Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In an LLNA study with mice (WIL Research 2012), SI values calculated for the substance concentrations 10, 25 and 50% were 1.7, 0.9 and 1.2 respectively Since there was no indication that the test substance elicits an SI ≥ 3 when tested up to 50%, CYASORB® UV-2908 Light Stabilizer was considered not to be a skin sensitizer. It was established that the EC3 value (the estimated test substance concentration that will give a SI =3) (if any) exceeds 50%.


Migrated from Short description of key information:
CYASORB® UV-2908 is not a skin sensitizer.

Justification for classification or non-classification

Skin:

Based on the results of the WIL Research study (2012), CYASORB® UV-2908 Light Stabilizer would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. The test substance does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.