Research article
- Genotoxicity, acute and subchronic oral toxicity assessments of postbiotics of Lacticaseibacillus rhamnosus IDCC 3201
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Shin-Yae Choi, Dahae Hong, Jin Seok Moon, O-Hyun Ban, Hee-Won Bae, Tae-Yoon Kim, You-Hee Cho
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Received May 8, 2026 Accepted May 20, 2026 Published online June 12, 2026
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DOI: https://doi.org/10.71150/jm.2605002
[Epub ahead of print]
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Abstract
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Supplementary Material
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Postbiotics derived from lactic acid bacteria (LAB) have attracted growing interest as stable and potentially safer alternatives to probiotics for use in foods and health-related products. Comprehensive safety evaluation remains essential before their broader application. In this study, we assessed the safety profiles of RHT3201, a postbiotic preparation derived from Lacticaseibacillus rhamnosus IDCC 3201, through genomic, genotoxic, acute oral, and subchronic oral toxicity studies. Whole-genome analysis showed that IDCC 3201 lacks antimicrobial resistance genes and exhibits no hemolytic activity, supporting the genomic safety of the source strain. RHT3201 showed no genotoxic potential in either in vitro or in vivo assays, as evidenced by no structural or numerical chromosomal aberrations at concentrations up to 5,000 μg/ml in CHL/IU cells and no increase in micronucleated polychromatic erythrocytes, with no suppression of bone marrow erythropoiesis by oral administration of RHT3201 at doses up to 15,000 mg/kg/day using a mouse model. In rats, single oral doses of up to 15,000 mg/kg caused no mortality, treatment-related clinical signs, or gross pathological abnormalities, indicating an approximate lethal dose greater than 15,000 mg/kg. In a 90-day repeated-dose oral toxicity study, no adverse treatment-related effects were observed at doses up to 5,000 mg/kg/day. Mild liver and thyroid histopathological findings were considered adaptive and reversible. Accordingly, the no-observed-adverse-effect level was determined to be 5,000 mg/kg/day. Taken together, these findings support the safety of RHT3201 as a LAB-derived postbiotic ingredient.
Research Support, Non-U.S. Gov't
- Safety Evaluation of Lactobacillus paracasei subsp. paracasei LC-01, Probiotic Bacterium
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Hao Zhang , Yu Wang , Jing Sun , Zirui Guo , Huiyuan Guo , Fazheng Ren
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J. Microbiol. 2013;51(5):633-638. Published online October 31, 2013
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DOI: https://doi.org/10.1007/s12275-013-3336-x
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Abstract
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The safety of Lactobacillus paracasei subsp. paracasei LC-01 was evaluated for its use as a potential probiotic. In our in vitro study, the antibiotic resistance and the ability to produce biogenic amine were determined. The results showed that the strain was sensitive to all tested antibiotics and did not produce biogenic amine except for tyramine. The oral toxicity of this strain was evaluated in Balb/C mice. One hundred mice were divided into 10 groups. Four groups were administered 0, 108, 109, or 1010 CFU/mouse per day dissolved in saline solution respectively, for 28 days. Three groups were injected intraperitoneally with 109 CFU/mouse dissolved in saline solution, and were killed 2, 5, and 10 days after injection. The last 3 groups were injected with the vehicle as controls respectively. The results showed that oral administration of the strain had no adverse effects on mouse body weight and that there was no treatment-associated bacterial translocation. Intraperitoneal administration caused a significant translocation to liver, spleen and kidney. However, this translocation did not cause illness or death throughout the experiment. The results suggest that L. paracasei subsp. paracasei LC-01 is likely to be safe for human consumption.
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