Methyl anthranilate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Data is from a NTRL report

Data source

Reference

Reference Type:

publication

Title:

Acute oral toxicity study of test chemical

Author:

NTRL

Year:

1992

Bibliographic source:

U.S. Environmental Protection Agency, NTRL report

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

40 CFR Part 163.81-1.
(ENVIRONMENTAL PROTECTION AGENCY. PESTICIDE PROGRAMS. Proposed Guidelines for Registering Pesticides in the U.S.; Hazard Evaluation:
Humans and Domestic Animals. Acute Oral Toxicity Study.)

Principles of method if other than guideline:

To determine to Acute oral toxicity of test chemical in rats.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl o-aminobenzoate

Cas Number:

134-20-3

Molecular formula:

C8H9NO2

IUPAC Name:

Methyl o-aminobenzoate

Test material form:

liquid

Details on test material:

IUPAC name: 2-Aminobenzoic acid, methyl ester
Mol. formula: C8H9NO2
Molecular Weight: 151.1641 gm/mol
Smiles: c1(c(cccc1)N)C(OC)=O
InChI: 1S/C8H9NO2/c1-11-8(10)6-4-2-3-5-7(6)9/h2-5H,9H2,1H3

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) : No
- Source: Charles River Breeding Laboratories. Inc;Wilmington. Mass
- Females (if applicable) nulliparous and non-pregnant: Not specified
- Rationale for use of males: Not specified
- Age at study initiation: Not specified
- Weight at study initiation:
Males: approx 230-230gm
Females: 180-250 gm
- Fasting period before study: 18 hours
- Housing: Individual in suspended stainless steel
- Historical data: Not specified
- Diet (e.g. ad libitum): Purina Laboratory Chow. ad libitum
- Water (e.g. ad libitum): Elizabethtown water Co. ad libitum
- Acclimation period: Not specified
- Microbiological status when known : no
- Method of randomisation in assigning animals to test and control groups : The animals are randomly selected for each study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified

IN-LIFE DATES: From: To:Not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Not specified
- Amount of vehicle (if gavage):Not specified
- Justification for choice of vehicle:Not specified
- Lot/batch no. (if required): Not specified
- Purity: Not specified

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

DOSAGE PREPARATION (if unusual): Liquids are administered as received.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not specified

Doses:

Single dose: 5.0 g/kg (5000 mg/kg bw)
Range-finding: 0.05, 0.10, 0.50, 1.0 and 2.0 g/kg (50, 100, 500, 1000 and 2000 mg/kg bw)
LD50: 1.2. 1.7. 2.5 and 3.5 g/kg (1200, 1700, 2500 and 3500 mg/kg bw)

No. of animals per sex per dose:

Total 80 animals (males and females)
Single dose level (5 g/kg): Ten (five/sex)
Range-finding Screen: Ten (one/sex/dose level)
LD50 Determination: Fifty (five/sex/dose level)
Control group: 10 (5 males, 5 females)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The test animals were observed approximately 1, 2 and 4 hours after dosing, and daily thereafter for fourteen days.
- Necropsy of survivors performed: yes; Gross post mortem examinations were performed on all surviving animals on Day 14 and on all animals which die or were found dead during the study. All abnormalities were recorded but no tissues were saved.
- Clinical signs including body weight: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Body weight: Body weights were checked before fasting, post fasting (prior to dosing) and Terminal: Any animals which do not survive for 14 days were weighed at the time of death or at the time they were found dead.

Results and discussion

Preliminary study:

A dose of 5 g/kg was administered initially to 10 animals (5/sex), unless the test substance was suspected to have an LD50 value of less than 5 g/kg.
If no animals die during the fourteen day post-dose observation period, no additional testing is required.
If deaths occur in animals dosed with 5 g/kg, or if the test substance is suspected to have an LD50 which is less than 5 g/kg, the following is done:
A preliminary range-finding screen is performed by administering five different dose levels (usually 0.05. 0.1. 0.5. 1.0 and 2.0 g/kg) to ten rats (one male; one female per dose level). If results do not provide adequate information for selecting doses for the LD50 determination, additional screening studies are performed. Animals were observed for viability for seven days after dosing. Based on the results of this screen, five geometrically spaced dose levels were selected and each dose was administered to ten animals (5/sex) for a determination of the LD50.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 800 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 300 - <= 3 300

Remarks on result:

other: 50% mortality observed

Mortality:

Single dose: All ten animals died after receiving 5 grams/kg of the test material.
Dose range finding: Only one animal died at 2000 mg/kg bw dose level.

