Toxicological Safety Assessment of Heat‐Treated Lactiplantibacillus plantarum OLL2712 as a Food Ingredient

Abstract

Lactiplantibacillus plantarum is a Gram‐positive, bacilli‐shaped bacterium commonly found in fermented foods and the human gastrointestinal tract. Heat‐treatment of L. plantarum OLL2712 prior to consumption has been found to have positive health effects. However, a full toxicological evaluation of heat‐treated L. plantarum OLL2712 cells (heat‐treated OLL2712) has not been conducted. In this regard, heat‐treated OLL2712 was evaluated for use as an ingredient in food and dietary supplements using a panel of toxicological tests including genotoxic and subchronic studies. Heat‐treated OLL2712 did not show any genotoxicity based on an in vitro mammalian chromosomal aberration test and in vivo mouse micronucleus assay up to 8.0 × 109 cells/mL and 6.4 × 1012 cells/kg, respectively. In the acute oral toxicity study, no toxic effects were observed at 5 × 1011 cells/kg body weight. In the 13‐week subchronic toxicity study, rats were administered (via gavage) heat‐treated OLL2712 at concentrations of 0.5 × 1011, 1.5 × 1011, and 5 × 1011 cells/kg body weight. Administration did not significantly impact mortality, body weight, food consumption, ophthalmology, hematology, clinical chemistry, coagulation, urinalysis, and macroscopic or microscopic findings. The no‐observed‐adverse‐effect level of heat‐treated OLL2712 in both sexes was 5 × 1011 cells/kg body weight/day, the highest dose tested.