Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 and KeratinoSensTM 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 yielded an alert for test item for skin sensitization based on the presence of the aromatic amine group, the predicted EC3 was 12% (weak sensitizer). The outcome of a DPRA assay demonstrated that test item is not expected to bind to proteins. The KeratinoSensTM assay indicated that test item did not activate the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes.

The in chemico and in vitro data do not indicate that test item has skin sensitizing potential. However, based on the DEREK prediction it cannot be excluded that test item is a skin sensitizer after metabolic activation in vivo. As this aspect is not or limitedly addressed in the non-animal tests, it is recommended to conduct further testing for skin sensitizing properties in vivo. 

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.