Eurofins Regulatory, Rheinfelden, Switzerland.
Environ Toxicol Chem. 2013 Feb;32(2):442-52. doi: 10.1002/etc.2085.
Diclofenac (DCF) is a widely used nonsteroidal anti-inflammatory drug that is regularly detected in surface waters. To support a robust aquatic risk assessment, two early life stage (ELS) tests, compliant with the Organisation for Economic Co-operation and Development (OECD) test guideline 210, were conducted in rainbow trout and in zebrafish. Population relevant endpoints, such as hatching, growth, and survival, and in the trout study, histopathological effects in potential target organs, were examined. The bioconcentration of DCF in rainbow trout was measured in a separate study according to OECD test guideline 305. The bioconcentration factor (BCF) in rainbow trout remained below 10, demonstrating no relevant bioconcentration of DCF in fish. In the rainbow trout ELS test, the no observed effect concentration (NOEC) including histopathology was 320 µg/L. The effect of DCF on zebrafish growth was less clear, and the NOEC can be interpreted as 10 µg/L. However, for a number of reasons, the authors consider the moderately reduced growth of zebrafish exposed to concentrations of up to 320 µg/L not a repeatable, treatment-related effect of DCF. This leads us to a conclusion that DCF has, with high probability, no adverse effect on both fish species up to 320 µg/L. This NOEC indicates a sufficient safety margin for fish populations, because concentrations of DCF in European rivers are in the range of ng/L to low µg/L.
双氯芬酸（DCF）是一种广泛使用的非甾体抗炎药，经常在地表水中检测到。为了支持强有力的水生风险评估，进行了两项符合经济合作与发展组织（OECD）测试指南 210 的早期生命阶段（ELS）测试，分别在虹鳟鱼和斑马鱼中进行。检查了与种群相关的终点，如孵化、生长和存活，以及在鳟鱼研究中潜在靶器官的组织病理学效应。根据 OECD 测试指南 305，在单独的研究中测量了双氯芬酸在虹鳟鱼中的生物浓缩。虹鳟鱼的生物浓缩因子（BCF）仍低于 10，表明双氯芬酸在鱼类中没有相关的生物浓缩。在虹鳟鱼 ELS 测试中，包括组织病理学的无观察效应浓度（NOEC）为 320µg/L。双氯芬酸对斑马鱼生长的影响不太明显，NOEC 可以解释为 10µg/L。然而，由于多种原因，作者认为暴露于高达 320µg/L 的浓度下的斑马鱼生长减缓，不是双氯芬酸的可重复、与处理相关的效应。这使我们得出结论，双氯芬酸极有可能对这两种鱼类在高达 320µg/L 的浓度下没有不良影响。这个 NOEC 表明鱼类种群有足够的安全裕度，因为欧洲河流中的双氯芬酸浓度在 ng/L 到低µg/L 范围内。
