National Academies Press: OpenBook
Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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EVALUATING CHEMICAL AND OTHER AGENT EXPOSURES FOR REPRODUCTIVE AND DEVELOPMENTAL TOXICITY

Subcommittee on Reproductive and Developmental Toxicology

Committee on Toxicology

Board on Environmental Studies and Toxicology

Commission on Life Sciences

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.

Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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    NATIONAL ACADEMY PRESS 2101 Constitution Ave., N.W. Washington, D.C. 20418

    NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

    This project was supported by Contract Nos. DAMD 17-89-C9086 and DAMD 17-99-C9049 between the National Academy of Sciences and the U.S. Department of Defense. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

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    Copyright 2001 by the National Academy of Sciences . All rights reserved.

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Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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    THE NATIONAL ACADEMIES

    National Academy of Sciences

    National Academy of Engineering

    Institute of Medicine

    National Research Council

    The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences.

    The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering.

    The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.

    The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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    SUBCOMMITTEE ON REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY

    CAROLE A. KIMMEL (Chair), U.S. Environmental Protection Agency, Washington, D.C.

    GERMAINE M. BUCK, University at Buffalo, State of New York

    MAUREEN H. FEUSTON, Sanofi Pharmaceuticals, Inc., Malvern, Pa.

    PAUL M.D. FOSTER, Chemical Industry Institute of Toxicology, Research Triangle Park, N.C.

    J. M. FRIEDMAN, University of British Columbia, Vancouver

    JOSEPH F. HOLSON, WIL Research Laboratories, Inc., Ashland, Ohio

    CLAUDE L. HUGHES, JR., Cedars-Sinai Medical Center, Los Angeles, Calif.

    JOHN A. MOORE, Institute for Evaluating Health Risks, Washington, D.C., and Sciences International, Alexandria, Va.

    BERNARD A. SCHWETZ, National Center for Toxicological Research, Rockville, Md.

    ANTHONY R. SCIALLI, Georgetown University Medical Center, Washington, D.C.

    WILLIAM J. SCOTT, JR., University of Cincinnati College of Medicine, Cincinnati, Ohio

    CHARLES V. VORHEES, University of Cincinnati College of Medicine, Cincinnati, Ohio

    BARRY R. ZIRKIN, The Johns Hopkins University School of Hygiene and Public Health, Baltimore, Md.

    Staff

    KULBIR S. BAKSHI, Program Director for the Committee on Toxicology

    ABIGAIL STACK, Project Director

    KATE KELLY, Editor

    MIRSADA KARALIC-LONCAREVIC, Information Specialist

    LEAH PROBST, Senior Project Assistant

    EMILY SMAIL, Project Assistant

    Sponsor

    U.S. DEPARTMENT OF DEFENSE

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    COMMITTEE ON TOXICOLOGY

    BAILUS WALKER, JR. (Chair), Howard University Medical Center and American Public Health Association, Washington, D.C.

    MELVIN E. ANDERSEN, Colorado State University, Denver

    GERMAINE M. BUCK, National Institutes of Health, Washington, D.C.

    ROBERT E. FORSTER II, University of Pennsylvania, Philadelphia

    WILLIAM E. HALPERIN, National Institute for Occupational Safety and Health, Cincinnati, Ohio

    CHARLES H. HOBBS, Lovelace Respiratory Research Institute and Lovelace Biomedical and Environmental Research Institute, Albuquerque, N.M.

    SAM KACEW, Department of Pharmacology Faculty of Medicine and University of Ottawa, Ontario

    NANCY KERKVLIET, Oregon State University, Agricultural and Life Sciences, Corvallis

    MICHAEL J. KOSNETT, University of Colorado Health Sciences Center, Denver

    MORTON LIPPMANN, New York University School of Medicine, Tuxedo

    ERNEST E. MC CONNELL, ToxPath, Inc., Raleigh, N.C.

