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EC number: 947-377-6
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 viability %
Standard deviation (SD)
Test item (NSC control)
Test item (corrected)
mean of 3 values (triplicate of the same extract)
- SD ≤ 18%;
- Negative control: OD value of the 3
replicates in the range ≥0.8 and ≤3.0
OD was measured after a 1:2 dilution
of the formazan extracts in isopropanol: the acceptability criteria
should be in the range >=0.4 and =<1.5 for the negative control.
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 substance.
The test item was applied during 42 minutes,
at the dose of 16 mg, to 3 living Reconstructed Human epidermis
(SkinEthic RHE® model) previously moistened with 10 µL of distilled
water. The treatment of the epidermis was followed by a rinse with 25 mL
of DPBS and a 42 hours 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. Additionally, 2 living Human skin model
surfaces were treated in the same manner but they were incubated in
culture medium instead of MTT solution in order to generate nonspecific
living colour controls.
The mean corrected percent viability of the
treated tissues was 95.9%, versus 1.3% in the positive control (5%
Sodium Dodecyl Sulfate). The mean percent tissue viabilities obtained
with the positive control and negative controls were within the range of
historical data and therefore validated the experiment.
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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