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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Aqueous methylcellulose
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: 1
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Clinical signs:
Signs of toxicity related to dose levels:
There were no mortalities, however, one male was killed in
extremis due to the appearance of a tumour on the neck of
the animal on Day 9 of the study. this was a carcinoma of
adnexal origin, probably a basal cell carcinoma. The tumour
was thought to have developed spontaneously and is not
treatment related.
Gross pathology:
Effects on organs:
No macroscopic abnormalities were observed.
Other findings:
Signs of toxicity (local):
Transient slight erythema with or without slight oedema was
seen in two males and all females on removal of the
dressings, resolving completely by Day 6. In addition,
localised spots were observed on two males and two females
in the first week of the study. No dermal response to
treatment was observed in the remaining animals throughout
the study with the exception of residual test substance
staining on the treatment site resolving completely by Day
6.

Applicant's summary and conclusion

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