    THOMAS E. MCKONE, Lawrence Berkeley National Laboratory and University of California, Berkeley

    HARIHARA MEHENDALE, The University of Louisiana at Monroe, Monroe

    DAVID H. MOORE, Battelle Memorial Institute, Bel Air, Md.

    LAUREN ZEISE, California Environmental Protection Agency, Oakland

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Staff

KULBIR S. BAKSHI, Program Director

SUSAN N.J. MARTEL, Program Officer

ABIGAIL E. STACK, Program Officer

RUTH E. CROSSGROVE, Publications Manager

KATHRINE J. IVERSON, Manager, Toxicology Information Center

AIDA C. NELL, Senior Project Assistant

EMILY L. SMAIL, Project Assistant

Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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    BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY

    GORDON ORIANS (Chair), University of Washington, Seattle

    JOHN DOULL, University of Kansas Medical Center, Kansas City

    DAVID ALLEN, University of Texas, Austin

    INGRID C. BURKE, Colorado State University, Fort Collins

    THOMAS BURKE, The Johns Hopkins University, Baltimore, Md.

    GLEN R. CASS, Georgia Institute of Technology, Atlanta

    WILLIAM L. CHAMEIDES, Georgia Institute of Technology, Atlanta

    CHRISTOPHER B. FIELD, Carnegie Institute of Washington, Stanford, Calif.

    JOHN GERHART, University of California, Berkeley

    J. PAUL GILMAN, Celera Genomics, Rockville, Md.

    DANIEL S. GREENBAUM, Health Effects Institute, Cambridge, Mass.

    BRUCE D. HAMMOCK, University of California, Davis

    ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, N.M.

    CAROL HENRY, American Chemistry Council, Arlington, Va.

    ROBERT HUGGETT, Michigan State University, East Lansing

    JAMES F. KITCHELL, University of Wisconsin, Madison

    DANIEL KREWSKI, University of Ottawa, Ottawa, Ontario

    JAMES A. MACMAHON, Utah State University, Logan

    CHARLES O'MELIA, The Johns Hopkins University, Baltimore, Md.

    WILLEM F. PASSCHIER, Health Council of The Netherlands, The Hague

    ANN POWERS, Pace University School of Law, White Plains, N.Y.

    KIRK SMITH, University of California, Berkeley

    TERRY F. YOSIE, American Chemistry Council, Arlington, Va.

    Senior Staff

    JAMES J. REISA, Director

    DAVID J. POLICANSKY, Associate Director and Senior Program Director for Applied Ecology

    RAYMOND A. WASSEL, Senior Program Director for Environmental Sciences and Engineering

    KULBIR BAKSHI, Program Director for the Committee on Toxicology

    ROBERTA M. WEDGE, Program Director for Risk Analysis

    K. JOHN HOLMES, Senior Staff Officer

Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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    COMMISSION ON LIFE SCIENCES

    MICHAEL T. CLEGG (Chair), University of California, Riverside

    PAUL BERG (Vice Chair), Stanford University, Stanford, Calif.

    FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C.

    JOANNA BURGER, Rutgers University, Piscataway, N.J.

    JAMES E. CLEAVER, University of California, San Francisco

    DAVID S. EISENBERG, University of California, Los Angeles

    NEAL L. FIRST, University of Wisconsin, Madison

    DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, Calif.

    DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, Calif.

    ARTURO GOMEZ -POMPA, University of California, Riverside

    COREY S. GOODMAN, University of California, Berkeley

    JON W. GORDON, Mount Sinai School of Medicine, New York, N.Y.

    DAVID G. HOEL, Medical University of South Carolina, Charleston

    BARBARA S. HULKA, University of North Carolina, Chapel Hill

    CYNTHIA J. KENYON, University of California, San Francisco

    BRUCE R. LEVIN, Emory University, Atlanta, Ga.

    DAVID M. LIVINGSTON, Dana-Farber Cancer Institute, Boston, Mass.

    DONALD R. MATTISON, March of Dimes, White Plains, N.Y.

    ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena

    ROBERT T. PAINE, University of Washington, Seattle

    RONALD R. SEDEROFF, North Carolina State University, Raleigh

    ROBERT R. SOKAL, State University of New York, Stony Brook

    CHARLES F. STEVENS, The Salk Institute for Biological Studies, La Jolla, Calif.

    SHIRLEY M. TILGHMAN, Princeton University, Princeton, N.J.

    RAYMOND L. WHITE, DNA Sciences, Inc., Mountain View, Calif.

    Staff

    WARREN R. MUIR, Executive Director

    JACQUELINE K. PRINCE, Financial Officer

    BARBARA B. SMITH, Administrative Associate

    LAURA T. HOLLIDAY, Senior Program Assistant

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OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY

Toxicological Effects of Methylmercury (2000)

Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer-Review Practices (2000)

Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000)

Modeling Mobile-Source Emissions (2000)

Toxicological Risks of Selected Flame-Retardant Chemicals (2000)

Copper in Drinking Water (2000)

Ecological Indicators for the Nation (2000)

Waste Incineration and Public Health (1999)

Hormonally Active Agents in the Environment (1999)

Research Priorities for Airborne Particulate Matter: I. Immediate Priorities and a Long-Range Research Portfolio (1998); II. Evaluating Research Progress and Updating the Portfolio (1999)

Ozone-Forming Potential of Reformulated Gasoline (1999)

Risk-Based Waste Classification in California (1999)

Arsenic in Drinking Water (1999)

Brucellosis in the Greater Yellowstone Area (1998)

The National Research Council's Committee on Toxicology: The First 50 Years (1997)

Toxicologic Assessment of the Army's Zinc Cadmium Sulfide Dispersion Tests (1997)

Carcinogens and Anticarcinogens in the Human Diet (1996)

Upstream: Salmon and Society in the Pacific Northwest (1996)

Science and the Endangered Species Act (1995)

Wetlands: Characteristics and Boundaries (1995)

Biologic Markers (5 reports, 1989-1995)

Review of EPA's Environmental Monitoring and Assessment Program (three reports, 1994-1995)

Science and Judgment in Risk Assessment (1994)

Ranking Hazardous Waste Sites for Remedial Action (1994)

Pesticides in the Diets of Infants and Children (1993)

Issues in Risk Assessment (1993)

Setting Priorities for Land Conservation (1993)

Protecting Visibility in National Parks and Wilderness Areas (1993)

Dolphins and the Tuna Industry (1992)

Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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Hazardous Materials on the Public Lands (1992)

Science and the National Parks (1992)

Animals as Sentinels of Environmental Health Hazards (1991)

Assessment of the U.S. Outer Continental Shelf Environmental Studies Program, Volumes I-IV (1991-1993)

Human Exposure Assessment for Airborne Pollutants (1991)

Monitoring Human Tissues for Toxic Substances (1991)

Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991)

Decline of the Sea Turtles (1990)

Copies of these reports may be ordered from

the National Academy Press

(800) 624-6242

(202) 334-3313

www.nap.edu

Page xiii Cite
Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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OTHER REPORTS OF THE COMMITTEE ON TOXICOLOGY

Acute Exposure Guideline Levels for Selected Airborne Contaminants, Volume 1 (2000)

Review of the US Navy's Human Health Risk Assessment of the Naval Air Facility at Atsugi, Japan (2000)

Methods for Developing Spacecraft Water Exposure Guidelines (2000)

Review of the U.S. Navy Environmental Health Center's Health-Hazard Assessment Process (2000)

Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers (2000)

Re-Evaluation of Drinking-Water Guidelines for Diisopropyl Methylphosphonate (2000)

Submarine Exposure Guidance Levels for Selected Hydrofluorocarbons: HFC-236fa, HFC-23, and HFC-404a (2000)

Review of the U.S. Army's Health Risk Assessments for Oral Exposure to Six Chemical-Warfare Agents (1999)

Toxicity of Military Smokes and Obscurants, Volume 1(1997), Volume 2 (1999), Volume 3 (1999)

Assessment of Exposure-Response Functions for Rocket-Emission Toxicants (1998)

Toxicity of Alternatives to Chlorofluorocarbons: HFC-134a and HCFC-123 (1996)

Permissible Exposure Levels for Selected Military Fuel Vapors (1996)

Spacecraft Maximum Allowable Concentrations for Selected Airborne Contaminants, Volume 1 (1994), Volume 2 (1996), Volume 3 (1996), Volume 4 (2000)

Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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Preface

The United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy.

Several individuals assisted the subcommittee by providing information on Naval operations, particularly on the Navy's health hazard evaluation program. We thank Captain David Macys (Office of Naval Research), Captain Lawrence Betts (Navy Environmental Health Center), Commander Victoria Cassano (Navy Environmental Health Center), Captain David Sack (Navy Environmental Health Center), Captain Kenneth Still (Navy Health Research Center's Toxicology Detachment), and James Crawl (Navy Environmental Health Center)

Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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for their interest and support of this project. We also gratefully acknowledge the following persons who provided valuable background information to the subcommittee: Stacy Arnesen (National Library of Medicine), George Daston (Procter and Gamble Company), James Donald (California Environmental Protection Agency), Elaine Faustman (University of Washington), Michael Shelby (National Institute of Environmental Health Sciences), and John Weiner (University at Buffalo, State of New York). The subcommittee thanks R. Woodrow Setzer, Jr. (U.S. Environmental Protection Agency) for providing guidance on statistical methods discussed in this report.

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James Chen (National Center for Toxicological Research), George Daston (Procter and Gamble Company), Jerry Heindel (National Institute of Environmental Health Sciences), Grace Lemasters (University of Cincinnati), and John Young (National Center for Toxicological Research).

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Donald Mattison (March of Dimes Birth Defects Foundation), appointed by the Commission on Life Sciences, who was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

We are also grateful for the assistance of NRC staff in the prepara-

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tion of this report. The subcommittee acknowledges Kulbir Bakshi, program director of the Committee on Toxicology and, in particular, Abigail Stack, project director for this report, without whose leadership and assistance this project could not have been completed. Other staff members contributing to this report were James Reisa, director of the Board on Environmental Studies and Toxicology (BEST); Carol Maczka, formerly BEST's senior program director for toxicology and risk assessment; Ruth Crossgrove, publications manager; Leah Probst, senior project assistant; and Emily Smail, project assistant.

Finally, we thank all the members of the subcommittee for their expertise and dedicated effort throughout the study.

Carole A. Kimmel, Ph.D.

Chair, Subcommittee on Reproductive and Developmental Toxicology

Bailus Walker Jr., Ph.D., M.P.H.

Chair, Committee on Toxicology

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Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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Contents

ABBREVIATIONS xxi
SSUMMARY 1
1     INTRODUCTION 11
    Subcommittee Task, 20
    Organization of the Report, 22
2     THE EVALUATIVE PROCESS: PART I. ASSESSING THE AVAILABLE DATA 24
    Principles and Objectives, 24
    General Description, 30
    Details of the Evaluative Process, 31
3     THE EVALUATIVE PROCESS: PART II. INTEGRATION OF TOXICITY AND EXPOSURE INFORMATION 57
    Interpretation of Toxicity Data, 57
    Quantitative Evaluation, 64
    Summary, 79
4     INCOMPLETE OR INSUFFICIENT DATA SETS 81
    Principles to Minimize Risk, 81
    Practical Application, 83
    Reducing Uncertainty, 84
Suggested Citation:"Front Matter." National Research Council. 2001. Evaluating Chemical and Other Agent Exposures for Reproductive and Developmental Toxicity. Washington, DC: The National Academies Press. doi: 10.17226/10007.
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5     RECOMMENDATIONS 86
    General Recommendations, 86
    Research Recommendations, 89
REFERENCES 92
APPENDIXES
    A     APPLICATION OF THE RECOMMENDED EVALUATIVE PROCESS TO SPECIFIC CHEMICALS 117
    B     ASCERTAINING INFORMATION ON THE REPRODUCTIVE AND DEVELOPMENTAL TOXICITY OF AGENT EXPOSURES 168
    C     HUMAN STUDY DESIGNS 198
    D     EXPERIMENTAL ANIMAL AND IN VITRO STUDY DESIGNS 206
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Abbreviations

ACGIH American Conference of Governmental Industrial Hygienists

ADI acceptable daily intake

AIHA American Industrial Hygiene Association

ATSDR Agency for Toxic Substances and Disease Registry

AUC area under the curve

BMD benchmark dose

CAS Chemical Abstract Service

CDC Centers for Disease Control and Prevention

CFC chlorofluorocarbon

Cmax peak threshold concentration

DART developmental and reproductive toxicology

EC European Commission

ECETOC European Centre for Ecotoxicology and Toxicology of Chemicals

EPA U.S. Environmental Protection Agency

ETICBACK Environmental Teratology Information Center Backfile

F1 first filial generation

FDA U.S. Food and Drug Administration

HEC human equivalent concentration

HFC 134a 1,1,1,2-tetrafluoroethane

HFC hydrofluorocarbon

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HSDB Hazardous Substance Data Base

IARC International Agency for Research on Cancer

ILO International Labor Organization

IPCS International Programme on Chemical Safety

IRIS Integrated Risk Information System (Administered by the U.S. Environmental Protection Agency)

JP-8 jet propellant-8

LC50 lethal concentration for 50% of the test animals

LD50 lethal dose for 50% of the test animals

LHRH luteinizing hormone releasing hormone

LOAEL lowest-observed-adverse-effect level

MDI metered dose inhaler

MeSH medical subject headings

MOE margin of exposure

MTD maximum tolerated dose

NCEA National Center for Environmental Assessment

NIEHS National Institute of Environmental Health Sciences

NIH National Institutes of Health

NIOSH National Institute for Occupational Safety and Health

NOAEL No-observed-adverse-effect level

NRC National Research Council

NTIS National Technical Information Service

NTP National Toxicology Program

OECD Organization for Economic Cooperation and Development

OR odds ratio

ORD Office of Research and Development

P generation parental animals

PEL permissible exposure limit

RACB reproductive assessment of continuous breeding

RfD reference dose

RR relative risk

RTECS Registry of Toxic Effects of Chemical Substances

SIDS screening information data set

SOP standard operating procedure

STEL Short-Term Exposure Limit

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TLV Threshold Limit Value

TOXNET Toxicology Data Network

UEL unlikely effect level

UF uncertainty factor

UNEP United Nations Environmental Program

WHO World Health Organization

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EVALUATING CHEMICAL AND OTHER AGENT EXPOSURES FOR REPRODUCTIVE AND DEVELOPMENTAL TOXICITY

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The United States Navy has been concerned for some time with protecting its military and civilian personnel from reproductive and developmental hazards in the workplace. As part of its efforts to reduce or eliminate exposure of Naval personnel and their families to reproductive and developmental toxicants, the Navy requested that the National Research Council (NRC) recommend an approach that can be used to evaluate chemicals and physical agents for their potential to cause reproductive and developmental toxicity. The NRC assigned this project to the Committee on Toxicology, which convened the Subcommittee on Reproductive and Developmental Toxicology, to prepare this report. In this report, the subcommittee recommends an approach for evaluating agents for potential reproductive and developmental toxicity and demonstrates how that approach can be used by the Navy.

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: James Chen (National Center for Toxicological Research), George Daston (Procter and Gamble Company), Jerry Heindel (National Institute of Environmental Health Sciences), Grace Lemasters (University of Cincinnati), and John Young (National Center for Toxicological Research).

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