Subchronic (90-day) repeated dose oral toxicity study of 2-hydroxybenzylamine acetate in rabbit.

Abstract 2-hydroxybenzylamine (2-HOBA), a naturally occurring compound found in buckwheat, has potential for use as a nutrition supplement due to its ability to protect against the damaging effects of oxidative stress. In a series of rodent toxicity studies, 2-HOBA acetate was well-tolerated and did not produce any toxic effects over 28 or 90 days of repeated oral administration. However, it remained necessary to test the potential toxicity of 2-HOBA acetate in a non-rodent species. In this investigation, 2-HOBA acetate was orally administered to male and female New Zealand White Rabbits for 90 days at doses of 100, 500, and 1000 mg·kg BW−1·day−1 (n = 5 per sex/group). As previously observed in rodents, 2-HOBA acetate administration was well tolerated. No toxic effects of 2-HOBA acetate were detected in body weight, feed consumption, hematology, blood chemistry, urine chemistry, organ weights, gross pathology or histopathology. Based on these findings, the no-observed-adverse-effect-level of 2-HOBA acetate in rabbits was determined to be 1000 mg·kg BW−1·day−1, which was the highest dose tested. These results provide further support for the safety of 2-HOBA acetate administration. Highlights • Daily oral administration of 2-hydroxybenzylamine at doses up to 1000 mg kg BW−1 ·day−1 for 90 days was examined in rabbits. • 2-Hydroxybenzylamine acetate did not induce any toxicological effects in rabbits. • These findings provide additional support for the safety of 2-hydroxybenzylamine consumption. [ABSTRACT FROM AUTHOR]