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  • Title: [Toxicological studies on pepleomycin sulfate (NK 631) II. Subacute toxicity of pepleomycin sulfate in rats (author's transl)].
    Author: Tsubosaki M, Irie Y, Ito K, Handa J, Ezura H, Kumagai M, Irie Y, Suzuki A, Yamashita T, Miyamoto K, Matsuda A, Konoha N.
    Journal: Jpn J Antibiot; 1978 Dec; 31(12):738-65. PubMed ID: 83405.
    Abstract:
    Studies on subactute toxicity and its recovery of pepleomycin sulfate (NK631) were carried out in both sexes of rats. NK 631 was administered intraperitoneally in dose levels of 0.3, 0.9, 2.7. 8.1 and 24.3 mg/kg/day for 30 days. After finishing administration of NK 631 for 30 days, 5 animals of each group were proceeded to recovery test for 35 days. During the course of the experiment, the body weight gains were suppressed in all dose levels except in 0.3 mg/kg group of male rats. The deaths were found in the animals treated with doses over 24.3 mg/kg during treatment period and in those over 2.7 mg/kg during recovery period. In biochemical and urinary analysis, the increases of serum GPT, BUN, Mg, Ca and urine glucose were moderately recognized in 8.1 mg/kg group. Additionally, in macroscopical and histopathological findings, bone damage was found in the animals treated with doses over 2.7 mg/kg during treatment and recovery periods. From these results, the maximum safety dose of NK 631 in subacute toxicity using rats were estimated to be about 0.3 mg/kg.
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