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PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
5
pubmed:dateCreated
2005-2-24
pubmed:abstractText
Single- and 13-week repeated-dose toxicities of Geranti Bio-Ge Yeast, organic germanium fortified yeasts, were investigated in dogs. Both sexes of Beagle dogs 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, no animal dead, moribund, or showing clinical signs or changes in body weight gain was found. In repeated-dose toxicity study, there were no considerable changes in ophthalmoscopy and urinalysis. Several alterations were observed in electrocardiography, hematology and blood biochemistry, including heart rate, R-R interval, QT correcting, reticulocytes, activated partial thromboplastin time and albumin/globulin ratio in only male dogs, but not in females, administered with Geranti Bio-Ge Yeast in a dose-independent manner. In gross findings, several cases of abnormal findings were observed in both control and treatment groups, showing diffuse dark brown to black discoloration of liver, in a dose-independent manner. In microscopic examination, mild lesions, including cholestasis and inflammatory cell foci in liver, kidneys and prostate, were found sporadically in both control and treatment groups. In spite of some alterations in electrocardiography, hematology, blood biochemistry, gross and microscopic findings, such effects were not considered to include toxicopathological significance, based on the marginal changes within normal ranges and 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 2,000 mg/kg in dogs, and that long-term treatment in clinical trials might not exert adverse effects.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
0388-1350
pubmed:author
pubmed:issnType
Print
pubmed:volume
29
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
555-69
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:15729010-Administration, Oral, pubmed-meshheading:15729010-Animals, pubmed-meshheading:15729010-Body Weight, pubmed-meshheading:15729010-Dogs, pubmed-meshheading:15729010-Dose-Response Relationship, Drug, pubmed-meshheading:15729010-Drug Administration Schedule, pubmed-meshheading:15729010-Eating, pubmed-meshheading:15729010-Electrocardiography, pubmed-meshheading:15729010-Female, pubmed-meshheading:15729010-Germanium, pubmed-meshheading:15729010-Heart, pubmed-meshheading:15729010-Kidney, pubmed-meshheading:15729010-Liver, pubmed-meshheading:15729010-Male, pubmed-meshheading:15729010-Organ Size, pubmed-meshheading:15729010-Organometallic Compounds, pubmed-meshheading:15729010-Prostate, pubmed-meshheading:15729010-Sex Factors, pubmed-meshheading:15729010-Toxicity Tests, pubmed-meshheading:15729010-Yeasts
pubmed:year
2004
pubmed:articleTitle
Oral single- and repeated-dose toxicity studies on Geranti Bio-Ge Yeast, organic germanium fortified yeasts, in dogs.
pubmed:affiliation
Biotoxtech Co., Ltd., Ochang Scientific and Industrial Complex, Cheongwon, Korea.
pubmed:publicationType
Journal Article, Comparative Study