OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 474: Mammalian Erythrocyte Micronucleus Test

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 474: Mammalian Erythrocyte Micronucleus Test
Author: OECD
Publisher: OECD Publishing
Total Pages: 21
Release: 2016-07-29
Genre:
ISBN: 9264264760
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The mammalian in vivo micronucleus test is used for the detection of damage induced by the test substance to the chromosomes or the mitotic apparatus of erythroblasts, by analysis of erythrocytes as sampled in bone marrow and/or peripheral blood cells of animals, usually rodents (mice or rats).

A Practical Guide to Toxicology and Human Health Risk Assessment

A Practical Guide to Toxicology and Human Health Risk Assessment
Author: Laura Robinson
Publisher: John Wiley & Sons
Total Pages: 401
Release: 2018-11-05
Genre: Science
ISBN: 1118881907
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Toxicology – the study of the adverse effects of chemicals on living organisms is the cornerstone to all aspects of chemical safety and knowledge of the subject is needed in a wide spectrum of fields from the chemical industry to medicine, emergency services, forensics, and regulatory science. Toxicology involves the study of symptoms, mechanisms, treatments and detection of poisoning ... especially the poisoning of people. The many problems arising from a poor understanding of toxicology and its applications in hazard communication and chemical safety motivated the author's training courses and webinars, leading to this valuable book. Providing a practical and accessible guide, A Practical Guide to Toxicology and Human Health Risk Assessment enables readers to quickly build up knowledge and understanding of toxicology and its use in hazard identification, which is a fundamental part of chemical risk assessment. The book also covers current toxicological testing strategies and the use of physicochemical test data in hazard identification and exposure assessment. Examples are provided throughout the book to highlight important issues along with a summary of the key points that have been covered in each of the respective chapters. The book concludes with a listing of online resources on toxicology and risk assessment.

Test No. 474: Mammalian Erythrocyte Micronucleus Test

Test No. 474: Mammalian Erythrocyte Micronucleus Test
Author: OECD
Publisher: OECD Publishing
Total Pages: 21
Release: 2014-09-26
Genre:
ISBN: 9264224297
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The mammalian in vivo micronucleus test detects damage induced by the test substance to the chromosomes or the mitotic apparatus of erythroblasts, by analysis of erythrocytes as sampled in bone marrow and/or peripheral blood cells of animals.

Drug Safety Evaluation

Drug Safety Evaluation
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
Total Pages: 996
Release: 2023-01-12
Genre: Medical
ISBN: 1119755859
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Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development.

30 years of the Comet Assay: an overview with some new insights

30 years of the Comet Assay: an overview with some new insights
Author: Amaya Azqueta
Publisher: Frontiers Media SA
Total Pages: 176
Release: 2015-08-21
Genre: Electrophoresis
ISBN: 2889196496
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By means of this ‘Frontiers in Genetics’ research topic, we are celebrating 30 years of the Comet Assay. The first paper on this single-cell gel electrophoresis assay was published in 1984 by O. Ostling and K.J. Johanson (Biochem. Biophys. Res. Commun. Vol.123: 291-298). The comet assay is a versatile and sensitive method for measuring single - and double-strand breaks in DNA. By including lesion-specific enzymes in the assay, its range and sensitivity are greatly increased, but it is important to bear in mind that their specificity is not absolute. The comet assay (with and without inclusion of lesion-specific enzymes) is widely used as a biomarker assay in human population studies - primarily to measure DNA damage, but increasingly also to assess the capacity of cells for DNA repair. Ostling and Johanson (Biochem. Biophys. Res. Commun., 1984) were also the first to report experiments to measure DNA repair, by simply following the decrease of DNA damage over time after challenging cells with ionising radiation. However, this approach is time-consuming and laborious as it requires an extended period of cell culture and is therefore not ideal for biomonitoring studies, which typically require high-throughput processing of many samples. As an alternative approach, the in vitro comet-based repair assay was developed: a cell extract is incubated with a DNA substrate containing specific lesions, and DNA incisions accumulate. The in vitro comet-based repair assay has been modified and improved over the past decade: it was first devised to measure base excision repair of oxidised purines in lymphocytes (Collins et al., Mutagenesis, 2001), but has since been adapted for other lesions and thus other repair pathways, as well as being applied to tissue samples in addition to cell suspensions. Even after 30 years, the comet assay is still in a growth phase, with many new users each year. Many questions are repeatedly raised, which may seem to have self-evident answers, but clearly, it is necessary to reiterate them for the benefit of the new audience, and sometimes being forced to think again about old topics can shed new light. Different applications of the comet assay are discussed in this special issue, including: genotoxicity testing in different organisms, human biomonitoring, DNA repair studies, environmental biomonitoring and clinical studies. Furthermore, we consider and where possible answer questions, including the ones raised by Raymond Tice at the 8th International Comet Assay Workshop in Perugia (Italy 2009): What is the spectrum of DNA damage detected by the various versions of the comet assay?; What are the limitations associated with each application?; What should be done to standardize the assay for biomonitoring studies?; Can the comet assay be used to monitor changes in global methylation status?; What cell types are suitable for detecting genotoxic substances and their effects in vivo and in vitro?; Can the assay be fully automated?; and more. So this ‘Frontiers in Genetics’ research topic is written for the beginner as well as for the experienced users of the comet assay.

