Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale.
Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale.
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DOI：
10.1080/01635581.2016.1224366
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发表时间：
2016-11
期刊：
影响因子：
--
通讯作者：
Williams GM
中科院分区：
文献类型：
--
作者：
Berry C;Brusick D;Cohen SM;Hardisty JF;Grotz VL;Williams GM
世界各地的监管机构根据一系列研究发现，非营养甜味剂三氯蔗糖是非致癌的。通过使用适当的关键词对电子数据库进行全面检索，对这些和其他研究进行了审查，并在此报告了审查结果。还提供了监管机构评估致癌性潜力所依赖的研究类型概述作为背景。理化和药代动力学/毒代动力学研究证实了在使用条件下的稳定性，并且未发现具有致癌潜力的代谢产物。体外和体内试验显示无经证实的遗传毒性活性。动物模型的长期致癌性研究未提供三氯蔗糖致癌潜力的证据。在健康成人的研究中，三氯蔗糖耐受性良好，没有毒性或其他可能提示潜在致癌作用的变化的证据。总之，即使暴露水平比预期的每日摄入水平范围大几个数量级，三氯蔗糖也没有表现出致癌活性。
Regulatory authorities worldwide have found the nonnutritive sweetener, sucralose, to be noncarcinogenic, based on a range of studies. A review of these and other studies found through a comprehensive search of electronic databases, using appropriate key terms, was conducted and results of that review are reported here. An overview of the types of studies relied upon by regulatory agencies to assess carcinogenicity potential is also provided as context. Physiochemical and pharmacokinetic/toxicokinetic studies confirm stability under conditions of use and reveal no metabolites of carcinogenic potential. In vitro and in vivo assays reveal no confirmed genotoxic activity. Long-term carcinogenicity studies in animal models provide no evidence of carcinogenic potential for sucralose. In studies in healthy adults, sucralose was well-tolerated and without evidence of toxicity or other changes that might suggest a potential for carcinogenic effects. In summary, sucralose does not demonstrate carcinogenic activity even when exposure levels are several orders of magnitude greater than the range of anticipated daily ingestion levels.
影响因子：
3.3
作者：
Aguilar, Fernando;Crebelli, Riccardo;Wright, Matthew
通讯作者：
Wright, Matthew
影响因子：
3.3
作者：
Aguilar, Fernando;Crebelli, Riccardo;Wright, Matthew
通讯作者：
Wright, Matthew