Acute and 28-day repeated dose toxicity evaluations of 2-hydroxybenzylamine acetate in mice and rats.

Abstract 2-hydroxybenzylamine (2-HOBA), a compound naturally found in buckwheat, has been shown to protect cells and tissues from the damaging effects of oxidative stress. The purpose of this report was to evaluate 2-HOBA in preclinical oral rodent toxicity studies. This report includes the results from three oral toxicity studies in rodents: a preliminary 28-day feeding study in mice, a 14-day acute oral toxicity study in rats, and a 28-day repeated dose oral toxicity study in rats. The preliminary mouse feeding study showed no adverse effects of 2-HOBA at concentrations up to 0.456% by weight in feed, but decreased food intake and weight loss were observed at 1.56% 2-HOBA in the diet, likely due to poor palatability. In the acute dosing study, 2000 mg/kg BW 2-HOBA resulted in mortality in one of the six tested female rats, indicating a median lethal dose of 2500 mg/kg BW. In the 28-day repeated oral dose study, small differences were observed between 2-HOBA treated and control group rats, but none of these differences were determined to be of toxicological significance. Together, these studies support the lack of toxicity of oral administration of 2-HOBA acetate at doses up to 1000 mg/kg BW d−1 in rodents. Highlights • 2-HOBA (up to 0.456% of feed) over 28 days did not cause adverse effects in mice. • 2-HOBA is a low-toxicity compound when given as an acute oral dose in rats. • Daily 2-HOBA administration did not induce toxic effects in a 28-day rat study. • These results support the safety of 2-HOBA for use as a dietary supplement. [ABSTRACT FROM AUTHOR]