Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: according to Hazelton protocol No. P 2/152, 1st revision
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
male
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
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

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)

Interpretation of results:
irritating
Remarks:
Migrated information Xi;R38 Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: in accordance with the recommended guidelines of the USA Interagency Regulatory Liaison Group
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml of 100% substance
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24h
Score:
4
Max. score:
6
Reversibility:
not specified
Remarks on result:
other: highly irritating
Interpretation of results:
highly irritating
Remarks:
Migrated information Xi;R41 Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

According to CLP the substance must be classified as irritating to skin category 2 with H315 (causes skin irritation) and for eye damage category 1 with H318 (causes serious eye damage)