Registration Dossier
Registration Dossier
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EC number: 612-936-2 | CAS number: 62041-01-4
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
A DEREK assessment, DPRA assay and KeratinoSensTM assay were performed in accordance with Section 8.3 of Annex VII of Regulation (EC) No 1907/2006 as amended in Commission Regulation (EU) 2016/1688 of 20 September 2016 and the strategy presented in ECHA Guidance on information requirements and chemical safety assessment Chapter R.7a.
The DEREK assessment, DPRA assay and KeratinoSensTM assay all predicted the test item to be a skin sensitizer. However, no reliable conclusion on skin sensitization potential can be drawn from these studies. Performance of an additional in vitro assay addressing the activation of dendritic cells would not yield additional information, irrespective if the study would give a negative or positive result. Therefore, it is considered justified to omit further in vitro testing and perform an in vivo test.
One in vivo study was performed (LLNA conducted according to OECD No.429 (2010)) and the compound was determined to be negative for skin sensitization.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
Negative result in animal test (LLNA).
According to Regulation (EC) No 1272/2008, table 3.4.2, this substance is not classified for this endpoint.
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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