Denzimol, a new anticonvulsant drug. III. Toxicological evaluation.

The toxicological characteristics of N-[beta-[4-(beta-phenylethyl)phenyl]- beta-hydroxyethyl]imidazole hydrochloride (denzimol, Rec 15-1533) a drug with a very good anti-convulsant activity in pharmacological studies carried out in different animal species, were evaluated in acute and chronic toxicity studies. The following overall results were obtained: the acute oral toxicity in mice and rats is of low order; in the chronic oral studies denzimol was generally well tolerated when given to rats for 13 and 26 weeks and to dogs for 52 weeks at different dosage levels. In particular, there was no evidence of remarkable neurological effects or lesions in any of these studies. The results of the studies in rats showed the major target organs for the toxicity of denzimol to be the liver and kidney, where mild, reversible changes were observed; instead in dogs no pathological effect was seen, at any of the dosages used (10, 30, 100 mg/kg p.o. per one year).