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EC number: 701-290-8 | CAS number: -
One hundred male rats (Sprague-Dawley), 10-12 weeks old, were randomly assigned to five groups of 20 males each. Following a period of acclimation each group was randomly assigned one of the following treatments: 20, 200 or 2000 mg/kg sucrose acetate isobutyrate (experimental groups), 25 mg/kg Apholate (positive control) or corn oil only (negative control). All treatments were administered by gavage as a single dose in corn oil. Within two hours after treatment, the males were mated with two untreated, virgin females for the following week. Subsequent matings using naive females were conducted during the third, fifth and seventh weeks after treatment. Mating during these weeks represent samples of post meiotic, meiotic and pre-meiotic stages of spermatogenesis, respectively. Twelve to fourteen days from the mid-week of their caging and presumptive mating all females were sacrificed with an overdose of ether. The uteri were exposed and the total implantation sites were counted and categorized as comprising viable fetuses, early deaths or late deaths. The major statistics of interest in the dominant lethal assay are pregnancy rate, early deaths per pregnancy and mean total implantations, and an increase in early fetal deaths per pregnancy is a direct and unequivocal measure of dominant lethal mutations. In this study, the only increases in early fetal deaths per pregnancy were observed, as expected, in the positive control group. Therefore, it is concluded that quantities of sucrose acetate isobutyrate ranging from the proposed use level to 100 times this level; administered orally in single doses did not cause dominant lethal mutations in rats.
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