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Methyl CCNU (urea, 1-(2-chloroethyl)-3-(4-methyl cyclohexyl)-1-nitroso), a compound with marked antitumor activity, was submitted to a preclinical pharmacological evaluation. The six dogs infused intravenously with 9.36, 6.25, 3.12, or 1.56 mg/kg survived. Treatment with 9.36 or 6.25 mg/kg caused transient neutropenia. Two of the three dogs treated with 9.36 mg/kg exhibited delayed reversible blood chemical changes on day 51, including a reversible elevation of serum glutamic oxaloacetic transaminase with maximal values of 87 and 57 RFU. The necropsies on day 364 to 368, revealed no histopathological lesions. The present observations agreed with previous findings that dogs surviving a single intravenous infusion of Methyl CCNU exhibited no irreversible toxicity, whereas monkeys, in earlier experiments, developed irreversible delayed and progressive renal lesions.