Safety evaluation of water-soluble palm fruit bioactives

Regul Toxicol Pharmacol. 2017 Aug;88:96-105. doi: 10.1016/j.yrtph.2017.05.021. Epub 2017 Jun 2.


Water-soluble palm fruit bioactives, derived from the aqueous stream of palm oil processing, have shown anti-diabetogenic effects in rodent models. To assess the safety of potential incorporation of this polyphenol-containing material in food, in vitro bacterial reverse mutation and in vitro chromosome aberration assays were conducted along with a 90-day subchronic toxicity study in Sprague-Dawley rats. Water-soluble palm fruit bioactives were inactive in the Ames and in vitro chromosome aberration assays up to the limit doses of 5000 μg/plate and 5000 μg/mL, respectively. In the 90-day feeding study, water-soluble palm fruit bioactives were administered via gavage at doses 0, 500, 1000 or 2000 mg/kg body weight/day. No significant effects were noted on body weight, food consumption, hematology, clinical chemistry, organ weights, and histopathological examination. The No Observable Adverse Effect Level was considered to be 2000 mg/kg body weight/day, the highest dose tested. These data provide evidence to support the safe use of water-soluble palm fruit bioactives in food or food ingredients.

Keywords: Genotoxicity; Oil palm; Polyphenols; Rat; Safety; Toxicity.

MeSH terms

  • Animals
  • Biological Factors / toxicity*
  • Body Weight / drug effects
  • Chromosome Aberrations
  • Dose-Response Relationship, Drug
  • Fruit / chemistry*
  • No-Observed-Adverse-Effect Level
  • Organ Size / drug effects
  • Palm Oil / chemistry*
  • Phoeniceae / chemistry*
  • Rats
  • Rats, Sprague-Dawley
  • Safety
  • Toxicity Tests, Subchronic
  • Water


  • Biological Factors
  • Water
  • Palm Oil