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EC number: 692-614-6
CAS number: 5660-53-7
7.6.2/1: Results of micronucleus assay
Test item 2000 mg/kg bw/day
Cyclophosphamide 50 mg/kg bw
In an in
vivo bone marrow micronucleus assay performed according to OECD
Guideline 474 and in compliance with GLP, Swiss male mice (6/group) were
distilled water by intraperitoneal injections at the dose level of 2000
mg/kg bw/day with 2 consecutive treatments at 24 h interval. The vehicle
and positive control groups (6 animals/group) received distilled water
and cyclophosphamide at 50 mg/kg bw, respectively. Bone marrow smears
were obtained from treatment, vehicle and positive control groups
approximately 24 h after last administration. Polychromatic (PCE) and
normochromatic (NCE) erythrocyte ratio was established by scoring a
total of 1500 erythrocytes. For each animal, the micronuclei were
counted in 3000 polychromatic erythrocytes. A preliminary toxicity study
on two animals was conducted before the main study at the dose of 2000
mg/kg bw/day for two consecutive days and was confirmed on three other
animals treated with the test item were compared to the concurrent
negative control group, a lower number of micronucleated PCE was
observed in the treated group. For this reason, statistical analysis by
chi-square test was not necessary for comparison between negative
control and experimental group. Positive control induced a statistically
significant increase in micronucleated polychromatic erythrocytes
indicating the validity of the study.
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