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
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2007
Bibliographic source:
IUCLID4 data set, 2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Hazelton protocol No. P 2/152, 1st revision
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
male

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: animals were their own control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24h exposure
Observation period:
72h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
3
Max. score:
8
Remarks on result:
other: abraded
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72h
Score:
4
Max. score:
8
Remarks on result:
other: abraded
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
3
Max. score:
8
Remarks on result:
other: abraded
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72h
Score:
2.33
Max. score:
8
Remarks on result:
other: abraded
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema:
24 h mean 3.0 (abraded), 3.17 (unabraded
72 h mean 4.0 (abraded), 4.0 (unabraded)
- Edema:
24 h mean 3.0 (abraded), 2.83 (unabraded)
72 h mean 2.33 (abraded), 2.17 (unabraded)
REVERSIBILITY: no data
OTHER EFFECTS: greenish colouration of treated skin

Any other information on results incl. tables

See also attached IUCLID4 dossier.

Conclusion: substance is irritating to skin: classification according to DSD Xi;R38; according to CLP as skin irritant catgeory 2 with H315 (causes skin irritation)

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Xi;R38 Criteria used for interpretation of results: EU