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: 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:
There were no significant signs of systemic toxicity.
Gross pathology:
Effects on organs:
There were no toxiclogically significant pathology
abnormalities observed.
Other findings:
Signs of toxicity (local):
Slight to moderate oedema was seen in most animals and
scabbing was seen in two animals. All signs of irritation
had completely resoved by day 7.

Applicant's summary and conclusion

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