Registration Dossier
Registration Dossier
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EC number: 283-029-3 | CAS number: 84522-34-9
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
A DEREK NEXUS assessment, DPRA, KeratinoSensTM and U-SensTM assay were performed.
The DPRA assay was inconclusive due to co-elution with the cysteine-containing peptide and precipitation of the test sample with the lysine-containing peptide and could not be used to decide on the skin sensitizing properties of the test item. The negative result in the KeratinoSensTM assay (<1.5-fold induction at test concentrations≤1000 mM with a cell viability of >70%) was confirmed by the negative DEREK NEXUS 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 U-SensTM assay would be positive. Based on all non-in vivo data available, the test item can be concluded to have no skin sensitizing properties.
In conclusion, the test item does not have any skin sensitizing properties. The substance does not have to be classified according to Regulation 1272/2008 and amendments.
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:
No skin sensitizing properties in DEREK NEXUS assessment, DPRA, KeratinoSensTM and U-SensTM assay.
According to Regulation (EC) No 1272/2008, table 3.4.2, this substance is not classified for this endpoint.
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