标准摘要
[中文适用范围]: 本文件规定了体外生物测定结果的生物等效性浓度(BEQ)推导方法,这些结果是基于对生物过程的影响测量得出的,例如酶诱导或细胞生长。所描述的概念可以用于任何经过适用性验证的生物测定。为推导BEQ浓度,样本对生物过程中产生的影响表示为一种参考化合物的浓度,该浓度对生物过程产生相同程度的影响。本文档中的“样本”一词涵盖环境样本、以及作为测试项目使用的纯物质或化学混合物。可为环境水样、环境水样的萃取液(包括自来水或包含一种或多于一种化学品的溶液)推导出BEQ浓度。 [外文原描述]: This document specifies the derivation of biological equivalence (BEQ) concentrations for results of in vitro bioassays which are based on measuring effects on a biological process such as enzyme induction or cellular growth. The concept described here can be used for any biological assay after the proof of its applicability. To derive BEQ concentrations, the effect on a biological process caused by a sample – i.e. the activity of the sample – is expressed in terms of a concentration of a reference compound which results in an equivalent effect on the process. The term "sample" used in this document addresses environmental samples as well as defined mixtures and pure compounds used as test item in a bioassay. BEQ concentrations can be derived for environmental water samples, extracts of environmental water samples including tap water or solutions of pure chemicals or mixtures of chemicals.
英文名称Water quality — Calculation of biological equivalence (BEQ) concentrations