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EC number: 203-214-4
CAS number: 104-57-4
Table 1: Results after treatment with the
test item and the controls
of 3 Tissues
Rel. Absor-bance [%] Tissue 1, 2 + 3**
Relative standard deviation
* Mean of three replicate wells after blank
** relative absorbance per tissue [rounded values]: (100x(absorbance
tissue))/ mean absorbance negative control
*** relative absorbance per treatment group [rounded values]: (100x(mean
absorbance test item/positive control))/ mean absorbance negative control
in vitro study was performed to assess the irritation potential of the
test item by means of the Human Skin Model Test. The test item did not
reduce MTT (test for direct MTT reduction), and it did not change colour
when mixed with deionised water (test for colour interference). Also its
intrinsic colour was not intensive. Consequently, additional tests with
freeze-killed or viable tissues were not necessary. Each
three tissues of the human skin model EpiDermTM were treated with the
test item, the negative or the positive control for 60 minutes. 30
of the test item were applied to each tissue, and spread to match the
surface of the tissue. 30 μL
of either the negative control (DPBS) or the positive control (5 % SLS)
were applied to each tissue. After treatment with the negative control
the absorbance values were well in the required range of the
acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes
treatment interval, thus assuring the quality of the tissues. Treatment
with the positive control induced a sufficient decrease in the relative
absorbance as compared to the negative control for the 60 minutes
treatment interval, and thus assuring the validity of the test system.
treatment with the test item the mean relative absorbance value
decreased to 29.6 % compared to the relative absorbance value of the
negative control. This value is below the threshold for irritancy of ≤
50 %. Therefore, the test item is considered to possess an irritant
conclusion, it can be stated that in this study and under the
experimental conditions reported, the substance is irritating to skin.
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