
	n	5	5	5	5	5	5	5	5	5	5
G3R-S1, M & 0.003	Mean	0.0603	0.3091	1.1114	3.6811	1.5653	1.3525	2.5139	2.2247	11.1456	0.7773
	±SD	0.0144	0.0443	0.1362	0.2995	0.1475	0.1389	0.3459	0.1964	1.0500	0.0410
	n	5	5	5	5	5	5	5	5	5	5
G4R-S1, M & 0.01	Mean	0.0588	0.2855	1.0342	3.4562	1.5955	1.4667	2.6629	2.0544	11.0513	0.8002
	±SD	0.0047	0.0646	0.1934	0.3473	0.1410	0.1680	0.4174	0.1116	1.5673	0.0632
	n	5	5	5	5	5	5	5	5	5	5
G5R-S1, M & 0.03	Mean	0.0634	0.2573	0.9271	3.7715	1.6424	1.3107	2.5709	2.0457	11.0238	0.8047
	±SD	0.0045	0.0237	0.0389	0.3217	0.1995	0.2368	0.1845	0.0832	1.7824	0.1078
	n	5	5	5	5	5	5	5	5	5	5

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

 

TABLE 14 (Contd…). SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g)

Refer Appendix 14

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Brain	Liver	Lungs
G1R-S1, F & 0	Mean	0.0844	0.2627	0.6449	0.1774	0.7681	1.0282	1.6710	1.9056	7.7762	0.5548
	±SD	0.0089	0.0746	0.1570	0.0185	0.1569	0.1540	0.2241	0.0674	1.2140	0.1117
	n	5	5	5	5	5	5	5	5	5	5
G2R-S1, F & 0.001	Mean	0.0701	0.2641	0.4909	0.1424	0.6306	0.9245	1.4684	1.9547	6.2143*	0.5757
	±SD	0.0143	0.0241	0.0599	0.0251	0.2350	0.0508	0.2197	0.0821	0.7613	0.1375
	n	5	5	5	5	5	5	5	5	5	5
G3R-S1, F & 0.003	Mean	0.0679*	0.2282	0.6751	0.1689	0.7332	1.0692	1.7266	1.9064	7.5760	0.5697
	±SD	0.0075	0.0528	0.1105	0.0394	0.0716	0.0643	0.0579	0.0676	0.4730	0.0641
	n	5	5	5	5	5	5	5	5	5	5
G4R-S1, F & 0.01	Mean	0.0821	0.2407	0.5675	0.1617	0.7008	1.1028	1.7580	2.0593	7.2939	0.6103
	±SD	0.0055	0.0527	0.0822	0.0195	0.1312	0.1081	0.0474	0.1819	0.4295	0.0422
	n	5	5	5	5	5	5	5	5	5	5
G5R-S1, F & 0.03	Mean	0.0752	0.2683	0.6673	0.1702	0.8668	0.9346	1.5202	1.9210	6.7598	0.5131
	±SD	0.0077	0.0511	0.1760	0.0417	0.2594	0.0657	0.1581	0.0338	0.3417	0.0535
	n	5	5	5	5	5	5	5	5	5	5

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

 

TABLE 14 (Contd…). SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g)

Refer Appendix 14

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Brain	Liver	Lungs
G1R-S2, M & 0	Mean	0.0780	0.2324	1.2377	3.5095	1.8341	1.6967	2.9047	2.0855	11.5166	0.9250
	±SD	0.0045	0.0434	0.1644	0.2226	0.1485	0.1649	0.3342	0.0909	0.6342	0.1927
	n	5	5	5	5	5	5	5	5	5	5
G2R-S2, M & 0.001	Mean	0.0637*	0.1850	1.0955	3.6139	1.6339	1.4274	2.6717	2.0728	10.4597	0.8585
	±SD	0.0042	0.0422	0.0573	0.1770	0.1920	0.1347	0.1864	0.0993	1.2004	0.1890
	n	5	5	5	5	5	5	5	5	5	5
G3R-S2, M & 0.003	Mean	0.0670	0.1874	1.0873	3.7194	1.6942	1.6438	2.9416	2.0732	11.6386	0.8751
	±SD	0.0030	0.0178	0.1784	0.2217	0.1771	0.2142	0.3032	0.1353	0.9159	0.0882
	n	5	5	5	5	5	5	5	5	5	5
G4R-S2, M & 0.01	Mean	0.0745	0.2171	1.0703	3.6026	1.7083	1.6291	2.7150	2.2215	11.3808	0.7662
	±SD	0.0082	0.0624	0.0780	0.2279	0.1748	0.1426	0.4498	0.1690	1.2347	0.0814
	n	5	5	5	5	5	5	5	5	5	5
G5R-S2, M & 0.03	Mean	0.0741	0.2359	1.1156	3.8373	1.6692	1.7256	2.8737	2.1288	11.2786	1.0004
	±SD	0.0104	0.0626	0.1464	0.1542	0.0622	0.1913	0.3486	0.1310	1.1752	0.1931
	n	5	5	5	5	5	5	5	5	5	5

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

 

 

 

 

TABLE 14 (Contd…). SUMMARY OF ABSOLUTE ORGAN WEIGHTS (g)

Refer Appendix 14

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Brain	Liver	Lungs
G1R-S2, F & 0	Mean	0.0712	0.2507	0.7244	0.1600	0.9830	1.2115	2.0160	2.0128	8.3380	0.7048
	±SD	0.0036	0.0569	0.0876	0.0111	0.1357	0.2378	0.2400	0.1386	1.1914	0.0788
	n	5	5	5	5	5	5	5	5	5	5
G2R-S2, F & 0.001	Mean	0.0770	0.2264	0.6656	0.1514	0.9318	1.1271	1.7686	1.9838	7.8166	0.7308
	±SD	0.0073	0.0444	0.0673	0.0170	0.2265	0.2264	0.1475	0.0976	0.5358	0.1027
	n	5	5	5	5	5	5	5	5	5	5
G3R-S2, F & 0.003	Mean	0.0814	0.2098	0.6703	0.1584	0.9083	1.2510	1.7679	2.0339	8.5590	0.8061
	±SD	0.0097	0.0408	0.0445	0.0189	0.0307	0.0790	0.0911	0.0913	0.6659	0.1247
	n	5	5	5	5	5	5	5	5	5	5
G4R-S2, F & 0.01	Mean	0.0775	0.2311	0.7049	0.1601	1.0539	1.2180	1.9252	2.0677	8.6764	0.6616
	±SD	0.0101	0.0370	0.0905	0.0292	0.1352	0.1180	0.2142	0.1413	1.2841	0.0877
	n	5	5	5	5	5	5	5	5	5	5
G5R-S2, F & 0.03	Mean	0.0780	0.2428	0.6719	0.1718	1.0883	1.1540	1.9751	1.9763	8.5713	0.7170
	±SD	0.0069	0.0542	0.1178	0.0198	0.2213	0.0672	0.2966	0.0940	1.2155	0.0484
	n	5	5	5	5	5	5	5	5	5	5

