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EC number: -
CAS number: -
Table 7.3.2/1: Results after
treatment for 30 minutes
Absorbance (OD) of Tissue 1 and 2
Mean Absorbance (OD) Tissue 1 and 2
Mean Absorbance (OD)* Tissue 1 and 2 minus Mean Blank
Mean Absorbance (OD) of2 Tissues*
Rel. Aborbance [%] (Viability)Tissue 1 and 2**
Absolute value of the Difference of the Rel. Absorbances [%]Tissue 1 and 2
[% of Negative Control]** (Viability)
Concerning acceptance criteria:
• The negative control OD is > 1.0 and < 2.6
(1.568 and 1.653).
• The mean relative viability of the
positive control is below 60% of the negative control viability (6.9%).
•The difference of viability between the two
relating tissues of a single item is < 20% (values between 0.5% to 7.0%)
in the same run (for positive and negative control tissues and tissues
of single test items).
A study was performed to assess the
eye irritation potential of the test item by means of the Human Cornea
Model Test. The study was conducted according to the OECD guideline No.
492 and in compliance with GLP.
The test item did not prove to be an MTT
reducer in the MTT pre-test. Also its intrinsic colour was not intensive
and it did not prove to dye water or isopropanol in the colour
interference pre-test. Therefore, additional tests with freeze-killed or
viable tissues did not have to be performed.
Each 50 µL of the test item, the negative
control (deionised water) or the positive control (methyl acetate) were
applied to each of duplicate tissue.
After treatment with the negative control
the absorbance values were well within the required acceptability
• mean OD > 1.0 and < 2.6 (MatTek criterion)
• mean OD > 0.8 and < 2.5 (OECD criterion)
thus showing the quality of the tissues.
Treatment with the positive control induced
a decrease below 60% compared with the negative control value in the
relative absorbance thus ensuring the validity of the test system.
The difference of viability between the two
relating tissues of a single test item was < 20% in the same run (for
positive and negative control tissues and tissues of single test items).
Irritating effects were not observed
following incubation with the test item. Compared with the value of the
negative control the relative mean absorption value corresponding to the
viability of the tissues did not decrease below 60% (93.4%).
In conclusion, it can be stated that in this
study and under the experimental conditions reported, the test item does
not possess any eye irritating potential.
With a percentage of tissue viability > 60%,
the test item does not require classification and labelling according to
the Regulation (EC) No 1272/2008 (CLP) and to the GHS.
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