Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity studies on rats and rabbits
Author:
Moreno O.M.
Year:
1973
Bibliographic source:
Unpublished report to RIFM. Report 2021
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Sex:
not specified

Administration / exposure

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals (total numer of animals, sex not specified
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1/10
Clinical signs:
In 5/10 animals anorexia on days 1, 2
1/10 animals extreme weakness prior to death

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study the LD50 was determined to be >5000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test item was determined. The study was conducted with 10 rabbits. They received a dermal application of 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. One of 10 animals died during the study. The calculated LD50 was determined to be >5000 mg/kg bw. Toxic effects were found in 5/10 animals on days 1 and 2. They showed signs of anorexia. An extreme weakness was found in 1 animal prior to death.