Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals

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Publisher :
ISBN 13 :
Total Pages : 96 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals by : DNH & W/DOE Environmental Contaminants Advisory Committee on Mutagenesis (Canada)

Download or read book Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals written by DNH & W/DOE Environmental Contaminants Advisory Committee on Mutagenesis (Canada) and published by . This book was released on 1986 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals

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Publisher :
ISBN 13 :
Total Pages : 84 pages
Book Rating : 4.:/5 (167 download)

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Book Synopsis Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals by : Canada. Health and Welfare Canada

Download or read book Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals written by Canada. Health and Welfare Canada and published by . This book was released on 1986 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Mutagenicity: Assays and Applications

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Publisher : Academic Press
ISBN 13 : 0128092602
Total Pages : 350 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Mutagenicity: Assays and Applications by : Ashutosh Kumar

Download or read book Mutagenicity: Assays and Applications written by Ashutosh Kumar and published by Academic Press. This book was released on 2017-09-26 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mutagenicity: Assays and Applications presents an extensive examination of the detection, assessment and future of mutagenicity, particularly as it concerns human health and the environment. Chapters focused on specific types of mutagens or testing methods for their detection collectively explore the current state of human and environmental mutagenesis, future perspectives and regulatory needs. The test procedures for measuring mutagenicity, their advantages and limitations are described with practical and procedural detail, along with their presentation and data processing aspects. It is an essential reference covering the breadth and depth of the field of mutagenicity studies and regulation. By providing both important introductory material and practical assays and applications, this book is useful to graduate students, academic and industry researchers and regulators at various stages of their careers, leading to improved risk assessment and regulation. Presents an up-to-date and in-depth review of the current state of mutagenesis research Draws upon the combined experience and expertise of an international group of highly respected editors and chapter authors Provides an introduction to the concept of mutagenesis with particular consideration given to novel chemicals and materials

Mutagenic Impurities

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Publisher : John Wiley & Sons
ISBN 13 : 1119551218
Total Pages : 548 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Mutagenic Impurities by : Andrew Teasdale

Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.

Guidelines for the Testing of Chemicals for Toxicity

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Publisher :
ISBN 13 :
Total Pages : 74 pages
Book Rating : 4.:/5 ( download)

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Book Synopsis Guidelines for the Testing of Chemicals for Toxicity by : Great Britain. Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment

Download or read book Guidelines for the Testing of Chemicals for Toxicity written by Great Britain. Committee on Toxicity of Chemicals in Food, Consumer Products, and the Environment and published by . This book was released on 1982 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Interpretation and Extrapolation of Chemical and Biological Carcinogenicity Data to Establish Human Safety Standards

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Publisher : Springer Science & Business Media
ISBN 13 : 3642493718
Total Pages : 200 pages
Book Rating : 4.6/5 (424 download)

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Book Synopsis Interpretation and Extrapolation of Chemical and Biological Carcinogenicity Data to Establish Human Safety Standards by : H.C. Grice

Download or read book Interpretation and Extrapolation of Chemical and Biological Carcinogenicity Data to Establish Human Safety Standards written by H.C. Grice and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Life Sciences Institute (lLSI) is a scientific foundation wh ich addresses critical health and safety issues of national and international concern. ILSI promotes international cooperation by pro viding the mechanism for scientists from government, industry and universities to work together on cooperative programs to generate and disseminate scientific data. The members and trustees of the Institute believe that questions regarding health and safety are best resolved when scientists can ex amine and discuss issues, as an independent body, se~arate from the political pressures of individual countries and the economic concerns of individual companies. Frequently, meaningful assessment of the risk of a test substance is hindered by the inherent inconsistencies in the system. The development and refinement of methods and systems to evaluate the safety of chemicals have evolved in a rapid and largely unplanned fashion. Attempts to improve the system have largely been directed toward broad general concerns, with little attention being given to specific problems or issues. A failure to resolve these problems has frequently resulted in increased testing costs and complications in the assessment and extrapolation of the results. Publicity surrounding toxicologic issues has created chronic public apprehension about the ability of science and government to deal effectively with these problems. In response to these difficulties, ILSI has assembled highly qualified and renowned scientists from research institutes, universities, government and industry, with relevant scientific knowledge and expertise regarding the issues that complicate risk assessment procedures.

OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Detailed Review Document on Classification Systems for Germ Cell Mutagenicity in OECD Member Countries

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Publisher : OECD Publishing
ISBN 13 : 9264078304
Total Pages : 25 pages
Book Rating : 4.2/5 (64 download)

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Book Synopsis OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Detailed Review Document on Classification Systems for Germ Cell Mutagenicity in OECD Member Countries by : OECD

Download or read book OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Detailed Review Document on Classification Systems for Germ Cell Mutagenicity in OECD Member Countries written by OECD and published by OECD Publishing. This book was released on 2002-05-10 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Detailed Review Document (DRD) presents an overview of classification systems/guidelines used in OECD Member countries relating to the mutagenicity of chemicals, based on responses to a questionnaire.

