Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
November 1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: limited justification

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulotions, Title 16 1 Section 1500.41
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Sample code n°: 507-43

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Remarks:
distilled
Amount / concentration applied:
0.5 g mixed with 0.5 ml distilled water
Duration of treatment / exposure:
not specified
Observation period:
72 h
Number of animals:
not specified

Results and discussion

In vivo

Results
Time point:
72 h
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None of the animals showed any observable to treatment throughout the 72 hours observation period.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Sample 507-43 is not considered to be an irritant to rabbit skin.
Executive summary:

EXPERIMENTAL PROCEDURE

The procedure employed was that prescribed by the consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41, o transcript of which is attached as an Appendix to this report.

On this occasion 0.5 g of the sample 507-43 was mixed with 0.5 ml distilled water before application to the skin.

RESULTS

None of the animals showed any observable to treatment throughout the 72 hours observation period.

CONCLUSION

Sample 507-43 is not considered to be an irritant to rabbit skin.