Toxicology and Carcinogenesis Studies of Ephedrine Sulfate (CAS No. 134-72-5) in F344/N Rats and B6C3F1 Mice (Feed Studies)

摘要

Ephedrine sulfate is a sympathomimetic amine that affects both the central and peripheral nervous systems. An effective bronchiodilator and weak vasoconstrictor, ephedrine sulfate is used extensively in nonprescription pharmaceutical preparations such as nose drops, cold tablets, cough syrups, and, in particular, asthma relief medicines. Ephedrine sulfate was nominated for carcinogenesis studies by the National Cancer Institue because of its widespread and long-term use for the relief of symptoms associated with asthma. In 14-day repeated-exposure studies, F344/N rats of each sex received diets containing 0-1,500 ppm ephedrine sulfate or drinking water containing 0-1,200 ppm ephedrine sulfate; B6C3F1 mice received diets or drinking water containing 0-5,000 ppm ephedrine sulfate. In the feed studies, the average feed consumption by dosed rats and mice was comparable to that of their respective controls. The average water consumption by rats and mice decreased with increasing concentration of ephedrine sulfate in the drinking water. Thus, subsequent studies used the feed route of administration. Under the conditions of these studies, there was no evidence of carcinogencity for F344/N rats or B6C3F1 mice of either sex receiving 125 or 250 ppm ephedrine sulfate in the diet for 2 years.