Mutagenicity Testing

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Publisher :
ISBN 13 :
Total Pages : 378 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Mutagenicity Testing by : S. Venitt

Download or read book Mutagenicity Testing written by S. Venitt and published by . This book was released on 1984 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: LABORATORY MANUAL. GENETIC TOXICOLOGY. BACTERIA. YEAST. FRUIT FLY. CULTURED MAMMALIAN CELLS. CYTOGENETIC TESTING. RODENTS. DOMINANT LETHAL TEST.

Pesticides in the Diets of Infants and Children

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Publisher : National Academies Press
ISBN 13 : 0309048753
Total Pages : 402 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Pesticides in the Diets of Infants and Children by : National Research Council

Download or read book Pesticides in the Diets of Infants and Children written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many of the pesticides applied to food crops in this country are present in foods and may pose risks to human health. Current regulations are intended to protect the health of the general population by controlling pesticide use. This book explores whether the present regulatory approaches adequately protect infants and children, who may differ from adults in susceptibility and in dietary exposures to pesticide residues. The committee focuses on four major areas: Susceptibility: Are children more susceptible or less susceptible than adults to the effects of dietary exposure to pesticides? Exposure: What foods do infants and children eat, and which pesticides and how much of them are present in those foods? Is the current information on consumption and residues adequate to estimate exposure? Toxicity: Are toxicity tests in laboratory animals adequate to predict toxicity in human infants and children? Do the extent and type of toxicity of some chemicals vary by species and by age? Assessing risk: How is dietary exposure to pesticide residues associated with response? How can laboratory data on lifetime exposures of animals be used to derive meaningful estimates of risk to children? Does risk accumulate more rapidly during the early years of life? This book will be of interest to policymakers, administrators of research in the public and private sectors, toxicologists, pediatricians and other health professionals, and the pesticide industry.

OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 483: Mammalian Spermatogonial Chromosomal Aberration Test

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Publisher : OECD Publishing
ISBN 13 : 9264264841
Total Pages : 13 pages
Book Rating : 4.2/5 (642 download)

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Book Synopsis OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 483: Mammalian Spermatogonial Chromosomal Aberration Test by : OECD

Download or read book OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 483: Mammalian Spermatogonial Chromosomal Aberration Test written by OECD and published by OECD Publishing. This book was released on 2016-07-29 with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt: This test measures structural chromosomal aberrations (both chromosome- and chromatid-type) in dividing spermatogonial germ cells and is, therefore, expected to be predictive of induction of heritable mutations in these germ cells.

OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies

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Publisher : OECD Publishing
ISBN 13 : 9264078487
Total Pages : 87 pages
Book Rating : 4.2/5 (64 download)

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Book Synopsis OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies by : OECD

Download or read book OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Notes for Analysis and Evaluation of Repeat-Dose Toxicity Studies written by OECD and published by OECD Publishing. This book was released on 2002-05-10 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: This document presents a general guide to the analysis and evaluation of data from studies involving repeated exposures of toxicity test species to pesticides and other chemicals.

Toxicity Testing for Assessment of Environmental Agents

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Publisher : National Academies Press
ISBN 13 : 0309164869
Total Pages : 270 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Toxicity Testing for Assessment of Environmental Agents by : National Research Council

Download or read book Toxicity Testing for Assessment of Environmental Agents written by National Research Council and published by National Academies Press. This book was released on 2006-04-07 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde

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Publisher : National Academies Press
ISBN 13 : 0309211964
Total Pages : 204 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde by : National Research Council

Download or read book Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde written by National Research Council and published by National Academies Press. This book was released on 2011-05-31 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Formaldehyde is ubiquitous in indoor and outdoor air, and everyone is exposed to formaldehyde at some concentration daily. Formaldehyde is used to produce a wide array of products, particularly building materials; it is emitted from many sources, including power plants, cars, gas and wood stoves, and cigarettes; it is a natural product in come foods; and it is naturally present in the human body as a metabolic intermediate. Much research has been conducted on the health effects of exposure to formaldehyde, including effects on the upper airway, where formaldehyde is deposited when inhaled, and effects on tissues distant from the site of initial contact. The U.S. Environmental Protection Agency (EPA) released noncancer and cancer assessments of formaldehyde for its Intergated Risk Information System (IRIS) in 1990 and 1991, respectively. The agency began reassessing formaldehyde in 1998 and released a draft IRIS assessment in June 2010. Given the complexity of the issues and the knowledge that the assessment will be used as the basis of regulatory decisions, EPA asked the National Research Council (NRC) to conduct an independent scientific review of the draft IRIS assessment. In this report, the Committee to Review EPA's Draft IRIS Assessment of Formaldehyde first addresses some general issues associated with the draft IRIS assessment. The committee next focuses on questions concerning specific aspects of the draft assessment, including derivation of the reference concentrations and the cancer unit risk estimates for formaldehyde. The committee closes with recommendations for improving the IRIS assessment of formaldehyde and provides some general comments on the IRIS development process.

