Lack of genotoxicity and subchronic toxicity in safety assessment studies of a <i>Clostridium beijerinckii</i> formulation.

ABSTRACT: A powder formulation of viable Clostridium beijerinckii bacteria (CBEI) was evaluated in a battery of genotoxicity studies and 14-day and 90-day repeat-dose toxicity studies in rats to evaluate CBEI as a food ingredient. All studies followed Organisation for Economic Co-operation and Development (OECD) protocols. CBEI (nonviable) was not mutagenic in an in vitro bacterial reverse mutation assay and was not clastogenic in an in vitro mammalian chromosomal aberration test. Viable CBEI was not genotoxic when evaluated in an in vivo mammalian cell micronucleus assay administered at up to 2.30 × 10¹¹ AFU/kg body weight/day. CBEI was administered to rats via gavage at target doses of 217, 434, and 868 mg/kg body weight/day (equivalent to 4.1 × 10¹⁰

SUBMITTER: Yu EJ 

PROVIDER: S-EPMC12918226 | biostudies-literature | 2026 Jun

REPOSITORIES: biostudies-literature