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 was considered to be positive in the DPRA using the Cysteine 1:10 prediction model, however, assignment to a reactivity class cannot be made since minor interference of the test item with SPCC occurred and co-elution of the test item with SPCL was observed. The test item is classified as negative in the KeratinoSensTM assay since no relevant induction was observed up to test concentrations of 2000 μM. In addition, the test item is classified as positive (increase in the expression levels of CD86 cell surface marker in the U937 cell line) under the experimental conditions described in this report.

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 is being performed (LLNA conducted according to OECD No.429 (2010)) and the test results will be provided after available.

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:

In-vitro/ in chemico tests: 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.

According to Regulation (EC) No 1272/2008, table 3.4.2, classification is not possible based on current available data.