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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline stdy

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG
Principles of method if other than guideline:
Five male and 5 female Wistar rats received per gavage 100, 250, 312, 400, 500 or 1000 mg m-chloroaniline/kg bw. Animals were observed for mortality, clinical signs and body weight gain during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
CAS no.: 108-42-9
purity: 99.5%
molecular weight. 127.6 g/mol
appearance: weak yellow liquid
density: 1.21 g/m³

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
100, 250, 312, 400, 500 or 1000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals/dose
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 353 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 400 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

At a dose of 100 mg/kg bw a bad general condition, ruffle fur, discharge of the nose, sedation, bloody shout and salivation was observed. Beginning with 250 mg/kg bw most of the animals revealed cyanosis and some animals showed gasping. At a dose of 1000 mg/kg bw 2 females had a lateral position 2 hours after application of the test substance and one female showed convulsions.

Pathological signs of the deceased animals at doses of 400 to 1000 mg/kg bw were changes of the gastrointestinal tract, brownish discoloured and edematuos lungs and at 500 mg/kg bw black discoulered livers. All animals sacrificed at the end of the study revealed no pathological signs.

The LD50 for male rats was ca. 400 mg/kg bw and the approximative LD50 for females was 353 mg/kg bw.

Applicant's summary and conclusion

Executive summary:

Five male and 5 female Wistar rats received per gavage 100, 250, 312, 400, 500 or 1000 mg m-chloroaniline/kg bw. Animals were observed for mortality, clinical signs and body weight gain during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.

The LD50 was approx. 353 mg/kg bw for female and 400 mg/kg bw for male rats.