title: Safety studies conducted on high-purity trans-resveratrol in experimental animals.
abstract: trans-Resveratrol is a naturally occurring polyphenolic compound found in a variety of foods, but predominantly in grapes. Safety studies were conducted on high-purity trans-resveratrol (Resvida), including skin and eye irritation, dermal sensitization, subchronic and reproductive toxicity, genotoxicity, and absorption, metabolism and excretion. Resvida was non-irritating to skin and eyes and non-sensitizing. It was non-mutagenic in a bacterial reverse mutation assay in Salmonella typhimurium and Escherichia coli, but exhibited clastogenic activity in a chromosomal aberration test in human lymphocytes. However, in an in vivo bone marrow micronucleus test in rats, Resvida was non-genotoxic. In a 28-day study, Resvida caused no adverse effects in rats at 50, 150 and 500 mg/kg bw/day. Similarly, in a 90-day study, Resvida did not cause any adverse effects in rats at up to 700 mg/kg bw/day; the highest dose tested. Resvida did not induce any adverse reproductive effects in an embryo-fetal toxicity study in rats at a dose of 750 mg/kg bw/day. Also, in vitro and in vivo absorption, metabolism, and excretion studies in Caco-2 cells, rat primary hepatocytes and male and female rats (in vivo) show that Resvida is readily absorbed, metabolized and excreted. These studies provide evidence that Resvida is well tolerated and non-toxic.
authors.affiliation: Burdock Group, Orlando, FL 32801, USA.
authors.forename: Lonnie D
authors.initials: LD
authors.lastname: Williams
authors.forename: George A
authors.initials: GA
authors.lastname: Burdock
authors.forename: James A
authors.initials: JA
authors.lastname: Edwards
authors.forename: Mareike
authors.initials: M
authors.lastname: Beck
authors.forename: Jochen
authors.initials: J
authors.lastname: Bausch
mesh_terms: D000818:Animals; D000975:Antioxidants / Q000493:pharmacokinetics / Q000633:toxicity*; D002869:Chromosome Aberrations; D004622:Embryo, Mammalian / Q000187:drug effects / Q000196:embryology; D047108:Embryonic Development / Q000187:drug effects; D005123:Eye / Q000187:drug effects / Q000473:pathology; D005260:Female; D006801:Humans; D023441:Local Lymph Node Assay; D008297:Male; D015162:Micronucleus Tests; D011247:Pregnancy; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D017208:Rats, Wistar; D012098:Reproduction / Q000187:drug effects; D000077185:Resveratrol; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D023422:Skin Irritancy Tests; D013267:Stilbenes / Q000493:pharmacokinetics / Q000633:toxicity*; D018675:Toxicity Tests
chemical_list: D000975:Antioxidants; D013267:Stilbenes; D000077185:Resveratrol