Genotoxicity Assessment

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Publisher : Humana
ISBN 13 : 9781493963027
Total Pages : 0 pages
Book Rating : 4.9/5 (63 download)

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Book Synopsis Genotoxicity Assessment by : Alok Dhawan

Download or read book Genotoxicity Assessment written by Alok Dhawan and published by Humana. This book was released on 2016-08-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic toxicology is recognized by geneticists and researchers concerned with the genetic impact of man-made chemicals. In Genotoxicity Assessment: Methods and Protocols, expert researchers in the field provide comprehensive genetic toxicology protocols. These include in vitro and in vivo protocols on mutation assays, cytogenetic techniques, and primary DNA damage, assays in alternate to animal models, and updated ICH guidelines. Written in the highly successful Methods in Molecular Biology series format, the chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, as well as key tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Genotoxicity Assessment: Methods and Protocols seeks to aid research students and scientists working in regulatory toxicology as well as biomedical, biochemical and pharmaceutical sciences.

The Assessment of Mutagenicity

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Publisher :
ISBN 13 : 9780662206248
Total Pages : 23 pages
Book Rating : 4.2/5 (62 download)

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Book Synopsis The Assessment of Mutagenicity by : Canada. Health Protection Branch

Download or read book The Assessment of Mutagenicity written by Canada. Health Protection Branch and published by . This book was released on 1993-01-01 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Health Protection Branch (HPB) Executive Committee established the Branch Genotoxicity Committee to develop recommendations on a branch-wide approach to the use of genotoxicity test results in toxicological assessment. This report, endorsed by the HPB Executive Committee, addresses the mandate under seven headings, namely: genotoxicity tests; mutagenicity testing strategy; genotoxicity tests as predictors of carcinogenicity; germ cell and somatic cell mutation; validation of genotoxicity tests; and, epidemiological extension of the regulatory process.

Guidelines for the Evaluation of Chemicals for Carcinogenicity

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Publisher :
ISBN 13 :
Total Pages : 106 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Guidelines for the Evaluation of Chemicals for Carcinogenicity by : Great Britain. Committee on Carcinogenicity of Chemicals in Food, Consumer Products, and the Environment

Download or read book Guidelines for the Evaluation of Chemicals for Carcinogenicity written by Great Britain. Committee on Carcinogenicity of Chemicals in Food, Consumer Products, and the Environment and published by . This book was released on 1991 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Practical Toxicology

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Publisher : CRC Press
ISBN 13 : 149870932X
Total Pages : 778 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Practical Toxicology by : David Woolley

Download or read book Practical Toxicology written by David Woolley and published by CRC Press. This book was released on 2017-03-16 with total page 778 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical Toxicology: Evaluation, Prediction, and Risk, Third Edition shows how to conduct a program of safety evaluation and testing and then to interpret and apply the resulting data and information in the real world, beginning with the basic concepts in toxicology and progressing to the interpretation of the resulting data. Revised and updated chapters on risk assessment guide the reader to setting the foundations necessary for submission to regulatory authorities. In addition, a new chapter in the book reviews the errors in toxicology, mistakes, misuse, mismanagement, and misunderstanding with a view to avoiding these in the future. New Chapters in the Third Edition: Toxicology in silico Errors in Toxicology Safety Assessment of Extractables and Leachables. This new edition follows a practical sequence from introducing the basics of toxicology (including the vital concept of normality in controls) to describing a test program and then interpreting the data and translating that to risk assessment that can be used in a number of real world situations where safety and secure risk assessment are essential. Although written primarily from the perspective of pharmaceutical development, the test designs and toxicological problems encountered in that field are entirely relevant to those with other classes of chemicals, the only difference being the regulatory context. Toxicology is an international discipline and the book has been written to take into account some of the differences in regulatory nuance between the main regions of the world. Completely revised and written in an easily accessible style, the text address several audiences—from students and post-graduates coming to the subject for the first time to established professionals who find themselves needing to learn about toxicology, toxicity testing, interpretation of the results, and risk assessment. It is intended primarily as a textbook, with case studies and information on where to go to ask questions, but can also be used as a practical reference book. It covers all the basics of toxicology and the main aspects of safety evaluation testing and risk assessment while reviewing critically the current state of the discipline. It also provides a foundation for those seeking registration or certification.