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

 

 

 

• SUMMARY OF ORGAN WEIGHT RELATIVE TO FASTING BODY WEIGHT (%) RECORD

Refer Appendix 15

Group, Sex & Dose (mg/L)		Fasting Body Weight (g)	Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Brain	Liver	Lungs
G1, M & 0	Mean	386.68	0.0136	0.0831	0.3338	0.8383	0.3095	0.2867	0.5483	0.4809	2.3638	0.1639
	±SD	22.16	0.0013	0.0115	0.0400	0.0344	0.0296	0.0336	0.0515	0.0325	0.2740	0.0153
	n	10	10	10	10	10	10	10	10	10	10	10
G2, M & 0.001	Mean	401.93	0.0130	0.0703*	0.3266	0.8066	0.3208	0.2933	0.5691	0.4802	2.3092	0.1464
	±SD	24.19	0.0014	0.0086	0.0284	0.0425	0.0189	0.0155	0.0453	0.0422	0.1353	0.0121
	n	10	10	10	10	10	10	10	10	10	10	10
G3, M & 0.003	Mean	376.20	0.0149	0.0796	0.3523	0.8719	0.3880*	0.3443*	0.6166	0.5370	2.4669	0.1665
	±SD	52.03	0.0029	0.0113	0.0945	0.1305	0.0740	0.0702	0.1345	0.0964	0.4689	0.0301
	n	10	10	10	10	10	10	10	10	10	10	10
G4, M & 0.01	Mean	404.10	0.0138	0.0700*	0.2576*	0.8509	0.3507	0.3077	0.5630	0.4776	2.3036	0.1526
	±SD	12.83	0.0012	0.0102	0.0334	0.0767	0.0244	0.0186	0.0313	0.0306	0.1312	0.0166
	n	10	10	10	10	10	10	10	10	10	10	10
G5, M & 0.03	Mean	416.49	0.0154	0.0594*	0.1831*	0.7728	0.3283	0.3364*	0.5819	0.4994	2.3384	0.1513
	±SD	20.28	0.0020	0.0070	0.0254	0.0462	0.0218	0.0191	0.0529	0.0300	0.1228	0.0113
	n	10	10	10	10	10	10	10	10	10	10	10

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

 

 

TABLE 15 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO FASTING BODY WEIGHT (%) RECORD

Refer Appendix 15

Group, Sex & Dose (mg/L)		Fasting Body Weight (g)	Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Brain	Liver	Lungs
G1, F & 0	Mean	266.75	0.0217	0.1201	0.2084	0.0605	0.2046	0.3252	0.5992	0.7246	3.2126	0.2233
	±SD	10.67	0.0021	0.0094	0.0176	0.0040	0.0228	0.0114	0.0321	0.0370	0.2174	0.0183
	n	10	10	10	10	10	10	10	10	10	10	10
G2, F & 0.001	Mean	268.34	0.0220	0.1230	0.2231	0.0604	0.2168	0.3212	0.5501*	0.7193	3.1393	0.2168
	±SD	17.73	0.0018	0.0172	0.0172	0.0055	0.0236	0.0257	0.0438	0.0502	0.4262	0.0360
	n	10	10	10	10	10	10	10	10	10	10	10
G3, F & 0.003	Mean	263.78	0.0204	0.1213	0.2199	0.0594	0.2323*	0.3129	0.5746	0.7082	2.8127	0.2230
	±SD	6.32	0.0019	0.0079	0.0098	0.0033	0.0086	0.0198	0.0299	0.0307	0.4265	0.0202
	n	10	10	10	10	10	10	10	10	10	10	10
G4, F & 0.01	Mean	267.15	0.0216	0.1161	0.2119	0.0593	0.2313*	0.3241	0.5817	0.7096	2.9623	0.2249
	±SD	9.27	0.0018	0.0086	0.0206	0.0044	0.0117	0.0134	0.0406	0.0317	0.4718	0.0116
	n	10	10	10	10	10	10	10	10	10	10	10
G5, F & 0.03	Mean	264.18	0.0246*	0.1159	0.2530*	0.0619	0.2250	0.3329	0.5841	0.7255	2.6596*	0.2074
	±SD	13.34	0.0023	0.0064	0.0248	0.0045	0.0368	0.0230	0.0486	0.0442	0.3444	0.0246
	n	10	10	10	10	10	10	10	10	10	10	10

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

 

TABLE 15 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO FASTING BODY WEIGHT (%) RECORD

