Oral toxicity evaluation of kefir-isolated Lactobacillus kefiranofaciens M1 in Sprague–Dawley rats

• Published in: Food and chemical toxicology Vol. 70; pp. 157 - 162
• Main Authors: Owaga, E.E., Chen, M.J., Chen, W.Y., Chen, C.W., Hsieh, R.H.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.08.2014; Elsevier
• Subjects: Animals; Anti-Allergic Agents - toxicity; Biological and medical sciences; Cultured Milk Products - microbiology; Cultured Milk Products - toxicity; Female; Food toxicology; Kidney - metabolism; Lactobacillus; Lactobacillus - isolation & purification; Lactobacillus kefiranofaciens M1; Liver - metabolism; Male; Medical sciences; No-Observed-Adverse-Effect Level; Organ Size; Ovary - metabolism; Probiotics; Probiotics - toxicity; Rats; Rats, Sprague-Dawley; Spleen - metabolism; Sprague–Dawley rat; Testis - metabolism; Toxicity; Toxicity Tests; Toxicology; Urinalysis; Weight Gain; PBS; MCV; ALP; Toxicity; GPT; No-observed-adverse-effect-level; INR; GOT; γGT; SD; APTT; Probiotics; RBC; cfu; MCH; MCHC; NOAEL; Sprague–Dawley rat; WBC; Urea-N; SPSS; Lactobacillus kefiranofaciens M1; GRAS; TP; Probiotic; Sprague-Dawley rat; Evaluation; Lactic acid bacteria; Rat; Rodentia; Oral administration; Vertebrata; Mammalia; Animal; Bacteria; Lactobacillaceae; Isolation; Lactobacillus
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2014.05.005

•L. kefiranofaciens M1 has shown novel anti-allergy probiotic properties.•Toxicity of L. kefiranofaciens M1 was evaluated in Sprague–Dawley rats.•No adverse effects on body weight gain, haematology, serum biochemistry.•No adverse changes in terminal organ weights and urinalysis parameters.•Histopathology of the organs revealed no toxicity effect. 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 3.0×108cfu/kg bw while the medium dose and high dose groups received 9.0×109cfu/kg bw and 1.8×1010cfu/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, 1.8×1010cfu/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.