Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
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Toxicological and safety evaluations of Weissella cibaria strain CMU in animal toxicity and genotoxicity

  • Dolan, Laurie C. (GRAS Associates, LLC) ;
  • Arceneaux, Benjamin G. (Nutrasource Pharmaceutical and Nutraceutical Services) ;
  • Do, Kyung‑Hyo (Laboratory of Veterinary Bacteriology and Infectious Diseases, College of Veterinary Medicine, Chungbuk National University) ;
  • Lee, Wan‑Kyu (Laboratory of Veterinary Bacteriology and Infectious Diseases, College of Veterinary Medicine, Chungbuk National University) ;
  • Park, Geun‑Yeong (R&D Center, OraPharm, Inc.) ;
  • Kang, Mi‑Sun (R&D Center, OraPharm, Inc.) ;
  • Choi, Kyung‑Chul (Laboratory of Biochemistry and Immunology, College of Veterinary Medicine, Chungbuk National University)
  • Received : 2021.11.09
  • Accepted : 2021.11.30
  • Published : 2022.07.15
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Abstract

Weissella cibaria belongs to the Lactobacillaceae family and has been isolated from traditional fermented foods and saliva of children with good oral health. Previous investigations have shown that W. cibaria CMU (Chonnam Medical University) is expected to be safe based on results of in silico and in vitro analyses. However, there is a lack of studies assessing its safety in vivo. A toxicological safety evaluation of W. cibaria CMU was performed using an acute oral safety study in rats, a 14-day oral range finding study, a subsequent 13-week oral toxicity study in rats and a genetic toxicity battery (in vitro bacterial reverse mutation, in vitro chromosome aberration in Chinese Hamster Ovary cells and in vivo micronucleus study in mice). The results of the studies in rats showed that the acute lethal dose of W. cibaria CMU is >5000 mg/kg body weight (bw)/day (1.8×109 CFU/kg bw/day) and the 14-day or 13-week no observed adverse effect level (NOAEL) is 5000 mg/kg bw/day (1.8×109 CFU/kg bw/day), the highest dose administered. W. cibaria CMU was non-mutagenic in the bacterial reverse mutation test and non-clastogenic or aneugenic in vitro and in vivo. In conclusion, the toxicological studies performed demonstrated W. cibaria CMU to be a safe strain to consume. This study is the first study examining the potential of a W. cibaria strain to cause genetic toxicity and subchronic toxicity in rats according to the Organization for Economic Cooperation and Development guidelines.

Keywords

Acknowledgement

The authors would like to thank the researchers at KCL for their technical support. The authors also thank Amy Mozingo for editorial assistance.

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