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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Principles of method if other than guideline:
Two rabbits were applied 500 µl of the test substance (Macrolexgrün G) at the inner side of one of the ears. The test material was fixed by an adhesive bandage for 24 hours. After 1 and 24 hours and 2, 3, 5, 6 and 7 days the skin areas were scored for erythema and edema according to Draize.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 days
Observation period:
7 days
Number of animals:
2 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Erythema and edema scores were = 0 at any time point.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Erythema and edema scores were = 0 at any time point.
Executive summary:

Two rabbits were applied 500 µl of the test substance (Macrolexgrün G) at the inner side of one of the ears. The test material was fixed by an adhesive bandage for 24 hours. After 1 and 24 hours and 2, 3, 5, 6 and 7 days the skin areas were scored for erythema and edema according to Draize. Erythema and edema scores were 0 at any time point. Macrolexgrün G was not irritating in this test.