Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 or test system 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)