Refer Appendix 15

Group, Sex & Dose (mg/L)		Fasting Body Weight (g)	Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Brain	Liver	Lungs
G1R-S1, M & 0	Mean	552.09	0.0122	0.0568	0.1991	0.6189	0.2482	0.2341	0.4696	0.3698	2.0313	0.1437
	±SD	23.20	0.0029	0.0180	0.0271	0.0667	0.0436	0.0258	0.0612	0.0185	0.2151	0.0174
	n	5	5	5	5	5	5	5	5	5	5	5
G2R-S1, M & 0.001	Mean	567.80	0.0110	0.0543	0.1770	0.6410	0.2756	0.2666	0.5017	0.3804	2.0198	0.1353
	±SD	15.03	0.0012	0.0068	0.0075	0.0630	0.0266	0.0495	0.0696	0.0281	0.3398	0.0108
	n	5	5	5	5	5	5	5	5	5	5	5
G3R-S1, M & 0.003	Mean	543.96	0.0111	0.0568	0.2043	0.6774	0.2877	0.2485	0.4615	0.4086	2.0475	0.1430
	±SD	14.54	0.0025	0.0079	0.0241	0.0620	0.0252	0.0228	0.0567	0.0288	0.1635	0.0093
	n	5	5	5	5	5	5	5	5	5	5	5
G4R-S1, M & 0.01	Mean	563.37	0.0105	0.0507	0.1832	0.6131	0.2831	0.2602	0.4714	0.3647	1.9577	0.1423
	±SD	15.77	0.0011	0.0118	0.0309	0.0541	0.0231	0.0270	0.0615	0.0189	0.2372	0.0142
	n	5	5	5	5	5	5	5	5	5	5	5
G5R-S1, M & 0.03	Mean	542.01	0.0117	0.0474	0.1714	0.6961	0.3022*	0.2412	0.4749	0.3781	2.0281	0.1494
	±SD	29.79	0.0012	0.0028	0.0094	0.0492	0.0212	0.0354	0.0333	0.0206	0.2464	0.0259
	n	5	5	5	5	5	5	5	5	5	5	5

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

 

TABLE 15 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO FASTING BODY WEIGHT (%) RECORD

Refer Appendix 15

Group, Sex & Dose (mg/L)		Fasting Body Weight (g)	Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Brain	Liver	Lungs
G1R-S1, F & 0	Mean	403.46	0.0211	0.0657	0.1620	0.0444	0.1945	0.2575	0.4184	0.4771	1.9492	0.1391
	±SD	47.67	0.0025	0.0200	0.0449	0.0066	0.0536	0.0485	0.0736	0.0536	0.3857	0.0330
	n	5	5	5	5	5	5	5	5	5	5	5
G2R-S1, F & 0.001	Mean	375.99	0.0187	0.0704	0.1303	0.0380	0.1681	0.2459	0.3902	0.5206	1.6500	0.1531
	±SD	16.10	0.0036	0.0076	0.0124	0.0070	0.0661	0.0087	0.0518	0.0312	0.1564	0.0364
	n	5	5	5	5	5	5	5	5	5	5	5
G3R-S1, F & 0.003	Mean	382.88	0.0177	0.0598	0.1763	0.0440	0.1917	0.2793	0.4513	0.4980	1.9802	0.1489
	±SD	9.28	0.0020	0.0148	0.0284	0.0096	0.0201	0.0172	0.0213	0.0161	0.1444	0.0183
	n	5	5	5	5	5	5	5	5	5	5	5
G4R-S1, F & 0.01	Mean	388.18	0.0212	0.0619	0.1465	0.0416	0.1805	0.2839	0.4530	0.5305	1.8789	0.1574
	±SD	9.11	0.0016	0.0130	0.0235	0.0045	0.0334	0.0238	0.0125	0.0448	0.1000	0.0126
	n	5	5	5	5	5	5	5	5	5	5	5
G5R-S1, F & 0.03	Mean	371.56	0.0202	0.0721	0.1793	0.0457	0.2333	0.2518	0.4087	0.5177	1.8192	0.1380
	±SD	13.11	0.0021	0.0125	0.0455	0.0105	0.0686	0.0193	0.0332	0.0239	0.0614	0.0121
	n	5	5	5	5	5	5	5	5	5	5	5

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

 

TABLE 15 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO FASTING BODY WEIGHT (%) RECORD

Refer Appendix 15

Group, Sex & Dose (mg/L)		Fasting Body Weight (g)	Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Brain	Liver	Lungs
G1R-S2, M & 0	Mean	689.86	0.0113	0.0337	0.1794	0.5089	0.2658	0.2460	0.4211	0.3023	1.6701	0.1342
	±SD	6.77	0.0006	0.0065	0.0236	0.0361	0.0209	0.0250	0.0487	0.0120	0.1053	0.0287
	n	5	5	5	5	5	5	5	5	5	5	5
G2R-S2, M & 0.001	Mean	693.79	0.0092*	0.0267	0.1579	0.5210	0.2355	0.2058	0.3851	0.2987	1.5077	0.1240
	±SD	8.53	0.0007	0.0060	0.0087	0.0267	0.0270	0.0202	0.0276	0.0122	0.1723	0.0285
	n	5	5	5	5	5	5	5	5	5	5	5
G3R-S2, M & 0.003	Mean	676.28	0.0099	0.0278	0.1603	0.5510	0.2509	0.2431	0.4348	0.3073	1.7229	0.1297
	±SD	28.85	0.0006	0.0034	0.0218	0.0444	0.0283	0.0303	0.0394	0.0282	0.1470	0.0155
	n	5	5	5	5	5	5	5	5	5	5	5
G4R-S2, M & 0.01	Mean	701.12	0.0106	0.0309	0.1526	0.5144	0.2437	0.2323	0.3866	0.3167	1.6221	0.1092
	±SD	15.65	0.0011	0.0087	0.0101	0.0399	0.0250	0.0183	0.0593	0.0207	0.1575	0.0100
	n	5	5	5	5	5	5	5	5	5	5	5
G5R-S2, M & 0.03	Mean	687.24	0.0108	0.0342	0.1626	0.5594	0.2429	0.2510	0.4178	0.3096	1.6383	0.1452
	±SD	25.50	0.0018	0.0085	0.0226	0.0398	0.0036	0.0247	0.0438	0.0083	0.1207	0.0251
	n	5	5	5	5	5	5	5	5	5	5	5

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

 

TABLE 15 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO FASTING BODY WEIGHT (%) RECORD