Clinical signs:

other: Some animals in all groups exhibited motor activity decrease, (from the 1 hour interval to Day 7), piloerection (from the 2 hour interval to Day 7). respiratory rate decrease (from the 1 hour interval to Day 2), and ataxia (at the 4 hour interval and on D

Gross pathology:

Necropsy observations are presented in table:

Other findings:

From Day 8 to termination no abnormalities were recorded for any animals.

Any other information on results incl. tables

Table 1: Dose levels and mortality for the preliminary range-finding study

Dose level (g/kg)	Mortality
0.05	0/2
0.10	0/2
0.50	0/2
1.0	0/2
2.0	1/2

 

Table 2: Dose levels, mortality data and LD50 calculations for the LD50 study

Dose level Gm/kg	Mortality
	Male	Female	Total
1.2	0/5	0/5	0/10
1.7	0/5	1/5	1/10
2.5	0/5	3/5	3/10
3.5	4/5	5/5	9/10
LD50 (gm/kg)	3.10	2.15	2.8
95% Confidence limits (gm/kg)	2.60 to 3.50	1.55 to 2.75	2.3 to 3.3

 

Table 3: Body weights (grams) and day of death; Dose level 1.2 gm/kg

Dose level (g/kg)	Animal no. and sex	Pretest weights		Interim deaths			Survivors
		Pre fast	Post fast	Terminal weight	Day of death	Change^a	Day 7	Change^a	Day 14	Change^a
1.2	2504 M	257	228				320	63	372	115
	2510 M	242	216				309	67	355	113
	2514 M	241	217				283	42	312	71
	2516 M	250	220				287	37	322	72
	2525 M	241	219				273	32	308	67
	2593 F	240	218				266	26	267	27
	2599 F	227	204				228	1	243	16
	2604 F	239	216				246	7	256	17
	2609 F	237	215				249	12	255	18
	2613 F	236	215				241	5	249	13

^aChange from prefasted weight (grams).

 

Table 4: Body weights (grams) and day of death; Dose level 1.7 gm/kg

Dose level (g/kg)	Animal no. and sex	Pretest weights		Interim deaths			Survivors
		Pre fast	Post fast	Terminal weight	Day of death	Change^a	Day 7	Change^a	Day 14	Change^a
1.7	2526M	232	210				266	34	305	73
	2534M	234	210				268	34	310	76
	2540M	230	205				271	41	304	74
	2541M	247	220				306	59	360	113
	2546M	251	220				296	45	340	89
	2616F	238	220				247	9	258	20
	2619F	145	221				266	21	295	50
	2628F	224	205				226	2	259	35
	2630F	231	215	NR	Day 2	-
	2595F	221	204				239	18	246	25

^aChange from prefasted weight (grams).

NR: Not recorded

Table 5: Body weights (grams) and day of death; Dose level 2.5 gm/kg

 

Dose level (g/kg)	Animal no. and sex	Pretest weights		Interim deaths			Survivors
		Pre fast	Post fast	Terminal weight	Day of death	Change^a	Day 7	Change^a	Day 14	Change^a
2.5	2512M	253	226				303	50	370	117
	2520M	236	211				288	52	330	94
	2523M	247	230				287	40	323	76
	2533M	231	210				266	35	305	74
	2539M	249	226				249	0	296	47
	2600F	235	212				229	-6	245	10
	2607F	230	208	200	Day 1	-30
	2610F	250	229	NR	Day 2	-
	2615F	249	225				254	5	266	17
	2621F	240	224	217	7 hrs	-23

^aChange from prefasted weight (grams).

