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This document is a report of the Workshop on a framework for the development and use of integrated approaches to testing and assessment which was held on 17-19 November 2014 in Crystal City VA, USA. This framework should provide guiding principles, and technical guidance on how results from ...
This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.
The OECD has been developing guidance documents and tools for the use of alternative methods such as (Q)SAR, chemical categories and Adverse Outcome Pathways (AOPs) as a part of Integrated Approaches for Testing and Assessment (IATA). However, there is a need for a systematic framework to characterise the individual biological and toxicological relevance of alternative methods in assessing chemicals in predicting toxicological endpoints.
Social pressure to minimize the use of animal testing, the ever-increasing concern on animal welfare, and the need for more human-relevant and more predictive toxicity tests are some of the drivers for new approaches to chemical screening. This book focuses on The Adverse Outcome Pathway, an analytical construct that describes a sequential chain of causally linked events at different levels of biological organization that lead to an adverse health or ecotoxicological effect. While past efforts have focused on toxicological pathway-based vision for human and ecological health assessment relying on in vitro systems and predictive models, The Adverse Outcome Pathway framework provides a simplified and structured way to organize toxicological information. Within the book, a systems biology approach supplies the tools to infer, link, and quantify the molecular initiating events and the key events and key event relationships leading to adverse outcomes. The advancement of these tools is crucial for the successful implementation of AOPs for regulatory purposes.
In this document the importance of mechanistic consideration in quantitative structure-activity relationship ((Q)SAR) analysis, the critical role of mechanistic consideration in improving various (Q)SAR approaches and possible integrative approaches of combining chemoinformatics and ...
The report outlines the technical aspects of the various approaches and methodologies available with respect to the assessment of risks from combined exposures to multiple chemicals. The document draws from approaches applied and experience gained in the regulatory context and will therefore be most relevant to the regulatory authorities addressing chemicals, the regulated community and other interested stakeholders.
This document presents a review of fish toxicity testing for the regulatory purpose of chemical safety. The main focus is on fish toxicity, but fish bioaccumulation is also considered where relevant.
In this book, both basic and advanced concepts are discussed for considering mixtures from initial exposure characterization through evaluation of risk associated with combined exposures. This book will provide an introduction to key issues and multiple options for evaluating both the toxicity of mixtures as well as the risk associated with exposure to mixtures. Additionally, promising tools adapted from other disciplines will be discussed in the context of mixtures toxicology and risk assessment. Finally, the discussion will move beyond chemical mixtures to address incorporating non-chemical stressors into toxicity studies and cumulative risk assessments. Although exposure to multiple chemical and non-chemical stressors is the rule, not the exception, consideration of mixtures in toxicology and risk assessment continues to be a significant challenge. This book will be an essential resource for researchers and professionals in the fields of toxicology, epidemiology, exposure science, risk assessment, and statistics.
Enables researchers to assess the effects of endocrine disrupters as well as comply with new environmental regulations Endocrine disrupters are chemicals both man-made and natural that interfere with the body's endocrine system, potentially resulting in adverse developmental, reproductive, neurological, and immune effects. In recent years, a number of regulatory authorities around the world have drafted or enacted legislation that requires the detection and assessment of the effects of endocrine disrupters on both humans and wildlife. In response, this book provides comprehensive, up-to-date information on the latest tested and proven methods used to detect and assess the environmental hazards posed by endocrine-disrupting chemicals. Endocrine Disrupters is divided into chapters covering each major taxon as well as chapters dedicated to hazard assessment and regulation. The book covers testing methods for all the vertebrate groups and several invertebrate phyla, including: Crustaceans and mollusks Insects Fish Amphibians and reptiles Birds and mammals Moreover, the book emphasizes practical, ethical testing methods that combine sensitivity, efficiency, statistical power, and reasonable cost. Each chapter is written by one or more international experts in ecotoxicology, offering readers step-by-step guidance for implementing each method based on the latest research and the authors' firsthand laboratory experience. Furthermore, all the chapters have been subjected to a rigorous peer review and edited in light of the reviewers' comments. References at the end of each chapter guide readers to the literature in the field. Endocrine Disrupters is recommended for scientists who need to test chemicals for possible endocrine-disrupting properties. It is also recommended for regulatory authorities who need to decide whether particular chemicals can be safely marketed.