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EC number: 204-649-2
CAS number: 123-76-2
The test item was assayed for the ability
to induce chromosomal damage in cultured human lymphocytes, following in
vitro treatment in the absence and presence of S9 metabolic activation,
according to OECD guideline 473. Three treatment series were included in
the study. A short term treatment was performed where the cells were
treated for 3 hours in the presence and absence of S9 metabolism. The
harvest time of 24 hours corresponding to approximately 1.5 cell cycle
was used. A long term(continuous) treatment was also performed, only in
the absence of S9 metabolism, until harvest at 24 hours. Solutions of
the test item were prepared in dimethylsulfoxide (DMSO).
Dose levels of 1160, 580, 290, 145, 72.5,
36.3, 18.2, and 9.08 µg/mL) were used for all treatment series.
Appropriate negative and positive control were included. Two replicate
cell cultures were prepared at each test point. For all treatment
series, dose levels were selected for the scoring of chromosomal
aberrations on the basis of the cytotoxicity of the test item treatments
(as determined by the reduction in mitotic index). Where no toxicity was
observed, the highest dose level was selected for scoring chromosomal
Dose levels selected for scoring were as
10.0, 5.00 and 2.50 with and without S9 in
case of 3 h treatment and
5.00, 1.25 and 0.313 without S9 in case of
24 h treatment.
For each replicate culture, 150 well
spread metaphases were scored to assess the frequency of aberrant cells.
Following treatment with the test item, no
statistically significant increase in the incidence of cells bearing
aberrations, including or excluding gaps, was observed at any dose level
and treatment condition. It is concluded that the substance does not
induce chromosomal aberrations in human lymphocytes after in vitro
treatment, under the reported experimental conditions.
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