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EC number: 228-726-5 | CAS number: 6337-43-5
The test item was assessed in the micronucleus assay for its potential to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse.
The test item was formulated in corn oil, which was also used as vehicle control. The volume administered orally was 10 mL/kg bw. 24 and 48 h after a signle administration of the test item the bone marrow cells were collected for micronuclei analysis.
Ten animals (5 males and 5 females) per test group were evaluated for the occurrence of micronuclei. At least 2000 PCE per animal were scored for micronuclei.
To describe a cytotoxic effect due to the treatment with the test item the ratio between polychromatic and normochromatic erytthrycytes was determined in the same sample and reported as the number of PCEs per 2000 erythrocytes.
The following dose levels of the test item were investigated:
24 h preparation interval: 500, 1000 and 2000 mg/kg bw
48 h preparation interval: 2000 mg/kg bw
As estimated by a pre-experiment 2000 mg/kg bw was suitable.
The mean number of PCE was not decreased after treatment with the test item as compared to the mean value of PCEs of the vehicle control indicatingf that the test item did not have any cytotoxic properties in the bone marrow.
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 and dose level after treatment with the test item. The mean values of micronuclei observed after treatment were below or near to the value of the vehicle control group.
40 mg/kg be cyclophosphmide administered orally 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 experimetal conditions reported, the test item did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse.
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