A repeated dose 28-day oral toxicity study of sodium dehydroacetate (DHA-S) in Wistar rats

Regul Toxicol Pharmacol. 2023 Jan:137:105313. doi: 10.1016/j.yrtph.2022.105313. Epub 2022 Dec 1.

Abstract

Sodium dehydroacetate (DHA-S) is a food additive and preservative. The present study was conducted to investigate the potential toxicity of repeated oral doses of DHA-S. DHA-S was administered orally by gavage to Wistar rats at doses of 0, 50, 100, or 200 mg/kg BW/day for 28 days, after which growth indicators, clinical pathology, organ weights, and histopathology were determined. Body weight and food consumption were significantly reduced at doses of 100 or 200 mg/kg BW, and some hematological indexes and organ weight were significantly affected, particularly in female rats. At a dose of 200 mg/kg BW, the blood coagulation activities were significantly reduced in female rats. At a dose of 100 or 200 mg/kg BW, the main blood biochemical parameters of both sexes were obviously affected. Similar histological changes in the hepatic and renal tissues were observed in both the treated (200 mg/kg BW DHA-S) and control animals. Female rats were more susceptible to most of the toxic effects caused by DHA-S, which further indicating a gender difference in the toxic phenotype profile of rats. Based on these results, the no observed adverse effect level (NOAEL) of DHA-S was determined to be 50 mg/kg BW/day in rats.

Keywords: 28-day subacute toxicity; Food additive; Oral toxicity; Preservative; Rats; Sodium dehydroacetate.

MeSH terms

  • Administration, Oral
  • Animals
  • Body Weight
  • Dose-Response Relationship, Drug
  • Female
  • Male
  • No-Observed-Adverse-Effect Level
  • Organ Size
  • Pyrones* / pharmacology
  • Rats
  • Rats, Wistar

Substances

  • dehydroacetic acid
  • Pyrones