Registration Dossier

Administrative data

Description of key information

In a reliable local lymph node assay to evaluate the sensitisation potential of the substance, mice (4 animals) were exposed to the substance for 3 consecutive days at concentrations 10%, 25% or 50% w/w. The SI for all treatment groups was below 3 and thus indicates that the substance is not a sensitiser.

Key value for chemical safety assessment

Skin sensitisation

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings of a reliable in vivo sensitisation study (LLNA) conducted on the substance, classification of the substance is not justified.