Genotoxicity studies on a high-purity rebaudioside A preparation.
Rebaudioside A (Reb A) is a steviol glycoside isolated from the leaves of the Stevia rebaudiana plant. This non-nutritive, natural sweetener is reported to be 250-450 times sweeter than sucrose and has potential for wide use in the US diet, and is used in Japan and South America today. The safety of Reb A has been investigated in several recently published studies and information on genotoxicity is described herein. Reb A was investigated for its potential to induce genotoxicity in three in vitro and two in vivo assays (conducted according to OECD guidelines). Reb A was non-mutagenic in an Ames test using Salmonella typhimurium and Escherichia coli, in a chromosomal aberration test using Chinese Hamster V79 cells and in a mouse lymphoma assay using L5178Y+/- cells, all studies were conducted at concentrations up to 5000 microg/ml, with and without metabolic activation. Also, Reb A was non-genotoxic in a bone marrow micronucleus test in mice at doses up 750 mg/kg bw and in an unscheduled DNA synthesis test in rats at 2000 mg/kg bw. These studies provide additional evidence that Reb A is not genotoxic at the doses tested and further support the generally recognized as safe determination of Reb A.
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Lonnie D
LD
Williams
George A
GA
Burdock
D000818:Animals; D045744:Cell Line, Tumor; D002869:Chromosome Aberrations / Q000187:drug effects; D006224:Cricetinae; D004247:DNA / Q000096:biosynthesis / Q000235:genetics; D004260:DNA Repair / Q000187:drug effects; D045786:Diterpenes, Kaurane / Q000633:toxicity*; D004926:Escherichia coli / Q000187:drug effects / Q000235:genetics; D005260:Female; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy / Q000473:pathology; D008297:Male; D051379:Mice; D015162:Micronucleus Tests; D009152:Mutagenicity Tests; D009153:Mutagens / Q000633:toxicity*; D051381:Rats; D013549:Sweetening Agents / Q000633:toxicity*
D045786:Diterpenes, Kaurane; D009153:Mutagens; D013549:Sweetening Agents; D004247:DNA; C025474:rebaudioside A