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:
November 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
This study was conducted under the principles of an Open Epicutaneous Test (OET. Test material is applied epicutaneously, uncovered, undiluted on the clipped flank of a Guinea Pig.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
guinea pig
Strain:
not specified

Test system

Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml of each test concentration (100, 30,10 and 3% in ethanol).
Duration of treatment / exposure:
Applications of the test material are repeated daily for 3 weeks or done 5-times weekly during 4 weeks, always using the same skin site.
Observation period:
24 hr after each application or at the end of each week.
Number of animals:
6-8 guinea pigs per concentration group

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
At a concentration of 30% after a single application, only slight irritation was observed at 10%, 30% and 100%.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The threshold toxic concentration of the test material was estimated as part of an open epicutaneous test.  A single application of 10% test material in ethanol was considered the lowest irritant concentration. A single application of 3.0% test material in ethanol was considered the highest non-irritant concentration.