NR: Not recorded

   

Table 6: Body weights (grams) and day of death; Dose level 3.5 gm/kg

Dose level (g/kg)	Animal no. and sex	Pretest weights		Interim deaths			Survivors
		Pre fast	Post fast	Terminal weight	Day of death	Change^a	Day 7	Change^a	Day 14	Change^a
3.5	2545M	230	214	200	Day 1	-30
	2559M	246	220	201	Day 1	-45
	2519M	230	205				254	24	298	68
	2537M	246	218	200	Day 1	-46
	2543M	248	223	206	Day 1	-42
	2625F	241	220	212	Day 1	-29
	2629F	235	315	208	Day 1	-27
	2697F	234	210	195	Day 1	-39
	2602F	219	200	187	Day 1	-32
	2603F	247	225	212	Day 1	-35

^aChange from prefasted weight (grams).

 

Table 7: Summary of in-life observations

Dose level (g/kg)	Observations	Time interval
		Hours			Days
		1	2	4	1	2	3	4	5-7	8-14
1.2	Ataxia	0	0	1	0	0	0	0	0	0
	Red oral discharge	1	0	0	0	0	0	0	0	0
	Respiratory Rate Increase	0	1	0	0	0	0	0	0	0
	Respiratory Rate Decrease	1	1	1	0	0	0	0	0	0
	Soft Stool	0	1	0	0	0	0	0	0	0
	Piloerection	0	1	0	0	0	0	0	1	0
	Abdominal Griping	0	0	0	1	0	0	0	0	0
	Motor Activity Decrease	7	5	1	2	0	0	0	1	0
1.7	Dead	0	0	0	0	1	1	1	1	1
	Ataxia	0	0	0	1	0	0	0	0	0
	Fine Tremors	0	0	0	1	0	0	0	0	0
	Clear oral discharge	1	0	0	0	0	0	0	0	0
	Respiratory Rate Decrease	0	2	1	4	0	0	0	0	0
	Piloerection	0	1	0	4	1	0	1	1	0
	Motor Activity Increase	0	0	0	0	0	0	1	0	0
	Motor Activity Decrease	4	4	5	5	4	0	0	0	0
2.5	Dead	0	0	0	2	3	3	3	3	3
	Ataxia	0	0	0	1	0	0	0	0	0
	Fine Tremors	0	0	0	1	0	0	0	0	0
	Clear nasal discharge	0	1	0	0	0	0	0	0	0
	Respiratory Rate Decrease	0	3	2	4	0	0	0	0	0
	Clear ocular discharge	0	0	1	0	0	0	0	0	0
	Fecal staining	0	0	0	1	1	0	0	0	0
	Soft stool	0	0	0	1	0	0	0	0	0
	Piloerection	0	4	1	3	4	4	0	2	0
	Motor Activity Increase	0	0	0	0	0	1	0	1	0
	Motor Activity Decrease	5	8	3	6	7	1	1	2	0
	Prostration	0	0	2	0	0	0	0	0	0
	Aggressive	0	0	0	0	0	1	0	0	0
3.5	Dead	0	0	0	7	9	9	9	9	9
	Ataxia	0	0	0	2	1	0	0	0	0
	Fine Tremors	0	0	0	1	0	0	0	0	0
	Clear oral discharge	2	1	0	1	0	0	0	0	0
	Respiratory Rate Decrease	2	5	1	2	1	1	0	0	0
	Clear ocular discharge	0	0	0	1	0	0	0	0	0
	Urinary staining	0	0	0	1	1	0	0	0	0
	Piloerection	0	7	4	2	0	1	0	0	0
	Abdominal griping	0	1	0	0	0	0	0	0	0
	Motor activity decrease	6	9	8	2	1	1	0	0	0
	Prostration	0	0	0	1	0	0	0	0	0
	Rales	1	1	0	0	0	0	0	0	0

 

Table 8: Day of death and necropsy observations (1.2 gm/kg)

