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.

David G. Allen has over 10 years experience in molecular and cellular biology. This includes the evaluation of toxicological and pharmacological data for the Food and Drug Administration (FDA), and the identification and validation of alternative toxicological assays that reduce or replace animal usage in regulatory safety testing. He received is BSc and PhD from North Carolina State University in Raleigh, and his MSc from the University of North Carolina in Wilmington. Dr Allen is currently Director of the Environmental and Regulatory Sciences Division of Integrated Laboratory Systems in North Carolina. This involves responsibility for the evaluation of alternative toxicological methods and comprehensive environmental services for the Environmental Protection Agency and the State of Georgia. The role includes all aspects of divisional management such as staffing, budget projections, and business development.

Introduction; The 3R's in Toxicity Testing - From Russell and Birch to 21st Century Toxicology; Regulatory Safety Testing - National and International Requirements; Efforts Towards International Harmonization of Acceptable Alternatives; Refinement Alternatives - Minimizing Pain and Distress in In Vivo Toxicity Testing; In Vitro Toxicity Testing - The Basics; Using Stem Cells in Toxicity Testing; Using Computers Instead of Cells - In Silico Approaches to Toxicity Testing; Acute Safety Testing; Acute Systemic Toxicity - Oral, Dermal, and Inhalation Exposures; Dermal Corrosivity and Irritation Testing; Ocular Corrosivity and Irritation Testing; Skin Sensitization Testing; Integrated Approaches to Acute Safety Testing; Endocrine Disruptors; In Vitro Receptor Binding Assays; In Vitro Receptor Transactivation Assays; Non-mamalian Approaches to Identifying Endocrine Active Substances; Subchronic and Chronic Toxicity Testing; Carcinogenicity - Genetic Toxicity Testing and Beyond; Reproductive and Developmental Toxicity Testing; Immunotoxicity Testing; Application of New Technologies; High Throughput Approaches to Toxicity Testing; Nanotechnology - New Challenges in Toxicity Testing