Refer Appendix 15

Group, Sex & Dose (mg/L)		Fasting Body Weight (g)	Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Brain	Liver	Lungs
G1R-S2, F & 0	Mean	455.59	0.0157	0.0551	0.1590	0.0352	0.2168	0.2670	0.4428	0.4427	1.8331	0.1549
	±SD	17.31	0.0014	0.0129	0.0185	0.0035	0.0368	0.0574	0.0533	0.0407	0.2773	0.0185
	n	5	5	5	5	5	5	5	5	5	5	5
G2R-S2, F & 0.001	Mean	460.81	0.0167	0.0491	0.1445	0.0328	0.2031	0.2443	0.3835	0.4305	1.6963	0.1582
	±SD	15.17	0.0014	0.0092	0.0148	0.0033	0.0544	0.0459	0.0234	0.0165	0.1011	0.0181
	n	5	5	5	5	5	5	5	5	5	5	5
G3R-S2, F & 0.003	Mean	469.23	0.0174	0.0448	0.1430	0.0337	0.1937	0.2667	0.3770	0.4338	1.8231	0.1723
	±SD	13.75	0.0022	0.0090	0.0120	0.0032	0.0079	0.0157	0.0212	0.0241	0.1153	0.0298
	n	5	5	5	5	5	5	5	5	5	5	5
G4R-S2, F & 0.01	Mean	465.45	0.0167	0.0495	0.1511	0.0344	0.2261	0.2613	0.4128	0.4439	1.8585	0.1418
	±SD	15.87	0.0023	0.0067	0.0150	0.0058	0.0243	0.0175	0.0339	0.0169	0.2182	0.0148
	n	5	5	5	5	5	5	5	5	5	5	5
G5R-S2, F & 0.03	Mean	461.92	0.0169	0.0525	0.1453	0.0372	0.2347	0.2499	0.4265	0.4277	1.8520	0.1554
	±SD	13.16	0.0016	0.0117	0.0244	0.0042	0.0414	0.0146	0.0533	0.0100	0.2257	0.0123
	n	5	5	5	5	5	5	5	5	5	5	5

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

 

 

• SUMMARY OF ORGAN WEIGHT RELATIVE TO BRAIN WEIGHT (%) RECORD

                                                                                                                                                                                                                                                         Refer Appendix 16

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Liver	Lungs
G1, M & 0	Mean	2.8383	17.3456	69.2794	174.8023	64.4115	59.5781	113.9661	490.5089	34.1041
	±SD	0.2209	2.6128	5.0849	10.1339	5.2294	5.3011	6.9641	31.7398	2.7914
	n	10	10	10	10	10	10	10	10	10
G2, M & 0.001	Mean	2.7231	14.7164*	68.6136	168.6355	66.9969	61.3321	119.1136	483.6524	30.7061*
	±SD	0.3071	2.0735	8.9845	10.7934	3.1326	4.1853	11.8486	44.7624	3.6060
	n	10	10	10	10	10	10	10	10	10
G3, M & 0.003	Mean	2.7770	15.0315	65.2040	163.3259	72.6590*	64.0134	114.3807	459.2982	31.0761
	±SD	0.2005	2.4006	9.0039	11.6559	10.1312	3.8304	5.9079	26.4934	2.3003
	n	10	10	10	10	10	10	10	10	10
G4, M & 0.01	Mean	2.9092	14.6617*	54.2385*	178.3017	73.5944*	64.5616*	118.0560	484.2703	31.9839
	±SD	0.3564	1.8244	8.6533	13.4642	5.5291	4.2735	5.5470	42.7550	3.0390
	n	10	10	10	10	10	10	10	10	10
G5, M & 0.03	Mean	3.0739	11.8791*	36.7840*	155.2971*	65.8986	67.4738*	116.7662	469.2654	30.3640*
	±SD	0.3368	1.1166	5.6566	14.1587	5.2826	3.9306	11.5400	30.1535	2.4171
	n	10	10	10	10	10	10	10	10	10

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

 

 

 

 

 

TABLE 16 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO BRAIN WEIGHT (%) RECORD

Refer Appendix 16

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Liver	Lungs
G1, F & 0	Mean	2.9949	16.5911	28.7523	8.3592	28.2683	44.9588	82.7345	444.4981	30.8757
	±SD	0.2330	1.2219	1.8396	0.4634	3.2204	2.3433	3.3633	37.4547	2.8408
	n	10	10	10	10	10	10	10	10	10
G2, F & 0.001	Mean	3.0651	17.0920	31.0575	8.3873	30.2041	44.6481	76.4746*	435.7334	30.0412
	±SD	0.2731	1.9201	1.9646	0.3263	3.1625	1.4511	2.9736	45.1410	3.8253
	n	10	10	10	10	10	10	10	10	10
G3, F & 0.003	Mean	2.8800	17.1723	31.1152	8.3968	32.8217*	44.2861	81.2733	397.9034	31.5390
	±SD	0.2873	1.6800	2.1292	0.5032	1.2212	3.7309	5.6667	63.5129	3.1338
	n	10	10	10	10	10	10	10	10	10
G4, F & 0.01	Mean	3.0410	16.3840	29.8388	8.3555	32.6268*	45.6924	82.0082	418.3269	31.7363
	±SD	0.2325	1.3593	2.3982	0.4578	1.7139	0.9970	4.9762	69.4725	1.9415
	n	10	10	10	10	10	10	10	10	10
G5, F & 0.03	Mean	3.3932*	16.0029	34.8434*	8.5337	31.0242	45.8946	80.5512	365.9909*	28.6267
	±SD	0.1874	0.9096	2.3157	0.4935	4.7443	1.6676	5.3364	35.3492	3.3625
	n	10	10	10	10	10	10	10	10	10

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

 

 

 

 

 

TABLE 16 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO BRAIN WEIGHT (%) RECORD

Refer Appendix 16

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Liver	Lungs
G1R-S1, M & 0	Mean	3.2906	15.4252	53.7842	167.2987	66.8639	63.2184	127.1285	550.6183	38.8836
	±SD	0.6914	5.1295	6.4141	15.1154	9.5998	5.2267	17.2846	68.8855	4.5525
	n	5	5	5	5	5	5	5	5	5
G2R-S1, M & 0.001	Mean	2.8935	14.3043	46.6729	168.8054	72.5737	70.4122	132.2192	532.3095	35.6500
	±SD	0.3364	1.6959	3.1671	16.6926	6.6649	14.4410	19.2952	91.9911	2.8149
	n	5	5	5	5	5	5	5	5	5
G3R-S1, M & 0.003	Mean	2.6865	13.8875	50.0831	166.9971	70.6540	60.9908	113.1073	502.5715	35.1610
	±SD	0.4367	1.4261	5.5974	24.9352	7.5196	6.3246	13.4373	48.0572	3.6884
	n	5	5	5	5	5	5	5	5	5
G4R-S1, M & 0.01	Mean	2.8773	14.0561	50.2151	168.3466	77.6278	71.3126	129.5710	536.9283	39.1751
	±SD	0.3756	3.9495	7.7035	16.3359	4.7939	5.8070	18.6087	60.2770	5.3006
	n	5	5	5	5	5	5	5	5	5
G5R-S1, M & 0.03	Mean	3.1088	12.5934	45.4113	184.1659	80.2156*	64.1326	125.9369	539.5649	39.5329
	±SD	0.3313	1.2689	3.3307	10.2242	8.3332	11.4265	11.5581	88.1002	6.6668
	n	5	5	5	5	5	5	5	5	5

