Cambridge Environmental Assessments, Cambridge, UK.
Corteva Agriscience™, Agriculture Division of DowDuPont™, Abingdon, UK.
Ecotoxicology. 2019 Dec;28(10):1198-1209. doi: 10.1007/s10646-019-02128-9. Epub 2019 Nov 6.
Wildlife can be exposed to chemicals in the environment from various anthropogenic sources. Ecotoxicity studies, undertaken to address the risks from potential exposure to chemicals, vary in their design e.g. duration of exposure, effect types and endpoints measured. Ecotoxicity studies measure biological responses to test item exposure. Responses can be highly variable, with limited opportunity for control of extrinsic sources of variability. It is critical to distinguish between treatment-related effects and background 'normal variability' when interpreting results. Historical control data (HCD) can be a valuable tool in contextualising results from single studies against previous studies performed under similar conditions. This paper discusses the case for better use of HCD in ecotoxicology assessments, illustrating with case studies the value and difficulties of using HCD in interpretation of results of standard and higher-tier study designs. HCD are routinely used in mammalian toxicology for human health assessments, but not directly in ecotoxicology. The possible reasons for this are discussed e.g., different data types, the potential to mask effects, and the lack of guidance. These concerns are real but not insurmountable and we would like to see organisations such as OECD, EFSA and USEPA develop guidance on the principles of HCD collection. Hopefully, this would lead to greater use of HCD and regulatory acceptance. We believe this is not only a scientifically valid approach but also an ethical issue that is in line with societally driven legal mandates to minimise the use of vertebrate testing in chemical regulatory decision making.
野生动物可能会从各种人为来源的环境中接触到化学物质。为了应对潜在暴露于化学物质的风险而进行的生态毒理学研究在设计上存在差异,例如暴露时间、测量的效应类型和终点。生态毒理学研究测量生物对测试物质暴露的反应。这些反应可能高度可变,对外源性变异性的控制机会有限。在解释结果时,区分与处理相关的效应和背景“正常变异性”至关重要。历史对照数据(HCD)可以成为将单一研究的结果与在类似条件下进行的先前研究进行对比的有价值的工具。本文讨论了在生态毒理学评估中更好地利用 HCD 的情况,通过案例研究说明了在解释标准和更高层次的研究设计的结果时使用 HCD 的价值和困难。HCD 通常用于人类健康评估的哺乳动物毒理学中,但不在生态毒理学中直接使用。讨论了可能存在的原因,例如不同的数据类型、潜在的掩蔽效应以及缺乏指导。这些问题确实存在,但并非无法克服,我们希望看到 OECD、EFSA 和 USEPA 等组织制定关于 HCD 收集原则的指南。希望这将导致更多地使用 HCD 和监管机构的认可。我们认为,这不仅是一种科学有效的方法,也是符合社会驱动的法律要求的伦理问题,即尽量减少脊椎动物测试在化学监管决策中的使用。