Registration Dossier
Registration Dossier
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EC number: 947-953-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Two in vitro studies, DPRA and LuSens 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: DPRA representing the 1st key event (peptide reactivity) and LuSens the 2nd key event (keratinocyte response). Both studies show no indication that the test item might be skin sensitizing, therefore it was concluded to not classify the substance as skin sensitising.
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'.
Negative results were obtained both in the DPRA and in the LuSens studies, leading to the conclusion that the substance is not skin sensitising.
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