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Administrative data

Description of key information

As recommended in the ECHA Guidance we have performed threein- vitroandin- chemicotests on skin sensitisation covering the key events of adverse outcome pathway (AOP):

 

1.)  Direct Peptide Reactivity Assay (DPRA)

In this guideline study under GLP conditions, the test item showed minimal reactivity towards bothpeptides.The test item is considered as non-sensitiser in the DPRA.

 

2.)  ARE-Nrf2 Luciferase Test Method (KeratinoSens™)

In this guideline study under GLP conditions, the test itemdid not induce the luciferase activity in the transgenic KeratinoSens™ cell line in at least two independent experiment runs. Therefore, the test item can be considered asnonsensitiser in the KeratinoSens™.

 

3.)  Human Cell Line Activation Test (h-CLAT)

In this guideline study under GLP conditions,the test item did upregulate the cell surface markers in at least two independent experiment runs. Therefore, the test item is considered to be a skin sensitiser in the h-CLAT.

 

For details, please see study summery.

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

 

Due to the AOP-based “two out of three” skin sensitization integrated testing strategy (ITS) for hazard identification we classify the substance as “non sensitiser” since the DRPA and KeratinoSens™ study were negative.