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

 

 

 

 

 

TABLE 16 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO BRAIN WEIGHT (%) RECORD

Refer Appendix 16

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Liver	Lungs
G1R-S1, F & 0	Mean	4.4327	13.8317	33.7533	9.3207	40.4282	53.8326	87.5483	407.1919	29.0474
	±SD	0.4538	4.0337	7.7509	1.0687	8.9695	6.6021	9.6405	53.9041	5.3018
	n	5	5	5	5	5	5	5	5	5
G2R-S1, F & 0.001	Mean	3.5851	13.5458	25.1798	7.2913	32.4573	47.3366	75.3511	318.5966*	29.3254
	±SD	0.6876	1.5927	3.5849	1.2715	12.4401	2.6770	12.5240	43.0116	6.2501
	n	5	5	5	5	5	5	5	5	5
G3R-S1, F & 0.003	Mean	3.5612*	12.0310	35.5293	8.8683	38.5364	56.1268	90.6017	397.8077	29.9447
	±SD	0.3534	3.0806	6.5197	2.1143	4.4958	3.7168	2.5791	29.2115	3.9142
	n	5	5	5	5	5	5	5	5	5
G4R-S1, F & 0.01	Mean	4.0232	11.7032	27.6466	7.8570	33.8741	53.6922	85.9114	355.6146	29.8553
	±SD	0.5630	2.5571	4.1735	0.6708	4.2039	4.8147	8.0397	26.8325	3.6968
	n	5	5	5	5	5	5	5	5	5
G5R-S1, F & 0.03	Mean	3.9166	13.9866	34.7265	8.8824	45.2711	48.6912	79.2429	352.0962	26.7355
	±SD	0.4354	2.7667	9.0140	2.2905	14.1490	3.9790	9.2948	21.3648	3.0704
	n	5	5	5	5	5	5	5	5	5

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

 

 

 

 

 

TABLE 16 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO BRAIN WEIGHT (%) RECORD

Refer Appendix 16

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Testes	Epididymides	Heart	Kidneys	Liver	Lungs
G1R-S2, M & 0	Mean	3.7448	11.2038	59.2597	168.4883	88.0547	81.4819	139.2254	553.1379	44.4903
	±SD	0.2574	2.4537	6.4616	12.4000	7.7917	8.4904	14.3618	41.1213	10.0762
	n	5	5	5	5	5	5	5	5	5
G2R-S2, M & 0.001	Mean	3.0809	8.8839	52.9787	174.7320	78.8065	69.0829	128.9840	504.2393	41.8345
	±SD	0.3046	1.8027	4.1910	12.7776	7.9544	8.1847	8.4829	48.2554	11.3755
	n	5	5	5	5	5	5	5	5	5
G3R-S2, M & 0.003	Mean	3.2378	9.0348	52.6099	180.0168	81.6498	79.3170	142.0757	562.4815	42.2227
	±SD	0.1567	0.4984	9.3499	16.1310	5.5903	9.0536	14.0691	46.1496	3.3069
	n	5	5	5	5	5	5	5	5	5
G4R-S2, M & 0.01	Mean	3.3739	9.8757	48.2398	162.8047	77.2158	73.8124	122.3398	515.0377	34.5709
	±SD	0.5000	3.1018	2.4682	14.6053	9.4541	9.6525	19.1779	67.9305	3.7051
	n	5	5	5	5	5	5	5	5	5
G5R-S2, M & 0.03	Mean	3.5075	11.0275	52.6565	181.0900	78.5166	81.1361	134.9411	529.0240	46.8404
	±SD	0.6505	2.5494	8.3657	17.4403	2.4151	8.1550	13.2719	32.4457	7.5763
	n	5	5	5	5	5	5	5	5	5

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

 

 

 

 

 

TABLE 16 (Contd…). SUMMARY OF ORGAN WEIGHT RELATIVE TO BRAIN WEIGHT (%) RECORD

Refer Appendix 16

Group, Sex & Dose (mg/L)		Adrenals	Thymus	Spleen	Ovaries	Uterus	Heart	Kidneys	Liver	Lungs
G1R-S2, F & 0	Mean	3.5491	12.3788	35.9879	7.9718	48.7475	59.8832	100.1698	413.7236	35.1070
	±SD	0.2341	2.4082	3.8249	0.6318	4.8367	8.9770	10.1992	46.9920	4.2961
	n	5	5	5	5	5	5	5	5	5
G2R-S2, F & 0.001	Mean	3.8855	11.3756	33.5912	7.6296	47.2110	56.7579	89.0903	394.4223	36.7857
	±SD	0.3471	1.8857	3.5259	0.7575	12.4587	10.5246	4.7899	26.6563	4.4392
	n	5	5	5	5	5	5	5	5	5
G3R-S2, F & 0.003	Mean	4.0129	10.3016	32.9641	7.7960	44.7123	61.5276	86.9351*	422.2119	39.5959
	±SD	0.5456	1.8764	1.8882	0.9813	2.1909	3.2859	2.8805	46.7270	5.7060
	n	5	5	5	5	5	5	5	5	5
G4R-S2, F & 0.01	Mean	3.7669	11.1677	33.9827	7.7238	50.8884	58.8484	92.9966	418.0586	31.9070
	±SD	0.6035	1.5091	2.0929	1.1069	4.4318	2.9845	6.6282	39.3569	2.5340
	n	5	5	5	5	5	5	5	5	5
G5R-S2, F & 0.03	Mean	3.9546	12.2553	33.9400	8.6915	54.7774	58.4491	99.6459	432.8233	36.3867
	±SD	0.3745	2.5846	5.4353	0.9116	8.8735	3.5221	11.2114	50.0358	3.7246
	n	5	5	5	5	5	5	5	5	5

