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CAS number: -
1. Summary of results.
Mean OD /disc (#)
Mean OD / product
# mean of 3 values (triplicate of the same extract)
OD: optical density
Negative control: OD value of the 3 replicates in the range ≥ 0.8 and ≤
3.0. The optical density 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 of the test item was performed in
a reconstructed human SkinEthic RHE® model, according
to OECD TG 439 (GLP study). Three epidermis units were treated with 16
μL test item for 42 minutes at room temperature. Exposure of
the test item was terminated by rinsing with 25 x 1 mL of DPBS. The
epidermis units were then incubated at 37°C for 42 hours in an incubator
with 5% CO2. The viability of each disk was assessed by incubating the
tissues with MTT, extracting the precipitated formazan crystals using
isopropanol during 2 hours under gentle agitation in the dark, and
measuring the concentration of formazan by determining the OD at 570 nm,
just after dilution of the extracts 1:2 in isopropanol. Under test
conditions, the mean percent viability of the treated tissues was
4.3%, versus 2.0% in the positive control (5% Sodium Dodecyl Sulfate).
Therefore, the test item must be considered as skin irritant (cat 2) or
skin corrosive (Cat 1).
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