Registration Dossier
Registration Dossier
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EC number: 608-855-7 | CAS number: 33288-71-0
Endpoint summary
Administrative data
Description of key information
Based on the in silico/in chemico/in vitro data available, the substance can be concluded to have no skin sensitizing properties.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A DEREK assessment, Direct Peptide Reactivity Assay (DPRA) assay, KeratinoSensTM assay and U-SENSTM 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 (v.6.0 July 2017).
The substance showed minimal lysine reactivity in the DPRA. However, since co-elution was observed with the synthetic peptide containing cysteine, and DPRA prediction and reactivity classification can be made based on depletion of synthetic peptide containing cysteine alone, the DPRA results obtained for the substance were inconclusive.
The substance was classified as negative in the KeratinoSensTM assay since negative results (<1.5-fold induction) were observed at test concentrations of ≤1000 μM in two out of three experiments. This result was confirmed by the negative DEREK NEXUS assessment and there is no indication that possible metabolites should be taken into account.
Since in the U-SENSTM assay the test item had precipitated at the end of the incubation, it cannot be stated whether the required amount of test item dissolved initially could still reach the cells to induce CD86 activity and the test item should be classified as positive according to the criteria of OECD 442E, although no induction of CD86 activity was observed.
However, based on the negative results from the KeratinoSensTM assay confirmed by a negative DEREK NEXUS, it is highly unlikely that the substance would induce CD86 activity in the U-SENSTM assay if no precipitation had occurred.
Based on the in silico/in chemico/in vitro data available, the substance can be concluded to have no skin sensitizing properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the in silico/in chemico/in vitro data available, the substance can be concluded to have no skin sensitizing properties.
The substance does not have to be classified according to Regulation 1272/2008 and amendments.
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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