Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin sensitisation:

A DEREK assessment, DPRA assay, KeratinoSensTM assay and a U-SensTM assay were performed in accordance with the strategy presented in ECHA Guidance on information requirements and chemical safety assessment Chapter R.7a.

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

The test item showed minimal cysteine and lysine reactivity in the DPRA. However, since the substance precipitated after incubation with the synthetic peptide containing lysine, the substance was concluded to be negative based on the cysteine model.

Since positive results (>1.5-fold induction) were observed at test concentrations of <1000 μM with a cell viability of >70% compared to the vehicle control in the KeratinoSensTM assay in two experiments, the test item is considered positive for skin sensitization related to this key event.

In addition, the 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 the test item may have skin sensitizing potential via activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes and/or via activation of dendritic cells. 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 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.