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: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG, B.4; OECD 404 (1981)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: New Zealand White KFM (SPF-quality)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Polyethylenglycol PEG 400
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Other effects:
The treated skin was stained orange, something which was considered in the evaluation of the study.

Applicant's summary and conclusion

Interpretation of results:
other: not classified