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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 754 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 681 mg/kg bw
Based on:
test mat.
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:
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.
Body weight:
Mean body weights [g] of males before and 4, 7 and 13 days after administration.
- 316 mg/kg bw dose group: 218/260/273/300
- 464 mg/kg bw dose group: 210/246/257/281
- 681 mg/kg bw dose group: 198/226/242/267
- 1000 mg/kg bw dose group: 220/--/--/--/--

Mean body weights [g] of females before and 4, 7 and 13 days after administration.
- 316 mg/kg bw: 182/205/208/216
- 464 mg/kg bw: 189/209/215/221
- 681 mg/kg bw: 181/175/182/208
- 1000 mg/kg bw: 199/--/--/--/--
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.

Applicant's summary and conclusion