GENERAL TOXICOLOGY OF NEW ANTITUSSIVE MOGUISTEINE

Moguisteine y)-methyl-3-ethoxycarbonylacetyl-1,3-thiazolidine, CAS 119 637-67-1), a new oral non-narcotic peripherally acting antitussive dru g, was submitted to toxicological evaluation. The oral (gavage) and in traperitoneal routes in mice and rats and the oral route in rabbits pr oduce very low acute toxicity. Administered by oral route, moguisteine proved to be well tolerated for 26 consecutive weeks and did not indu ce any general or local effect at up to the respective doses of 240 an d 60 mg/kg/day for rats and dogs. In oral (dietary) carcinogenicity st udies, moguisteine did not exhibit any carcinogenic effect in mice and rats treated for 87 and 104 weeks, respectively, at up to the dose of 600 mg/kg/day. These results are supported by the absence, of both in vitro an in vivo, of mutagenic potential. Considering the overall res ults of the toxicological studies, it can be affirmed that moguisteine enjoys reliable tolerability, as also shown by a wide safety margin c alculated on the basis of the