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EC number: 946-413-8
CAS number: -
7.3.2/1: Main test - Individual and mean corrected OD values and tissue
viabilities for the test item, the negative and positive controls
Mean OD/disc (#)
Mean viability %
Difference of viability %
mean of 3 values (triplicate of the same extract)
An in vitro eye irritation test using the
Reconstructed human Cornea-like Epithelium (RhCE) (EpiOcular™ tissue)
model was performed according to the OECD Guideline 492 and in
compliance with GLP to predict the acute eye irritation potential of the
The test substance was reduced in fine
powder and applied to two DPBS pre-treated RhCE (EpiOcular™ tissue
model) during 6 hours at 37°C, 5% CO2, 95% humidity (standard culture
conditions). The exposure period was followed by extensive rinsing with
PBS at room temperature, a 25-minute post-exposure immersion period at
room temperature and a 17-hour and 55-minute post-exposure incubation at
standard culture conditions. The tissue viability was measured by
performing a MTT assay.
The mean percent tissue viability of the
RhCE replicates treated with the test substance was 101.18% versus
26.37% in the positive control (Methyl acetate).
Under the test conditions and in accordance
with Regulation EC No. 1272/2008, the test substance was identified as
not requiring classification for eye irritation or serious eye damage.
It corresponds to the UN GHS No Category. No hazard statement and no
signal word are required.
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