Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat (Sprague Dawley (CD))
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
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 mortalities and no evidence of a systemic
response in any animal throughout the syudy. A slight
bodyweight loss and/or a slight reduction in bodyweight gain
was seen in 3 females. All other animals showed normal
bodyweight gains.
Gross pathology:
Effects on organs:
No macroscopic abnormalities were observed.
Other findings:
Signs of toxicity (local):
Transient slight to well defined erythema with or without
well defined oedema was seen in all animals resolving
completely by Day 7. Desquamation of the treatment site was
noted for one female on Day 3 only. In addition, residual
test substance staining of the treatment site was observed
in all rats, resolving by Day 8.

Applicant's summary and conclusion

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