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EC number: 275-702-5
CAS number: 71617-10-2
A guinea pig maximisation test was performed to assess the skin contact
sensitisation potential of the test material in albino guinea pigs. The
method used followed the one described in the current OECD guidelines
no. 406 "Skin sensitisation" and the method B.6 of Commission Directive
Twenty test and ten control animals were used for the main study.
Based on the results of sighting tests, the concentrations of test
material for the inducton and challenges phases were selected as follows:
5% w/v in arachis oil B.P.
undiluted as supplied
undiluted as supplied and 75% v/v in 1:1 ethanol/diethylphthalate
The test material produced a 0% (0/20) sensitisation rate and was
classified as a non-sensitiser to guinea pig skin. The test material did
not meet the criteria for classification as a sensitiser according to EC
labelling regulations. No risk phrase is required.
When tested in a guinea pig maximisation test in
Dunkin-Hartley guinea pigs at the concentrations given above, isopentyl
p-methoxycinnamate did not induce skin
sensitisation in any of the test animals. Accordingly, isopentyl
p-methoxycinnamate was classified as a
non-sensitiser to guinea pig skin.
Additional information on the sensitising and
photosensitising potential of isopentyl p-methoxycinamate is available
from 3 recently conducted patch tests in humans (Cardoso et al. 2009;
Chew et al. 2010; Pentinga et al. 2009; see the attached pdf files).
In the study conducted by Cardoso et al. (2009), 83
patients with suspected photoaggravated facial dermatitis or systemic
dermatitis were tested with a series of potential photoallergens,
including isopentyl p-methoxycinnamate (at a concentration of 10%). Only
one patient showed a positive reaction to isopentyl p-methoxycinnamate.
In the study of Chew et al. (2010) 50 patients with
chronic actinic dermatitis underwent sensitisation and
photosensitisation patch tests with 10 suspected photoallergens, among
them isopentyl p-methoxycinnamate (used at a concentration of 10% in
petrolatum). No positive reactions to isopentyl p-methoxycinnamate were
observed in this study.
Pentinga et al. (2009) subjected 18 patients sensitive to
cinnamate-related compounds to a photopatch test with 12 cinnamate-like
compounds, including isopentyl p-methoxycinnamate (used at a
concentration of 10% in petrolatum). None of the study subjects showed a
positive reaction to isopentyl p-methoxycinnamate.
The results of these 3 studies in humans suggest that
isopentyl p-methoxycinnamate is virtually devoid of any photosensitising
activity in humans.
According to the results of the guinea pig maximisation test and
the 3 studies in humans, isopentyl p-methoxycinnamate does not meet the
current EU-CLP criteria for classification as a skin sensitiser. No risk
phrase is required.
The respiratory sensitisation potential of isopentyl
p-methoxycinnamate was not evaluated. Hence, this substance cannot be
classified with respect to this endpoint.
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