ORAL SINGLE- AND REPEATED-DOSE TOXICITY STUDIES ON GERANTI BIO-GE YEAST^[○!R], ORGANIC GERMANIUM FORTIFIED YEASTS, IN RATS

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Single- and 13-week repeated-dose toxicities of Geranti Bio-Ge Yeast^[○!R], organic germanium fortified yeasts, were investigated in rats Both sexes of Sprague-Dawley rats were orally administered once at a dose of 2,000 mg/kg in single-dose toxicity or daily for 13 weeks at doses of 500, 1,000 or 2,000 mg/kg in repeated-dose toxicity tests In single-dose toxicity test to determine dose levels in repeated-dose toxicity study, the body weight gain was suppressed at 2,000 mg/kg, although no death, clinical signs and pathological findings related to the treatment were observed In repeated-dose toxicity test, there were no clinical signs in animals administered up to 2,000 mg/kg, except one rat died due to a gavage error In addition, no significant changes in feed consumption and body weight gain were obtained during the treatment period, in spite of week-to-week fluctuation of water consumption There were no considerable changes in ophthalmoscopy, urinalysis, hematology and serum biochemistry, except a significant decrease in albumin/globulin ratio in males treated with 1,000 mg/kg In contrast, a significant increase in relative heart weight was observed in both male and female rats treated with a high dose (2,000 mg/kg) of Geranti Bio-Ge Yeast^[○!R] In microscopic examination, mild lesions were found sporadically in both control and treatment groups in a dose-independent manner In spite of some alterations in water consumption, serum biochemistry and organ weights, such effects were not considered to include toxicopathological significance, based on the lack of dose-dependency, consistent time-course and gender relationship Taken together, it is suggested that no observed adverse effect level (NOAEL) of Geranti Bio-Ge Yeast^[○!R] is considered to be over 2,000 mg/kg in rats, and that long-term oral intake in humans might not exert adverse effects
日本トキシコロジー学会の論文
2004-12-27

ORAL SINGLE- AND REPEATED-DOSE TOXICITY STUDIES ON GERANTI BIO-GE YEAST^[○!R], ORGANIC GERMANIUM FORTIFIED YEASTS, IN RATS

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