Registration Dossier

Diss Factsheets

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
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
yes

Test animals

Species:
other: rat, Sprague-Dawley

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Moistened with arachis oil BP
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:
No deaths occured. No signs of systemic toxicity were noted
during the study period. No toxicologically significant
effects on bodyweight were noted during the study.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy of animals killed at
the end of the study.
Other findings:
Signs of toxicity (local):
No signs of dermal irritation were noted during the study
period.

Applicant's summary and conclusion

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