TOXICOLOGICAL SAFETY ASSESSMENT OF IOMEPROL, A NEW X-RAY CONTRAST AGENT

The toxicology of pharmaceutical formulations of iomeprol, a new nonio nic iodinated radiographic contrast agent, was studied in rodents (mic e, rats and guinea-pigs) and non-rodents (rabbits and dogs). When inje cted intravascularly the acute toxicity of iomeprol, both in terms of median lethal dose and symptoms, was comparable to that of analogous t riiodinated nonionic contrast media (CM). Intravenous daily dosing for 4 weeks showed that iomeprol was well tolerated at doses as high as t he maximum dose anticipated for clinical use. Moreover, the compound d id not possess reproductive, developmental, or genetic toxicity. Tissu e tolerability was completely superimposable on those of reference CM such as iopamidol and iohexol. Finally, no antigenic potential was det ected either in mice or guinea-pigs. These favourable toxicological ch aracteristics bode well for iomeprol as an intravascular radiographic contrast agent.