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 the test substance was considered not to be a skin sensitizer, since there was no indication that the test substance elicits an SI ≥ 3 when tested up to 50%. 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:
An LLNA study mice with the test substance is available, performed according to OECD and EU guidelines as well as GLP principles.

Justification for classification or non-classification

Based on the above mentioned result, classification according to the CLP Regulation (EC) 1272/2008 and the Dangerous Substance Directive 67/548/EC is not considered necessary.