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EC number: -
CAS number: -
the test item and the positive control, the mean relative viability ±rel.
standard deviation of the three individual tissues was calculated and
used for classification according to the following prediction model:
mean tissue viability <50%
the current test, an irritation potential leading to H315 classification
of EU according to regulation (EC) 1272/2008, and GHS category 2
according to UN GHS (published 2003, last (7th revision
2017) is recommended if the mean relative tissue viability of three
individual tissues is reduced to<50%
of the negative control. After
treatment with the test item the mean relative absorbance value was
reduced to 60.13%.This
value is above the threshold for irritancy of ≤ 50%. Therefore, the test
item is not considered to possess an irritant potential.
The in vitro skin irritation potential of
the test substance as assessed a Human Skin Model Test design to meet
the following guideline:
Three tissues of the human skin model
EpiSkin™ were treated with the test item, a negative control (PBS) or a
positive control (5% sodium lauryl sulfate) for 15 minutes at 37 ± 1.5
°C, 5 ± 0.5% CO2. Tissues were then washed to remove test material and
following a further 42 hours post exposure incubation an MTT assay was
run on the tissue samples to assess tissue viability were included.
The test item reduced MTT (pre-test for
direct MTT reduction); however, it did not dye water, when mixed with it
(pre-test for colour interference). Due to MTT reduction additional
tests with freeze-killed tissues were necessary.
The negative and positive control absorbance
values were well within the required acceptability criterion thus
showing the quality and validity of the test system.
Following treatment with the test item the
mean relative absorbance value decreased to 60.13%. This value is above
the threshold for irritancy of ≤ 50%. Therefore, the test item is not
considered to possess an irritant potential.
In conclusion, it can be stated that in this
study and under the experimental conditions reported the test substance
is not irritant to skin according to UN GHS and the EU CLP regulation.
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