Registration Dossier

Administrative data

Description of key information

Skin sensitisation:

A DEREK assessment, DPRA assay, a KeratinoSensTM assay and a U-SensTM assay were available.

DEREK NEXUS version 5.0.2 did not yield any alerts for skin sensitization for the test item.

Related to co-elution of test item with synthetic peptides containing lysine in the DPRA assay, no conclusion can be drawn on binding of the test item to lysine. Despite that (minor) co-elution of the test item with synthetic peptides containing cysteine (SPCC) was observed, the test item showed 22.7% SPCC depletion in the reactivity assay. Therefore TEST ITEM was considered to be positive in the DPRA.

Negative results (<1.5-fold induction) were observed in the KeratinoSensTM assay at test concentrations of1000 mM in two out of three experiments, therefore test item is considered negative for skin sensitization related to this key event. In addition, test item is classified as positive (increase in the expression levels of CD86 cell surface marker in the U937 cell line) when tested in the U937 cell line activation Test (U-SensTM) assay.

In conclusion, there are indications that test item has skin sensitizing potential via binding to proteins followed by activation of dendritic cells. Moreover, in absence of non-animal tests to determine its potency adequately for classification purposes, it is recommended to perform an in vivo test with test item.

One in vivo study was performed (LLNA conducted according to OECD No.429 (2010)) and the compound was determined to be positive for skin sensitization, EC3=10.7%.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation:

Positive, EC3: 10.7% in animal test (LLNA).

According to Regulation (EC) No 1272/2008, table 3.4.4, this substance is classified as Category 1B for this endpoint.