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EC number: 227-876-9
CAS number: 6021-61-0
The study was performed to investigate the
potential of test item to induce micronuclei in polychromatic
erythrocytes (PCE) in the bone marrow of the mouse. The test article was
formulated in polyethylene glycol 400 (PEG 400). PEG 400 was used as
vehicle control. The volume administered orally (gavage) was 10 ml/kg
b.w.. 24 h and 48 h after a single administration of the test article
the bone marrow cells were collected for micronuclei analysis. Ten
animals (5 males, 5 females) per test group were evaluated for the
occurrence of micronuclei. At least 2000 polychromatic erythrocytes
(PCE) per animal were scored for micronuclei.
To describe a cytotoxic effect due to the
treatment with the test article the ratio between polychromatic and
normochromatic erythrocytes (NCE) was determined in the same sample and
reported as the number of NCE per 2000 PCE.
The following dose levels of the test
article were investigated: at 24 h preparation interval 200, 670 and
2000 mg/kg b.w.; at 48 h preparation interval 2000 mg/kg b.w..
The highest guideline-recommended dose
(2000 mg/kg) was estimated by a pre-experiment to be suitable. The
animals expressed slight toxic reactions. After treatment with the test
article the mean number of NCEs was increased as compared to the
corresponding vehicle controls thus indicating that test item had
In comparison to the corresponding vehicle
controls there was no statistically significant or biologically relevant
enhancement in the frequency of the detected micronuclei at any
preparation interval after administration of the test article and with
any dose level used.
40 mg/kg b.w. cyclophosphamide
administered per os was used as positive control which showed a
statistically significant increase of induced micronucleus frequency.
In conclusion, it can be stated that
during the study described and under the experimental conditions
reported, the test article did not induce micronuclei as determined by
the micronucleus test with bone marrow cells of the mouse.
Therefore, the substance is considered to
be non-mutagenic in the micronucleus assay.
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