Current opinion in toxicology最新文献

The Alarming Consequences of Workforce Reductions at the FDA, EPA, NIH and CDC in the United States☆ 美国FDA、EPA、NIH和CDC裁员的惊人后果☆

IF 4.6

Current opinion in toxicology Pub Date : 2025-05-02 DOI: 10.1016/j.cotox.2025.100530

Martin van den Berg PhD (Editor-in-Chief, Regulatory Toxicology & Pharmacology and Current Opinion in Toxicology), Daniel R. Dietrich PhD (Editor-in-Chief, Chemico-Biological Interactions, Computational Toxicology, and Journal of Toxicology and Regulatory Policy), Sonja von Aulock PhD (Editor-in-Chief, ALTEX – Alternatives to Animal Experimentation), Anna Bal-Price PhD (Editor-in-Chief, Reproductive Toxicology), Michael D. Coleman PhD (Editor-in-Chief, Environmental Toxicology and Pharmacology), Mark T.D. Cronin PhD (Editor-in-Chief, Computational Toxicology), Paul Jennings PhD (Editor-in-Chief, Toxicology in Vitro), Angela Mally PhD (Editor-in-Chief, Toxicology Letters), Mathieu Vinken PhD (Editor-in-Chief, Toxicology and NAM Journal), Matthew C. Wright PhD (Editor-in-Chief, Food and Chemical Toxicology)

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Assessment of immunotoxicity in the 21st century: Where we are and what we need to replace animals 21世纪免疫毒性评估：我们在哪里以及我们需要什么来取代动物

IF 4.6

Current opinion in toxicology Pub Date : 2025-04-24 DOI: 10.1016/j.cotox.2025.100529

Victor J. Johnson , Dori R. Germolec , Michael I. Luster , Emanuela Corsini

{"title":"Assessment of immunotoxicity in the 21st century: Where we are and what we need to replace animals","authors":"Victor J. Johnson , Dori R. Germolec , Michael I. Luster , Emanuela Corsini","doi":"10.1016/j.cotox.2025.100529","DOIUrl":"10.1016/j.cotox.2025.100529","url":null,"abstract":"<div><div>The field of immunotoxicity assessment has traditionally relied on animal models, which have raised ethical concerns and presented limitations in terms of predictive accuracy and relevance to human health. This paper reviews the current state of immunotoxicity evaluation, emphasizing the importance of transitioning away from animal testing. Modern approaches, including in vitro methods, human-based studies, adverse outcome pathways (AOPs), and computational modeling, are discussed as viable alternatives. These non-animal methods offer enhanced predictive power and the potential for regulatory acceptance, though technical and practical challenges remain. Case studies demonstrate the success of non-animal methods, such as AOP-based assessments for skin sensitization and the pyrogen assay using whole blood cytokine assays. Despite these advances, further research is needed in areas like respiratory sensitization, developmental immunotoxicology (DIT), and microphysiological systems (MPS). Recommendations are provided to accelerate the adoption of new approach methodologies (NAMs), focusing on AOP frameworks. In conclusion, the paper highlights the key findings from current non-animal immunotoxicity research and issues a call to action for advancing these methods to improve safety assessment practices in the 21st century.</div></div>","PeriodicalId":93968,"journal":{"name":"Current opinion in toxicology","volume":"43 ","pages":"Article 100529"},"PeriodicalIF":4.6,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144154589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Developmental neurotoxicity as a case example for a six-step framework for the sustainable regulatory implementation of NAMs 发育性神经毒性作为NAMs可持续监管实施六步框架的案例

IF 4.6

Current opinion in toxicology Pub Date : 2025-04-01 DOI: 10.1016/j.cotox.2025.100528

