Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms

Subcommittee to Review Permethrin Toxicity from Military Uniforms

Committee on Toxicology

Board on Environmental Studies and Toxicology

Commission on Life Sciences

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.
1994



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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Subcommittee to Review Permethrin Toxicity from Military Uniforms Committee on Toxicology Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1994

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms 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 competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The National Academy of Sciences is a private, non-profit, 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 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. Robert M. White 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 Alberts and Dr. Robert M. White are chairman and vice chairman, respectively, of the National Research Council. The project was supported by the U.S. Army under contract No.DAMD 17-89-C-9086. Additional copies of this report are available from the Board on Environmental Studies and Toxicology, 2101 Constitution Avenue, N.W., Washington, D.C. 20418 Copyright 1994 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Subcommittee to Review Permethrin Toxicity from Military Uniforms ERNEST EUGENE MCCONNELL (Chair), Consultant, Raleigh, N.C. IAN GREAVES, University of Minnesota, Minneapolis, Minn. CAROLE KIMMEL, U.S. Environmental Protection Agency, Washington, D.C. RALPH KODELL, U.S. Food and Drug Administration, Jefferson, Ark. LOREN KOLLER, Oregon State University, Corvallis, Oreg. MICHELE MEDINSKY, Chemical Industry Institute of Toxicology, Research Triangle Park, N.C. ANNE WOLVEN-GARRET, Consultant, Atlanta, Ga. Staff KULBIR S. BAKSHI, Project Director and Program Director RICHARD D. THOMAS, Program Director (until May 1994) RUTH E. CROSSGROVE, Editor CATHERINE M. KUBIK, Senior Program Assistant WANDA J. SMARR, Project Assistant Sponsor: U.S. Army

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Committee on Toxicology ROGENE F. HENDERSON (Chair), Lovelace Biomedical and Environmental Research Institute, Albuquerque, N.Mex. R. HAYS BELL, Eastman Kodak Company, Rochester, N.Y. DEAN E. CARTER, University of Arizona, Tucson, Ariz. DEBORAH A. CORY-SLECHTA, University of Rochester School of Medicine, Rochester, N.Y. CHARLES E. FEIGLEY, University of South Carolina, Columbia, S.C. DONALD E. GARDNER, ManTech Environmental Technology, Inc., Research Triangle Park, N.C. DAVID W. GAYLOR, U.S. Food and Drug Administration, Jefferson, Ark. WALDERICO M. GENEROSO, Oak Ridge National Laboratory, Oak Ridge, Tenn. IAN A. GREAVES, University of Minnesota, Minneapolis, Minn. SIDNEY GREEN, U.S. Food and Drug Administration, Laurel, Md. CAROLE A. KIMMEL, U.S. Environmental Protection Agency, Washington, D.C. LOREN D. KOLLER, Oregon State University, Corvallis, Oreg. ERNEST EUGENE MCCONNELL, Raleigh, N.C. MICHELE A. MEDINSKY, Chemical Industry Institute of Toxicology, Research Triangle Park, N.C. ROBERT SNYDER, Rutgers University, Piscataway, N.J. BAILUS WALKER, JR., University of Oklahoma, Oklahoma City, Okla. HANSPETER R. WITSCHI, University of California, Davis, Calif. GERALD N. WOGAN, Massachusetts Institute of Technology, Cambridge, Mass. GAROLD S. YOST, University of Utah, Salt Lake City, Utah

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Staff of Committee on Toxicology KULBIR S. BAKSHI, Program Director RICHARD D. THOMAS, Program Director (until May 1994) MARVIN A. SCHNEIDERMAN, Senior Staff Scientist RUTH E. CROSSGROVE, Editor CATHERINE M. KUBIK, Senior Program Assistant RUTH P. DANOFF, Project Assistant (until November 1993) WANDA SMARR, Project Assistant

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Board on Environmental Studies and Toxicology PAUL G. RISSER (Chair), Miami University, Oxford, Ohio FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C. MICHAEL J. BEAN, Environmental Defense Fund, Washington, D.C. EULA BINGHAM, University of Cincinnati, Cincinnati, Ohio EDWIN H. CLARK, Clean Sites, Inc., Alexandria, Va. ALLAN H. CONNEY, Rutgers University, Piscataway, N.J. JOHN L. EMMERSON, Eli Lilly & Company, Greenfield, Ind. ROBERT C. FORNEY, Unionville, Pa. ROBERT A. FROSCH, Harvard University, Cambridge, Mass. KAI LEE, Williams College, Williamstown, Mass. JANE LUBCHENCO, Oregon State University, Corvallis, Oreg. GORDON ORIANS, University of Washington, Seattle, Wash. FRANK L. PARKER, Vanderbilt University, Nashville, Tenn., and Clemson University, Anderson, S.C. GEOFFREY PLACE, Hilton Head, S.C. DAVID P. RALL, Washington, D.C. LESLIE A. REAL, Indiana University, Bloomington, Ind. KRISTIN SHRADER-FRECHETTE, University of South Florida, Tampa, Fla. GERALD VAN BELLE, University of Washington, Seattle, Wash. BAILUS WALKER, JR., Washington, D.C.

