Workshop Report: Scoping for the Development of a Proposal for an OECD Guidance Document on Fish Vitellogenin Assessment.

IF 8.4 4区 环境科学与生态学 Q2 ENVIRONMENTAL SCIENCES
Natalie Burden, Catherine Aubee, Jacqueline Augusiak, Marta Baccaro, Svenja Boehler, Francois Brion, Rebecca J Brown, Katherine K Coady, Zhichao Dang, Elke Eilebrecht, Teresa Fagundes, Tom Fisher, Mike Fryer, Zhenglei Gao, Tracey Goodband, Markus Hecker, Henrik Holbech, Stefan Hoeger, Miriam Jacobs, Ioanna Katsiadaki, Philippa Kearney, Oliver Koerner, Julie Krzykwa, Joseph Marini, Richard Maunder, Samuel K Maynard, Frank Mikkelsen, Valentin Mingo, Grace H Panter, Audrey Pearson, Francesca Pellizzato, Edward R Salinas, Suzanne Z Schneider, Amy Snow, Fiona Sewell, Petra Stahlschmidt, Karen Thorpe, Daniel L Villeneuve, Lennart Weltje, James R Wheeler, Hiroshi Yamamoto
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引用次数: 0

Abstract

This report summarises discussions of an international workshop in May 2024, aiming to scope the development needs of a proposal for an Organisation for Economic Cooperation and Development (OECD) Guidance Document on vitellogenin (VTG) analysis and assessment. VTG, an egg-yolk precursor protein in oviparous species, is an informative marker of possible chemical-induced endocrine activity (particularly estrogenicity). Vitellogenin measurement is included in several standardised Test Guidelines published by the OECD and United States Environmental Protection Agency for the assessment of endocrine activity of chemicals in fish (and one in amphibians). However, in vivo VTG data across and within fish species can be highly variable and influenced by both technical and biological factors, affecting the reliability and interpretation of results. This poses a challenge for regulatory decision making and can trigger potentially unnecessary vertebrate studies or prevent necessary further investigations. The workshop brought together 42 experts from different sectors and geographies, to discuss three key aspects regarding VTG assessment: 1) technical/laboratory factors and VTG quantification; 2) data handling and statistics, and 3) interpreting the biological relevance of VTG responses. The workshop participants discussed the development and needs of a Guidance Document to provide harmonised recommendations, best practices, quality assurance criteria, and minimum reporting standards for VTG assessment in regulatory studies across the different test guidelines. Several areas were identified where further work and discussion are needed to inform on the development of the Guidance Document, such as the use of historical control data, the identification of potential outliers, the presentation of data, and analysis of case study examples. Provision of such a Guidance Document will further support the use of VTG as a relevant marker for a key aspect of endocrine activity assessment for regulatory decision making. A formal project was subsequently accepted onto the OECD Test Guideline workplan in April 2025.

研讨会报告:制定经合组织鱼类卵黄原蛋白评估指导文件提案的范围。
本报告总结了2024年5月国际研讨会的讨论,旨在确定经济合作与发展组织(OECD)关于卵黄蛋白原(VTG)分析和评估的指导文件提案的发展需求。VTG是卵生物种的一种卵黄前体蛋白,是一种可能的化学诱导内分泌活性(特别是雌激素性)的信息标记。卵黄原蛋白的测量已列入经合发组织和美国环境保护局出版的若干标准化测试准则,用于评估鱼类(和两栖动物)体内化学品的内分泌活动。然而,鱼类之间和鱼类内部的体内VTG数据可能变化很大,并受到技术和生物因素的影响,从而影响结果的可靠性和解释。这对监管决策提出了挑战,并可能引发不必要的脊椎动物研究或阻止必要的进一步调查。研讨会汇聚了来自不同行业和地区的42位专家,讨论了VTG评估的三个关键方面:1)技术/实验室因素和VTG量化;2)数据处理和统计,以及3)解释VTG反应的生物学相关性。研讨会的参加者讨论了指引文件的发展及需要,以就不同测试指引的规管研究提供统一的建议、最佳做法、质素保证准则及最低报告标准。确定了需要进一步开展工作和讨论的几个领域,以便为指导文件的制定提供信息,例如使用历史控制数据、识别潜在异常值、提供数据以及分析案例研究示例。提供这样一份指导文件将进一步支持使用VTG作为监管决策中内分泌活动评估的一个关键方面的相关标记。一个正式项目随后于2025年4月被纳入经合组织测试指南工作计划。
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来源期刊
Integrated Environmental Assessment and Management
Integrated Environmental Assessment and Management ENVIRONMENTAL SCIENCESTOXICOLOGY&nbs-TOXICOLOGY
CiteScore
5.90
自引率
6.50%
发文量
156
期刊介绍: Integrated Environmental Assessment and Management (IEAM) publishes the science underpinning environmental decision making and problem solving. Papers submitted to IEAM must link science and technical innovations to vexing regional or global environmental issues in one or more of the following core areas: Science-informed regulation, policy, and decision making Health and ecological risk and impact assessment Restoration and management of damaged ecosystems Sustaining ecosystems Managing large-scale environmental change Papers published in these broad fields of study are connected by an array of interdisciplinary engineering, management, and scientific themes, which collectively reflect the interconnectedness of the scientific, social, and environmental challenges facing our modern global society: Methods for environmental quality assessment; forecasting across a number of ecosystem uses and challenges (systems-based, cost-benefit, ecosystem services, etc.); measuring or predicting ecosystem change and adaptation Approaches that connect policy and management tools; harmonize national and international environmental regulation; merge human well-being with ecological management; develop and sustain the function of ecosystems; conceptualize, model and apply concepts of spatial and regional sustainability Assessment and management frameworks that incorporate conservation, life cycle, restoration, and sustainability; considerations for climate-induced adaptation, change and consequences, and vulnerability Environmental management applications using risk-based approaches; considerations for protecting and fostering biodiversity, as well as enhancement or protection of ecosystem services and resiliency.
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