[Mutagenicity studies of iodixanol, a new non-ionic isotonic contrast medium]

A new non-ionic isotonic contrast medium, iodixanol (a diastereomeric mixture of 5,5'-[(2-hydroxytrimethylene) bis (acetylimino)] bis [N, N'-bis (2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzene-dicarboxamide]) was studied for mutagenicity by using the Ames method, in vitro cytogenetics and micronucleus test. Iodixanol had no mutagenic effect on S. typhimurium (TA1535, TA1537, TA1538, TA98 and TA100) or E. coli (WP2uvrA) in the reverse mutation assay with or without metabolic activations. In the cytogenetic study, iodixanol had no effect on the Chinese hamster cells with or without metabolic activations. Intravenous injections of iodixanol for two times at a dose of 800, 1,600 or 3,200 mgI/kg in the mouse micronucleus test did not increase the incidence of micronucleated polychromatic erythrocytes. These results show that iodixanol has no mutagenic potential.