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Description of key information

Two in vitro studies, Lu-Sens and U-Sens were ran to assess the skin sensitisation potency of the test substance in a weight of evidence approach. The 2 studies conducted represent 2 key events in the adverse outcome pathway:Lu-Sens representing the 2nd key event (Keratinocyte induction of cyto-protective gene pathways)and U-sens the 3rd key event (activation of dendritic cells). Both studies give indication that the test item might be skin sensitizing, therefore it was concluded to regard the substance as skin sensitizing category 1.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification

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 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 U-Sens and in the Lu-Sens studies, leading to the conclusion that the substance is probably skin sensitizer, category 1. The data are not sufficient for further sub- categorization.