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EC number: 442-390-9 | CAS number: -
The potential clastogenicity of the test article was evaluated in the micronucleus test. The study was conducted according to OECD GLP (1997), US FDA GLP, and US EPA GLP regulations. The test method was based on EEC Directive 2000/32/EC, Part B.12 (June 8, 2000) and OECD Guideline 474 (July 21, 1997). The test material was administered as received. Five male rats per group were administered Milli-Q water (negative control), 50 mg/kg cyclophosphamide (CP, positive control) or the test article at 2000 (two group) mg/kg via oral intubation. Bone marrow was harvested at 24 hours (one test article group and negative control) and 48 hours (one test article group and positive control) after dosing. All animals were normal immediately after dose administration. The incidence of micronucleated polychromatic erythrocytes in the bone marrow of negative control animals was within the historical range and CP (positive control) induced a significant increase in the number of micronucleated polychromatic erythrocytes indicating that the assay was valid. No increase in the mean frequency of micronucleated polychromatic erythrocytes was observed in the bone marrow of animals treated with the test article. Animals treated with the test article showed no decrease in the ratio of polychromatic to normochromatic erythrocytes compared with the negative controls which indicated there was no toxic effect on the erythropoiesis. Based on the results of this test, the test article is not clastogenic.
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