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EC number: 232-190-8 | CAS number: 7789-79-9
All criteria for a valid test were met. Cyclophosphamide (CP) induced a significant increase in micronucleated PCEs (p<0.01) and a reduction in the PCEs/ECs ratio of 14.1 % and 13.4 % in female and male mice, respectively. In addition, the negative and positive control data were consistent with historical control data, indicating that the study was validly conducted.
The purpose of this study was to evaluate the clastogenic potential of the test item, as measured by its ability to induce micronuclei in the polychromatic erythrocytes (PCEs) in the bone marrow of ICR mice.
According to the result to mice in the range finding study, a two oral administration at 24 hours interval of the substance was conducted by oral gavages to 5 male mice and 5 female mice per group at 0 (vehicle control, corn oil), 250, 500, 1000 mg/kg bw. Five male mice and five female mice received a two abdominal injection dosage of 40 mg/kg of CP as positive control. The dose volume for all groups was 10 ml/kg. All mice were euthanized at approximately 24 hours following the final treatment. After euthanasia, bone marrow was collected from sternum, and smears were prepared and stained with Giemsa stain. 2000 PCEs per animal were examined microscopically for the presence of micronucleated PCEs. The proportion of PCEs to total erythrocytes (PCEs/ECs ratio) was also determined to evaluate the test article bone marrow toxicity.
Under the conditions of the assay described in this report, a two oral administration of the test item at all dose level, did not induce a significant increase in the incidence of micronucleated PCEs in the bone marrow of male and female ICR mice. Therefore, the substance was concluded to be negative in the in vivo mouse micronucleus assay.
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