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EC number: 208-589-8
CAS number: 534-15-6
The test item was considered to be non-corrosive to the skin.
According to OECD439 The test item was classified as non-irritant. The
following classification criteria apply:
EU CLP Not classified for Irritation.
UN GHS Not classified for Irritation (category 3 can not be determined).
No prediction of eye irritation can be made using for the test substance
Mean OD570 Values and Viabilities for the Negative Control Item,
Positive Control Item and Test Item
Mean OD570of individual tissues
Mean OD570of duplicate tissues
Relative mean % tissue viability = [mean OD570 of test item/ mean OD570
fo negative control] x 100
Coefficient of variation = [standard deviation/ mean OD570 of duplicate
tissues] x 100
OD = Optical density
* = The mean percentage viability of the negative control tissue is set
na = Not applicable
The purpose of this test is to evaluate the corrosivity potential of the
test item using the EpiDerm™ Human Skin Model after treatment periods of
3 and 60 minutes.
Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue.
Cytotoxicity is determined by the reduction of MTT
(3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to
formazan by viable cells in the test item treated tissues relative to
the corresponding negative control. The results are used to make a
prediction of the corrosivity potential of the test item.
Duplicate tissues were treated with the test item for exposure periods
of 3 and 60 minutes. Negative and positive control groups were treated
for each exposure period. At the end of the exposure period the test
item was rinsed from each tissue before each tissue was taken for
MTT-loading. After MTT loading each tissue was placed in 2 mL
Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed
thoroughly and triplicate 200 µL
samples were transferred to the appropriate wells of a pre-labeled
96-well plate. The optical density (OD) was measured at 570 nm (OD570).
Data are presented in the form of percentage viability (MTT reduction in
the test item treated
tissues relative to negative control tissues).
The relative mean viabilities for each treatment group were as follows:
*The mean viability of the negative control tissues is set at 100%
Quality criteria: The quality criteria required for acceptance of
results in the test were satisfied.
Based on the results of in-vitro skin irritation and skin corrosion
studies, the substance is not an irritating or corrosive to the skin.
The substance is therefore not classification according to EU CLP
regulation as a skin irritant or skin corrosive.
Based on the result of an in-vitro eye (BCOP) study no prediction of eye
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