Genotoxicity, acute and subchronic toxicity evaluation of fermented Morinda officinalis

Qian Tao1, Dong Peng2, Pan Li2

  • 1Infinitus (China) Co., Ltd., Guangzhou, 510623, China.

Insights

Fermented Morinda officinalis (FMO) shows no genotoxicity or acute toxicity. Subchronic studies confirm FMO is safe for use as functional food and medicine, with a no observed adverse effect level not less than 8 g/kg BW/day.

Area of Science:

  • Pharmacology and Toxicology
  • Food Science
  • Herbal Medicine

Background:

  • Morinda officinalis possesses significant pharmacological properties, making it a candidate for functional food and medicinal applications.
  • Traditional fermentation enhances Morinda officinalis, but its toxicological profile remains uncharacterized.

Purpose of the Study:

  • To comprehensively assess the toxicological characteristics of fermented Morinda officinalis (FMO) for the first time.
  • To establish the safety profile of FMO for potential use in functional foods and medicine.

Main Methods:

  • Genotoxicity was evaluated using the Ames test, mammalian erythrocyte micronucleus test, and mouse primary spermatocyte chromosome aberration test.
  • Acute toxicity was assessed via oral gavage in mice and rats at a dose of 20 g/kg BW.
  • A 90-day subchronic toxicity study was conducted in rats with FMO administered at doses up to 8 g/kg BW/day.

Main Results:

  • FMO demonstrated no genotoxicity across all tested assays.
  • Acute toxicity studies revealed no mortality or adverse effects at a dose of 20 g/kg BW.
  • Subchronic studies showed no significant impact on mortality, body weight, food consumption, organ weights, hematology, serum biochemistry, or urinalysis in rats up to 8 g/kg BW/day.

Conclusions:

  • Fermented Morinda officinalis (FMO) is non-toxic and free from genotoxic effects.
  • The no observed adverse effect level (NOAEL) for FMO was determined to be not less than 8 g/kg BW/day in rats.
  • These findings support the safe consumption and application of FMO as a functional food and medicinal agent.