Special toxicology--physical dependence potential, antigenicity and mutagenicity--of mabuterol.

The physical dependence potency of dl-1- (4-amino-3-chloro-5-trifluoromethyl-phenyl)-2-tert.-butyl-amino-ethanol hydrochloride (mabuterol) was tested in male rats dosed with 20, 100 and weekly increasing doses of 20, 40, 60, 80 and 100 mg/kg over 7 weeks. The results were compared with those after the same increasing dosages of morphine. 10 males were used per group. The effects of the antagonist levallorphan on drug dependency were also studied. No withdrawal signs were observed in any mabuterol-treated groups. No antigenic potency of mabuterol was found in a series of studies on guinea pigs and rats. In a series of mutagenicity studies (Ames-test, DNA repair test and micronucleus test) it could be demonstrated that mabuterol is not a mutagen.