Amy Brooks and Hanna Schuster have co-authored a journal article that reviews the use of historical control data (HCD) in the interpretation of ecotoxicity data, with the aim of discussing the case for better use of HCD in ecotoxicology assessments, using case studies to show the use of HCD in the interpretation of a range of different studies. It is hoped that this will raise the issue in ecotoxicology and encourage organisations such as OECD and EFSA to develop guidance on how to perform such assessments on historical data, leading to greater use and regulatory acceptance. 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.
You can read the full open access article on the ‘Ecotoxicology’ journal website:
Historical control data for the interpretation of ecotoxicity data: are we missing a trick?
Authors: Amy C. Brooks, Manousos Foudoulakis, Hanna S. Schuster and James R. Wheeler
Abstract: 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.
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