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EC number: 202-993-8
CAS number: 101-97-3
Test item concentration in µg/mL
Mitototic indices in % of control
aberrant cells in % excl. Gaps
Exposure period 4 h without S9-Mix
Exposure period 22 h without S9 Mix
Exposure period 4 h with S9 Mix
The test item, dissolved in DMSO, was
assessed for its potential to induce structural chromosomal aberrations
in human lymphocytes in vitro in three independent experiments. 150
metaphases were evaluated for structural chromosomal aberrations, except
for the positive control in Experiment II, in the absence of S9 mix,
where only 50 metaphases were evaluated.
The highest applied concentration in this
study (1642.0 µg/mL of the test item, approx. 10 mM) was chosen with
regard to the molecular weight of the test item and with respect to the
current OECD Guideline 473.
Dose selection of the cytogenetic experiment
was performed considering the toxicity data and the solubility of the
test item in accordance with the OECD Guideline 473. In Experiment I in
the absence and presence of S9 mix, in Experiment IIB in the absence of
S9 mix and in Experiment IIA in the presence of S9 mix, no cytotoxicity
was observed up to the highest applied concentration. In Experiment IIA
in the absence of S9 mix no cytotoxicity was observed up to the highest
evaluated concentration. Toxic effects, indicated by reduced mitotic
indices were observed at higher concentrations.
In Experiments I and IIB, neither a
statistically significant nor a biologically relevant increase in the
number of cells carrying structural chromosomal aberrations was observed
after treatment with the test item. Only in Experiment IIA a minor but
statistically significant increase was observed in the absence of S9 mix
following continuous treatment, therefore a confirmatory experiment with
closer concentrations was performed (reported as Exp. IIB).
No evidence of an increase in polyploid
metaphases was noticed after treatment with the test item as compared to
the control cultures. Appropriate mutagens were used as positive
controls. They induced statistically significant increases in cells with
structural chromosome aberrations. In conclusion, it can be stated that
under the experimental conditions reported, the test item did not induce
structural chromosomal aberrations in human lymphocytes in vitro.
Therefore, is considered to be
non-clastogenic in this chromosome aberration test, when tested up to
insoluble concentrations (phase separation) and in Experiment IIA up to
the highest evaluable concentration.
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