3-chloro-o-toluidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to OECD Guideline. Not conducted under GLP. Purity of test substance was not stated.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-chloro-o-toluidine

EC Number:

201-756-6

EC Name:

3-chloro-o-toluidine

Cas Number:

87-60-5

Molecular formula:

C7H8ClN

IUPAC Name:

3-chloro-2-methylaniline

Details on test material:

- substance no.: 85/48
- name of test substance: 3-chloro-2-methylanilin

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG
- Weight at study initiation: 198-220 g
- Fasting period before study: 16 h
- Housing: stainless steel wire mesh cages, Type DK-III (Becker&Co., Castrop-Rauxel, FRG).
- Diet: ad libitum, Kliba-Labordiaet, FA. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water: ad libitum, tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

as 0.5% aqueous solution

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: formulation corresponds to the physiological medium

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

1000; 681; 464 and 316 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of application. At least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 754 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 681 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 681 mg/kg bw

Based on:

test mat.

Mortality:

Mortality in males after 1 hour; 1, 2, 7 and 14 days
- 316 mg/kg bw: 0/0/0/0/0
- 464 mg/kg bw: 0/0/0/0/0
- 681 mg/kg bw: 0/1/1/1/1
- 1000 mg/kg bw: 0/5/5/5/5

Mortality in females after 1 hour; 1, 2, 7 and 14 days
- 316 mg/kg bw: 0/0/0/0/0
- 464 mg/kg bw: 0/0/0/0/0
- 681 mg/kg bw: 0/2/3/3/3
- 1000 mg/kg bw: 0/5/5/5/5

Clinical signs:

other: In the first minutes up to one day all animals in all dose groups showed dyspnea, apathy, abnormal position, staggering and a general poor state. No clinical signs were found from the second day after treatment.

Gross pathology:

No abnormalities were observed in sacrificed animals, whereas in 1 female a yellow-brown coloured liver was seen. All animals that died suffered from a congestive hyperemia.