IN-VIVO MUTAGENICITY STUDIES WITH IODINATED GLYCEROL AZEO

Previous studies have shown that iodinated glycerol azeo is positive i n a number of in vitro mutagenicity assays including the Ames assay (T A100; TA1535), mouse lymphoma assay, Chinese hamster ovary (cytogeneti c) assay and in one in vivo study, the sex-linked-recessive-lethal ass ay in Drosophila. Prior studies have also shown that the drug is negat ive in the mouse micronucleus assay. We now report that the drug is al so negative for mutagenic activity in a number of other in vivo tests. Single intraperitoneal doses of 25, 125 and 250 mg/kg were without ef fect in the rat bone marrow chromosomal aberration assay. Single oral doses of 30, 75, 150 and 300 were negative in the rat hepatocyte DNA-r epair assay. Single intraperitoneal doses of 30 and 100 mg/kg were wit hout effect in the sister chromatid exchange (SCE) assay in the mouse. Statistically significant effects were seen at 200 and 300 mg/kg in t he initial SCE assay and at 300 and 350 mg/kg in the confirmatory SCE assay. The rationale for considering the SCE results to be anomalous a nd thus not relative to the overall safety evaluation of the drug is p resented. (C) 1997 Elsevier Science B.V.