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EC number: 240-521-2
CAS number: 16470-24-9
The test article was assessed for its
potential to induce structural chromosome aberrations in V79 cells of
the Chinese hamster in vitro in the absence and presence of metabolic
activation by S9 mix.
Preparation of chromosomes was done 7 h
(high dose), 18 h (low, medium and high dose) and 28 h (high dose) after
start of the treatment with the test article. The treatment interval was
4 h. In each experimental group two parallel cultures were used. Per
culture 100 metaphases were scored for
structural chromosome aberrations.
The following dose levels were evaluated:
Experiment I both with and without S9 mix:
7 h: 1.0 mg/ml
18 h: 0.3; 2.0; 5.0 mg/ml
28 h: 5.0 mg/ml
Experiment II with S9 mix:
7 h: 5.0 mg/ml
In the pre-experiment on toxicity (colony
forming ability) in the absence and presence of S9 mix the colony
forming ability was reduced with 1.0 mg/ml and higher (without S9 mix)
and 3.0 mg/ml and higher (with S9 mix). Higher concentrations than 5.0
mg/ml were not applied.
Also, in the cytogenetic experiments the
mitotic index was reduced at least after treatment with the highest dose
level at fixation intervals 7 and 18 h (in the absence of S9 mix) and 28
h (in the absence and presence of S9 mix).
In the rirst experiment in the absence of
S9 mix the test article did not increase the frequency of cells with
aberrations at any fixation interval. At fixation interval 7 h, in one
test group (1.0 mg/ml) the statistical analysis revealed a significant
result. This effect was due to the randomly extremely low control rate.
As the aberration rate of the test group is near to the control range of
this study and within our historical control data the statistical result
is not regarded as biologically relevant.
In the presence of S9 mix, at fixation
interval 7 h the aberration rate was distinctly increased after
treatment with 5.0 mg/ml as compared to the corresponding· solvent
control. This result could not be confirmed. In addition, the metaphase
quality was relatively poor so that an accurate scoring was partially
inhibited. Similar observations were made on the slides treated with
lower dose levels on which not enough scorable cells could be found.
A second experiment was performed to
clarify the effects observed in the first experiment. In this experiment
II, there was no incidence of an increased aberration rate after
treatment with 5.0 mq/ml. On both slides enough scorable cells with good
spreading quality could be scored.
Therefore, the finding observed in
experiment I is not regarded as biologically relevant. At fixation
intervals 18 and 28 the aberration rates were not biologically
relevantly increased as compared to the solvent controls.
In the occurence of polyploid metaphases
evaluation no relevant deviation from the control data was found after
treatment with the test article.
In conclusion, it can be stated that in
the described study and under the experimental conditions reported, the
test article did not induce structural chromosome aberrations in the V79
Chinese Hamster cell line.
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