Toxicity Sutdies on Nsc 109229, L-Asparaginase, Merck, Sharpe and Dohme, Lot No. 0965-Hsl-2-006, Following Daily I.V. Administration to Rhesus Monkeys
(Englisch)
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Toxicity studies were carried out on this lot of L-Asparaginase following intravenous administration to single Rhesus monkeys at dose levels of 500 and 350 I.U./kg, B.I.D. x 5. This dose regimen resulted in hepatotoxicity as indicated by BSP retention and fatty liver both on gross and microscopic examination. In the animal treated with 500 I.U./kg, the BSP was normal on the day of sacrifice whereas no reversal was noted in the animal treated with 350 I.U./kg. Both dose regimens resulted in loss of weight associated with a decrease in food consumption and the emaciation was more marked in the animal treated with the higher dose. Neither dose level was pyrogenic when rectal temperatures were followed serially following the first dose of the enzyme. A slight decrease in WBC was noted on the last day of treatment and three days post treatment in the animal treated with the higher dose but only on the last day of treatment in the animal treated with the lower dose. Reversal of these parameters occurred in both animals. Drug treatment at both dose levels resulted in a decrease in cholesterol with a return to original levels in the animal treated with the lower dose. In both animals there was a decrease in total protein and globulin which was noted on the higher dose animal at the end of the treatment period and on the lower dose animal three days post treatment. (Author)