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Oral toxicity evaluation of kefir-isolated Lactobacillus kefiranofaciens M1 in Sprague-Dawley rats
Abstract:
Lactobacilli kefiranofaciens M1 has shown novel immunomodulation and anti-allergy probiotic attributes in cell and animal models. An acute oral toxicity assessment of L. kefiranofaciens M1 was evaluated in Sprague-Dawley rats. The rats were randomly assigned to four groups (12 rats/sex/group): the low dose group was orally gavaged with L. kefiranofaciens M1 at 3.0×10(8)cfu/kg bw while the medium dose and high dose groups received 9.0×10(9)cfu/kg bw and 1.8×10(10)cfu/kg bw, respectively, for 28days. The control group received phosphate buffer saline. The body weights were measured weekly while blood samples were collected for haematology and serum biochemistry tests. Histopathology of the organs (heart, liver, kidney, adrenal glands, spleen, ovary, testis), and urinalysis were conducted on study termination. The body weight gain of the L. kefiranofaciens M1 and control groups were comparable during the administration period. Overall, L. kefiranofaciens M1 did not induce adverse effects on haematology, serum biochemistry, and urinalysis parameters. Gross and microscopic histopathology of the organs revealed no toxicity effect of L. kefiranofaciens M1. In conclusion, 1.8×10(10)cfu/kg bw of L. kefiranofaciens M1 was considered as the no-observed-adverse-effect-level (NOAEL), which was the highest dose tested in the present study.
Insights
Lactobacillus kefiranofaciens M1, a probiotic with anti-allergy properties, showed no adverse effects in Sprague-Dawley rats. The highest tested dose of 1.8×10(10)cfu/kg bw was determined as the no-observed-adverse-effect-level (NOAEL).
Area of Science:
- Microbiology
- Toxicology
- Probiotics
Background:
- Lactobacillus kefiranofaciens M1 exhibits promising immunomodulatory and anti-allergy effects in preliminary studies.
- Assessing the safety profile of probiotic strains is crucial for their therapeutic application.
Purpose of the Study:
- To evaluate the acute oral toxicity of Lactobacillus kefiranofaciens M1 in Sprague-Dawley rats.
- To determine the no-observed-adverse-effect-level (NOAEL) of L. kefiranofaciens M1.
Main Methods:
- Rats were administered varying doses of L. kefiranofaciens M1 (3.0×10(8) to 1.8×10(10)cfu/kg bw) or a control (PBS) for 28 days.
- Comprehensive assessments included body weight monitoring, hematology, serum biochemistry, urinalysis, and organ histopathology.
Main Results:
- No significant differences in body weight gain were observed between L. kefiranofaciens M1 and control groups.
- Hematology, serum biochemistry, and urinalysis parameters remained unaffected by L. kefiranofaciens M1 administration.
- Gross and microscopic examination of organs revealed no treatment-related toxicity.
Conclusions:
- Lactobacillus kefiranofaciens M1 demonstrated a lack of oral toxicity in Sprague-Dawley rats at the tested doses.
- The highest dose of 1.8×10(10)cfu/kg bw was identified as the no-observed-adverse-effect-level (NOAEL).