Pre-clinical toxicological studies with muzolimine

Toxicological studies were carried out to assess the acute, sub-chronic and embryotoxicity of muzolimine, administered orally to a number of animal species. The results showed that muzolimine had only slight acute toxicity, of the same degree in the mouse, rat, rabbit and dog. In the sub-chronic toxicity studies over 90 days, the presenting symptom in rats and dogs was a pronounced diuresis and, apart from the kidney, no other organ or organ systems were impaired. Macroscopic and microscopic changes in the kidney were the pharmacological result of overdosage, i.e. excessive diuresis, and not due to typical toxic renal damage. Embryotoxicity studies on pregnant rats and rabbits showed that toxic (rat) or lethal doses (rabbits) had no embryotoxic or teratogenic effects.