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 result of an LLNA study according to OECD 429, a Buehler test (according to OECD 406) and the clinical study published indicated that L Menthol is not sensitizing and consequently does not require classification for this endpoint as set out in Regulation (EC) No. 1272/2008 or in Directive 67/548/EEC respectively.


Migrated from Short description of key information:
No sensitization effects were noted.

Respiratory sensitisation

Endpoint conclusion
Additional information:

Respiratory sensitization is currently classified primarily based on human clinical, epidemiological or observational data and case reports because there is no standardized animal model for this end-point.

Most, if not all, respiratory sensitizers were so far tested positive in the LLNA. There are indications that cytokines produced by the draining lymph node cells after skin exposure might identify respiratory sensitizers (IPSC (2008) Skin sensitization in chemical safety. Geneva World Health Organization, International Programme on Chemical Safety, Harmonization Project Document No. 5). Considered the other way around since L Menthol was tested negative in the LLNA test the risk of being a respiratory sensitizer is low.

Justification for classification or non-classification

No sensitization effects were noted. L Menthols does not need to be classified for the skin sensitisation endpoint as set out in Regulation (EC) No. 1272/2008 or in Directive 67/548/EEC respectively.