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EC number: 252-744-2
CAS number: 35836-73-8
7.3.1/1: Individual and mean corrected OD values and tissue viabilities
for the test item, the negative and positive controls
= optical density
= blank corrected optical density
7.3.1/2: Mean tissue viability and Standard Deviations for the test
item, the negative and positive controls
in vitro skin irritation study was performed according to
Guideline OECD 439 and in compliance with GLP, using the EPISKINTM reconstructed
human epidermis model.
test item, Nopol, was applied topically on triplicate tissues and
incubated at room temperature for 15 minutes. At the end of the
treatment period, each tissue was rinsed with D-PBS and incubated for 42
h at 37°C, 5% CO2 in a humidified incubator. The cell viability was then
assessed by means of the colorimetric MTT reduction assay. Relative
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). In the preliminary tests, the
test item was found not to have direct MTT reducing properties or
acceptance criteria for the negative and positive controls were
fulfilled. The study was therefore considered to be valid.
treated tissues appeared white, which was considered to be indicative of
dead tissues. Following a 15 minute exposure and 42 h of recovery
period, the relative mean viability of the tissues treated with the test
item was 7% with a Standard Deviation of 1% as assessed by the MTT
assay. As the mean viability was < 50% the results met the criteria for
an irritant response.
Nopol is classified in category 2 (H315) according to Regulation (EC)
No. 1272/2008 (CLP) and GHS.
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