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

 

 

 

 

 

 

 

 

 

 

• SUMMARY OF CHAMBER (EXPOSURE) CONDITIONS
  
  
  
  • Refer Appendix 17
  
  
  
  

Group & Conc. (mg/L)		Temp.  (°C)	Rh (%)	O2 (%)	CO2  (ppm)	Air inlet flow rate (L/min)*	BZC (mg/L)
G1/G1R-S1/G1R-S2 & 0	Mean	22.43 to 22.52	54.36 to 54.80	20.43 to 20.44	616.47 to 613.52	20.00	-
	±SD	0.26	1.45 to 1.55	0.21 to 0.23	4.65 to 5.87	0.00	-
G2/G2R-S1/G2R-S2 & 0.001	Mean	22.49 to 22.52	54.74 to 55.21	20.45	615.90 to 617.92	20.00	0.0011
	±SD	0.25 to 0.27	1.43 to 1.49	0.21 to 0.23	4.93 to 5.63	0.00	0.00
G3/G3R-S1/G3R-S2 & 0.003	Mean	22.47 to 22.54	54.73 to 54.97	20.44 to 20.45	616.43 to 617.71	20.00	0.0031
	±SD	0.27	1.50 to 1.60	0.21 to 0.23	4.68 to 5.79	0.00	0.000
G4/G4R-S1/G4R-S2 & 0.01	Mean	22.47 to 22.53	54.78 to 55.07	20.45 to 20.46	616.51 to 618. 67	20.00	0.0105 to 0.0106
	±SD	0.26 to 0.27	1.53 to 1.61	0.21 to 0.23	5.04 to 5.62	0.00	0.0004
G5/G5R-S1/G5R-S2 & 0.03	Mean	22.46 to 22.53	54.92 to 55.07	20.43 to 20.45	617.44 to 618.60	20.00	0.0307 to 0.0308
	±SD	0.25 to 0.27	1.49 to 1.57	0.22 to 0.23	4.56 to 6.09	0.00	0.0003 to 0.0005

• *: Values were constant throughout the exposure; hence standard deviation is zero, Temp.: Temperature; Rh: Relative Humidity; O₂: Oxygen Concentration;

      CO₂: Carbon Dioxide Concentration; BZC: Breathing Zone Concentration:

• SD: Standard Deviation;


•  


•  


•  


•  

 

• SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (a)     / (b) × (c)
1	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5   (Test Item)	1200	20	360	0.17
		1890			0.26
		4580			0.64
		5240			0.73
2	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1170	20	360	0.16
		1850			0.26
		4410			0.61
		5200			0.72
3	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1190	20	360	0.17
		1850			0.26
		4460			0.62
		5250			0.73
4	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1130	20	360	0.16
		1800			0.25
		4400			0.61
		5180			0.72
5	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1170	20	360	0.16
		1840			0.26
		4430			0.62
		5270			0.73
8	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1670	20	360	0.23
		1900			0.26
		4600			0.64
		5520			0.77
9	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1830			0.25
		4390			0.61
		5130			0.71

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (b)     / (b) × (c)
10	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1150	20	360	0.16
		1840			0.26
		4420			0.61
		5220			0.73
11	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1200	20	360	0.17
		1770			0.25
		4430			0.62
		5180			0.72
12	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1130	20	360	0.16
		1860			0.26
		4420			0.61
		5220			0.73
15	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1820			0.25
		4640			0.64
		5130			0.71
16	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1260	20	360	0.17
		1880			0.26
		4430			0.62
		5210			0.72
17	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1270	20	360	0.18
		1780			0.25
		4890			0.68
		5360			0.74
18	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1350	20	360	0.19
		1700			0.24
		4880			0.68
		5370			0.75

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (c)     / (b) × (c)
19	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1190	20	360	0.17
		1890			0.26
		4440			0.62
		5230			0.73
22	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1170	20	360	0.16
		1860			0.26
		4390			0.61
		5190			0.72
23	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1250	20	360	0.17
		1780			0.25
		4940			0.69
		5380			0.75
24	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1180	20	360	0.16
		1840			0.26
		4390			0.61
		5180			0.72
25	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1160	20	360	0.16
		1830			0.25
		4370			0.61
		5060			0.70
26	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1240	20	360	0.17
		1890			0.26
		4430			0.62
		5240			0.73

•  

 

 

 

 

 

 

 

 

 

            TABLE 18 (Contd…).  SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (d)     / (b) × (c)
29	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item))	1380	20	360	0.19
		1860			0.26
		4650			0.65
		5240			0.73
30	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1120	20	360	0.16
		1830			0.25
		4350			0.60
		5240			0.73
31	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1440	20	360	0.20
		1850			0.26
		4800			0.67
		5130			0.71
32	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1190	20	360	0.17
		1880			0.26
		4400			0.61
		5230			0.73
33	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1820			0.25
		4430			0.62
		5230			0.73
36	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1170	20	360	0.16
		1840			0.26
		4410			0.61
		5200			0.72

•  

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (e)     / (b) × (c)
37	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1180	20	360	0.16
		1840			0.26
		4550			0.63
		5340			0.74
38	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1850			0.26
		4410			0.61
		5180			0.72
39	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1180	20	360	0.16
		1860			0.26
		4380			0.61
		5210			0.72
40	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1450	20	360	0.20
		1850			0.26
		4830			0.67
		5440			0.76
43	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1180	20	360	0.16
		1840			0.26
		4390			0.61
		5200			0.72

•  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (f)      / (b) × (c)
44	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1860			0.26
		4400			0.61
		5210			0.72
45	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1190	20	360	0.17
		1870			0.26
		4430			0.62
		5230			0.73
46	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1190	20	360	0.17
		1870			0.26
		4420			0.61
		5220			0.73
47	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1200	20	360	0.17
		1850			0.26
		4380			0.61
		5230			0.73
50	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1180	20	360	0.16
		1890			0.26
		4390			0.61
		5190			0.72
51	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1840			0.26
		4380			0.61
		5180			0.72

