Registration Dossier
Registration Dossier
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EC number: 256-283-8 | CAS number: 46830-22-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study dating from 1992 by Clouzeau demonstrated sensitization in all animals. However, an in-depth review of the study report revealed several major problems with the study. Furthermore, the test susbstance was not identified and considering the test period, was most probably not a production sample. For these reasons, a new, GLP study has been conducted on a sample with exactly the same substance identity as the registration. This study demonstrated that there was a complete absence of sensitization to the test material. Based on this, the substance is not considered to be sensitizing for classification purposes.
Migrated from Short description of key information:
A guideline study conducted to GLP on a sample with the same substance identity as the registered substance did not show any sensitization in the test animals.
Justification for selection of skin sensitisation endpoint:
Substance has no vapour pressure and aerosols are not produced during manufacture and use. Therefore, the only sensitization end-point which is concerned is dermal.
Justification for classification or non-classification
Substance was not sensitizing to skin in a GLP guideline study.
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.
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