Dose level g/kg	Animal no. and sex	Day of death	Type of death^a	Observations
1.2	2504 M	Day 1	T	Lungs: dark red foci, mottled dark red 20%; liver: mottled pale 30%; kidneys: pale; adrenals: pale red.
	2510 M	Day 14	T	Lungs: dark red foci, mottled dark red 20%; adrenals: dark red.
	2514 M	Day 14	T	Lungs: mottled dark red 80%; kidneys: pale; adrena1s: pale red.
	2516 M	Day 14	T	Lungs: dark red foci; liver: mottled pale 30%; kidneys: mottled pale 60%; adrenals: pale red.
	2525 M	Day 14	T	Lungs: dark red foci; liver: mottled pale 50%; kidneys: mottled pale 40%; adrenals: pale red.
	2593 F	Day 14	T	Lungs: dark red foci; adrenals: dark red foci.
	2599 F	Day 14	T	Lungs: dark red foci, mottled dark red 30%; liver: mottled pale 40%; adrenals: pale red.
	2604 F	Day 14	T	Lungs: dark red foci, mottled dark red 30%; liver: mottled pale 30%; adrenals: pale red.
	2609 F	Day 14	T	Lungs: mottled dark red 60%; liver: mottled pale 30%; adrenals: pale red.
	2613 F	Day 14	T	Lungs: dark red foci; adrenals: dark red foci.

T= Terminal (Killed on day 14)

Table 9: Day of death and necropsy observations (1.7 gm/kg)

Dose level g/kg	Animal no. and sex	Day of death	Type of death^a	Observations
1.7	2526M	Day 1	T	Lungs: dark red foci; adrenals: dark red; mesentary lymph nodes: bright red.
	2534M	Day 14	T	Lungs: dark red foci; adrenals: pale red.
	2540M	Day 14	T	Lungs: dark red foci, mottled dark red 20%; adrenals: pale red.
	2541M	Day 14	T	Adrenals: dark red foci.
	2546M	Day 14	T	Lungs: dark red foci; mottled pale 10%; kidneys: mottled pale 50%; adrenals: pale red.
	2616F	Day 14	T	Lungs: dark red foci, mottled dark red 20% adrenals: dark red foci.
	2619F	Day 14	T	Lungs: dark red foci; adrenals: pale red.
	2628F	Day 14	T	Lungs: dark red foci, mottled dark red 60%; adrenals: pale red.
	2630F	Day 2	F	Clear oral discharge; lungs: pale, tan patches 50%; liver: mottled tan; stomach: contains dark brown fluid; intestines: contain brown fluid; kidneys: tan; adrenals: dark red; urinary bladder: contains brown fluid.
	2595F	Day 14	T	Lungs: dark red foci.

T= Terminal (Killed on day 14)

F=Found dead (Day given is day found dead).

 

Table 10: Day of death and necropsy observations (2.5 gm/kg)

Dose level g/kg	Animal no. and sex	Day of death	Type of death^a	Observations
2.5	2512M	Day 14	T	Lungs: dark red foci; liver: mottled pale 40%; kidneys: mottled pale 30%; adrenals: pale red.
	2520M	Day 14	T	Lungs: dark red foci; liver: mottled pale 40%; kidneys: mottled pale 20%; adrenals: pale red.
	2523M	Day 14	T	Lungs: dark red foci, mottled dark red 30%; liver: anterior edges clear; kidneys: mottled pale 60%; adrenals: pale red.
	2533M	Day 14	T	Lungs: dark red foci; liver: mottled pale 40%; kidneys: mottled pale 50%; adrenals: pale red.
	2539M	Day 14	T	Lungs: dark red foci; kidneys: mottled pale 70%; adrenals: pale red.
	2600F	Day 14	T	Lungs: dark red foci; liver: mottled pale 20%; adrenals: pale red.
	2607F	Day 1	F	Brain: blood vessels injected; lungs: mottled dark red and pale 70%; stomach: contains thick tan material; intestines: contain reddish yellow viscous fluid; kidneys: pale; adrenals: dark red.
	2610F	Day 2	F	Clear oral discharge; clear nasal discharge; yellow urinary staining; lungs: pale red; liver: mottled tan, dark red foci; intestines: contain dark red-black fluid; spleen: diminished, black wrinkled; kidneys: tan; adrenals: dark red.
	2615F	Day 14	T	Lungs: dark red foci; adrenals: pale red.
	2621F	7 hours	F	Stomach: contains tan fluid; jujunum: contains reddish yellow fluid; duodenum: contains tan fluid; adrenals: dark red.

