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EC number: 928-779-0
CAS number: -
The in vitro KeratinoSens™
assay enables detection of the sensitising potential of a test item by
addressing the second molecular key event of the adverse outcome pathway
(AOP), namely the activation of keratinocytes, by quantifying the
luciferase activity in the transgenic cell line KeratinoSens™. The
luciferase activity, assessed by luminescence measurement, compared to
the respective solvent controls is used to support discrimination
between skin sensitisers and non-sensitisers.
The test item was was dissolved in
DMSO. Based on a molecular weight of 396.29 g/mol a stock solution of
200 mM was prepared. Based
on the stock solution a set of twelve master solutions in 100% solvent
was prepared by serial dilution using a constant dilution factor of 1:2.
These master solutions were diluted 1:100 in cell culture medium. The
following concentration range was tested in the assay:
2000, 1000, 500, 250, 125, 61.5,
31.25, 15.63, 7.81, 3.91, 1.95, 0.98 µM
incubated with the test item for 48 h at 37°C. After exposure cells were
lysed and luciferase activity was assessed by luminescence measurement.
In the first experiment, a max
luciferase activity (Imax) induction of 3.64 was determined
at a test item concentration of 500 µM. The corresponding cell viability
was 25.6%. Only at a test item concentration of 500 µM a significant
luciferase induction >1.5 was found.The calculated EC1.5was
< 1000 µM (307.69 µM).
In the second experiment, a max
luciferase activity (Imax) induction of 1.20 was determined
at a test item concentration of 1000 µM. The corresponding cell
viability was 32.5%. No significant luciferase induction >1.5 was found.
Therefore, noEC1.5could be calculated.
No dose response for luciferase
activity induction was observed for each individual run as well as for
an overall luciferase activity induction.Under the condition of this
study the test item is therefore considered as a "non sensitiser". The
controls confirmed the validity of the study.
In this study under the given
conditions the test item did not induce the luciferase activity in the
transgenic KeratinoSens™ cell line in at least two independent
experiment runs. Therefore, based on the results of this study, the test
item can be considered as a "non
sensitiser". The data generated with this test
should be considered in the context of integrated approached such as
IATA, combining the result with other complementary information, e.g.
derived from in vitro assays addressing other key events of the skin
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