Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 255-527-0 | CAS number: 41741-86-0
Endpoint summary
Administrative data
Description of key information
The test article was found sensitizing in a Maximization study and in an Optimization study.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The test substance was investigated for its sensitizing potential in a GLP-compliant Maximization test according to OECD guideline 406. Pirbright White guinea pigs received intradermal induction treatments with 5% in oleum arachidis and one epicutaneous induction treatment with 50% in vaseline. For intradermal induction, three pairs of injections (adjuvant/saline; test item in vehicle; test item in adjuvant/saline) were given. Epidermal challenge was performed by occlusive application for 24 h two weeks later (10% in vaseline). The control group was exposed to vehicle only during this procedure. 55 and 75% of the animals were sensitised by the test article under the experimental conditions employed. The sensitivity of the strain is controlled every six month with a known sensitizer. In conclusion, the test substance is considered to be a skin sensitizer in albino guinea pigs and requires classification.
The test substance was investigated for its sensitizing potential in a GLP-compliant Optimization test according to OECD guideline 406. Pirbright White guinea pigs received three occlusive epicutanous induction treatments with 40% test substance in distilled water. After a rest period of 10 to 14 days, an epidermal challenge was performed by occlusive application for 6 h two weeks later (40% in water). The control group was exposed to vehicle only during this procedure. Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to a modified Draize scoring scale. 75% and 80% of the animals were sensitised by the test article under the experimental conditions employed. In conclusion, the test substance is considered to be a skin sensitizer in albino guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is classified for sensitization with category 1B under Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
