Safety and toxicity assessment of Lactobacillus salivarius AP-32 with Probiotic potential in vivo and in vitro.

2026-04
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 210

PubMed: 41577224
DOI: 10.1016/j.fct.2026.115970

Study Design

Population: In 14-day acute and 90-day subchronic toxicity studies in rodents
Methods: 14-day acute and 90-day subchronic toxicity studies; mutagenicity testing in vivo and in vitro, including chromosomal aberrations in mouse spermatogonia, bone marrow cytotoxicity, and the Ames test (5000 μg/mL); Caco-2 cell toxicity, acid and bile tolerance, intestinal adhesion, antimicrobial activity, and M2 macrophage induction

Lactobacillus salivarius AP-32 (namely Ligilactobacillus salivarius AP-32, L. salivarius AP-32), isolated from the human gut, has shown a favorable safety profile. In 14-day acute and 90-day subchronic toxicity studies in rodents, no adverse effects were observed. The maximum tolerated dose was 16 g/kg body weight in the acute study, and the no-observed-adverse-effect level in the 90-day study was 1.88 g/kg body weight. It showed no mutagenicity in vivo or in vitro, including no chromosomal aberrations in mouse spermatogonia, no bone marrow cytotoxicity, and no mutagenic response in the Ames test (5000 μg/mL). L. salivarius AP-32 exhibited γ-hemolysis and bile salt hydrolase activity. It was non-toxic to Caco-2 cells, did not induce cytotoxicity, and demonstrated strong acid and bile tolerance, intestinal adhesion, and antimicrobial activity against Helicobacter pylori, Salmonella enterica subsp. enterica, Escherichia coli, Listeria monocytogenes, and Vibrio parahaemolyticus, while inducing M2 macrophages. Prior research indicated milk and soybean fermentated L. salivarius AP-32 held potential in regulating blood glucose, alleviating neonatal jaundice, and suppressing vaginal and urinary tract pathogens. These findings supported its safety and potential as a probiotic.

Research Insights

Supplement	Dose	Health Outcome	Effect Type	Effect Size	Source
Lactobacillus salivarius	—	Improved Probiotic Safety	Beneficial	Moderate	View source Lactobacillus salivarius AP-32 ... has shown a favorable safety profile. In 14-day acute and 90-day subchronic toxicity studies in rodents, no adverse effects were observed.
Lactobacillus salivarius	—	Induced Immunomodulatory Effects	Beneficial	Small	View source while inducing M2 macrophages.
Lactobacillus salivarius	—	No Mutagenic Effects	Beneficial	Moderate	View source It showed no mutagenicity in vivo or in vitro, including no chromosomal aberrations in mouse spermatogonia, no bone marrow cytotoxicity, and no mutagenic response in the Ames test (5000 μg/mL).
Lactobacillus salivarius	—	Reduced Pathogen Growth	Beneficial	Moderate	View source demonstrated strong acid and bile tolerance, intestinal adhesion, and antimicrobial activity against Helicobacter pylori, Salmonella enterica subsp. enterica, Escherichia coli, Listeria monocytogenes, and Vibrio parahaemolyticus