Genetically Modified Model Report on Toxicology and Carcinogenesis Study of Glycidol (CAS No. 556-52-5) in Genetically Modified Haploinsufficient P16Ink4a/p19Arf Mice (Gavage Study) PDF Download
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Author: J. K. Dunnick
Publisher: DIANE Publishing
ISBN: 1437902243
Category :
Languages : en
Pages : 81
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Book Description
Glycidol is used as a chemical intermediate in the pharmaceutical industry, as a stabilizer in the manufacture of vinyl polymers, and as an intermediate in the synthesis of glycerol, Glycidol ethers, and amines. Glycidol was nominated for carcinogenecity study by the Environmental Protection Agency (EPA). Glycidol was selected for study in the haploinsufficient p16Ink4a/p19Arf mouse because it was found to be carcinogenic in rats and mice in conventional 2-year rodent studies (NTP, 1990), but was negative in a study in p53+/- mice (Tennant et al., 1999). In this study, male and female mice received Glycidol (greater than 95% pure) by gavage for 40 weeks. Genetic toxicology studies were conducted in mouse peripheral blood erythrocytes. Illustrations.
Author: J. K. Dunnick
Publisher: DIANE Publishing
ISBN: 1437902243
Category :
Languages : en
Pages : 81
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Book Description
Glycidol is used as a chemical intermediate in the pharmaceutical industry, as a stabilizer in the manufacture of vinyl polymers, and as an intermediate in the synthesis of glycerol, Glycidol ethers, and amines. Glycidol was nominated for carcinogenecity study by the Environmental Protection Agency (EPA). Glycidol was selected for study in the haploinsufficient p16Ink4a/p19Arf mouse because it was found to be carcinogenic in rats and mice in conventional 2-year rodent studies (NTP, 1990), but was negative in a study in p53+/- mice (Tennant et al., 1999). In this study, male and female mice received Glycidol (greater than 95% pure) by gavage for 40 weeks. Genetic toxicology studies were conducted in mouse peripheral blood erythrocytes. Illustrations.
Author:
Publisher: Elsevier
ISBN: 1630670316
Category : Technology & Engineering
Languages : en
Pages : 230
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Book Description
This book discusses the current research on monochloropropanediol (MCPD) and glycidyl esters in edible oils. These potentially harmful contaminants are formed during the industrial processing of food oils during deodorization. The mechanisms of formation for these contaminants, as well as research identifying possible precursor molecules are reviewed. Strategies which have been used successfully to decrease the concentrations of these contaminants in edible oils are discussed, including the removal of precursor molecules before processing, modifications of deodorization protocol, and approaches for the removal of these contaminants after the completion of processing. Analytical strategies for accurate detection and quantitation of MCPD and glycidyl esters are covered, along with current information on their toxicological properties. This book serves as a single point of reference for the significant research related to these contaminants. Details the mechanisms of formation for these contaminants and research identifying possible precursor molecules Presents successful strategies to decrease the concentrations of these contaminants in edible oils Includes the analytical strategies for accurate detection and quantitation of the contaminants along with their toxicological properties.
Author:
Publisher:
ISBN:
Category : Carcinogenicity testing
Languages : en
Pages : 146
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Book Description
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1119551218
Category : Medical
Languages : en
Pages : 548
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Book Description
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.
Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 0470934751
Category : Medical
Languages : en
Pages : 455
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Book Description
This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.
Author: Lois Swirsky Gold
Publisher: CRC Press
ISBN: 9781439810644
Category : Medical
Languages : en
Pages : 840
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Book Description
This unique new reference contains the Carcinogenic Potency Database (CPDB), which analyzes results of decades of animal cancer tests, including all Technical Reports of the National Toxicology Program (NTP) and the general published literature. A guide to the literature of animal cancer tests, the CPDB includes references to each published experiment and never-before published analyses. For each of 5,000 long-term experiments on 1,300 chemicals, the user-friendly format includes data on the species, strain, and sex of the test animal; features of experimental protocol such as the route of administration, duration of dosing, dose levels, and duration of the experiment; histopathology and tumor incidence; the shape of the dose-response curve; published author's opinion about the carcinogenicity at each site; and reference to the original publication of the test results. In addition, a measure of carcinogenic potency, the TD50, its statistical significance and confidence limits, are given for each tumor site. An overview is provided of earlier publication updates, such as positivity rates, reproducibility, interspecies extrapolation, and ranking possible carcinogenic hazards. The book also includes a summary of the NTP genetic toxicity test results on 1,500 chemicals, which are referenced to the original publications, including the Salmonella (Ames) test, L5178Y mouse lymphoma cell mutation test, chromosome aberration and sister chromatid exchange tests in cultured Chinese hamster ovary cells, and the sex-linked recessive lethal mutation test in Drosophila melanogaster. An index with chemicals listed by CAS number allows cross referencing between the carcinogenicity and genotoxicity databases, making data easy to find.
Author: Hyman J. Zimmerman
Publisher: Lippincott Williams & Wilkins
ISBN: 9780781719520
Category : Medical
Languages : en
Pages : 850
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Book Description
Written by the foremost authority in the field, this volume is a comprehensive review of the multifaceted phenomenon of hepatotoxicity. Dr. Zimmerman examines the interface between chemicals and the liver; the latest research in experimental hepatotoxicology; the hepatotoxic risks of household, industrial, and environmental chemicals; and the adverse effects of drugs on the liver. This thoroughly revised, updated Second Edition features a greatly expanded section on the wide variety of drugs that can cause liver injury. For quick reference, an appendix lists these medications and their associated hepatic injuries. Also included are in-depth discussions of drug metabolism and factors affecting susceptibility to liver injury.
Author: IARC Working Group on the Evaluation of the Carcinogenic Risk of Chemicals to Humans
Publisher: IARC Monographs on the Evaluat
ISBN:
Category : Crafts & Hobbies
Languages : en
Pages : 420
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Book Description
Evaluates the carcinogenic risk to humans posed by exposure to some Industrial Chemicals and Dyestuffs.
Author: J. K. Dunnick
Publisher: DIANE Publishing
ISBN: 1428988815
Category : Medical
Languages : en
Pages : 364
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Book Description
Phenolphthalein (PH) was commonly used as a laxative for most of the 20th cent. The use of PH in laxatives has decreased since 1997 when the FDA proposed to withdraw its classification as an OTC drug. PH has been previously evaluated in carcinogenecity studies in 1996. The major route of human exposure to PH is via ingestion, dermal contact, & inhalation of contaminated air originating from process units manufacturing the compound. In this study, the carcinogenic effects of PH were studied in the haploinsufficient p16Ink4a/p19Arf mouse model as an ongoing goal to seek model systems for toxicology & carcinogenesis studies, especially those that can provide mechanistic info. relative to understanding an agent¿s model of action. Illustrations.
Author: Harry A. Milman
Publisher: William Andrew Inc.
ISBN: 9780815513568
Category : Medical
Languages : en
Pages : 856
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Book Description
In 1961 the National Cancer Institute initiated a program to conduct bioassays of selected compounds to determine whether they might be carcinogens. Although some similarities continue with the program as it was in 1961, there are many more differences. Since 1985 when the first edition of this book appeared, these differences have been substantial enough to merit an updated version. This updated edition will provide the reader with an overview of how to proceed with the various tests and how the data are eventually used for regulatory decisions.
