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For long-term toxicological studies, mizoribine at the dose of 2.5 mg/kg body weight was administered orally to two male and two female Beagle dogs for 36 consecutive months, once a day, 6 days a week, with a day-off on the 7th of each week. As a control group, 2 male and 2 female dogs were kept under the same conditions as the treated group. The above experiment resulted in no abnormal general symptoms being found in either group. In addition, body weight gain instead of weight loss was observed in both groups. Moreover, hematological and biological parameters were in the normal range, and no statistical difference was obtained between the two groups. An additional 10 mg/kg of mizoribine was administered once to both groups at the months of 6, 12, 18, 24, or 36 after the onset of this toxicological study so as to determine the pharmacokinetic behavior of serum mizoribine. This resulted in no significant difference being observed between the two groups. Therefore, it can be inferred that accumulation of mizoribine is not induced by its long-term repeated administration. In fertility study, the analysis of the sperm and the mating ability of a male dog with an appropriate healthy female dog revealed that mizoribine at this dose did not provoke any abnormalities in male gonadal functions.

journal of toxicological sciences

Long-term toxicological studies with mizoribine (Bredinin) in beagle dogs. The first report. Blood chemistries, pharmacokinetics of mizoribine and fertility studies of the male dogs.