Oral single- and repeated-dose toxicity studies on Geranti Bio-Ge yeast, organic germanium fortified yeasts, in rats

J Toxicol Sci. 2004 Dec;29(5):541-53. doi: 10.2131/jts.29.541.

Abstract

Single- and 13-week repeated-dose toxicities of Geranti Bio-Ge Yeast, 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. 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 is considered to be over 2,000 mg/kg in rats, and that long-term oral intake in humans might not exert adverse effects.

Publication types

  • Comparative Study

MeSH terms

  • Administration, Oral
  • Animals
  • Body Weight / drug effects
  • Dose-Response Relationship, Drug
  • Drinking / drug effects
  • Drug Administration Schedule
  • Eating / drug effects
  • Female
  • Germanium*
  • Heart / drug effects
  • Heart / physiology
  • Male
  • Organ Size / drug effects
  • Organometallic Compounds / administration & dosage
  • Organometallic Compounds / toxicity*
  • Rats
  • Rats, Sprague-Dawley
  • Sex Factors
  • Yeasts*

Substances

  • Organometallic Compounds
  • Germanium