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EC number: 946-413-8 | CAS number: -
Table 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)
OD: optical density
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 test substance.
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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