T= Terminal (Killed on day 14)

F=Found dead (Day given is day found dead).

 

 

Table 11: Day of death and necropsy observations (3.5 gm/kg)

Dose level g/kg	Animal no. and sex	Day of death	Type of death^a	Observations
3.5	2545M	Day 1	F	Brain: blood vessels injected; stomach: pyloric region - reddish tint, pronounced vascularization, contains thick tan material; intestines: appeared reddened, contain reddish yellow fluid; kidneys: pale; adrenals: dark red.
	2559M	Day 1	F	Brain: blood vessels injected; lungs: wrinkled; stomach: contains thick grey green material; intestines: vascu1arized, contains thick brown fluid; spleen: extremely diminished; kidneys: mottled pale 30%; adrenals: dark red.
	2519M	Day 14	T	Adrenals: pale red
	2537M	Day 1	F	Clear oral discharge; red nasal discharge; brain: blood vessels injected; lungs: dark red foci; mottled dark red 20%; stomach: pyloric region - vascularized, contains thick tan substance; intestines: vascularized, contain red fluid; adrenals: pale red; testes: undescended.
	2543M	Day 1	F	Fecal staining; brain: blood vessels injected; left lung; mottled black; liver: mottled pale, clear edges; stomach: distended with gas, contains grey green fluid; intestines: pronounced vascularization, contain thin brown fluid; spleen: diminished; adrenals: extremely dark red.
	2625F	Day 1	F	Brain: blood vessels injected; lungs: dark red foci; liver: clear edges; stomach: pyloric region - reddish tint, contains thick tan material; intestines: contain reddish yellow viscous fluid; kidneys: pale; adrenals: pale red.
	2629F	Day 1	F	Lungs: mottled tan 50%; liver: clear edges; stomach: distended with gas, contains viscous tan substance; kidneys: mottled pale 50%; adrenals: dark red.
	2697F	Day 1	F	Clear oral discharge; lungs: mottled dark red 30%; liver: mottled pale 30%; stomach: distended with yellow tan fluid; intestines: contain yellow tan fluid; spleen: roughened; kidneys: pale; adrenals: pale red.
	2602F	Day 1	F	Brain: blood vessels injected; lungs: mottled dark red 30%, dark red foci; liver: clear edges; stomach: distended with gas, contains thick tan material and black material; intestines: black material in duodenum; kidneys: pale; adrenals: dark red.
	2603F	Day 1	F	Lungs: dark red foci 100%; stomach: contains viscous tan material; intestines: contains reddish yellow fluid; kidneys: mottled pale 40%; adrenals: pale red.

 

T= Terminal (Killed on day 14)

F=Found dead (Day given is day found dead).

Table 12: Body weights (grams) of Control group

Animal no.	Sex	Pre fast	Post fast	Day 7	Change^a	Day 14	Change^a
2509	M	259	230	318	59	350	91
2527	M	250	221	290	40	317	67
2549	M	251	227	310	59	350	99
2554	M	252	222	315	63	352	100
2556	M	251	225	297	46	322	71
2571	F	235	212	253	18	264	29
2577	F	238	217	253	15	278	40
2581	F	254	228	262	8	280	26
2584	F	233	210	249	16	242	9
2588	F	210	201	230	20	255	45

^aChange from initial (prefasted) weight.

