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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
Study period:
from 01/10/1986 to 15/10/1986
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
as adopted on 12th May 1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
other: clear liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
one group of animals, comprising 5 males and 5 females, was treated with a single dermal dose of the test substance at 2000 mg/kg of bodyweight
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

see attachement

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item should not be classified for acute dermal toxicity in accordance with GHS system and CLP regulation Regulation (EC) No 1272/2008
Executive summary:

One group of Wistar rats, comprising 5 males and 5 females, was treated with a single dermal dose of the test item at 2000 mg/kg bodyweight for 24 hours. No mortalities occurred and no signs of systemic toxicity were observed during exposure and the following 14 -day observation period.

The treated skin surface of the animals showed areas with erythema and scales. These lesions disappeared during the second week of observation. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 2.0 g/body weight.