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EC number: 218-690-9
CAS number: 2216-51-5
There is no reproductive toxicity data on L Menthol.
Justification for Read-across:
Based on the identical profiles of the different Menthols we can use
them for read across studies as described in the Read-Across
Justification for Menthols (see file MentholsReadAcrossFinal.pdf in
section 13). 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
In OECD SIDS, L Menthol (CAS 2216-51-5), D Menthol (CAS
15356-60-2) and DL Menthol (CAS 89-78-1) were recognized as a category
group. Investigations on toxicokinetics show that L-, D-, DL- and the
unspecified Menthol are well absorbed via the oral route. For all of the
isomers, elimination is rapid and mainly occurs as glucuronic acid
conjugates via urine, minor amounts via faeces. Significant differences
in toxicokinetic properties of Menthol isomers were not reported.
The available toxicity data indicate very similar toxicity
profiles for D-, L-, DL Menthol and the unspecified Menthol isomer
mixture. In mammalian species the low toxicity is manifested in LD50
values generally greater than 2000 mg/kg bw/day in acute studies,
limited toxicity in repeated dose studies, and no effects in teratology
evaluations. Irritation to skin and eyes was slight to moderate.
DL-Menthol is a racemic mixture of the D- and L- isomers and contains
both isomers in equal proportion. Data gaps for L Menthol can therefore
be filled by the respective results with the racemic mixture or the D
Due to above discussion, to this endpoint, reproductive properties
of L Menthol can be thought equivalent to the tested substance DL
Menthol (The NOAEL in this study on rats was determined at 375 mg/kg
Detail for the waiving approach:
histopathological examinations of the reproduction organs of rats and mice
did not show any changes in repeated dose toxicity studies of DL
Menthol and also in carcinogenicity studies of DL Menthol, we can
anticipate the same conclusion for L Menthol.
L Menthol is not considered to be embryo-or fetotoxic or teratogenic.
No changes were observed during the histopathological examinations of
the reproductive organs of rats and mice in the combined repeated dose
and 2 years carcinogenicity toxicity studies following exposure to the
Menthol isomer mixture: DL Menthol.
The L Menthol has no developmental toxicity and no teratogenicty
properties in well performed gavage studies in various species (rat,
mouse, rabbit, hamster) at the highest dose of 185 (for mice) to 425
(for rabbits) mg/kg bw. Since we could only derived a NOEL for these 4
species we can consider that the L Menthol has no developmental or
The L Menthol should therefore not be classified either on reproduction
toxicity or teratogenicity.
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