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EC number: 204-649-2
CAS number: 123-76-2
In a first step, the test item was assayed
for the ability of reducing MTT per se. No colour change and absence of
particle in suspension were noticed in the MTT solution at the end of
the incubation period, indicating that the test item could not direct
interact with MTT. In a second step, the test item was assayed for the
ability of colouring water per se. No colour change was noticed;
spectral analysis of the test item in water, to evaluate the ability of
the test chemical to absorb light at 595 nm, was performed. The value
obtained for the Optical Density (OD) was 0.069, indicating that the
test item does not have a potential interfering ability. Based on these
results, no additional controls were added in the Main Assay.
In the main assay, the mean Optical
Density of Blank Controls was 0.0, lower than the maximum acceptable
value (0.1). The negative control gave the expected baseline value
(Optical Density values of the three replicates higher or equal to 0.6)
and variability (Standard Deviation of the % viability lower or equal to
18), in agreement with guideline indications. According to the method,
the mean value is considered the baseline value of the experiment and
thus represents 100 % of cell viability. Positive control results
indicated an appropriate cell death with an acceptable relative cell
viability (4% of the negative control value). Variability between
replicates gave also the expected value (SD of % viability = 1.9). Based
on the stated criteria, mean viability, expressed as percentage of the
negative control, lower or equal to 40 % and standard deviation of %
viability equal or lower than 18, the study was accepted as valid. The
mean cell viability of the test itme was 62 %, when compared to the
negative control. Acceptable intra-replicate variability was obtained
(SD of % viability = 1.7 lower than 18).
The potential of the test item to be
irritant to the skin was investigated through an in vitro skin
irritation study, using a commercial reconstructed human epidermis (RhE)
model named EPISKIN™. The study was performed according to the OECD
Guideline 439. The test item, as well as controls, were tested for their
ability to impair cell viability after an exposure period of 15 minutes
followed by a 42 ± 1 hour recovery period. The final endpoint of the
assay is the colorimetric measurement of MTT reduction (blue formazan
salt) in the test system being this reaction an index of cell viability.
Before the main assay, the substance was tested for its direct MTT
reduction potential and for its ability of colouring water per se.
The blank, negative and positive controls
gave acceptable results and the study was accepted as valid. After
appropriate subtraction, the mean cell viability of the test item
treated tissues was 62 %. Based on the tissue viability obtained, the
substance is not considered to be a skin irritant.
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