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    INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY

    WORLD HEALTH ORGANIZATION



    TOXICOLOGICAL EVALUATION OF CERTAIN
    VETERINARY DRUG RESIDUES IN FOOD



    WHO FOOD ADDITIVES SERIES 27





    Prepared by:
      The thirty-sixth meeting of the Joint FAO/WHO Expert
      Committee on Food Additives (JECFA)



    World Health Organization, Geneva 1991


         The International Programme on Chemical Safety (IPCS) is a
    joint venture of the United Nations Environment Programme, the
    International Labour Organisation, and the World Health Organization. 
    The main objective of the IPCS is to carry out and disseminate
    evaluations of the effects of chemicals on human health and the
    quality of the environment.  Supporting activities include the
    development of epidemiological, experimental laboratory, and risk-
    assessment methods that could produce internationally comparable
    results, and the development of manpower in the field of toxicology. 
    Other activities carried out by the IPCS include the development of
    know-how for coping with chemical accidents, coordination of
    laboratory testing and epidemiological studies, and promotion of
    research on the mechanisms of the biological action of chemicals.

         IPCS gratefully acknowledges the assistance provided by the
    International Life Sciences Institute (ILSI) in the form of editing of
    the toxicological monographs by Dr L. Fishbein and by providing a
    typist and typing facilities for their production.

    CONTENTS

    Preface

    Monograph Format

    Anthelminthic Drugs

         Closantel
         Ivermectin
         Levamisole

    Antimicrobial Agents

         Benzylpencillin
         Oxytetracycline

    Growth Promoters

         Carbadox
         Olaquindox

    Annexes

         Annex 1   Reports and other documents
                   resulting from meetings of
                   the Joint FAO/WHO 
                   Expert Committee on Food
                   Additives

         Annex 2   Abbreviations used in the 
                   Monographs

         Annex 3   Joint FAO/WHO Expert Committee
                   on Food Additives, Rome, 
                   5-14, February, 1990

         Annex 4   Recommendations on compounds
                   on the agenda

    PREFACE

         The monographs contained in this volume were prepared by the
    thirty-sixth Joint FAO/WHO Expert Committee on Food Additives (JECFA),
    which met in Rome, Italy, 5-14 February 1990.  These monographs
    summarize the safety data on selected veterinary drug residues
    reviewed  by the Committee.  The data reviewed in these monographs
    form the basis for acceptable daily intakes (ADIs) established by the
    Committee.

         The thirty-sixth report of JECFA has been published by the World
    Health Organization as WHO Technical Report Series No. 799.  The
    participants in the meeting are listed in Annex 3 of the present
    publication and a summary of the conclusions of the Committee is
    included as Annex 4.

         Residue monographs on veterinary drugs that were evaluated at the
    thirty-sixth meeting of JECFA will be issued separately by FAO as FAO
    Food and Nutrition Paper No. 41/3.  These toxicological monographs
    should be read in conjunction with the residues monographs and the
    report.

         Reports and other documents resulting from previous meetings of
    the Joint FAO/WHO Expert Committee on Food Additives are listed in
    Annex 1.

         JECFA serves as a scientific advisory body to FAO, WHO, their
    Member States, and the Codex Alimentarius Commission, primarily
    through the Codex Committee on Food Additives and Contaminants and the
    Codex Committee on Residues of Veterinary Drugs in Foods, regarding
    the safety of food additives, residues of veterinary drugs, and
    contaminants in food.  Committees accomplish this task by preparing
    reports of their meetings and publishing specifications and
    toxicological monographs, such as those contained in this volume, on
    substances that they have considered.

         The toxicological monographs contained in this volume are based
    upon working papers that were prepared by Temporary Advisers.  A
    special acknowledgement is given to those who prepared these working
    papers; Dr. D. Arnold, Animal Nutrition and Residue Research,
    Institute for Veterinary Medicine, Berlin (West); Dr. W.C. Keller,
    Center for Veterinary Medicine, U.S. Food and Drug Administration,
    Rockville, M.D., U.S.A.; Dr. F.X.R. van Leeuwen, National Institute of
    Public Health and Environmental Protection, Bilthoven, The
    Netherlands; Professor A. Rico, Professor of Biochemistry, National
    Veterinary School, Toulouse, France; and Dr. K.N. Woodward, Division
    of Toxicology and Environmental Protection, Department of Health,
    London, England.

         Many proprietary unpublished reports are referenced.  These were
    voluntarily submitted to the Committee by various producers of the
    veterinary drugs under review and in many cases these reports
    represent the only safety data available on these substances.  The
    temporary advisers based the working papers they developed on all the
    data that were submitted, and all these studies were available to the
    Committee when it made its evaluations.

         From 1972 to 1975 the toxicology monographs prepared by Joint/WHO
    Expert Committees on Food Additives were published in the WHO Food
    Additives Series; after 1975 this series was available in the form of
    unpublished WHO documents provided upon request to the Organization. 
    WHO Food Additives Series Volume No. 20, which was prepared by the
    twenty-ninth Committee in 1985, through  WHO Food Additives Series
    Volume No. 24, which was prepared by the thirty-third Committee in
    1988, were published by the Cambridge University Press.  Beginning
    with WHO Food Additives Series No. 25, which was prepared by the
    thirty-fourth Committee, WHO is producing these volumes as priced
    documents.

         The preparation and editing of the monographs included in this
    volume have been made possible through the technical and financial
    contributions of the Participating Institutions of the International
    Programme on Chemical Safety (IPCS), which support the activities of
    JECFA.  IPCS is a joint venture of the United Nations Environment
    Programme, the International Labour Organisation, and the World Health
    Organization, which is the executing agency.  One of the main
    objectives of the IPCS is to carry out and disseminate evaluations of
    the effects of chemicals on human health and the quality of the
    environment.

         The designations employed and the presentation of the material in
    this publication do not imply the expression of any opinion whatsoever
    on the part of the organizations participating in the IPCS concerning
    the legal status of any country, territory, city, or area or its
    authorities, or concerning the delimitation of its frontiers or
    boundaries.  The mention of specific companies or of certain
    manufacturers' products does not imply that they are endorsed or
    recommended by those organizations in preference to others of a
    similar nature that are not mentioned.

         Any comments or new information on the biological or
    toxicological data on the compounds reported in this document should
    be addressed to: Joint WHO Secretary of the Joint FAO/WHO Expert
    Committee on Food Additives, International Programme on Chemical
    Safety, World Health Organization, Avenue  Appia, 1211 Geneva 27,
    Switzerland.

    MONOGRAPH FORMAT

         Note:  Each monograph in this document follows the general format
    presented below.  Each heading may not, however, be applicable to all
    monographs.

    1.   EXPLANATION

    2.   BIOLOGICAL DATA

         2.1    Biochemical aspects

                2.1.1   Absorption, distribution and excretion

                2.1.2   Biotransformation

                2.1.3   Effects on enzymes and other biochemical
                        parameters

         2.2    Toxicological studies

                2.2.1   Acute toxicity studies

                2.2.2   Short-term toxicity studies

                2.2.2.1-2.2.2.X   Species tested

                2.2.3   Long term/carcinogenicity studies

                2.2.4   Reproduction studies

                2.2.5-2.2.X       Special studies

         2.3    Observations in humans

    3.   COMMENTS

    4.   EVALUATION

    5.   REFERENCES





















    See Also:
       Toxicological Abbreviations