Validation of Alternative Methods for Toxicity Testing

Validation of Alternative Methods for Toxicity Testing PDF

Author: Chantra Eskes

Publisher: Springer

Published: 2016-09-26

Total Pages: 407

ISBN-13: 3319338269

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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 History of Alternative Test Methods in Toxicology

The History of Alternative Test Methods in Toxicology PDF

Author:

Publisher: Academic Press

Published: 2018-10-20

Total Pages: 352

ISBN-13: 0128136987

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The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement,Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated, miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing, capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialized areas, such as inhalation toxicity studies. The History of Alternative Test Methods in Toxicology uses a chronological approach to demonstrate how the use of alternative methods has evolved from their conception as adjuncts to traditional animal toxicity tests to replacements for them. This volume in the History of Toxicology and Environmental Health series explores the history of alternative test development, validation, and use, with an emphasis on humanity and good science, in line with the Three Rs (Replacement, Reduction, Refinement) concept expounded by William Russell and Rex Burch in 1959 in their now-classic volume, The Principles of Humane Experimental Technique. The book describes the historical development of technologies that have influenced the application of alternatives in toxicology and safety testing. These range from single cell monocultures to sophisticated miniaturised and microfluidic organism-on-a-chip devices, and also include molecular modelling, chemoinformatics and QSAR analysis, and the use of stem cells, tissue engineering and hollow fibre bioreactors. This has been facilitated by the wider availability of human tissues, advances in tissue culture, analytical and diagnostic methods, increases in computational processing capabilities, and a greater understanding of cell biology and molecular mechanisms of toxicity. These technological developments have enhanced the range and information content of the toxicity endpoints detected, and therefore the relevance of test systems and data interpretation, while new techniques for non-invasive diagnostic imaging and high resolution detection methods have permitted an increased role for human studies. Several key examples of how these technologies are being harnessed to meet 21st century safety assessment challenges are provided, including their deployment in integrated testing schemes in conjunction with kinetic modelling, and in specialised areas, such as inhalation toxicity studies.

Alternative Toxicological Methods

Alternative Toxicological Methods PDF

Author: Harry Salem

Publisher: CRC Press

Published: 2003-03-26

Total Pages: 616

ISBN-13: 0203008790

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Bringing together the recent and relevant contributions of over 125 scientists from industry, government, and academia in North America and Western Europe, Alternative Toxicological Methods explores the development and validation of replacement, reduction, and refinement alternatives (the 3Rs) to animal testing. Internationally recognized scientist

Toxicity Testing for Assessment of Environmental Agents

Toxicity Testing for Assessment of Environmental Agents PDF

Author: National Research Council

Publisher: National Academies Press

Published: 2006-04-07

Total Pages: 270

ISBN-13: 0309164869

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Toxicity testing in laboratory animals provides much of the information used by the Environmental Protection Agency (EPA) to assess the hazards and risks associated with exposure to environmental agents that might harm public health or the environment. The data are used to establish maximum acceptable concentrations of environmental agents in drinking water, set permissible limits of exposure of workers, define labeling requirements, establish tolerances for pesticides residues on food, and set other kinds of limits on the basis of risk assessment. Because the number of regulations that require toxicity testing is growing, EPA called for a comprehensive review of established and emerging toxicity-testing methods and strategies. This interim report reviews current toxicity-testing methods and strategies and near-term improvements in toxicity-testing approaches proposed by EPA and others. It identifies several recurring themes and questions in the various reports reviewed. The final report will present a long-range vision and strategic plan to advance the practices of toxicity testing and human health assessment of environmental contaminants.

Alternative Methods for Toxicity Testing

Alternative Methods for Toxicity Testing PDF

Author: United States Environmental Protection Agency (EPA)

Publisher: Createspace Independent Publishing Platform

Published: 2018-07-10

Total Pages: 90

ISBN-13: 9781722683344

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Alternative Methods for Toxicity Testing: Regulatory Policy Issues

Alternatives for Dermal Toxicity Testing

Alternatives for Dermal Toxicity Testing PDF

Author: Chantra Eskes

Publisher: Springer

Published: 2017-11-21

Total Pages: 592

ISBN-13: 3319503537

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This book provides comprehensive information on the alternative (non-animal) dermal toxicity test methods currently available for industrial, regulatory, and academic use and also explores potential future developments. It encompasses all areas of dermal toxicity, including skin irritation, skin corrosion, skin sensitization, UV-induced effects, and skin genotoxicity. An individual chapter is devoted to each test method, with coverage of the scientific basis, validation status and regulatory acceptance, applications and limitations, available protocols, and potential role within testing strategies. In addition, perspectives from the test developer are presented, for example regarding critical steps in the protocol. The closing section addresses areas that may be of relevance for the future of dermal toxicity safety testing, including the validation and regulatory acceptance of integrated testing strategies, novel complex skin models, and high-throughput screening techniques.

Alternatives to Animal Testing

Alternatives to Animal Testing PDF

Author: Hajime Kojima

Publisher: Springer

Published: 2018-12-27

Total Pages: 130

ISBN-13: 9811324476

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This open access book presents recent advances in the pure sciences that are of significance in the quest for alternatives to the use of animals in research and describes a variety of practical applications of the three key guiding principles for the more ethical use of animals in experiments – replacement, reduction, and refinement, collectively known as the 3Rs. Important examples from across the world of implementation of the 3Rs in the testing of cosmetics, chemicals, pesticides, and biologics, including vaccines, are described, with additional information on relevant regulations. The coverage also encompasses emerging approaches to alternative tests and the 3Rs. The book is based on the most informative contributions delivered at the Asian Congress 2016 on Alternatives and Animal Use in the Life Sciences. It will be of value for those working in R&D, for graduate students, and for educators in various fields, including the pharmaceutical and cosmetic sciences, pharmacology, toxicology, and animal welfare. The free, open access distribution of Alternatives to Animal Testing is enabled by the Creative Commons Attribution license in International version 4: CC BY 4.0.

Reducing, Refining and Replacing the Use of Animals in Toxicity Testing

Reducing, Refining and Replacing the Use of Animals in Toxicity Testing PDF

Author: Dave Allen

Publisher: Royal Society of Chemistry

Published: 2013-10-31

Total Pages: 362

ISBN-13: 1849737924

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Toxicity testing is used to assess the safety or hazards presented by substances such as industrial chemicals, consumer products, and pharmaceuticals. At present, many methods involve laboratory animals. Alternative procedures, some involving human cell-based technologies, are now being developed which reduce, refine, or replace animal usage and minimize the pain and distress caused. These new tests must protect public health and the environment at least as well as currently accepted methods. This book describes the ever-expanding "toolbox" of methods available to assess toxicity. Such techniques often result from our growing understanding of the biochemical and cellular pathways that mediate toxicity mechanisms. This permits evaluations of information generated from several sources to generate a "weight of evidence". By combining in silico, in vitro, and ex vivo methods with technologies that rely on biochemical- and cell-based in vitro assays, toxicologists are developing mechanistically based alternatives to live animal experimentation. This text also explores the complexities associated with adequate validation, and the assessment of test reliability and relevance. It provides an essential reference source for postgraduates, academics and industrialists working in this rapidly changing area.