Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study - acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Principles of method if other than guideline:
Code of Federal Regulations, Title 16, Section 1500.41 - Patch-Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: left rump side clipped - right rump side clipped and abraded
Vehicle:
other: oil - not further specified
Controls:
not required
Duration of treatment / exposure:
24 hours
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
1.1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU