[Toxicological studies on pepleomycin sulfate (NK631), IV. Chronic toxicity of pepleomycin sulfate in rats (author's transl)].

Studies on chronic toxicity and its recovery of pepleomycin sulfate (NK 631) were carried out in both sexes of rats. NK 631 was administered intraperitoneally in dose levels of 0.15, 0.3, 0.6, 1.2 and 2.4 mg/kg/day for 180 days. After finishing administration of NK 631 for 180 days, animals of each group were proceeded for 35 days recovery test. During the course of the experiment, the body weight gains were suppressed in all dose levels except for 0.15 mg/kg group of female. The deaths were found in all dose levels except for 0.15 mg/kg level of male during treatment and recovery periods. In biochemical and urinary findings, the increase of serum BUN, Mg, inorganic P. and urine glucose were slightly recognized in the animals treated with doses over 0.6 mg/kg. Additionally, in macroscopical and histopathological findings, bone damage and renal lesions were found in the animals treated with doses over 0.6 mg/kg during treatment and recovery periods. From these results, the maximum safety dose of NK 631 in chronic toxicity study using rats were estimated to be at less than 0.15 mg/kg.