Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Justification for classification or non-classification

Skin sensitisation

Regarding the classification of the substance for skin sensitisation the results of the two individual assays of the in vitro skin sensitisation test battery need to be taken together as they reflect 2 key events in the adverse outcome pathway (AOP) leading to skin sensitisation. For this reason, a weight of evidence approach is applied for the test battery stating that: 'any two of the three tests determine the overall results, i.e. any two positive results drive the prediction of a sensitizer, while any two negative results drive the prediction of a test substance to be a non-sensitizer'.

Positive results were obtained both in the DPRA and in the h-CLAT studies, leading to the conclusion that the substance is probably skin sensitizer, category 1. The data are not sufficient for further sub-categorization.