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

Test animals

Species:
other: Rat (Charles River)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Purified 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 was no systemic response from any animal during the
study.
Gross pathology:
Effects on organs:
No abnormalities were noted in any animal at the macroscopic
examination at study termination on day 15.
Other findings:
Signs of toxicity (local):
Very slight irritation was observed in one female after
bandage removal. In addition very slight to well defined
irritation was seen in one female from day 4. These
reactions had resolved by day 9.


A small area of scab formation was seen in two females from
day 3 and one from day 5 and was also seen on one male from
day 7. These reactions had resolved by day 13.

Applicant's summary and conclusion

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