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EC number: 239-387-8
CAS number: 15356-60-2
Low acute toxicity for oral route ( 2000 mg/kg bw).Low acute toxicity dermal (5000 mg/kg bw) extrapolated to D-MentholIt can be expected the same low acute toxicity for the inhalation route.
Justification for Read-across:
Based on the identical 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 the Acute toxicity studies :
Structure/activity relations and computer
systems compiled under OECD-Toolbox don’t
flag up any structural alerts and classified D-menthol and its isomers
in Class I (i.e. Low hazard according to Cramer classification).
Therefore, even if the acute oral toxicity
studies were not performed according to guideline methods they may be
accepted on a scientific point of view to evaluate this endpoint.
An oral acute toxicity study in rat were
performed on D-menthol and D/L-menthol in the same laboratory and using
the same protocol. The LD50 was > 2046mg/kg for D-menthol. Similar range
of values has been founded on the isomers in several studies.
Another LD50 value of 3.4 g/kg in mice was
found for L-Menthol.
There aren’t any dermal acute toxicity data
in rat on D-menthol according to current guideline methods. However,
based on the similarity of menthol isomers, one evaluates this end-point
based on read-across with the isomers.
Ten rabbits received a single dermal
application of L-menthol at the dose of 5g/kg/body weight. Observations
were made for 14 days. No mortality or clinical signs were observed
during the 14-day observation period. The LD50 was determined to be
greater than 5g/kg based on 0/10 deaths at the dose.
Moreover, four healthy albino rabbits
received a dermal application of neat menthol racemic. Prior to
application, the backs of all animals were clipped free of hair and
epidermal abrasionswere made, over the
lipped area of exposure. Menthol racemic at 5 ml/kg (i.e 5g/kg) body
weight was applied to the clipped intact and abraded skin areas. The
test areas were covered with a rubber sleeve or dam which fit snugly
around each animal. After the 24-hour exposure period, the rubber
sleeves were removed and the reactions were recorded. The animals were
observed for 14 days after dosing. No deaths occurred. The acute dermal
LD50 was determined to exceed 5ml/kg body weight.
Taken together, it can be assumed that the
acute oral and dermal toxicity of D-menthol are low. Although no
experimental studies are
available the low
systemic toxicity of
menthols (LD50 >
2000 mg/kg bw)
that is documented
for oral application and single dermal contact can be expected also
for the inhalation route.
Test results from studies performed by oral and dermal exposure indicate
LD50 values beyond the limits for classification and hence D-menthol
does not meet the criteria for classification and labelling for these
endpoints, as set out in Regulation (EC) NO. 1272/2008. Inhalative
exposure is not expected to have significant toxic effects, given the
experience from use over many decades of human exposure. This includes
the absence of aspiration hazards, which would have been reported if
present. However, animal data according to standard tests are not
Specific target organ toxicity: According to CLP classification
criteria, the substance does not meet the criteria for classification
and labelling for this endpoint (STOT single exposure) as set out in
Regulation (EC) No. 1272/2008 as no indications were observed in acute
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