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EC number: 619-496-0 | CAS number: 960404-59-5
- Clinical signs of toxicity in test animals:
Test article-related clinical observations noted in the 500 mg/kg/bw/day group included clear material around the mouth and/or on the ventral neck on study days 0 and 2, and yellow material on various body surfaces (hindlimb[s], ventral neck, anogenital area, and urogenital areas), and unkempt appearance on study days 1 and 2.
Test article-related clinical observations noted in the 250 mg/kg/bw/day group included clear material on the forelimb(s), ventral neck, and/or ventral trunk on study day 2. All other clinical findings in the test article-treated groups were noted with similar incidence in the vehicle control group, were limited to single animals, were not noted in a dose-related manner, and/or were common findings for laboratory mice of this age and strain.
- Test article-related effects on body weights were noted in the 500 mg/kg/bw/day group. Statistically significant mean body weight losses were noted in the 500 mg/kg/bw/day group from study days 0 to 2 compared to the vehicle control group. As a result, mean body weights were 9.5% and 9.8% lower than the vehicle control group on study days 2 and 3, respectively. There were no other test article-related effects on body weight.
- Test article-related effects on food consumption were noted in the 500 mg/kg/bw/day group. Lower mean food consumption values were noted in the 500 mg/kg/bw/day from study days 0 to 3 and correlated with body weight losses noted for this group. There were no other test article-related effects on food consumption.
In an in vivo Micronucleus test, male CD-1 mice were exposed once daily for 3 consecutive days to 125, 250 and 500 mg/kg/bw/day of BMS-587319-03 (suspended in arachis oil (peanut oil)) according to OECD 474 guideline and GLP principles.
The test substance did not produce a statistically significant increase in the percent mean number of micronucleated polychromatic erythrocytes (%MN-PCEs) compared to the vehicle control group. No bone marrow cytotoxicity was noted in any male mice at any test substance dosage level. Reliable negative and positive controls were included.
Based on the results, it is concluded that BMS-587319-03 is not clastogenic under the conditions of the Micronucleus test.
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