Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 31 AUG 1976 to 16 SEP 1976
Reliability:
2 (reliable with restrictions)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA guideline (Federal register 38, No. 187, 27.9.1973, p.27019)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped intact and clipped scarified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period:
48 h after removal of patch with observation time points immediately after removal and 24 h later.
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Remarks on result:
other: clipped intact and clipped scarified
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Remarks on result:
other: clipped intact and clipped scarified

Applicant's summary and conclusion

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