Jonathan Blum , Kristina Bartmann , Joyce de Paula Souza , Ellen Fritsche

{"title":"Developmental neurotoxicity as a case example for a six-step framework for the sustainable regulatory implementation of NAMs","authors":"Jonathan Blum , Kristina Bartmann , Joyce de Paula Souza , Ellen Fritsche","doi":"10.1016/j.cotox.2025.100528","DOIUrl":"10.1016/j.cotox.2025.100528","url":null,"abstract":"<div><div>New Approach Methodologies (NAMs) are advancing toxicology by offering reliable, human-relevant alternatives to traditional animal methods. This review outlines a six-step framework guiding NAMs from development to regulatory approval, using the Developmental Neurotoxicity (DNT) in vitro battery (IVB) as an example.</div><div>The framework begins with the development of robust test systems with human-relevant models (step 1). Next, a NAM-based roadmap aligns testing strategies with regulatory needs and encourages early stakeholder engagement (step 2). Test method readiness is assessed for biological relevance, reproducibility, and reliability (step 3). Scientific validation includes technical characterization, independent expert review, and transparent public data sharing (step 4). OECD recognition ensures a rigorous evaluation process before NAMs are included in official guidelines (step 5). Lastly, public availability through Contract Research Organizations (CROs) guarantees compliance with Good Laboratory Practice (GLP) and facilitates regulatory adoption (step 6).</div><div>This DNT IVB lifecycle exemplifies the implementation of NAMs, continuously evolving with scientific progress. It supports initiatives like the European Roadmap towards phasing out animal testing and the Safe and Sustainable by Design (SSbD) framework under the European Green Deal. By providing a structured pathway, this lifecycle approach fosters NAM-based, human-centric risk assessments for a more sustainable future in chemical safety testing.</div></div>","PeriodicalId":93968,"journal":{"name":"Current opinion in toxicology","volume":"42 ","pages":"Article 100528"},"PeriodicalIF":4.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143895795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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The European Partnership PARC’s role in actively promoting the uptake of new approach methodologies and next-generation risk assessment into regulatory risk assessment practice 欧洲伙伴关系PARC在积极推动新方法方法和下一代风险评估纳入监管风险评估实践中的作用

IF 4.6

Current opinion in toxicology Pub Date : 2025-01-29 DOI: 10.1016/j.cotox.2025.100517

Matthias Herzler , Mirjam Luijten , Philip Marx-Stoelting , Gilles Rivière

{"title":"The European Partnership PARC’s role in actively promoting the uptake of new approach methodologies and next-generation risk assessment into regulatory risk assessment practice","authors":"Matthias Herzler , Mirjam Luijten , Philip Marx-Stoelting , Gilles Rivière","doi":"10.1016/j.cotox.2025.100517","DOIUrl":"10.1016/j.cotox.2025.100517","url":null,"abstract":"<div><div>Existing approaches for human health risk assessment of chemicals have overall provided a high level of protection for EU citizens. However, the established assessment schemes face numerous challenges. Ethical and scientific concerns about using animals for safety testing have triggered awareness of the need for a paradigm shift, requiring new concepts for chemical risk assessment complementing and, in the long run, replacing existing schemes. Next-Generation Risk Assessment (NGRA) using new approach methodologies (NAMs) is commonly regarded as the way forward. However, adequately meeting regulatory needs is challenging. The European Partnership for the Assessment of Risks from Chemicals (PARC) supports the development of NGRA frameworks and their implementation at all levels, from developing adverse outcome pathways (AOPs), NAMs and integrated approaches to testing and assessments (IATAs), to designing new conceptual approaches and formulating strategic roadmaps. A particular strength of PARC is its focus on interaction and collaboration with stakeholders from all sectors of the chemical risk assessment community to promote cooperation, advance research, increase knowledge of chemical risk assessment and train methodological skills. Its results will help launch European and national strategies to reduce risks posed by hazardous chemicals, to reduce animal testing and to implement NGRA strategies in regulatory practice.</div></div>","PeriodicalId":93968,"journal":{"name":"Current opinion in toxicology","volume":"42 ","pages":"Article 100517"},"PeriodicalIF":4.6,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143508661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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The key characteristics concept 关键特征概念

IF 4.6

Current opinion in toxicology Pub Date : 2024-12-27 DOI: 10.1016/j.cotox.2024.100515

Martyn T. Smith

{"title":"The key characteristics concept","authors":"Martyn T. Smith","doi":"10.1016/j.cotox.2024.100515","DOIUrl":"10.1016/j.cotox.2024.100515","url":null,"abstract":"<div><div>In evaluating whether a chemical can cause cancer or another adverse outcome, three lines of evidence are typically considered: epidemiology, animal bioassays and mechanistic evidence. The key characteristics (KCs) form the basis of a uniform approach for searching, organizing, and evaluating mechanistic evidence to support hazard identification. KCs are the established properties of the toxicants themselves and are generated from our understanding of mechanisms of toxicity. KCs have been published for carcinogens, endocrine disruptors and reproductive, liver immune and cardiovascular toxicants. We noted that several KCs were common to different types of toxicants, whereas others were highly specific. Hence, there may be overlapping umbrella KCs for potentially hazardous bioactive chemicals that could be used in predictive toxicology. There are, however, also clearly unique KCs for chemicals that primarily target a specific organ and these unique KCs could be especially important to predicting target organ toxicity. It is possible that <em>in silico</em> approaches, <em>in vitro</em> tests, and <em>in vivo</em> biomarkers could be developed, which predict the “umbrella” and “unique” KCs of hazardous chemicals. However, given the significance of human evidence, the development of a set of biomarkers that could be used to measure the KCs in molecular epidemiology studies is also important.</div></div>","PeriodicalId":93968,"journal":{"name":"Current opinion in toxicology","volume":"41 ","pages":"Article 100515"},"PeriodicalIF":4.6,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143132944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Advancements in the developmental zebrafish model for predictive human toxicology 斑马鱼发育模型预测人类毒理学研究进展。

