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EC number: 948-069-4
CAS number: -
Table 7.3.1/1: Mean OD540 Values and
Percentage Viabilities for the Negative Control Item, Positive Control
Item and Test Item
Mean OD540of triplicate tissues
±SD of OD540
Relative individual tissue viability (%)
Relative mean viability (%)
± SD of Relative mean viability (%)
Negative Control Item
Positive Control Item
*= The mean viability of the
negative control tissues is set at 100%
An in vitro skin irritation study was
performed according to the OECD Guideline 439 and in compliance with
GLP, using the EPISKINTM reconstructed human epidermis model.
The purpose of this test was to
evaluate the skin irritation potential of the test material using the
EPISKINTMreconstructed human epidermis model after a
treatment period of 15 minutes followed by a post-exposure incubation
period of 42 hours. The principle of the assay is based on the
measurement of cytotoxicity in reconstructed human epidermal cultures
following topical exposure to the test item by means of the colorimetric
MTT (3‑[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide)
reduction assay. Cell viability is measured by enzymatic reduction of
the yellow MTT tetrazolium salt to a blue formazan salt (within the
mitochondria of viable cells) in the test item treated tissues relative
to the negative controls.
This test was designed to be
compatible with the OECD Guideline No. 429 and method B.46 of Commission
Regulation (EC) No. 440/2008/EC and was performed in compliance with
Triplicate tissues were treated with
the test material for an exposure period of 15 minutes. At the end of
the exposure period each tissue was rinsed before incubating for
42 hours. At the end of the post‑exposure incubation period each tissue
was taken for MTT-loading. After MTT loading a total biopsy of each
epidermis was made and placed into micro tubes containing acidified
isopropanol for extraction of formazan crystals out of the MTT‑loaded
At the end of the formazan extraction
period each tube was mixed thoroughly and duplicate 200 µL samples were
transferred to the appropriate wells of a pre‑labelled 96‑well
plate. The optical density was measured at 540 nm.
The relative mean viability of the
test item treated tissues
was 40.7 ± 2.7 %, after the 15‑minute exposure period.
quality criteria required for acceptance of results in the test were
a relative mean tissue viability < 50 %, the test material was
considered to be irritant.
Under the experimental conditions of this
study, the test substance is classified for skin irritation Category 2
according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
study is considered as acceptable and satisfies the requirement for skin
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