Registration Dossier

Administrative data

Description of key information

A DEREK assessment, Direct Peptide Reactivity Assay (DPRA) assay KeratinoSensTM assay and U-SENSTM assay were performed.

DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization of the test item. The test item showed minimal cysteine reactivity and no lysine reactivity. The depletion of the synthetic peptides containing cysteine was 1% and test item was concluded to be negative in the DPRA. Test Item was classified as positive in the KeratinoSensTM assay since positive results (<1.5-fold induction) were observed at test concentrations of 1000 mM with a cell viability of >70% compared to the vehicle control. In addition, test item was classified as positive in the USensTM assay since clear positive results (150% increase) were observed at test concentrations with a cell viability of >70% compared to the vehicle control in 2 out of 3 experiments.

In conclusion, there are indications that test item may have skin sensitizing properties. However, taking all relevant data into account, determination whether test item can be presumed to have the potential to produce significant sensitization in humans (Cat. 1A or not) is not possible based on nonanimal testing approaches, as required in Annex VII, section 8.3 of the REACH regulation and therefore, additional in vivo testing is recommended to assess the potency of test item.

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.