IF 4.6

Current opinion in toxicology Pub Date : 2024-12-24 DOI: 10.1016/j.cotox.2024.100516

Mackenzie L. Morshead, Robyn L. Tanguay

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Implementing AOPs use for pesticide neurotoxicity assessment 实施AOPs在农药神经毒性评价中的应用

IF 4.6

Current opinion in toxicology Pub Date : 2024-10-29 DOI: 10.1016/j.cotox.2024.100505

Barbara Viviani , Miriam Midali , Melania Maria Serafini , Iris Mangas

{"title":"Implementing AOPs use for pesticide neurotoxicity assessment","authors":"Barbara Viviani , Miriam Midali , Melania Maria Serafini , Iris Mangas","doi":"10.1016/j.cotox.2024.100505","DOIUrl":"10.1016/j.cotox.2024.100505","url":null,"abstract":"<div><div>Due to the unique characteristics of the nervous system, chemical exposures pose significant challenges in establishing definitive links to neurological adverse health effects. The key obstacles to neurotoxicity assessment include the complexity of the nervous system, species differences, extended developmental time, and cumulative exposure risks. Regulatory agencies have long required neurotoxicity testing, which has relied primarily on animal models. With increased mechanistic understanding and technological progress, other approaches become possible that could address some of the limitations of traditional neurotoxicity testing (e.g. high cost, ethical concerns, low precision, or human relevance). Recent international efforts to develop adverse outcome pathways (AOPs) and AOP-informed Integrated Approaches to Testing and Assessment offer new possibilities for neurotoxicity testing and assessment. This mini review highlights the advances, while addressing limitations, in the development and application of AOPs for both adult and developmental neurotoxicity as a way to address shortcomings in regulatory neurotoxicity assessment. Case studies are provided to illustrate the recent successful integration of AOPs into regulatory decision-making for pesticide risk assessment.</div></div>","PeriodicalId":93968,"journal":{"name":"Current opinion in toxicology","volume":"41 ","pages":"Article 100505"},"PeriodicalIF":4.6,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143132945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Adverse outcome pathway networks as the basis for the development of new approach methodologies: Liver toxicity as a case study 将不良后果路径网络作为开发新方法的基础：以肝脏毒性为例

IF 4.6

Current opinion in toxicology Pub Date : 2024-09-29 DOI: 10.1016/j.cotox.2024.100504

Mathieu Vinken

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New approach methodologies (NAMs) in drug safety assessment: A vision of the future 药物安全性评估中的新方法（NAMs）：未来展望

IF 4.6

Current opinion in toxicology Pub Date : 2024-09-04 DOI: 10.1016/j.cotox.2024.100502

Ruth A. Roberts

{"title":"New approach methodologies (NAMs) in drug safety assessment: A vision of the future","authors":"Ruth A. Roberts","doi":"10.1016/j.cotox.2024.100502","DOIUrl":"10.1016/j.cotox.2024.100502","url":null,"abstract":"<div><div>Much progress has been made in reducing and refining animal use in toxicology testing, but progress in the use of new approach methodologies (NAMs) to replace animals is disappointing. There are many highly sophisticated NAMs available, but societal, regulatory and political barriers to their implementation remain. Change requires vision, starting with imagining a future where we are successful. Specifically, this would comprise the registration of safe and effective medicines without animal tests. How do we achieve this vision? Thinking differently, in silico methods could be used to provide a detailed assessment of target- and modality-related toxicological risks, coupled with modelling of exposure. In vitro NAMs such as microphysiological systems, microelectrode array and ion channel panels could then be employed to address hypothetical risks. Finally, the safety of first time in human trials could be assessed and assured using circulating nanobots that measure conventional clinical pathology parameters alongside new biomarkers such as circulating tissue DNA. This may seem the stuff of fantasy, but imagination is key to shaping a better future and all change starts with a vision, however far-fetched it may seem today.</div></div>","PeriodicalId":93968,"journal":{"name":"Current opinion in toxicology","volume":"40 ","pages":"Article 100502"},"PeriodicalIF":4.6,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142314942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Editorial: Transforming toxicology one cell at a time: A special issue on the application of scRNA-seq to the study of environmental response 社论：一次改变一个细胞的毒理学：关于应用 scRNA-seq 研究环境反应的特刊

IF 4.6

Current opinion in toxicology Pub Date : 2024-09-02 DOI: 10.1016/j.cotox.2024.100503

Patrick Allard, Justin A. Colacino, Kristine L. Willett

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