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Absence of renal adverse effects from β-myrcene dietary administration in OECD guideline-compliant subchronic toxicity study
Food and Chemical Toxicology ( IF 4.3 ) Pub Date : 2018-07-04 , DOI: 10.1016/j.fct.2018.07.004
Maria Bastaki , Michel Aubanel , Mark Bauter , Thierry Cachet , Jan Demyttenaere , Maodo Malick Diop , Christie L. Harman , Shim-mo Hayashi , Gerhard Krammer , Xiaodong Li , Craig Llewellyn , Odete Mendes , Kevin J. Renskers , Jürgen Schnabel , Benjamin P.C. Smith , Sean V. Taylor

β-Myrcene is a flavoring substance that occurs naturally in a large variety of foods. At the request of the European Food Safety Authority (EFSA) for additional toxicological data on β-myrcene, groups of Sprague Dawley rats (10/sex/group) were administered diets containing 0, 700, 2100, or 4200 ppm of β-myrcene designed to provide nominal doses of 0, 50, 150, or 300 mg/kg bw/day in a 90-day GLP-compliant study. Based on body weights, feed consumption, and substance stability data, final estimated daily intakes of β-myrcene were calculated to be 20.4, 58.8, and 115.2 mg/kg bw for males and 24.2, 70.0, and 135.9 mg/kg bw for females. No effects on clinical observations, hematology and clinical chemistry parameters, organ weights, or macroscopic and histopathological examinations were found attributable to ingestion of β-myrcene. The oral no-observed-adverse-effect level (NOAEL) for rats of both sexes was the highest dose tested. Based on feed consumption and test substance stability in the diet, the NOAEL was calculated to be 115 and 136 mg/kg bw/day for males and females, respectively.



中文翻译:

在经合组织准则下的亚慢性毒性研究中,无β-月桂烯饮食饮食对肾脏的不良影响

β-月桂烯是多种食物中天然存在的调味物质。应欧洲食品安全局(EFSA)的要求,提供有关β-月桂烯的其他毒理学数据,对Sprague Dawley大鼠组(每组10只/性别)进行饮食,使其饮食中含有0、700、2100或4200 ppm的β-月桂烯在一项为期90天的GLP兼容研究中,设计用于提供0、50、150或300 mg / kg bw /天的标称剂量。根据体重,饲料消耗和物质稳定性数据,最终估计的男性每日β-月桂烯摄入量为20.4、58.8和115.2 mg / kg bw,女性为24.2、70.0和135.9 mg / kg bw 。没有发现由于摄入β-月桂烯对临床观察,血液学和临床化学参数,器官重量或宏观和组织病理学检查有影响。雌雄同体大鼠的口服未观察到的不良反应水平(NOAEL)是测试的最高剂量。根据饲料中的饲料消耗和测试物质的稳定性,男性和女性的NOAEL分别为115和136 mg / kg bw /天。

更新日期:2018-07-04
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