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Staff of Board on Environmental Studies and Toxicology JAMES J. REISA, Director DAVID J. POLICANSKY, Associate Director and Program Director for Natural Resources and Applied Ecology GAIL CHARNLEY, Acting Program Director for Human Toxicology and Risk Assessment (since May 1994) RICHARD D. THOMAS, Associate Director and Program Director for Human Toxicology and Risk Assessment (until May 1994) LEE R. PAULSON, Program Director for Information Systems and Statistics RAYMOND A. WASSEL, Program Director for Environmental Sciences and Engineering

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Commission on Life Sciences THOMAS D. POLLARD (Chair), Johns Hopkins Medical School, Baltimore, Md. BRUCE N. AMES, University of California, Berkeley, Calif. JOHN C. BAILAR, III, McGill University, Montreal, Quebec MICHAEL BISHOP, Hooper Research Foundation, University of California Medical Center, San Francisco, Calif. JOHN E. BURRIS, Marine Biological Laboratory, Woods Hole, Mass. MICHAEL T. CLEGG, University of California, Riverside, Calif. GLENN A. CROSBY, Washington State University, Pullman, Wash. LEROY E. HOOD, University of Washington, Seattle, Wash. MARIAN E. KOSHLAND, University of California, Berkeley, Calif. RICHARD E. LENSKI, Michigan State University, East Lansing, Mich. EMIL A. PFITZER, Hoffmann-La Roche Inc., Nutley, N.J. MALCOLM C. PIKE, University of Southern California School of Medicine, Los Angeles, Calif. HENRY C. PITOT, III, University of Wisconsin, Madison, Wisc. PAUL G. RISSER, Miami University, Oxford, Ohio JOHNATHAN M. SAMET, University of New Mexico School of Medicine, Albuquerque, N.Mex. HAROLD M. SCHMECK, JR., Armonk, N.Y. CARLA J. SHATZ, University of California, Berkeley, Calif. SUSAN S. TAYLOR, University of California at San Diego, La Jolla, Calif. P. ROY VAGELOS, Merck & Company, Whitehouse Station, N. J. JOHN L. VANDEBERG, Southwestern Foundation for Biomedical Research, San Antonio, Tex. TORSTEN N. WIESEL, Rockefeller University, New York, N.Y. PAUL GILMAN, Executive Director

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Other Recent Reports of The Board on Environmental Studies and Toxicology Science and Judgment in Risk Assessment (1994) Environmental Information for Outer Continental Shelf Oil and Gas Decisions (1994) Measuring Lead Exposure in Infants, Children, and Other Sensitive Populations (1993) Health Effects of Ingested Fluoride (1993) 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) Biologic Markers in Immunotoxicology (1992) Dolphins and the Tuna Industry (1992) Environmental Neurotoxicology (1992) 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) Tracking Toxic Substances at Industrial Facilities (1990) Biologic Markers in Pulmonary Toxicology (1989) Biologic Markers in Reproductive Toxicology (1989) These reports may be ordered from the National Academy Press(800) 624-6242 or (202) 334-3313

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Preface Military personnel sometimes must be rapidly deployed to areas where life-threatening, insect-borne diseases are prevalent. This places such personnel at an increased risk of contracting diseases such as malaria, scrub typhus, leishmaniasis, and Lyme disease. The suddenness of deployments and movement after deployment often precludes the use of protection or control measures. To protect against specific disease risks from insect bites, the U.S. Army has formulated a clothing impregnant containing permethrin, a pyrethroid insecticide that is effective against disease vectors such as mosquitoes, ticks, and other arthropods. The Army proposes to use permethrin-impregnated fabric to manufacture battle-dress uniforms (BDUs). BDUs, made from either 100% cotton fabric or 50% nylon and 50% cotton fabric, are used to camouflage soldiers. The U.S. Environmental Protection Agency has classified permethrin as a potential carcinogen, so there might be concern that soldiers wearing permethrin-impregnated BDUs would face an unacceptable level of cancer risk. In response to that potential concern, the Army requested that the National Research Council (NRC) review the toxicological and exposure data and make recommendations regarding long-term exposure to permethrin. This project was assigned to the NRC's Committee on Toxicology (COT). The Subcommittee on Permethrin Toxicity from Military Uniforms was established within COT to perform this task. The subcommittee reviewed the toxicity data as well as the exposure and pharmacokinetic data on permethrin and assessed the suitability of military personnel wearing permethrin-impregnated BDUs on a long-term basis. The report of the subcommittee is intended for use by the Army

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms in deciding whether to impregnate BDUs with permethrin to protect soldiers from arthropod-borne diseases. The subcommittee in this report also assessed the risk to garment workers who handle permethrin-impregnated fabric. The subcommittee gratefully acknowledges Lieutenant Colonel Holly Doyne, Colonel Frederick Erdtmann, and Colonel Eric Evenson of the U.S. Army for their interest and support of the project. We also thank other persons who provided information for the subcommittee, including Major Stephen Berté, Lieutenant Colonel Phillip Pierce, Lieutenant Colonel Lyman Roberts, Hubert Snodgrass (all of the U.S. Army), and David Taplin (University of Miami). We are grateful to the NRC's anonymous reviewers for their many helpful comments and suggestions that have resulted in improvements of the subcommittee's report. This report could not have been produced without the untiring efforts of the NRC staff, including James J. Reisa, director, Board on Environmental Studies and Toxicology; Richard D. Thomas, program director, COT; Ruth E. Crossgrove, editor; Wanda Smarr, project assistant; and Catherine Kubik, senior program assistant. The subcommittee especially acknowledges its great debt to Kulbir S. Bakshi, who not only ably fulfilled the role of project director, but contributed substantially to the drafting and revision of the report. Without his skills and input, our task could never have been completed in the timely manner it has been. Finally, we would like to thank all members of the subcommittee for their expertise, input, and support throughout our deliberations. Ernest Eugene McConnell, Chair Subcommittee to Review Permethrin Toxicity from Military Uniforms Rogene F. Henderson, Chair Committee on Toxicology

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms Contents     SUMMARY   1  1   INTRODUCTION   17  2   EXPOSURE ASSESSMENT   23      Military Nonfield Personnel   23      Military Field Personnel   25      Garment Workers   25      Recommendations   26  3   PHARMACOKINETICS OF PERMETHRIN   27      Absorption of Permethrin   27      Interactions   31      Metabolism   32      Hydrolysis   34      Oxidation   35      Relationship to Toxicity   35      Elimination   37      Distribution   38      Summary and Conclusions   39      Recommendations   40  4   ACUTE AND SHORT-TERM TOXICITY OF PERMETHRIN   43      Acute Toxicity   43      Subacute and Subchronic Toxicity   48      Conclusions   55

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms  5   DERMAL AND OCULAR TOXICITY OF PERMETHRIN   57      Dermal Toxicity   57      Ocular Toxicity   64      Conclusions   65  6   NEUROTOXICITY OF PERMETHRIN   67      Human Data   68      Animal Data   68      Conclusions   71      Recommendations   72  7   LIVER AND OTHER ORGAN TOXICITY OF PERMETHRIN   73      Liver Toxicity   73      Other Organ Toxicity   74      Conclusions   75  8   IMMUNOTOXICITY OF PERMETHRIN   77      Conclusions   78      Recommendations   78  9   REPRODUCTIVE AND DEVELOPMENTAL TOXICITY OF PERMETHRIN   79      Rat Studies   80      Mouse Studies   82      Rabbit Studies   82      Other Studies   82      Conclusions   84  10   GENOTOXICITY OF PERMETHRIN   87      Gene Mutations   87      Chromosomal Effects   88      Other Genotoxic Effects   91      Conclusions   91  11   CARCINOGENICITY OF PERMETHRIN   93      Carcinogenicity Studies in Mice   93

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Health Effects of Permethrin-Impregnated Army Battle-Dress Uniforms      Carcinogenicity Studies in Rats   98      Tumor Promotion Studies: Shimkin Mouse Lung Bioassay   101      Conclusions   101      Carcinogenicity Risk Assessment   102  12   SUMMARY OF RECOMMENDATIONS   107      Exposure Assessment   108      Pharmacokinetics   108      Dermal Toxicity   109      Neurotoxicity   110      Immunotoxicity   110      Genotoxicity   110     REFERENCES   113     APPENDIX A   129