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EC number: 807-159-2
CAS number: 69701-99-1
Results after treatment with MEDOL-10 and the
Absor-banceWell 1(Tissue 1/2)
Absor-banceWell 2 (Tissue 1/2)
Absor-banceWell 3 (Tissue 1/2)
Mean Absor-bance (Tissue 1/2)
Mean Ab-sorbance (OD) of 3 Wells minus Blank
Mean Ab-sorbance (OD) of 2 Tissues
Absor-bance [% of Negative Control]*
Rel. Absor-bance [% of Negative Control]*
absorbance [rounded values]:
The optical pre-experiment (colour interference pre-experiment) to
investigate the test item’s colour change potential in water did not led
to a change in colour.
Optical evaluation of the MTT-reducing capacity of the test item after 1
hour incubation with MTT-reagent did not show blue colour.
The test item is considered to be non-corrosive to skin:
• since the viability after 3 minutes exposure is greater than 50%
• the viability after 1 hour exposure is greater than 15%
The acceptance criteria are met:
• the mean OD of the tissue replicates treated with the negative
control is ≥ 0.8 and ≤ 2.8 for every exposure time (range: 1.412 to
• the mean viability of the tissue replicates treated with the
positive control for 1 hour, is <15% compared to the negative control
• the Coefficient of Variation (CV) in the range 20 – 100%
viability between tissue replicates is ≤ 30% (range: 1.0% to 9.8%)
This in vitro study was performed to assess the
corrosive potential of MEDOL-10 by means of the Human
Skin Model Test with EpiDerm™ tissues models.
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).
Consequently, additional tests with freeze-killed or
viable tissues to determine correction factors for
calculating the true viability in the main experiment
were not necessary.
Independent duplicate tissues of EpiDerm™ were exposed
to either the test item, the negative control
(deionised water) or the positive control (8.0 N KOH)
for 3 minutes and 1 hour, respectively.
After exposure to the negative control the absorbance
values met the required acceptability criterion of a
mean OD570 ≥ 0.8 and ≤ 2.8 for both treatment
intervals thereby confirming the acceptable quality of
Exposure to the positive control induced a decrease in
the relative absorbance as compared to the negative
control, both for the 3 minutes exposure period and
for the 1 hour exposure period. The 1 hour exposure
caused a decrease of the cell viability < 15% of the
negative control. The CV in the range 20 – 100%
viability between the tissue replicates is ≤ 30%, thus
the validity of the test system and the specific batch
of the tissue models is confirmed.
After exposure of the tissues to the test item the
relative absorbance value did not decrease (100.9%)
after 3 minutes exposure. After 1 hour exposure the
relative absorbance value was reduced to 81.1%. Both
values did not affect the threshold for corrosivity
which is defined to be 50% after the 3 minutes
exposure and 15% after the 1 hour exposure. Therefore,
the test item is not considered to be corrosive.
In conclusion, it can be stated that in this study and
under the reported experimental conditions, the test
item MEDOL-10 is non corrosive to skin according to EU
CLP and UN GHS.
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