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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 36





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



        World Health Organization, Geneva 1996


         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.


    ISBN 92 4 166036 8
	
    CONTENTS

    Preface

    Anthelminthic agents
       Doramectin
       Moxidectin
       Febantel, fenbendazole and oxfendazole

    Antimicrobial agents
       Ceftiofur
       Chlortetracycline and tetracycline

    Antiprotozoal agent
       Diclazuril

    Annexes

       Annex 1   Reports and other documents
                 resulting from previous 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, Geneva,
                 6-15 June 1995

       Annex 4   Recommendations on compounds
                 on the agenda

       Annex 5   Corrigenda

    

    PREFACE

         The monographs contained in this volume were prepared at the
    forty-fifth meeting of the Joint FAO/WHO Expert Committee on Food
    Additives (JECFA), which met in Geneva, Switzerland, 6-15 June 1995.
    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 forty-fifth report of JECFA will be published by the World
    Health Organization in the WHO Technical Report Series. 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 the veterinary drugs that were evaluated at
    the forty-fifth meeting of JECFA will be issued separately by FAO as
    Food and Nutrition Paper No. 41/8. These toxicological monographs
    should be read in conjunction with the residue monographs and the
    report.

         Reports and other documents resulting from previous meetings of
    JECFA 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, naturally
    occurring toxicants, and contaminants in food. Committees accomplish
    this task by preparing reports of their meetings and publishing
    specifications or residue monographs 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 at the beginning of each monograph to
    those who prepared these working papers.

         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. Special acknowledgement is
    made to these advisers. The monographs were edited by Dr H.
    Galal-Gorchev, Geneva, Switzerland.

         From 1972 to 1975 the toxicological monographs prepared by JECFA
    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 No. 20, which was prepared by the
    twenty-ninth Committee in 1985, through WHO Food Additives Series 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 has been 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 supports 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.





















    See Also:
       Toxicological Abbreviations