Determination of the safety of Halomonas sp. KM-1-derived d-β-hydroxybutyric acid and its fermentation-derived impurities in mice and Japanese adults

Biosci Biotechnol Biochem. 2024 Aug 26;88(9):1073-1080. doi: 10.1093/bbb/zbae088.

Abstract

The use of halophilic bacteria in industrial chemical and food production has received great interest because of the unique properties of these bacteria; however, their safety remains under investigation. Halomonas sp. KM-1 intracellularly stores poly-D-β-hydroxybutyric acid under aerobic conditions and successively secretes D-β-hydroxybutyric acid (D-BHB) under microaerobic conditions. Therefore, we tested the safety of Halomonas sp. KM-1-derived D-BHB and the impurities generated during D-BHB manufacturing at a 100-fold increased concentration in acute tests using mice and daily intake of 16.0 g D-BHB in Japanese adults for 12 weeks. In the mice test, there were no abnormalities in the body weights or health of mice fed the purified D-BHB or its impurities. In the Japanese adult test, blood parameters and body condition showed no medically problematic fluctuations. These findings indicate that Halomonas sp. KM-1 is safe and can be used for commercial production of D-BHB and its derivatives.

Keywords: Halomonas sp; d-β-hydroxybutyric acid; fermentation impurities; ketone body; safety.

MeSH terms

  • 3-Hydroxybutyric Acid* / chemistry
  • 3-Hydroxybutyric Acid* / pharmacology
  • Adult
  • Animals
  • Body Weight
  • East Asian People
  • Female
  • Fermentation*
  • Halomonas* / chemistry
  • Humans
  • Hydroxybutyrates* / chemistry
  • Hydroxybutyrates* / pharmacology
  • Japan
  • Male
  • Mice

Substances

  • 3-Hydroxybutyric Acid
  • Hydroxybutyrates