Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study not under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: U.S. Department of Transportation, 49 CFR 173.136-137
Principles of method if other than guideline:
U.S. Department of Transportation skin irritation method, 49 CFR 173: up to 4 hour occlusive exposure, observation to 48 hours or through 14 days., if needed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0.5ml per test site was applied.
Duration of treatment / exposure:
3 minutes, 60 minutes, and 4 hours.
Observation period:
30 to 60 minutes, and 48 hours.
Number of animals:
6
Details on study design:
The test substance (0.5mL/site) was applied to 3 intact skin sites then covered with gauze patches. The test material was kept in contact with the skin for 3 minutes, 60 minutes and 4 hours. The sites were washed with sterile water for injection following the exposure period to prevent further contact with the test article. The test sites were scored for erythema, edema, and/or corrosion at 30 to 60 minutes and 48 hours post exposure.

Results and discussion

In vivo

Results
Irritation parameter:
other: qualitative summary of results
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: No corrosion seen at any test site.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: U.S. Department of Transportation
Conclusions:
Irreversible alteration or destruction of the tissue did not occur at any of the test sites. The test article is not corrosive to the skin of albino rabbits according to the DOT guidelines.