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EC number: 239-387-8
CAS number: 15356-60-2
D-Menthol is :Skin irritant.Slightly eye irritant
The ocular irritation potential of D-menthol
at 50% and 100% according
to the current OECD-guideline 405 was assessed. All examinations were
performed in the same institute according to the same protocol; the
means of Draize scores were
recorded after 24, 48, and
72 h. The vehicle diethylphthalate (DEP) alone used in these tests
didn’t shown any irritating properties in the opposite eye of the animals.
In all studies with the test compounds only slight reactions of cornea and conjunctiva
were observed, depending on
the concentration tested. There
was no reaction in the iris observed in all cases. Moreover,
after treatment with menthol liquid (at
50 and 100%) slight redness of conjuctival was
seen on day 3
in 2/4 animals. This
adverse effect recovered completely within 7 days.
Then, a 50% diethylphtalate solution of
D-menthol caused slight conjunctival irritation to the rabbit eye.
In a primary dermal irritation study (four
SFP albino female rabbits), were dermally exposed to 0.5ml of 5
different concentrations of D-menthol in DiEthyl Phthalate (DEP) (i.e.
HR 89/620005 - 100%, 50%, 25%, 5% and 1%) for 4 hours according to OECD
404 guideline. The test was performed
in the same institute and following the same protocol than L-menthol.
Very slight erythema (barely perceptible) was
observed up to 25%, whereas at higher concentration and undiluted,
moderate to severe erythema is recorded (such was almost the case with
D-menthol (HR 89/620005, 100%) was examined
for its skin irritating potential in a valid study conducted according
to OECD test guideline n°404 and under GLP. D-menthol was a dermal
irritant at 100% and at 50%. However, 25% diethylphthalate solution
shall not be classified as skin irritant.
Skin irritation: The substance D-menthol at 100% meets the
criteria for classification and labelling for this endpoint, as set out
in Regulation (EC) No. 1272/2008. Based on a valid key study performed
according to OECD 404 protocol, the substance showed irritating
properties with a maximum draize score of 3 that were reversible
although not fully reversed at the highest concentration of 100% but the
underlying skin remained intact. At concentrations of 50% and below, the
test data did not meet the criteria for classification as skin irritant.
Eye irritation: according to CLP classification criteria,
the substance does not meet the criteria for classification and
labelling for this endpoint since all scores were below the limits
specified for eye irritation Category 2 as set out in Regulation (EC)
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