•  

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (g)     / (b) × (c)
52	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1750			0.24
		4480			0.62
		5250			0.73
53	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1760			0.24
		4410			0.61
		5300			0.74
54	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1150	20	360	0.16
		1790			0.25
		4430			0.62
		5250			0.73
57	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1210	20	360	0.17
		1830			0.25
		4380			0.61
		5200			0.72
58	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1130	20	360	0.16
		1770			0.25
		4370			0.61
		5240			0.73
59	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1180	20	360	0.16
		1890			0.26
		4390			0.61
		5200			0.72

•  

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (h)     / (b) × (c)
60	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1190	20	360	0.17
		1870			0.26
		4430			0.62
		5170			0.72
61	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1190	20	360	0.17
		1880			0.26
		4410			0.61
		5230			0.73
64	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1300	20	360	0.18
		1830			0.25
		4380			0.61
		5280			0.73
65	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1160	20	360	0.16
		1890			0.26
		4580			0.64
		5270			0.73
66	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5   (Test Item)	1180	20	360	0.16
		1880			0.26
		4320			0.60
		5130			0.71
67	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1170	20	360	0.16
		1830			0.25
		4400			0.61
		5200			0.72

 

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (i)      / (b) × (c)
68	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1200	20	360	0.17
		1790			0.25
		4430			0.62
		5220			0.72
71	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1170	20	360	0.16
		1820			0.25
		4400			0.61
		5390			0.75
72	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1210	20	360	0.17
		1890			0.26
		4490			0.62
		5230			0.73
73	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1150	20	360	0.16
		1870			0.26
		4420			0.61
		5250			0.73
74	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1190	20	360	0.17
		1880			0.26
		4380			0.61
		5170			0.72
75	G1  (Air Only)	-	20	360	-
	G2, G3, G4 and G5  (Test Item)	1180	20	360	0.16
		1870			0.26
		4420			0.61
		5160			0.72

 

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (j)      / (b) × (c)
78	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1170	20	360	0.16
		1850			0.26
		4400			0.61
		5190			0.72
79	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1160	20	360	0.16
		1850			0.26
		4380			0.61
		5170			0.72
80	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1150	20	360	0.16
		1780			0.25
		4400			0.61
		5190			0.72
81	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1170	20	360	0.16
		1850			0.26
		4410			0.61
		5220			0.73
82	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1160	20	360	0.16
		1900			0.26
		4340			0.60
		5140			0.71
85	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1180	20	360	0.16
		1830			0.25
		4420			0.61
		5220			0.73

 

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (k)     / (b) × (c)
86	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item))	1130	20	360	0.16
		1820			0.25
		4380			0.61
		5180			0.72
87	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1210	20	360	0.17
		1860			0.26
		4470			0.62
		5240			0.73
88	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1190	20	360	0.17
		1880			0.26
		4520			0.63
		5250			0.73
89	G1 (Air Only)	-	20	360	-
	G2, G3, G4 and G5 (Test Item)	1570	20	360	0.22
		1820			0.25
		4770			0.66
		5520			0.77

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (l)      / (b) × (c)
1	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1370	20	360	0.19
		1900			0.26
		4970			0.69
		5340			0.74
2	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1190	20	360	0.17
		1810			0.25
		4630			0.64
		5230			0.73
3	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1260	20	360	0.17
		1740			0.24
		4830			0.67
		5200			0.72
4	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1300	20	360	0.18
		1810			0.25
		4720			0.66
		5120			0.71
5	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1230	20	360	0.17
		1830			0.25
		4400			0.61
		5170			0.72
8	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1330	20	360	0.18
		1930			0.27
		4700			0.65
		5140			0.71
9	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1340	20	360	0.19
		1830			0.25
		4850			0.67
		5250			0.73

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (m)   / (b) × (c)
10	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1370	20	360	0.19
		1900			0.26
		4830			0.67
		5350			0.74
11	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1360	20	360	0.19
		1950			0.27
		4860			0.68
		5400			0.75
12	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1360	20	360	0.19
		1820			0.25
		4850			0.67
		5360			0.74
15	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1400	20	360	0.19
		1850			0.26
		4860			0.68
		5260			0.73
16	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1420	20	360	0.20
		1720			0.24
		4840			0.67
		5310			0.74
17	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1400	20	360	0.19
		1750			0.24
		4840			0.67
		5550			0.77
18	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1460	20	360	0.20
		1730			0.24
		4810			0.67
		5500			0.76

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (n)     / (b) × (c)
19	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1480	20	360	0.21
		1770			0.25
		4730			0.66
		5390			0.75
22	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1440	20	360	0.20
		1770			0.25
		4970			0.69
		5230			0.73
23	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1410	20	360	0.20
		1760			0.24
		4800			0.67
		5470			0.76
24	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1470	20	360	0.20
		1770			0.25
		4710			0.65
		5290			0.73
25	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1480	20	360	0.21
		1750			0.24
		4640			0.64
		5270			0.73
26	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1520	20	360	0.21
		1730			0.24
		4610			0.64
		5430			0.75

•  

 

 

 

 

 

 

 

 

 

            TABLE 18 (Contd…).  SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (o)     / (b) × (c)
29	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1470	20	360	0.20
		1790			0.25
		4820			0.67
		5310			0.74
30	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1520	20	360	0.21
		1840			0.26
		4890			0.68
		5550			0.77
31	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1520	20	360	0.21
		1820			0.25
		4840			0.67
		5360			0.74
32	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1470	20	360	0.20
		1870			0.26
		4740			0.66
		5160			0.72
33	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1420	20	360	0.20
		1730			0.24
		4850			0.67
		5530			0.77
36	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1730	20	360	0.24
		1460			0.20
		4750			0.66
		5490			0.76

•  

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (p)     / (b) × (c)
37	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1510	20	360	0.21
		1810			0.25
		4670			0.65
		5570			0.77
38	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1490	20	360	0.21
		1790			0.25
		4720			0.66
		5780			0.80
39	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1520	20	360	0.21
		1740			0.24
		4780			0.66
		5700			0.79
40	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1590	20	360	0.22
		1810			0.25
		4830			0.67
		5750			0.80
43	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1340	20	360	0.19
		1860			0.26
		4820			0.67
		5670			0.79

