Subchronic (90-Day) repeated dose toxicity study of disodium adenosine-5'-triphosphate in rats

Regul Toxicol Pharmacol. 2020 Oct:116:104760. doi: 10.1016/j.yrtph.2020.104760. Epub 2020 Aug 6.

Abstract

Adenosine-5'-triphosphate (ATP) is the primary source of energy for cells and oral supplementation with ATP offers numerous different health benefits, including the regulation of blood flow and muscle contraction. In this study, ATP, disodium salt, was administered by gavage to rats for 90 consecutive days at doses of 0 (control), 500, 1000, and 2000 mg kg BW-1·d-1 (n = 10 per sex/group). Subchronic administration of ATP was well tolerated at all dose levels. Body weights and feed consumption body weight gains were similar between ATP-treated and control rats. Minor differences were seen in hematology and blood chemistry; however, these changes were not dose related and therefore not of biological or toxicological significance. Only one difference was observed in absolute organ weights, females of the high dose had increased kidney and increased relative kidney and liver weights; however, these differences were not seen in males nor appeared to be dose related. No biological or toxicological significant differences were observed in thyroid function or urine analysis. The incidence of histopathological lesions was low and similar between treated and control groups. Based upon these findings, the no-observed-adverse-effect level (NOAEL) was determined to be ≥ 2000 mg kg BW-1·d-1, which was the highest dose tested.

Keywords: ATP; Disodium adenosine-5′-triphosphate; Preclinical; Rodent; Safety.

MeSH terms

  • Adenosine Triphosphate / toxicity*
  • Administration, Oral
  • Animals
  • Female
  • Male
  • No-Observed-Adverse-Effect Level
  • Rats, Sprague-Dawley
  • Toxicity Tests, Subchronic

Substances

  • Adenosine Triphosphate