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

Regul Toxicol Pharmacol. 2018 Dec:100:52-58. doi: 10.1016/j.yrtph.2018.10.017. Epub 2018 Oct 22.

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.

Keywords: Preclinical; Rabbit; Safety; Salicylamine; γ-Ketoaldehydes.

MeSH terms

  • Administration, Oral
  • Animals
  • Benzylamines / toxicity*
  • Dietary Supplements
  • Female
  • Functional Food
  • Male
  • No-Observed-Adverse-Effect Level
  • Rabbits
  • Toxicity Tests, Subchronic

Substances

  • Benzylamines
  • 2-(aminomethyl)phenol