A tiered approach to threshold of regulation

被引:151
作者
Cheeseman, MA [1 ]
Machuga, EJ [1 ]
Bailey, AB [1 ]
机构
[1] US FDA, Ctr Food Safety & Appl Nutr, Washington, DC 20204 USA
关键词
threshold of regulation; structure-activity relationships; structural alerts; food additives; mutagenicity; food packaging;
D O I
10.1016/S0278-6915(99)00024-1
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
This paper presents methods for extending the principle of a single "threshold of regulation" to a range of dietary concentrations between 0.5 and 15 parts per billion by using structure-activity relationships, genotoxicity. and short-term toxicity data. Thc database used to develop the FDA's threshold of regulation was examined to determine whether structural parameters or the result of certain short-term toxicity tests could be used to define a subset of less potent substances that supports higher threshold levels, In addition, results of reproductive toxicity rests for 3306 compounds and other multidose toxicity tests for 2542 compounds were compared with the database of carcinogenic potencies to establish that carcinogenic endpoints are the must conservative toxicity endpoint for establishing thresholds of regulation. (C) 1999 Elsevier Science Ltd. All rights reserved.
引用
收藏
页码:387 / 412
页数:26
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