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EC number: 442-390-9
CAS number: 40573-09-9
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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