Animal Toxicology

Acute toxicity studies have been performed on intravenously administered Tc-99m-tetrofosmin in male and female rats and rabbits. There were no deaths recorded in either species at doses equivalent to almost 1100 times the tetrofos- min content of the MHD. The transient signs of lethargy in male rabbits at these dosages were the only adverse effects noted. In 14-day repeat-dose studies in rats and rabbits, there were no deaths with cumulative doses of over 10,000 times the tetrofosmin content of a single MHD. There were no toxicologically significant changes in clinical chemistry data, no histopathological changes of note, and only a few minor organ weight changes relative to control animals.^7,11

Additional acute intravenous toxicity studies using tetrofosmin sulphosalicylate alone as the test article in rats and dogs confirmed the above findings and determined the LD₅₀ in rats between 4200 and 7000 times the MHD. Some effects on the central nervous system were observed at doses in excess of 4200 and 1500 times MHD in rats and dogs, respectively.⁷

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