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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 did not yield any alerts for skin sensitization of the test item.

In the cysteine reactivity assay the test item showed 2.5% SPCC depletion while in the lysine reactivity assay the test item showed 4.5% SPCL depletion. As a result the test item was considered to be negative in the DPRA and classified in the “no or minimal reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.

The test item was classified as negative in the KeratinoSensTM assay since negative results (<1.5-fold induction) were observed at test concentrations of1000 mM.

In conclusion, there are no indications that test item has skin sensitizing properties. The current data-set is considered to be sufficient to conclude that the test item does not have to be classified for skin sensitizing properties. 

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 Derek Prediction, DPRA assay and KeratinoSensTM assay.

According to Regulation (EC) No 1272/2008, table 3.4.2, this substance is not classified for this endpoint.