Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
from September to October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
- 3 instead of 5 animals/sex used
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals

Species:
rat
Strain:
other: Shoe:Wist
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 0.9 % sodium chloride solution
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

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

Any other information on results incl. tables

At 2000 mg/kg no compound-related clinical findings were observed. Two male and one female rat showed a body weight loss in week 1. In addition, one of the two male rats showed a reduced body weight gain throughout the study period, when compared to the 90% range of historical reference data used in our laboratory. Autopsy revealed no compound-related findings. No animal died in the course of the study.

Applicant's summary and conclusion

Executive summary:

The acute dermal toxicity of the test substance was low with a LD50 value exceeding 2000 mg/kg bw in rats according to OECD TG 402. At the limit-dose 2000 mg/kg no animal died, no clinical findings, slight efffects on body weight gain and no gross pathological findings were observed during the 14-day post observation period.