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EC number: 945-898-3
CAS number: 97675-63-3
test - Individual and mean corrected OD values and tissue viabilities
for the test item, the negative and positive controls
OD (570 nm) measurements
cOD (570 nm) measurements
Mean cOD (570 nm)
= Optical density
= blank corrected optical density
test - Mean tissue viability and standard deviations for the test item,
the negative and positive controls
cOD (570 nm)
= Standard deviation
in vitro eye irritation test using the EpiOcular™ cornea epithelial
model was performed according to the OECD Guideline 492 and in
compliance with GLP to predict the acute eye irritation potential of the
tests were performed to detect the ability of the test item to directly
reduce MTT as well as its colouring potential. Following the preliminary
tests, the test substance and both the negative and positive controls
were applied topically on duplicate tissues of Reconstructed Human
Cornea-like Epithelium, and incubated at +37°C for 30 min. At the end of
the treatment period, each tissue was rinsed with D-PBS, incubated for
12 min at room temperature to remove any remaining test substance
absorbed into the tissue, blotted on absorbent material, and then
incubated for another 120 min at 37°C, 5% CO2 in a humidified incubator.
The cell viability was then assessed by means of the colorimetric MTT
reduction assay. Mean viability values were calculated for each tissue
and expressed as a percentage of the mean viability of the negative
control tissues which was set at 100% (reference viability).
the preliminary tests, the test substance was found not to have direct
MTT reducing properties or colouring potential. In the main test, the
relative mean viability of the tissues treated with the test substance
was 88% with a standard deviation of 3%. As the mean viability was > 60%
after the MTT reduction, the results met the criteria for a non-irritant
acceptance criteria for the negative and positive controls were
fulfilled. The study was therefore considered to be valid.
the test conditions, the test substance is considered to be non-irritant
to Reconstructed Human Cornea-like Epithelium; therefore it is not
classified according to the Regulation (EC) N° 1272-2008 and to the GHS.
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