Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Materials Studio
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
other: Substance ground and moistened with 0.85% saline
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: no data
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: no data
Score:
0
Other effects:
Erythema (grade 1) was recorded in 2 animals at 1 hour but was no longer evident at 24 hours.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information