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EC number: 814-308-5
CAS number: 63286-42-0
Table 1. Mean absorption and tissue viability in the in
vitro skin corrosion test with the test item
Values are corrected for background absorption (0.0433).
Isopropanol was used to measure the background absorption.
SD = Standard deviation
Duplicate exposures are indicated by A and B.
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
The study was performed to OECD TG 431 and EU Method B.40
BIS to assess the skin corrosion potential of the test item in
accordance with GLP using a human three dimensional epidermal model
(EpiDerm (EPI-200)). The test was performed on a total of 4 tissues per
test item together with a negative control and positive control. Two
tissues were used for a 3-minute exposure to the test item and two for a
1-hour exposure. 50 μl of the undiluted test item was added (with a
pipette) into the 6-well plates on top of the skin tissues. The
remaining tissues were treated with 50 μl Milli-Q water (negative
control) and with 50 μl 8N KOH (positive control), respectively. The
positive control had a mean relative tissue viability of 7.6% after 1
hour exposure. The absolute mean OD570 (optical density at 570 nm) of
the negative control tissues was within the laboratory historical
control data range. In the range of viability 20 - 100% the Coefficient
of Variation between tissue replicates was less than 11%, indicating
that the test system functioned properly. Skin corrosion is expressed as
the remaining cell viability after exposure to the test item. The
relative mean tissue viability obtained after 3-minute and 1-hour
treatments with the test item compared to the negative control tissues
was 112% and 103%, respectively. Because the mean relative tissue
viability for the test item was not below 50% after the 3-minute
treatment and not below 15% after the 1-hour treatment the test item is
considered to be not corrosive. Under the conditions of this study, the
test item is not corrosive in the in vitro skin corrosion test.
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