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Safety assessment of Bacillus licheniformis Me1 isolated from milk for probiotic application
Vadakedath Nithya1, Serva P Muthukumar, Prakash M Halami
1Department of Food Microbiology, CSIR-Central Food Technological Research Institute, Mysore, India.
Abstract:
In this study, an in vivo toxicological safety assessment of Bacillus licheniformis Me1, a native isolate from milk, was performed. An acute toxicity study in male albino Wistar rats demonstrated no treatment-related illness or mortality. A 90-day subchronic oral toxicity study using 2 doses (1.1 × 10(10) and 1.1 × 10(11) colony-forming unit [CFU]/kg body weight [BW], respectively) failed to show dose-dependent illness or mortality. Moreover, neither significant differences in serum biochemical and hematological analyses nor histopathological changes in organs or tissues were found when compared to the control groups. The no-observed-adverse-effect level (NOAEL) was found to be greater than 1.1 × 10(11) CFU/kg BW. The in vivo micronucleus assay in mice did not reveal any signs of genotoxic effect at any of the doses tested. Furthermore, dermal and acute eye irritation tests conducted in rabbits showed no edema or erythema and ocular lesions. These results suggest that B licheniformis Me1 can be considered safe for food industry applications.
Insights
Bacillus licheniformis Me1, a milk isolate, underwent safety testing. Studies showed no adverse effects in rats, mice, or rabbits, indicating its safety for food industry use.
Area of Science:
- Microbiology
- Toxicology
- Food Safety
Background:
- Bacillus licheniformis is a common bacterium found in various environments.
- Probiotics require rigorous safety assessments before food industry application.
- Strain Me1 was isolated from milk, necessitating toxicological evaluation.
Purpose of the Study:
- To conduct a comprehensive in vivo toxicological safety assessment of Bacillus licheniformis Me1.
- To determine the No-Observed-Adverse-Effect Level (NOAEL) for Bacillus licheniformis Me1.
- To evaluate the genotoxic and irritation potential of Bacillus licheniformis Me1.
Main Methods:
- Acute and 90-day subchronic oral toxicity studies in Wistar rats.
- Serum biochemical, hematological, and histopathological analyses.
- In vivo micronucleus assay in mice and dermal/eye irritation tests in rabbits.
Main Results:
- No treatment-related illness or mortality observed in acute or subchronic oral toxicity studies.
- No significant differences in hematology, serum biochemistry, or histopathology compared to controls.
- No genotoxic effects in mice and no dermal or ocular irritation in rabbits.
Conclusions:
- The No-Observed-Adverse-Effect Level (NOAEL) for Bacillus licheniformis Me1 is greater than 1.1 × 10(11) colony-forming units/kg body weight.
- Bacillus licheniformis Me1 demonstrated a lack of genotoxicity and local irritation.
- Bacillus licheniformis Me1 is considered safe for applications in the food industry.
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