About the Series: In the tradition of Methods in Enzymology and Methods in Neurosciences, Academic Press is pleased to announce a new serial: Methods in Toxicology. There is a pressing need among researchers involved in toxicologic investigation for a series of publications that organizes and presents information on the latest experimental methodologies. To address the needs of researchers in toxicology, toxicologic pathology, pharmacology, and clinical biochemistry, this new serial provides comprehensive descriptions of state-of-the-art methods for evaluating drug and chemical toxicity. Thematic volumes focus on mechanistic approaches to the study of toxicity both in vitro and in vivo, taking advantage of the recent advances in the biological and chemical sciences that allow closer scrutiny of the mechanisms by which agents cause damage. Each volume begins with an introductory chapter that offers a broad guide to the application of methods addressed in that volume. Subsequent chapters contain detailed descriptions of research protocols, accessible both to experts and those new to toxicologic investigation. Included in each chapter are clearly defined procedures, discussions of limitations of the method, comparative considerations (species, sex, strain), interpretations of results, and explanations of how the methods may serve as alternatives to in vivo testing. Each volume of Methods in Toxicology is available in case binding for the library and Wire-O-binding for the laboratory. About the Book: Concurrent with the development of biological systems for in vitro toxicologic investigations (Volume 1A-In Vitro Biological Systems), techniques have evolved to detect and evaluate the diverse effects produced when toxicants interact with these systems. This volume describes methods for detecting and quantifying pertubations in various cellular parameters related to cell dysfunction and death (including apoptosis) associated with adverse toxicant action. Each endpoint measurement probes one aspect of the response of the biological system to a toxicant. When several techniques are used in combination, it is possible to derive a more complete understanding of the mechanism of toxicity at the cellular, tissue, or organ level. The methods collected here are organized by major categories of toxic effects, such as membrane damage, disruption of energy metabolism, and lipid peroxidation, commonly monitored by toxicologists during a comprehensive toxicity study. Specialized techniques of interest and value in mechanistic investigations are included. As with the first volume, the goal is not to obtain an exhaustive collection of methods, but rather to assemble in a single central reference a set of valuable techniques that are used for toxicologic investigations, along with cautionary remarks on their use and limitations.

About the Series:In the tradition of Methods in Enzymology and Methods in Neurosciences, Academic Press is pleased to announce a new serial: Methods in Toxicology. There is a pressing need among researchers involved in toxicologic investigation for a series of publications that organizes and presents information on the latest experimental methodologies. To address the needs of researchers in toxicology, toxicologic pathology, pharmacology, and clinical biochemistry, this new serial provides comprehensive descriptions of state-of-the-art methods for evaluating drug and chemical toxicity. Thematic volumes focus on mechanistic approaches to the study of toxicity both in vitro and in vivo, taking advantage of the recent advances in the biological and chemical sciences that allow closer scrutiny of the mechanisms by which agents cause damage. Each volume begins with an introductory chapter that offers a broad guide to the application of methods addressed in that volume. Subsequent chapters contain detailed descriptions of research protocols, accessible both to experts and those new to toxicologic investigation. Included in each chapter are clearly defined procedures, discussions of limitations of the method, comparative considerations (species, sex, strain), interpretations of results, and explanations of how the methods may serve as alternatives to in vivo testing. Each volume of Methods in Toxicology is available in case binding for the library and Wire-O-binding for the laboratory. About the Book:Concurrent with the development of biological systems for in vitro toxicologic investigations (Volume 1A-In Vitro Biological Systems), techniques have evolved to detect and evaluate the diverse effects produced when toxicants interact with these systems. This volume describes methods for detecting and quantifying pertubations in various cellular parameters related to cell dysfunction and death (including apoptosis) associated with adverse toxicant action. Each endpoint measurement probes one aspect of the response of the biological system to a toxicant. When several techniques are used in combination, it is possible to derive a more complete understanding of the mechanism of toxicity at the cellular, tissue, or organ level. The methods collected here are organized by major categories of toxic effects, such as membrane damage, disruption of energy metabolism, and lipid peroxidation, commonly monitored by toxicologists during a comprehensive toxicity study. Specialized techniques of interest and value in mechanistic investigations are included. As with the first volume, the goal is not to obtain an exhaustive collection of methods, but rather to assemble in a single central reference a set of valuable techniques that are used for toxicologic investigations, along with cautionary remarks on their use and limitations.

