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EC number: 202-903-7
CAS number: 100-94-7
Table 2: Individual and mean OD570 values, individual and mean viability
values, standard deviations and coefficients of variation
Test substance identification
[% of NC]
Table 3: Historic control data of NC and PC of skin irritation test
Historic Range of NC
Mean + 2 SD
Mean – 2 SD
Jan 2017 – Mar 2019
Historic Range of PC
Relative Viability [%]
The objective of the study was to assess the skin irritation and
corrosion potential of the test substance. Using the methods currently
available, a single in vitro assay is not sufficient to cover the full
range of skin irritating/corrosion potential. Therefore, two in vitro
assays were part of this in vitro skin irritation and corrosion test
strategy: The Skin Corrosion Test (SCT) and Skin Irritation Test (SIT).
However, in the current case the results derived with SIT alone were
sufficient for a final assessment. Therefore, further testing in SCT was
The potential of the test substance to cause dermal irritation was
assessed by a single topical application of ca. 25 μL bulk volume (about
19 mg) undiluted ground test substance to a reconstructed
three-dimensional human epidermis model (EpiDerm™). Before application
the epidermis surface was moistend with 25 μL sterile PBS. Thereafter,
the solid ground test material was applied directly onto the tissue
surface and distributed together with the fluid, so that the surface of
the epidermis model was uniformly and completely covered.
The Skin Irritation Test was performed with three EpiDerm™ tissues,
which were incubated with the test substance for 1 hour followed by a
42-hour post-incubation period. In addition to the test substance, 30 μL
/ tissue of a negative control (PBS) and a positive control (5% SDS)
were applied to three tissues each.
Tissue destruction was determined by measuring the metabolic activity of
the tissue after exposure/post-incubation by using a colorimetric test.
The reduction of mitochondrial dehydrogenase activity measured by
reduced formazan production after incubation with a tetrazolium salt
(MTT) was chosen as endpoint. The formazan production of the epidermal
tissues treated with the test substance is compared to that of negative
control tissues. The quotient of the values indicates the relative
The following results were obtained in the EpiDerm™ Skin Irritation Test
The test substance is not able to reduce MTT directly, which was
demonstrated in a pretest. Therefore, an additional MTT reduction
control KC (freeze-killed control tissues) was not introduced.
The relative mean viability of the tissues treated with the test
substance determined after an exposure period of 1 hour with an about
42-hour post-incubation was 89%.
Application of the positive control 5% SDS showed a relative mean
viability of the tissues of 3.6% and reflects the expected sensitivity
of the tissues. The mean OD570 of the negative control (PBS) fulfill the
acceptance criteria and demonstrate the validity of the assay.
Based on the results observed and by applying the evaluation criteria,
it was concluded that the test substance does not show a skin irritation
potential in the EpiDerm™ in vitro skin irritation and corrosion test
strategy under the test conditions chosen.
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