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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 25





    Prepared by:
      The 34th meeting of the Joint FAO/WHO Expert
      Committee on Food Additives (JECFA)



    World Health Organization, Geneva 1990


         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.



    CONTENTS

    Preface

    Monograph Format

    Antihelminthic

         Albendazole

    Antiprotozoal agents

         Dimetridazole
         Ipronidazole
         Ronidazole

    Antimicrobial sulfonamides

         Sulfadimidine
         Sulfathiazole

    Growth promoter

         Trenbolone acetate

    Trypanosides

         Diminazene
         Isometamidium

     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   1989 JECFA participants
         Annex 4   Accceptable daily intakes, other
                   toxicological recommendations and
                   information on specifications
         Annex 5   Further toxicological studies and
                   other information required or desired

    PREFACE

         The monographs contained in this volume were prepared by the
    thirty-fourth Joint FAO/WHO Expert Committee on Food Additives
    (JEFCA), which met in Geneva, Switzerland, 30 January-8 February 1989.
    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-fourth report of JECFA has been published by the World
    Health Organization as WHO Technical Report Series No. 788. 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. Further information required or desired is listed
    in Annex 5.

         Residues monographs on the veterinary drugs that were evaluated
    at the thirty-fourth meeting of JECFA will be issued separately by FAO
    in the FAO Food and Nutrition Paper Series. 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.

         JEFCA 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 R. Benson, US Environmental Protection Agency, Denver,
    Colorado, USA; Dr F.X.R. van Leeuwen, National Institute of Public
    Health and Environmental Protection, Bilthoven, The Netherlands; Dr
    J.C. McLean, Swinburne Institute of Technology, Hawthorn, Australia;
    Dr E. Schlede, Max van Pettenkofer Institute of the Federal Office
    of Public Health, Berlin, FRG; Dr K.N. Woodward, Division of
    Toxicology and Environmental Protection, Department of Health, London,
    England; and Dr M.S. Yong, Bureau of Veterinary Drugs, Ottawa,
    Canada.

         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
    FAO/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. Beginning with WHO Food Additives Series No, 20, which
    was prepared by the twenty-ninth Committee in 1985 until WHO Food
    Additives Series No. 24, which was prepared by the thirty-third
    Committee in 1988, volumes in this series were published by the
    Cambridge University Press. Beginning with this issue, 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 Organization, 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 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

              Level causing no toxicological effect

              Estimate of acceptable daily intake

              Further work or information
                   Required for substances given a temporary ADI
                   Desired

    5.   REFERENCES





















    See Also:
       Toxicological Abbreviations