Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
yes

Test animals

Species:
other: Rat (Wistar)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Test substance moistened with deionised water
Duration of exposure:
24 h

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: None
Gross pathology:
Effects on organs: No treatment-related macroscopic effects were observed.
Other findings:
Signs of toxicity (local):
Signs of skin irritation (scabs, oedema, desquamation) had completely resolved in most animals by day 13. One female still showed signs of slight irritation (scabs, oedema, areas of new skin) at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU