Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes
Author: National Research Council
Publisher: National Academies Press
Total Pages: 226
Release: 2004-06-04
Genre: Science
ISBN: 0309166411

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

Mechanisms of Cell Death

Mechanisms of Cell Death
Author: Zahra Zakeri
Publisher:
Total Pages: 236
Release: 1999
Genre: Science
ISBN:

Contains papers from a July 1998 conference held at the Queens College Campus of the City University of New York. Papers are arranged in sections on mechanisms and general considerations, programmed (developmental) cell death, and cell death and pathological and clinical situations. Specific topics

Drinking Water and Health,

Drinking Water and Health,
Author: National Research Council
Publisher: National Academies Press
Total Pages: 476
Release: 1986-02-01
Genre: Nature
ISBN: 0309036879

The most recent volume in the Drinking Water and Health series contains the results of a two-part study on the toxicity of drinking water contaminants. The first part examines current practices in risk assessment, identifies new noncancerous toxic responses to chemicals found in drinking water, and discusses the use of pharmacokinetic data to estimate the delivered dose and response. The second part of the book provides risk assessments for 14 specific compounds, 9 presented here for the first time.

The Zebrafish

The Zebrafish
Author: Joseph A. Holden
Publisher: Cambridge University Press
Total Pages: 157
Release: 2013-01-21
Genre: Science
ISBN: 1139620630

The zebrafish (Danio rerio) is a valuable and common model for researchers working in the fields of genetics, oncology and developmental sciences. This full-color atlas will aid experimental design and interpretation in these areas by providing a fundamental understanding of zebrafish anatomy. Over 150 photomicrographs are included and can be used for direct comparison with histological slides, allowing quick and accurate identification of the anatomic structures of interest. Hematoxylin and eosin stained longitudinal and transverse sections demonstrate gross anatomic relationships and illustrate the microscopic anatomy of major organs. Unlike much of the current literature, this book is focused exclusively on the zebrafish, eliminating the need for researchers to exclude structures that are only found in other fish.

How Tobacco Smoke Causes Disease

How Tobacco Smoke Causes Disease
Author: United States. Public Health Service. Office of the Surgeon General
Publisher:
Total Pages: 728
Release: 2010
Genre: Government publications
ISBN:

This report considers the biological and behavioral mechanisms that may underlie the pathogenicity of tobacco smoke. Many Surgeon General's reports have considered research findings on mechanisms in assessing the biological plausibility of associations observed in epidemiologic studies. Mechanisms of disease are important because they may provide plausibility, which is one of the guideline criteria for assessing evidence on causation. This report specifically reviews the evidence on the potential mechanisms by which smoking causes diseases and considers whether a mechanism is likely to be operative in the production of human disease by tobacco smoke. This evidence is relevant to understanding how smoking causes disease, to identifying those who may be particularly susceptible, and to assessing the potential risks of tobacco products.

Extremophile Fishes

Extremophile Fishes
Author: Rüdiger Riesch
Publisher: Springer
Total Pages: 329
Release: 2015-01-24
Genre: Science
ISBN: 3319133624

This book summarizes the key adaptations enabling extremophile fishes to survive under harsh environmental conditions. It reviews the most recent research on acidic, Antarctic, cave, desert, hypersaline, hypoxic, temporary, and fast-flowing habitats, as well as naturally and anthropogenically toxic waters, while pointing out generalities that are evident across different study systems. Knowledge of the different adaptations that allow fish to cope with stressful environmental conditions furthers our understanding of basic physiological, ecological, and evolutionary principles. In several cases, evidence is provided for how the adaptation to extreme environments promotes the emergence of new species. Furthermore, a link is made to conservation biology, and how human activities have exacerbated existing extreme environments and created new ones. The book concludes with a discussion of major open questions in our understanding of the ecology and evolution of life in extreme environments.

Toxicity Testing in the 21st Century

Toxicity Testing in the 21st Century
Author: National Research Council
Publisher: National Academies Press
Total Pages: 217
Release: 2007-10-05
Genre: Nature
ISBN: 0309109922

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.

The Micronucleus Assay in Toxicology

The Micronucleus Assay in Toxicology
Author: Siegfried Knasmüller
Publisher: Royal Society of Chemistry
Total Pages: 684
Release: 2019-07-18
Genre: Science
ISBN: 1788018494

Concerns about the adverse health effects of chemicals and radiation present in the environment and at workplaces have created the need for better detection systems to assess their potential to cause DNA damage in humans and other organisms across ecosystems. The Micronucleus Assay in Toxicology is the first comprehensive volume concerning the use of micronucleus assays in genetic toxicology. It succinctly explains the mechanisms by which genotoxins cause micronucleus formation and its relation to diseases. Furthermore, it describes the methods which are currently used for the analyses of micronuclei in different types of cells in human in vivo biomonitoring studies, routine in vivo tests with rodents, in vitro studies with human and mammalian cells, environmental monitoring with invertebrates and vertebrates such as molluscs, fish and, also, in plant bioassays. Moreover, this book also focuses on the use of the micronucleus technique in other research areas, including the detection of DNA damage caused by important groups of genotoxic carcinogens (heavy metals, industrial chemicals, cytotoxic drugs, pesticides, ionising radiation, etc.) as well as study designs, statistical analyses, international regulatory guidelines, and the development of automated scoring devices for this assay. This book will serve as both, a reference and a guide to students, and investigators in biomedical, biochemical and pharmaceutical sciences interested in gaining a better understanding of the biology of micronuclei and their application in measuring DNA damage caused by natural or man-made genotoxins.