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EC number: 254-996-9
CAS number: 40601-76-1
The test material was subjected to a micronucleus assay in mice to
detect potential chromosome breaking activity according to the method of
In the assay, 6 animals of each sex were included in each treatment
group and 8 animals of each sex in the negative control group (5 animals
in the treated groups and 8 animals in the control group were used for
Each mouse was medicated per gavage once daily on two consecutive days
with the vehicle used for the test material (negative control), with
cyclophosphamide at a concentration of 50 mg/kg bw (positive control) or
with the test material at one of three dose levels (200, 1000 or 5000
mg/kg bw). The test material and the controls were administered in a
standard volume of 20 ml/kg bw. This treatment schedule was selected to
expose a high proportion of the cell population to the test material
during two successive S-phases of the cell cycle.
24 Hours after the second treatment (48 hours after the first
treatment), the mice were sacrificed and bone marrow was removed from
the femora and prepared on slides for examination. One thousand
polychromatic erythrocytes (PCE) as well as one thousand normochromatic
erythrocytes (NCE) were scored. The ratio of PCE to NCE based on 1500
cells (PCE + NCE) counted per animal was used as a measure of the toxic
efficacy of the test material.
After treatment of the mice with the test material, no substance-related
increase of micronucleated erythrocytes was observed at any dose level
tested in comparison with the negative control group. No toxic effects
of the test material were observed. As expected, the positive controlg
roup showed a significant increase in the number of micronucleated
erythrocytes in comparison with the negative control group.
In conclusion, it can be stated that during this mouse micronucleus
assay with the test material no chromosome-breaking activity or damage
to the mitotic apparatus could be detected under the experimental
conditions reported and thus no evidence of any potential chromosome
mutagenic activity was demonstrable.
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