Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

A modified LLNA (IMDS) according to OECD TG 429 was conducted on 6 female mice per dose group with test substance concentrations of 0 % (vehicle control), 2 %, 10 % and 50 %. The study does point to a non-specific (irritant) and specific immunostimulating (sensitizing) potential of the test item. Although it is not possible to calculate an exact EC value from the data obtained, it can be assumed that the EC value is in any case below 2 %. In accordance with ECHA guidance, Chapter R.8, Table R.8 -23 (2010) this value corresponds to at least a strong skin sensitizer.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I and to Regulation (EU) No 286/2011 classification is warranted as Skin Sens. 1A (H317).