Scientific Safety Assessment of RHT3201®: Genotoxicity and Oral Toxicity Studies
Safety evaluation is a critical step in the development of postbiotic ingredients. A study published in the Journal of Microbiology (2026) investigated the genomic safety, genotoxicity, and oral toxicity of RHT3201®, a postbiotic preparation derived from Lacticaseibacillus rhamnosus IDCC 3201, developed by ILDONG Bioscience.
The study employed a comprehensive safety assessment approach, combining genomic characterization, in vitro and in vivo genotoxicity tests, and acute and 90-day repeated-dose oral toxicity studies.
Key Research Findings
1. Genomic Safety
Whole-genome sequencing identified no acquired antimicrobial resistance genes.
No known virulence-associated genes were detected.
No hemolytic activity was observed.
Antibiotic susceptibility testing showed no atypical resistance patterns.
2. Genotoxicity Assessment
No significant chromosomal aberrations were observed in CHL/IU cells at concentrations up to 5,000 μg/mL.
In the mouse micronucleus assay, no significant increase in micronucleated polychromatic erythrocytes (MNPCEs) was detected at doses up to 15,000 mg/kg.
No evidence of bone marrow erythropoiesis suppression was observed.
3. Acute Oral Toxicity
No mortality or treatment-related clinical abnormalities were observed in rats following single oral administration at doses up to 15,000 mg/kg.
The approximate lethal dose was determined to be greater than 15,000 mg/kg.
4. 90-Day Subchronic Oral Toxicity
No treatment-related adverse effects were identified at doses up to 5,000 mg/kg/day.
Hematological and biochemical parameters showed no significant adverse changes.
Minor liver and thyroid histopathological findings were considered adaptive and reversible.
The No-Observed-Adverse-Effect Level (NOAEL) was established at 5,000 mg/kg/day, the highest dose tested.
Conclusion
These findings provide a comprehensive preclinical safety dataset for RHT3201®, covering genomic characteristics, genotoxic potential, and repeated-dose oral toxicity.
At ILDONG Bioscience, we continue to support the development of scientifically characterized probiotic and postbiotic ingredients through systematic safety evaluation and research.
Reference: Choi et al. (2026). Genotoxicity, acute and subchronic oral toxicity assessments of postbiotics of Lacticaseibacillus rhamnosus IDCC 3201. Journal of Microbiology, 64(6), e2605002.
