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 skin sensitising potential of the test substance was investigated in a study according to OECD test guideline 429 under GLP. Concentrations of 10, 25 and 50% were applied topically (open) on the dorsal side of the ears of NMRI six mice each. This application was repeated twice (24 and 48h after the first application). On day 4, after humane killing on the mice, the lymph nodes were removed and the cells suspended. In addition to the primary endpoint of cell count (expressed as stimulation index), ear thickness and weight and lymph node weight were measured. As the stimulation index for all three tested concentration was clearly below 1.4, i.e. the threshold for a positive result, the test substance is not considered to be a skin sensitiser.


Migrated from Short description of key information:
Based on the results of the only available (and reliable) study (LLNA), the test substance is not considered to be a skin sensitiser.

Justification for classification or non-classification

As the test substance did not induce any skin sensitisation, it is not classified regarding this health effect.