Alternatives For Dermal Toxicity Testing

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.

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.

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 scientists present what has been accomplished thus far in developing acceptable alternatives to traditional animal toxicological assessment and provide potentially new initiatives. In over 40 chapters, the book addresses 7 themes, beginning with the validation and regulatory acceptance of alternatives in the US, the UK, and Western Europe. Then the book covers methods based on the mechanisms of eye irritation at the ocular surface, dermal toxicity testing, and assessing neurotoxicity. It also includes a case study in the use of alternatives to determine the mechanism of sulfur mustard action and discusses the role of transgenics and toxicokinetics in the development of alternative toxicity tests. Finally the book presents recent innovations in alternatives, including the use of archival data, and in silico techniques. Focusing on the science and not the politics, Alternative Toxicological Methods concisely discusses the application of state-of-the-art methods and explores cutting-edge research related to developing and validating alternatives to animal testing. This book will benefit toxicologists, cosmetic chemists, pharmacologists, experimental biologists, dermatologists, ophthalmologists, and regulatory officers in their quest for applying the 3Rs to the use of animals in toxicological testing of drug candidates, chemicals, and cosmetics.

Acute toxicity tests are an area of focus for developing alternative assays and approaches to address animal welfare concerns. In the context of this document, acute toxicity studies refer to studies involving a single exposure to a test chemical and include those assessing systemic toxicity as ...

Presents up-to-date concepts and approaches to the theory and practice of alternatives to animal testing and promotes technology transfer. The text addresses some of the ramifications of the National Institutes of Health Revitalization Act of 1993 which instructs the NIH to fund replacement, reduction and refinement alternatives. It also describes the likely impact of the European Union's Cosmetic Directive, which bans marketing of animal tested cosmetics in Europe after 1997 if alternatives are available. Contributions are grouped into five categories including: dermal toxicity; immunotoxicity; neurotoxicity; and oral/dermal/ocular validation.

Written by authorities in the field, this book provides a “bottom up” approach to studying skin toxicology. Principles and Practice of Skin Toxicology clearly outlines basic concepts, cites historical and modern references and contains a dictionary for easy reference. The inclusion of global legislation and regulatory aspects on the topic makes this a comprehensive review for every practitioner, clinical researcher in industry and academia, and MSc and PhD student of toxicology. Different sections cover skin structure and function, principles and measurement of skin absorption, clinical aspects of dermal toxicity and in vitro alternatives. A section on regulatory and legislative aspects includes case studies from the UK that fulfill European Union and US FDA requirements. A glossary provides definitions of technical terms, and the chapters contain an introduction, learning boxes and summary section for ease of use. Includes a chapter on drug delivery through the skin. Addresses risk assessment: a key area for the interpretation of skin absorption data that is rarely covered.

Toxicogenomics-Based Cellular Models is a unique and valuable reference for all academic and professional researchers employing toxicogenomic methods with respect to animal testing for chemical safety. This resource offers cutting-edge information on the application of toxicogenomics to developing alternatives to current animal toxicity tests. By illustrating the development of toxicogenomics-based cellular models for critical endpoints of toxicity and providing real-world examples for validation and data analysis, this book provides an assessment of the current state of the field, as well as opportunities and challenges for the future. Written by renowned international toxicological experts, this book explores ‘omics technology for developing new assays for toxicity testing and safety assessment and provides the reader with a focused examination of alternative means to animal testing. Describes the state-of-the-art in developing toxicogenomics-based cellular models for chemical-induced carcinogenicity, immunotoxicity, developmental toxicity, neurotoxicity and reproduction toxicity Illustrates how to validate toxicogenomics-based alternative test models and provides an outlook to societal and economic implementation of these novel assays Includes an overview of current testing methods and risk assessment frameworks Provides a real-world assessment by articulating the current development and challenges in toxicogenomics while suggesting ways to move this field forward