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EC number: 220-562-2
CAS number: 2814-77-9
with data on study results is attached (PigmentRed4_CometAssay_result
RED 2GC was assayed in an in vivo alkaline comet (single cell gel
electrophoresis) assay for the detection of DNA strand breaks in cells
or nuclei isolated from liver, glandular stomach, duodenum and testis
tissue of male CD rats, as well as ovary tissue from female CD rats. The
test item was administered orally to rats once daily for three days at
0, 24 and 45 hours, and the tissues were sampled at 48 hours (3 hours
after the last dose).
RED 2GC was suspended in 0.8% aqueous hydroxypropylmethylcellulose. The
dose levels for the main study had been selected based on the result of
a preliminary Limit test of 2000 mg/kg b.w./day, p.o employing two
animals per dose. No signs of systemic toxicity were noted.
ascending dose levels of 400, 1000 or 2000 mg VERSAL RED 2GC/kg
b.w./day, p.o. and the vehicle (0.8% aqueous
hydroxypropylmethylcellulose) were administered three times at 0, 24 and
45 hours. The positive reference item (125 mg ethyl methane sulfonate/kg
b.w./day, p.o.) was administered two times at 24 and 45 hours. Each
group consisted of 5 male and 5 female rats. The administration volume
was 20 mL/kg b.w./day. The test was divided in 4 different preparation
groups containing one or two animals of each group which were tested in
parallel at each stage of the experiment.
signs of systemic toxicity were noted up to the highest dose level of
2000 mg VERSAL RED 2GC/kg b.w./day, p.o.
cells of liver, glandular stomach, duodenum and testis (males) or
ovaries (females) per animal and tissue collected 48 hours post 1st
administration were evaluated. The grade of DNA fragmentation is
expressed in percent tail DNA (% tail intensity).
with VERSAL RED 2GC did not cause any test item-related increase in the
tail intensity for the cells of liver, glandular stomach, duodenum and
testis (all males) or ovaries (females) at any of the three tested dose
levels of 400, 1000 and 2000 mg test item/kg b.w./day compared to the
vehicle control data.
group mean values of the median tail intensities of the test item
treatment groups were between 6.325% and 7.83%, 9.58% and 11.806% or
11.554% and 12.856% for liver, stomach and duodenum cells, respectively.
The corresponding values for vehicle control were 4.726%, 8.152% or
12.554% for liver, stomach and duodenum cells, respectively. The mean
values of the median tail intensity were between 5.341% and 6.220% or
1.082% and 1.681% for the cells of testis and ovaries, respectively. The
corresponding values for vehicle control were 5.326% or 1.782% for the
cells of testis and ovaries, respectively.
values obtained were within the upper limits of the historical control
data, except for the vehicle control group of stomach cells and test
item treatment groups of liver and stomach cells which were slightly
above the background data. As the slightly higher data are no extreme
outliers, were within published historical control data and older rats
at an age of 9 – 12 weeks were used, to assure maternity of the animals
for evaluation of testis and ovary cells, the results are considered
acceptable for the inclusion into the historical control data and the
test is considered valid.
of ethyl methane sulfonate (positive reference) significantly increased
the % tail intensity for the cells of liver, glandular stomach, duodenum
and testis (all males) or ovaries (females).
values were well within the historical background data, except the
positive control for the stomach and duodenum cells which were above the
historical background data. As the positive control is significantly
increased, the data are considered acceptable for the inclusion into the
historical control data and the test is considered valid.
conclusion, under the present test conditions VERSAL RED 2GC tested up
to the highest reasonable dose level of 2000 mg/kg b.w. per day by
repeated oral administration to male and female rats for three days
showed no genotoxic properties in the in vivo alkaline comet (single
cell gel electrophoresis) assay employing cells of the liver, glandular
stomach, duodenum and testis (males) or ovaries (females).
the same system, ethyl methane sulfonate (positive reference item)
induced significant damage.
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