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:

There is no reliable enough skin sensitization study on D-Menthol according to current guideline methods. However, based on the similarity within isomers, we can evaluate this end-point based on read-across with the isomers.

Justification for Read-across:

Based on the comparable profiles on OECD-Toolbox of the different menthols we can use them for read across studies. These isomers are L-menthol (CAS 2216-51-5), D-menthol (CAS 15356-60-2) and DL-menthol (CAS 89-78-1)

Moreover, a comparative physico-chemical profile of these isomers reinforces this similarity. As structural isomers, the members of the menthol category share the same molecular weight. Of particular importance to environmental  effects and human effects are the values for partition coefficient (log Kow around 3), vapour pressure (from 17 Pa at 25°C for the DL-menthol to 21 Pa 25°C for the natural L-menthol ) and water solubility ( moderately soluble from 410 mg/l at 25°C for the natural L-menthol to 470 mg/l at 25°C for the DL-menthol). The read across is consistent based on these physico-chemical parameters.

Skin sensitization:

No sensitization effect was shown in the poorly reliable study conducted on D-Menthol. No sensitization effects were noted in mice under the conditions of an LLNA test. The significant cell proliferation is observed at a stimulation index SI of 2.79 (at 10%) instead of 3 when using 3H-thymidine. At the lowest concentration (1%) SI = 2.02. There were no indication of skin irritancy neither in the preliminary study nor in the main study.

No sensitization effects were observed in guinea pig non maximization test (i.e Buehler test, induction phase at 25% where there is no clue on mild irritation).

Moreover, there are several other experimental and clinical published data sustaining the lack of skin sensitisation potential of L-Menthol (constituting supporting studies).

On the whole, and considering the absence of alerts related to the rotatoty powder of isomers the  D-Menthol is concluding as none skin sensitizer in accordance with the criteria of classification and labelling.


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

Justification for classification or non-classification

D-menthol is concluded not skin sensitizing and consequently does not require any classification for this endpoint as set out in Regulation (EC) No. 1272/2008.