Six month inhalation studies of pirbuterol acetate aerosol in the beagle dog and squirrel monkey.

Groups of Beagle dogs and Squirrel monkeys were exposed to aerosols of pirbuterol acetate, a new bronchodilator at doses of 0, 200, 400 and 800 micrograms of pirbuterol/kg body weight daily for 6 months. Each group consisted of 4 dogs or 6 monkeys per sex. Dogs were exposed by face mask and monkeys were exposed by head only in a manifold. Plasma drug concentrations indicated that expected levels of drug exposure were achieved in both species. No significant alterations were revealed in physical appearance and body weights, hematological and blood biochemical analyses, urinalyses, ophthalmoscopy, assessment of cardiovascular status, pulmonary function or gross and histopathology. Examination of the respiratory tract showed no morphological changes that could be attributed to pirbuterol acetate inhalation.

A three month inhalation toxicity study in the squirrel monkey (Saimiri sciureus) with terbutaline sulfate (Bricanyl).

A study of the subacute toxicity of inhaled terbutaline sulfate was performed in the Squirrel monkey (Saimiri sciureus). 3 groups of monkeys were exposed 1 h daily 7 days/week for 3 months to terbutaline sulfate aerosols at concentrations of 0.039, 0.185 and 0.799 mg terbutaline/litre of air respectively. A fourth group was a chamber control receiving air only. The following clinical parameters were evaluated: physical appearance and behavior, weight gain, ophthalmoscopic appearance, electrocardiograms, hemograms, blood biochemical profiles and urinalyses. At termination necropsies were conducted and organ weights determined. A variety of staining techniques was employed in the histopathological examination of tissues. Special attention was given to heart and lung. The distribution of goblet cells in sections from the main bronchi and trachea was also investigated. Occasionally a few animals in both the intermediate and high dose groups showed small amounts of exudate and frothing around the mouth during exposure to their respective terbutaline aerosols. No other changes that could be attributed to the exposure to terbutaline aerosols were seen in any parameter.