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:

The test article was evaluated at a concentration of 10% in DMSO, with DMSO as the vehicle control and 25% HCA as the positive control.

All animals survived the in-life phase of the study and were observed to be normal. Ear thickness measurements and clinical observations indicated that treatment with the test article did not result in dermal irritation.


Migrated from Short description of key information:
In a LLNA study in mice, topical application of the test article at 10% in DMSO resulted in an SI value of 2.3. Therefore, the test article was considered not to be a skin sensitizer.

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for sensitisation.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for skin sensitisation.