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EC number: 700-957-0
CAS number: 1141852-17-6
- Gene mutation in bacteria
The bacterial gene mutation assay (Ames test) was conducted in
compliance with OECD guideline 471 and under GLP conditions (Sokolowski,
2010). The assay was performed in two independent experiments both
performed in the absence and in the presence of liver microsomal
activation system (S9 mix). In the first experiment (pre-experiment),
the direct plate incorporation procedure was conducted with the
Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and
the Escherichia coli strain WP2 uvrA at concentrations ranging from 3 to
5000 µg/plate for a period of 48 h. In the second experiment,
concentrations ranging from 33 to 5000 µg/plate were analysed using the
same strains, but with modification of the study design (with
pre-incubation period of 60 min). No signs of cytotoxicity, evident as a
reduction in the number of revertants, were observed in both
experiments. Precipitation of the test substance occurred at doses ≥
2500 µg/plate, but did not influence data evaluation. The number of
revertants was not increased at any concentrations tested. The positive
and negative controls included showed the expected results in each
experiment. Under the experimental conditions reported, the test
substance did not induce mutations in the bacterial mutation assay in
the absence and presence of metabolic activation in the selected strains
of S. typhimurium (TA 98, TA 100, TA 1535 and TA 1537) and E. coli WP2
- Chromosome aberrations
The test substance Y-15866 was assayed in an in vitro mammalian
chromosome aberration test conducted in accordance with GLP and similar
to OECD guideline 473 (Hall, 2010). In two independent experiments, V79
Chinese hamster cells were treated with the test substance at
concentrations up to 6950 µg/mL, with and without metabolic activation
system (S9 mix). In the first experiment, continuous treatment with the
test substance for 4 h followed by a 14 h-recovery period was performed.
Since no clear cytotoxicity indicated by reduced mitotic indices or
reduced cell numbers was observed up to the highest concentration, 6950
µg/mL was chosen as top treatment concentration in Experiment II. In
this experiment, cells were analogously treated with the test substance
in the presence of S9 (4 h + 14 h recovery period). In the absence of
S9, cells were continuously treated for a period of 18 h without
recovery period. Since no dose-response relationship was observed for
cytotoxic effects in both experiments, concentrations used for
evaluation of chromosome aberrations were selected based on the highest
non-cytotoxic concentration tested. Thus, concentrations chosen for
chromosome analysis ranged from 156.3 to 6950 µg/mL in Experiment I and
39.1 to 6950 µg/mL in Experiment II. In both experiments, no
biologically relevant increase in the number of cells carrying
structural chromosome aberrations was observed after treatment with the
test substance in the absence and presence of S9 mix. The positive
control substances yielded the expected results. Under the conditions of
this chromosome aberration assay, it was concluded that Y-15866 did not
show clastogenic activity in V79 Chinese hamster cells.
The available data on genetic toxicity of Y-15866 are conclusive
but not sufficient for classification according to the CLP
(1272/2008/EC) and DSD (67/548/EEC) criteria.
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