Beneficial Microorganisms in Agriculture, Food and the Environment

Beneficial Microorganisms in Agriculture, Food and the Environment
Author: Ingvar Sundh
Publisher: CABI
Total Pages: 343
Release: 2012
Genre: Agricultural microbiology
ISBN: 9781780640082
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Microorganisms are widely used in various beneficial applications, including food, pest control, bioremediation, biodegradation, biofuel processes, and plant symbiosis and growth stimulation. This book provides an overview of the available methodology for safety assessments of microorganisms, including determination of their infectivity and whether they produce toxic or sensitizing substances. Also covered are the regulatory systems in risk assessment and management of microbial products, quarantine legislations, international treaties, the importance of public risk perception and risk reducti

Information Resources in Toxicology, Volume 1: Background, Resources, and Tools

Information Resources in Toxicology, Volume 1: Background, Resources, and Tools
Author:
Publisher: Academic Press
Total Pages: 1055
Release: 2020-05-16
Genre: Technology & Engineering
ISBN: 0128137258
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This new fifth edition of Information Resources in Toxicology offers a consolidated entry portal for the study, research, and practice of toxicology. Both volumes represents a unique, wide-ranging, curated, international, annotated bibliography, and directory of major resources in toxicology and allied fields such as environmental and occupational health, chemical safety, and risk assessment. The editors and authors are among the leaders of the profession sharing their cumulative wisdom in toxicology's subdisciplines. This edition keeps pace with the digital world in directing and linking readers to relevant websites and other online tools.Due to the increasing size of the hardcopy publication, the current edition has been divided into two volumes to make it easier to handle and consult. Volume 1: Background, Resources, and Tools, arranged in 5 parts, begins with chapters on the science of toxicology, its history, and informatics framework in Part 1. Part 2 continues with chapters organized by more specific subject such as cancer, clinical toxicology, genetic toxicology, etc. The categorization of chapters by resource format, for example, journals and newsletters, technical reports, organizations constitutes Part 3. Part 4 further considers toxicology's presence via the Internet, databases, and software tools. Among the miscellaneous topics in the concluding Part 5 are laws and regulations, professional education, grants and funding, and patents. Volume 2: The Global Arena offers contributed chapters focusing on the toxicology contributions of over 40 countries, followed by a glossary of toxicological terms and an appendix of popular quotations related to the field.The book, offered in both print and electronic formats, is carefully structured, indexed, and cross-referenced to enable users to easily find answers to their questions or serendipitously locate useful knowledge they were not originally aware they needed. Among the many timely topics receiving increased emphasis are disaster preparedness, nanotechnology, -omics, risk assessment, societal implications such as ethics and the precautionary principle, climate change, and children's environmental health. - Introductory chapters provide a backdrop to the science of toxicology, its history, the origin and status of toxicoinformatics, and starting points for identifying resources - Offers an extensive array of chapters organized by subject, each highlighting resources such as journals, databases,organizations, and review articles - Includes chapters with an emphasis on format such as government reports, general interest publications, blogs, and audiovisuals - Explores recent internet trends, web-based databases, and software tools in a section on the online environment - Concludes with a miscellany of special topics such as laws and regulations, chemical hazard communication resources, careers and professional education, K-12 resources, funding, poison control centers, and patents - Paired with Volume Two, which focuses on global resources, this set offers the most comprehensive compendium of print, digital, and organizational resources in the toxicological sciences with over 120 chapters contributions by experts and leaders in the field

Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 1: Principles and Practice of Toxicologic Pathology

Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 1: Principles and Practice of Toxicologic Pathology
Author: Wanda M. Haschek
Publisher: Academic Press
Total Pages: 1154
Release: 2021-10-20
Genre: Medical
ISBN: 0128218290
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Haschek and Rousseaux's Handbook of Toxicologic Pathology, recognized by many as the most authoritative single source of information in the field of toxicologic pathology, has been extensively updated to continue its comprehensive and timely coverage. The fourth edition has been expanded to four separate volumes due to an explosion of information in this field requiring new and updated chapters. Completely revised with a number of new chapters, Volume 1, "Principles and the Practice of Toxicologic Pathology," covers the practice of toxicologic pathology in three parts: Principles of Toxicologic Pathology, Methods in Toxicologic Pathology, and the Practice of Toxicologic Pathology. Other volumes in this work round out the depth and breadth of coverage.Volume 2 encompasses "Toxicologic Pathology in Safety Assessment" and "Environmental Toxicologic Pathology". These two sections cover the application of toxicologic pathology in developing specific product classes, principles of data interpretation for safety assessment, and toxicologic pathology of major classes of environmental toxicants. Volumes 3 and 4 provide deep and broad treatment of "Target Organ Toxicity", emphasizing the comparative and correlative aspects of normal biology and toxicant-induced dysfunction, principal methods for toxicologic pathology evaluation, and major mechanisms of toxicity. These volumes comprise the most authoritative reference on toxicologic pathology for pathologists, toxicologists, research scientists, and regulators studying and making decisions on drugs, biologics, medical devices, and other chemicals, including agrochemicals and environmental contaminants. Each volume is being published separately. - Provides new chapters on digital pathology, juvenile pathology, in vitro/in vivo correlation, big data technologies and in-depth discussion of timely topics in the area of toxicologic pathology - Offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology - Features hundreds of full-color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations

Biointeractions of Nanomaterials

Biointeractions of Nanomaterials
Author: Vijaykumar B. Sutariya
Publisher: CRC Press
Total Pages: 484
Release: 2014-07-29
Genre: Medical
ISBN: 1466582383
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An examination of the widespread application of nano materials in biology, medicine, and pharmaceuticals and the accompanying safety concerns, Bio-interactions of Nano Materials addresses the issues related to toxicity and safety of nano materials and nano systems. It covers the interactions in biological systems and presents various tools and methods used to evaluate the nano toxicity and nano safety issues. Written by leading scientists, the book focuses on the bio-interaction of nano materials, covering various techniques and tests which have been developed to evaluate the toxicity of materials at the nano level. The book highlights the challenges of bio-interactions of nano materials and possible solutions to those challenges. It addresses the assessment and characterization of nano systems in bio-environments, toxicity and bio-sensing devices for toxicity assessment, carbon nano tubes and pulmonary toxicity, and nano toxicity of solid lipid nanoparticles. It also discusses nano safety concerns and solutions, including the effects of nano particles on different organs and regulatory implications of nano materials. These particles may be used to encapsulate drugs, recognize biological markers, or visualize body tissues among many other possibilities, all enabling their widespread application in biology, medicine, and pharmaceutics. Indeed, these nano materials may have beneficial effects that have not even been imagined. This book gives you an understanding of the safety issues, how to assess for them, and how to mitigate them to move forward in research and development of new applications for nano materials.