Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Justification for type of information:
Guideline study under GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: U.S. 49 CFR 173.136 (a) and 173.137
Principles of method if other than guideline:
A U.S. DOT standard skin corrosion method was used.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Purity 100%, Brownish White Flaky Solid, Lot # 01008AA

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
6 white rabbits were used in the test study.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
A 1 square inch quaze patch was held to the test area (intact skin)
Duration of treatment / exposure:
3 minutes, 60 minutes, and 4 hours
Observation period:
48 hours
Number of animals:
6
Details on study design:
Six animals were treated by introducing the test substance under gauze patches measuring 1 square inch held on with non-irritating tape at 3 test sites. The test substance was kept in contact with the skin for 3 minutes, 60 minutes, and 4 hours by wrapping with an impervious bandage. After the exposure period, the test sites were washed with sterile water. Initial readings were scored for erythema, edema and /or corrosion 30-60 minutes post exposure. Readings were made again at the end of 48 hours.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Remarks on result:
no indication of irritation

Any other information on results incl. tables

None of the animals exhibited any signs of skin corrosion at any of the test sites. The test substance is not considered corrosive to the skin of albino rabbits according to the test study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not considered corrosive to the skin of albino rabbits according to the guideline U.S. DOT corrosion test.