The United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James Chen (National Center for Toxicological Research), George Daston (Procter and Gamble Company), Jerry Heindel (National Institute of Environmental Health Sciences), Grace Lemasters (University of Cincinnati), and John Young (National Center for Toxicological Research).

The new field of toxicogenomics presents a potentially powerful set of tools to better understand the health effects of exposures to toxicants in the environment. At the request of the National Institute of Environmental Health Sciences, the National Research Council assembled a committee to identify the benefits of toxicogenomics, the challenges to achieving them, and potential approaches to overcoming such challenges. The report concludes that realizing the potential of toxicogenomics to improve public health decisions will require a concerted effort to generate data, make use of existing data, and study data in new waysâ€"an effort requiring funding, interagency coordination, and data management strategies.

Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.

Nationally, toxicology programs have evolved from a traditional exploration of the chemistry and applied toxicity of chemicals and drugs to a more comprehensive study of toxicology and toxicology testing as independent entities. Consequently, the second edition of Principles of Toxicology Testing starts with basic toxicological principles, including absorption, distribution, metabolism, and elimination of toxins, including chemicals and drugs. The book then continues with animal (in vivo) and in vitro toxicology testing methods associated with toxicological analysis and preclinical drug development. As in the first edition, the book begins with an introduction into the fundamentals of toxicology (Section I) to prepare readers for the subsequent topics and continues through with a discussion of toxicokinetics and human risk assessment. This introductory material is useful in understanding the applications of toxicology testing. Section II describes the fundamental principles of toxicology testing in animals in greater detail. This section describes acute toxicity studies as well as subchronic and chronic studies performed on animals. Special emphasis is placed on study design and determination of classical indicators for acute and chronic testing, such as the LD50. The book examines other short- and long-term animal toxicity testing methodologies, including dermal, ocular, and reproductive toxicity testing. In addition, mutagenicity and carcinogenicity studies are also discussed in separate chapters. Section III introduces and discusses in vitro alternatives to animal toxicology tests. This section emphasizes cell culture methodology and cellular methods for acute systemic toxicity, target organ toxicity, and local toxicity. The contributors present the advantages and disadvantages of alternative methods. They also describe the use of high-throughput screening and its applications, the concepts of standardization and validation of in vitro techniques (especially large, organized validation efforts currently supported by US and EU regulatory agencies), and the theories supporting the development of in vitro methodologies. This second edition is a must-read for undergraduate and graduate toxicology students. Industrial and academic research centers will also find the text useful for establishing a toxicology testing laboratory.

Cell culture techniques allow a variety of molecular and cell biological questions to be addressed, offering physiological conditions whilst avoiding the use of laboratory animals. In addition to basic techniques, a wide range of specialised practical protocols covering the following areas are included: cell proliferation and death, in-vitro models for cell differentiation, in-vitro models for toxicology and pharmacology, industrial application of animal cell culture, genetic manipulation and analysis of human and animal cells in culture.

The growing consumer interest in health and fitness has expanded the market for a wide range of products, from yoga mats to the multiple dietary supplements now on the market. Supplements are popular, but are they safe? Many dietary supplements are probably safe when used as recommended. However, since 1994 when Congress decided that they should be regulated as if they were foods, they are assumed to be safe unless the Food and Drug Administration can demonstrate that they pose a significant risk to the consumer. But there are many types of products that qualify as dietary supplements, and the distinctions can become muddled and vague. Manufacturers are not legally required to provide specific information about safety before marketing their products. And the sales of supplements have been steadily increasingâ€"all together, the various types now bring in almost $16 billion per year. Given these confounding factors, what kind of information can the Food and Drug Administration use to effectively regulate dietary supplements? This book provides a framework for evaluating dietary supplement safety and protecting the health of consumers.

This edited book, Cytotoxicity - New Insights into Toxic Assessment, is intended to present some strategies, methods, interpretations and recent advances in order to facilitate scientific research on in vitro toxic responses, presenting both theoretical and practical aspects.

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.