•  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (q)     / (b) × (c)
44	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1810	20	360	0.25
		1430			0.20
		4870			0.68
		5320			0.74
45	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1670	20	360	0.23
		1880			0.26
		4640			0.64
		5740			0.80
46	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1460	20	360	0.20
		1800			0.25
		4660			0.65
		5500			0.76
47	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1470	20	360	0.20
		1810			0.25
		4630			0.64
		5400			0.75
50	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1370	20	360	0.19
		1850			0.26
		4700			0.65
		5520			0.77
51	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1580	20	360	0.22
		1840			0.26
		4850			0.67
		5320			0.74

•  

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (r)     / (b) × (c)
52	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1630	20	360	0.23
		1830			0.25
		4850			0.67
		5280			0.73
53	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1500	20	360	0.21
		1740			0.24
		4870			0.68
		5380			0.75
54	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1310	20	360	0.18
		1800			0.25
		4400			0.61
		5160			0.72
57	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1480	20	360	0.21
		1770			0.25
		4890			0.68
		5410			0.75
58	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1460	20	360	0.20
		1820			0.25
		4850			0.67
		5440			0.76
59	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1550	20	360	0.22
		1780			0.25
		4720			0.66
		5640			0.78

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (s)      / (b) × (c)
60	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1550	20	360	0.22
		1780			0.25
		4800			0.67
		5710			0.79
61	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1540	20	360	0.21
		1790			0.25
		4710			0.65
		5780			0.80
64	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1530	20	360	0.21
		1790			0.25
		4700			0.65
		5640			0.78
65	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1550	20	360	0.22
		1810			0.25
		4740			0.66
		5590			0.78
66	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1540	20	360	0.21
		1770			0.25
		4730			0.66
		5680			0.79
67	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1510	20	360	0.21
		1780			0.25
		4890			0.68
		5750			0.80

 

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (t)      / (b) × (c)
68	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1150	20	360	0.16
		1820			0.25
		4380			0.61
		5180			0.72
71	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1190	20	360	0.17
		1880			0.26
		4430			0.62
		5230			0.73
72	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1190	20	360	0.17
		1850			0.26
		4420			0.61
		5200			0.72
73	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1180	20	360	0.16
		1870			0.26
		4490			0.62
		5250			0.73
74	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1570	20	360	0.22
		1820			0.25
		4780			0.66
		5750			0.80
75	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1530	20	360	0.21
		1760			0.24
		4730			0.66
		5590			0.78

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (u)     / (b) × (c)
78	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1570	20	360	0.22
		1730			0.24
		4820			0.67
		5610			0.78
79	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1150	20	360	0.16
		1800			0.25
		4370			0.61
		5180			0.72
80	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1560	20	360	0.22
		1810			0.25
		4860			0.68
		5510			0.77
81	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1580	20	360	0.22
		1770			0.25
		4950			0.69
		5420			0.75
82	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1540	20	360	0.21
		1780			0.25
		4730			0.66
		5740			0.80
85	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1520	20	360	0.21
		1790			0.25
		4860			0.68
		5680			0.79

 

 

 

 

 

 

 

 

 

 

• TABLE 18 (Contd…). SUMMARY OF NOMINAL CONCENTRATION

Day	Group	Test item Used (mg) (a)	Air flow rate (L/minute) (b)	Minute (min) (c)	Nominal Concentration (mg/L) (v)     / (b) × (c)
86	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1590	20	360	0.22
		1820			0.25
		4800			0.67
		5560			0.77
87	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1170	20	360	0.16
		1910			0.27
		4420			0.61
		5200			0.72
88	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1140	20	360	0.16
		1850			0.26
		4400			0.61
		5170			0.72
89	G1R-S1&S2 (Air Only)	-	20	360	-
	G2R-S1&S2, G3R-S1&S2, G4R-S1&S2 and G5R-S1&S2. (Test Item)	1540	20	360	0.21
		1820			0.25
		4810			0.67
		5760			0.80

 

Applicant's summary and conclusion

Conclusions:

Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item, Agrocer Red 112 was found to be 0.03 mg/L when exposed for 6 hours/day, 5 days/week, for 13 weeks by flow-past nose-only inhalation route to Sprague Dawley rats. The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females

Executive summary:

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., control (G1), low dose (G2), mid dose- I (G3), mid dose- II (G4), 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)]. Each main group comprised of 20 animals (10 males and 10 females) and each recovery group comprised of 10 animals (5 males and 5 females). Animals allocated to Groups G2/ G2R - S1 & G2R - S2, G3/ G3R - S1 & G3R - S2, G4/ G4R - S1 & G4R - S2 and G5/ G5R - S1 & G5R - S2 were exposed to test item Agrocer Red 112 for 6 hours per day, 5 days per week, for 13 consecutive weeks., at a nominal target concentration of 0.001, 0.003, 0.01 and 0.03 mg/L. Animals of the control group (G1/ G1R - S1 & G1R - S2) received air only inhalation for 6 hours/5 days per week for 13 consecutive weeks. The inhalation exposure of test item/air was achieved by a flow-past, nose-only dynamic inhalation exposure system supplied by CH Technologies, USA.

All animals were observed once daily for clinical signs and twice daily for mortality.  Body weight was recorded on first exposure (day 1), twice during first four weeks and weekly once thereafter. Feed consumption was recorded weekly. Ophthalmoscopic examination was performed during the acclimatization period for all groups, and during Week 13 for main groups (G1 and G5), during Week 26 for recovery groups i.e., Satellite - I (G1R and G5R) and Week 39 for Satellite – II (G1R and G5R). Neurological/Functional test was performed during Week 13 for G1 and G5 groups and during Week 26 and 39 for satellite - I and satellite - II for recovery group animals respectively.

At the end of treatment and recovery periods, all animals were fasted overnight (water was provided ad libitum), and the next day, blood, urine, and Broncho alveolar lavage fluid (BALF) samples were collected and analysed. Subsequently, the animals were sacrificed and subjected to gross pathological examination, and the organs were collected, weighed, and preserved. The tissues/organs in vehicle control and high dose group animals including recovery animals were subjected to histopathological examinations.

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