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Subchronic Oral Dose Toxicity Study of Enterococcus Faecalis 2001 (EF 2001) in Mice
Yeun-Hwa Gu1, Takenori Yamasita2, Ki-Mun Kang3
1Department of Radiological Science, Faculty of Health Science, Junshin Gakuen University, Fukuoka, Japan.
Heat-treated Enterococcus Faecalis 2001 (EF 2001) showed no significant toxicity in mice during single and repeated oral administrations. EF 2001 is safe for preventive medicine applications, with an LD50 greater than 5,000 mg/kg.
Area of Science:
- Microbiology
- Toxicology
- Preventive Medicine
Background:
- Enterococcus Faecalis 2001 (EF 2001) is a heat-treated bacterium used in preventive medicine.
- General toxicity studies are essential to ensure the safety of such products.
Purpose of the Study:
- To evaluate the general toxicity of EF 2001 following single and repeated oral administrations in mice.
- To determine the safety of EF 2001 for potential application in preventive medicine.
Main Methods:
- Male and female ICR mice received EF 2001 orally via gavage at doses of 1,000, 3,000, or 5,000 mg/kg/day for 13 weeks.
- Distilled water served as the control.
- Evaluations included general condition observation, body weight, food and water consumption, blood tests, urinalysis, and pathological examinations.
Main Results:
- No significant differences were observed between the EF 2001 and control groups in any of the measured parameters.
- No abnormal symptoms or deaths occurred during the study period.
- The 50% lethal dose (LD50) was estimated to be greater than 5,000 mg/kg body weight/day for both sexes.
Conclusions:
- EF 2001 demonstrates no notable toxicity upon single and repeated oral administration in mice.
- The product is considered safe for oral ingestion and has potential for use in preventive medicine.
- EF 2001 is speculated to not adversely affect living organisms due to a lack of cellular and organ toxicity.
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