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EC number: 239-387-8
CAS number: 15356-60-2
There is neither mutagenic nor cytogenic data
for D-menthol (CAS 15356-60-2) but several datas on a
menthol isomer called also "D-Menthol" (CAS 15356 -70 -4). To
sustain our argumentation we built a weight of evidence based on all
The number of the tests performed, the nature
of the test items, the protocols used and the results obtained are
scientifically acceptable to evaluate this endpoint sufficiently.
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
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
Details on endpoint datas:
L-menthol was neither mutagenic in in vitro
gene mutation study in bacteria (Ames test),
nor genotoxic on mammalian cells.
Moreover with menthol racemic, no
mutagenicity was observed in several published bacterial studies.
Recently, no mutagenicity of the substance menthol racemic was confirmed
in a study (GLP) with five mutant strains of Salmonella typhimurium
according OECD 471 guideline. Several
publications support the non genotoxicity of menthol racemic.
However, two in vivo studies revealed positive results in replicative
DNA synthesis in mice and in rat.
Structure/activity relations and computer
systems compiled under OECD-Toolbox don’t
flag up any structural alerts, any DNA and protein binding potential on
D-menthol and its isomers.
Moreover, a series of in vitro tests on the "D-menthol" (CAS 15356
-70-4) and the isomeric mixture do not suspect any mutagenic or
These evidences are strengthened by an in vivo test performed
recently on the mixture of isomeric form (OECD / GLP).
Overall, we can conclude that D-menthol and its isomers have not
genotoxic or carcinogenic hazard. Subsequently, additional
carcinogenicity test can be waived based on the weight of evidence
Due to the
weight of evidence approach we can assume that D-menthol does not need
to be classified for this endpoint.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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