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EC number: 946-413-8
CAS number: -
7.3.1/1: Main test - Individual and mean OD values and tissue
viabilities for the test item, the negative and positive controls
Mean OD / disc
Mean OD / product
mean of 3 values (triplicate of the same extract)
The difference of viability between the 3 tissues treated with the
test item was 22.2%, instead of 18% at the maximum as initially
As the test item remains clearly classified as “Non irritant
to the skin”, even when considering each replicate separately, this
deviation has no impact on the conclusion and the validity of the study.
An in vitro skin irritation test using the
Reconstructed Human Epidermis (SkinEthic RHE® model) was performed
according to the OECD Guideline 439 and in compliance with GLP to
predict the acute skin irritation potential of the test item.
The test item was applied after powder
reduction, at the dose of 16 mg, to 3 living Reconstructed Human
epidermis (SkinEthic RHE® model) during 42 minutes, followed by a rinse
with 25 mL of PBS and a 41 hours and 25 minutes post-incubation period
at 37°C, 5% CO2. Cell viability was then measured by enzymatic
conversion of the vital dye MTT into a blue formazan salt that was
quantitatively measured after extraction from tissues.
The mean corrected percent viability of the
treated tissues was 119.7% (considered as 100%), versus 1.6% in the
positive control (5% Sodium Dodecyl Sulfate).
Under the test conditions and in accordance
with Regulation EC No. 1272/2008, the test item was considered as
non-irritant to skin. It corresponds to UN GHS No Category. No hazard
statement or signal word is required.
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