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EC number: 821-749-7
CAS number: 154581-97-2
the results derived from the MTT assay were not unclear or borderline,
the IL-1 α concentration in the medium was not determined.
Results after treatment with the test item
Absor-bance 570 nmTissue 1*
Absor-bance 570 nmTissue 2*
Absor-bance 570 nmTissue 3*
Mean Absor-bance of 3 Tissues
Relative Absor-bance [%] Tissue 1, 2 + 3**
Relative Standard Deviation [%]***
Rel. Absor-bance[% of Negative Control]****
of two replicate wells after blank correction
absorbance per tissue [rounded values]: (100 x (absorbance tissue) ) /
mean absorbance negative control
Standard Deviation: (Standard Deviation / Mean Absorbance of 3 tissues )
absorbance per treatment group [rounded values]: (100 x (mean absorbance
test item)) / mean absorbance negative control
The possible skin irritation potential of the substance was tested in
compliance with OECD TG 439 and GLP principles. Each three tissues of
the human skin model EpiSkin™ were treated by topical application of 10
µl of the undiluted test item, the negative control (deionised water) or
the positive control (5% Sodium lauryl sulfate) for 15 minutes. After
about 42.25 hour post-exposure incubation period, determination of the
cell viability was performed. Cell viability is measured by
dehydrogenase conversion of MTT
[3-(4,5-dimethylthiazole-2-yl)-2,5-diphenyl-tetrazoliumbromide], in cell
mitochondria, into a blue formazan salt that is quantitatively measured
after extraction from tissues. The percent reduction of cell viability
in comparison of untreated negative controls is used to predict skin
irritation potential. The relative mean tissue viability obtained after
15 minutes treatment with the substance compared to the negative control
tissues was 59.6%. This value is above the threshold for irritancy of <=
50%. Therefore, the test item is not considered to be a skin irritant
under the conditions of this study. After treatment with the negative
control the absorbance values were well within the required
acceptability criterion of mean OD >= 0.6 till <= 1.5 (actual values
0.612-0.617), the mean relative tissue viability of the positive control
was <= 40% (4.3%) and the rel. standard
deviations in between tissues of the same treatment group were <= 18%
(below 13%) indicating that the test system functioned properly.
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