Registration Dossier
Registration Dossier
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EC number: 228-391-5 | CAS number: 6258-06-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A combination of several in vitro methods addressing key steps of the adverse outcome pathway for skin sensitization, i.e.protein reactivity (DPRA), activation of keratinocytes (LuSens assay) and activation of dendritic cells (MUSST/h-CLAT) has been conducted to assess the skin sensitizing potential of the substance. The strategy is described in Bauch C Kolle SN, Ramirez T, Eltze T, Fabian E, Mehling A, Teubner W, van Ravenzwaay B, Landsiedel R., 2012.Putting the parts together: combining in vitro methods to test for skin sensitizing potentials. Regul Toxicol Pharmacol. 63: 489-504.
The substance bound do both Cystein and Lysine containing peptides and activated cultivated dentritic cells. It did not induce an oxidative stress response in a keratinocyte cell line. Since two of the three assays are positive, the substance is identified as a skin sensitizer.
A skin sensitizing (quantitative) potency assessment using the reported results is not possible at the time of writing of this summary. A GHS subcategory could not be assigned.
Migrated from Short description of key information:
Threee in-vitro studies were performed to cover all relevant steps of the adverse outcome pathway for protein binding. The substance activated denttric cells and showed strong binding to synthetic peptides. It is therefore judged to be a skin sensitizer by the adverse outcome pathway for skin sensitization (weight-of-evidence).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
no data
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
Based on the available in-vitro/in-chemico data, the substance is considered to be skin sensitizer.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
Based on the available in-vitro/in silico data, the substance is considered to be a skin sensitizer (Cat 1). The data set does not allow assignment of a sub-category.
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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