Intentional Human Dosing Studies for EPA Regulatory Purposes

Intentional Human Dosing Studies for EPA Regulatory Purposes PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309166411
Category : Science
Languages : en
Pages : 226

Book Description
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 PDF Author: Zahra Zakeri
Publisher:
ISBN:
Category : Science
Languages : en
Pages : 236

Book Description
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

Toxicological Profile for Lead

Toxicological Profile for Lead PDF Author:
Publisher:
ISBN:
Category : Lead
Languages : en
Pages : 584

Book Description


Toxicological Profile for Cobalt

Toxicological Profile for Cobalt PDF Author:
Publisher:
ISBN:
Category : Cobalt
Languages : en
Pages : 170

Book Description


Drinking Water and Health,

Drinking Water and Health, PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309036879
Category : Nature
Languages : en
Pages : 476

Book Description
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 PDF Author: Joseph A. Holden
Publisher: Cambridge University Press
ISBN: 1139620630
Category : Science
Languages : en
Pages : 157

Book Description
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 PDF Author: United States. Public Health Service. Office of the Surgeon General
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 728

Book Description
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.

The Micronucleus Assay in Toxicology

The Micronucleus Assay in Toxicology PDF Author: Siegfried Knasmüller
Publisher: Royal Society of Chemistry
ISBN: 1788018494
Category : Science
Languages : en
Pages : 684

Book Description
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.

Extremophile Fishes

Extremophile Fishes PDF Author: Rüdiger Riesch
Publisher: Springer
ISBN: 3319133624
Category : Science
Languages : en
Pages : 329

Book Description
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.

Introduction to In Vitro Cytotoxicology

Introduction to In Vitro Cytotoxicology PDF Author: Frank A. Barile
Publisher: CRC Press
ISBN: 1000012913
Category : Medical
Languages : en
Pages : 285

Book Description
First Published in 1994, Introduction to In Vitro Cytotoxicology examines in vitro cytotoxicology, which offers new methodologies to toxicity testing. This important new discipline of modern toxicology is gaining increased acceptance as a viable alternative to traditional testing methods. The text discusses the application of in vitro cytotoxicology to toxicity testing and human risk assessment, and it analyzes the advantages and limitations of the tests performed under scientific and regulatory conditions. The book also reviews the optimum utilization of certain tests for specific groups of chemicals relevant to validation programs currently in progress. This book is a useful reference tool for students, researchers, and practitioners interested in academic, industrial, and regulatory toxicology; environmental health; cell biology; pharmacology; dentistry; or human and veterinary medicine.