Table 13: NECROPSY OBSERVATIONS - CONTROL ANIMALS (TERMINAL - DAY 14)

Animal no.	Sex	Observations
2509	M	Kidneys: mottled pale 30%; adrenals: dark red foci
2527	M	Lungs: dark red foci throughout; liver: mottled pale 20%; kidneys: mottled pale 50%; adrenals: dark red.
2549	M	Lungs: dark red foci; adrenals: pale red
2554	M	Lungs: dark red foci; kidneys: mottled pale 70%; adrenals: dark red foci.
2556	M	Lungs: dark red foci throughout; liver: mottled pale 60%; kidneys: pale; adrena1s: pale red.
2571	F	Lungs: dark red foci throughout; adrenals: dark red foci.
2577	F	Adrenals: pale red.
2581	F	Kidneys: mottled pale 50%; adrenals: pale red
2584	F	Lungs: mottled dark red 40%; adrenals: pale red
2588	F	Lungs: mottled bright red 30%; adrenals: pale red.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

Acute oral toxicity study was carried out on rats to determine the toxic nature of test chemical.50% mortality was observed at a dose level of 2800 mg/kg bw with 95% confidence limit of 2300 to 3300 mg/kg bw. Thus, the LD50 value was >2000 mg/kg bw indicating that the test chemical is not toxic to rats when administered orally and can be classified under the category ‘Not classified’.

Executive summary:

Acute oral toxicity study was carried out on rats to determine the toxic nature of test chemical. A total of 80 Male and female Sprague-Dawley rats were used during the study. The test chemical was administered orally by gavage at various dose ranges for 14 days. The study was carried out in three different stages; Single dose study, a dose of 5 g/kg is administered initially to 10 animals (5/sex), unless the test substance is suspected to have an LD50 value of less than 5 g/kg. If no animals die during the fourteen day post-dose observation period, no additional testing is required; Range finding study, If deaths occur in animals dosed with 5 g/kg, or if the test substance is suspected to have an LD50 which is less than 5 g/kg, the following is done: A preliminary range-finding screen is performed by administering five different dose levels (usually 50, 100, 500, 1000 and 2000 mg/kg) to ten rats (one male; one female per dose level). If results do not provide adequate information for selecting doses for the LD50 determination, additional screening studies are performed; and LD50 determination study, animals were observed for viability for seven days after dosing. Based on the results of this screen, four geometrically spaced dose levels ie. 1200, 1700, 2500 and 3500 mg/kg bw were administered and each dose was administered to ten animals (5/sex) for a determination of the LD50. The test chemical was administered by oral intubation, using a ball-tipped intubation needle. Doses were calculated using pre-fasted body weights. Whenever possible, a constant concentration of test substance was administered at all doses (i.e., varying doses were achieved by varying the volume of the dosing mixture) 60 ml of test substance per kg of body weight was considered the maximum volume which can be administered to a rat; doses in excess of this amount were not administered. In order to provide control data, ten animals (5/sex) were dosed with methylcellulose in a volume of 45.0 ml/kg [Because maximum dose specified in protocol (60 ml/kg) was found to be excessive, dose was reduced to 45 ml/kg]. Mortality data, in-life observations (14 days) and necropsy observations for these animals are tabulated. The test animals were observed approximately 1, 2 and 4 hours after dosing, and daily thereafter for fourteen days. Gross post mortem examinations were performed on all surviving animals on Day 14 and on all animals which die or were found dead during the study. All abnormalities were recorded but no tissues were saved. Body weights were checked before fasting, post fasting (prior to dosing) and Terminal; any animals which do not survive for 14 days were weighed at the time of death or at the time they were found dead. Mortality was observed in all animals at dose level of 5000 mg/kg bw and only one animal died at 2000 mg/kg bw dose in range finding study. Some animals in all groups exhibited motor activity decrease, (from the 1 hour interval to Day 7), piloerection (from the 2 hour interval to Day 7), respiratory rate decrease (from the 1 hour interval to Day 2), and ataxia (at the 4 hour interval and on Days 1 and 2). All surviving animals exhibited body weight gains at Day 14, the majority of animals exhibited body weight gains at Day 7, except for one animal which exhibited a slight weight loss and one animal which showed no change. Animals dying prior to termination exhibited weight losses. From Day 8 to termination no abnormalities were recorded for any animals. 50% mortality was observed at a dose level of 2800 mg/kg bw with 95% confidence limit of 2300 to 3300 mg/kg bw. Thus, the LD50 value was >2000 mg/kg bw indicating that the test chemical is not toxic to rats when administered orally and can be classified under the category ‘Not classified’.