Abstract:
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.
摘要:
β-月桂烯是一种天然存在于多种食物中的调味物质。应欧洲食品安全局(EFSA)要求提供有关β-月桂烯的其他毒理学数据,SpragueDawley大鼠组(10/性别/组)接受了包含0、700、2100或4200ppmβ-月桂烯的饮食,旨在提供标称剂量为0、50、150或300mg/kgbw/天。根据体重,饲料消费,和物质稳定性数据,经计算,男性β-月桂烯的最终日摄入量为20.4、58.8和115.2mg/kgbw,女性为24.2、70.0和135.9mg/kgbw。对临床观察没有影响,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可归因于摄入β-月桂烯。男女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。根据饲料消耗量和试验物质在日粮中的稳定性,男性和女性的NOAEL计算为115和136毫克/千克体重/天,分别。