title: Mutagenicity and safety evaluation of ethanolic extract of Prunus mume.
abstract: The ethanolic extract of Prunus mume (EPM) is a novel polyphenol preparation derived from branches (with leaves) of Prunus mume, which could be used as a functional ingredient for antioxidant and antiobesity therapy. The purpose of this study was to evaluate the safety of EPM. An EPM was prepared and evaluated for oral acute and subacute toxicity in Sprague-Dawley rats, while its mutagenic potential was assessed by a reverse mutation test using Salmonella typhimurium, by a bone marrow cell micronucleus test using ICR mice, and by a sperm abnormality test using ICR mice. The results showed no acute lethal effects at the maximal tested EPM dose of 20 g/kg bw in either rats or mice, suggesting that EPM can be regarded as virtually nontoxic. Administration at levels of 0.84, 1.67, and 3.33 g/kg bw to rats for 30 d did not induce any significant hematological, clinical, chemical, or histopathological changes. No mutagenicity evidence was detected in any of the 3 mutagenic tests. The level of "no observed adverse effect" (NOAEL) for EPM was above 3.33 g/kg bw for the subacute toxicity study.
authors.affiliation: Dept. of Food Science and Nutrition, School of Biosystems Engineering and Food Science, Zhejiang Univ., Hangzhou 310029, Zhejiang Province, PR China.
authors.forename: Baiyi
authors.initials: B
authors.lastname: Lu
authors.forename: Xiaoqin
authors.initials: X
authors.lastname: Wu
authors.forename: Yuejie
authors.initials: Y
authors.lastname: Dong
authors.forename: Jinyan
authors.initials: J
authors.lastname: Gong
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhang
mesh_terms: D000818:Animals; D000431:Ethanol; D005260:Female; D005419:Flavonoids / Q000032:analysis; D055951:Functional Food; D007783:Lactones / Q000032:analysis; D008297:Male; D051379:Mice; D008813:Mice, Inbred ICR; D009153:Mutagens / Q000737:chemistry / Q000633:toxicity*; D019055:No-Observed-Adverse-Effect Level; D010636:Phenols / Q000032:analysis; D010936:Plant Extracts / Q000737:chemistry / Q000633:toxicity*; D018515:Plant Leaves / Q000737:chemistry; D018547:Plant Stems / Q000737:chemistry; D059808:Polyphenols; D027861:Prunus / Q000737:chemistry*; D011897:Random Allocation; D051381:Rats; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects; D018675:Toxicity Tests; D014315:Triterpenes / Q000032:analysis
chemical_list: D005419:Flavonoids; D007783:Lactones; D009153:Mutagens; D010636:Phenols; D010936:Plant Extracts; D059808:Polyphenols; D014315:Triterpenes; D000431:Ethanol