Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
There are no details on the study protocol. The test material was applied to the skin of 10 rabbits. Mortality and/or systemic effects were observed over a 14 day period. Gross necropsy was conducted on all animals.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No information given

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
Not specified.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 (sex not specified)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
There were no effects observed
Body weight:
not specified
Gross pathology:
Necropsy findings were routine and not compound-related.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not acute dermal toxic. The LD50 is > 5000 mg/kg bw.
Executive summary:

In the current study the acute dermal toxicity of the test item was assessed in rabbits. The study was not according to OECD and GLP was not specified.

The test material was applied to the skin of 10 rabbits. Mortality and systemic effects were observed over a period of 14 days. Gross necropsy was conducted on all animals. The dose used was 5000 mg/kg bw.

No animals died during the course of the study and no specific compound-related effects were observed. Therefore, the dermal acute LD50 is > 5000 mg/kg bw.