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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

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 were occlusively applied 1000 or 2000 mg m-chloroaniline/kg bw. The test substance was applied on gauze covering about 10% of the body surface and caped with aluminium foil. After 24 hours the test substance was remouved with lukewarm water. The 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

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Duration of exposure:
24 hours
Doses:
1000 or 2000 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:
> 1 000 - < 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Signs of intoxicition at a dose of 2000 mg/kg bw were cyanosis and sedation on male and female rats. A single female rats showed at a dose of 1000 mg/kg bw cyanosis, gaunt flanks and a bad general condition. All other animals revealed no symptoms at a dose of 1000 mg/kg bw.

Pathological signs of the deceased animals at doses of 2000 mg/kg bw were changes of the gastrointestinal tract, brownish discoloured lungs and the urinary bladder was filled plump with liquid on males and one female. The gastrointestinal tract was partly black discoloured on 2 females and one female showed a clay-coloured liver. The animals which died during the post-observation period were cyanotic. All animals sacrificed at the end of the study revealed no pathological signs.

The LD50 is > 1000 and < 2000 mg/kg bw for female rats and ca. 2000 mg/kg bw for male rats.

Applicant's summary and conclusion

Executive summary:

Five male and 5 female Wistar rats were occlusively applied 1000 or 2000 mg m-chloroaniline/kg bw. The test substance was applied on gauze covering about 10% of the body surface and caped with aluminium foil. After 24 hours the test substance was remouved with lukewarm water. The 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.

Signs of intoxicition at a dose of 2000 mg/kg bw were cyanosis and sedation on male and female rats. A single female rats showed at a dose of 1000 mg/kg bw cyanosis, gaunt flanks and a bad general condition. All other animals revealed no symptoms at a dose of 1000 mg/kg bw.

The LD50 is > 1000 and < 2000 mg/kg bw for female rats and ca. 2000 mg/kg bw for male rats.