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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 29





    Prepared by:
      The thirty-eighth 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.



    CONTENTS

    Preface

    Monograph Format

    -adrenoceptor blocking agent

         Carazolol

    Anthelmintic agents

         Febantel
         Fenbendazole
         Oxfendazole
         Summary

    Antimicrobial agents

         Spiramycin
         Tylosin

    Tranquilizers

         Azaperone
         Chlorpromazine
         Propionylpromazine

    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,
              22-31 January, 1991

    Annex 4.  Recommendations on compounds on the agenda


    PREFACE

         The monographs contained in this volume were prepared by the
    thirty-eighth Joint FAO/WHO Expert Committee on Food Additives
    (JECFA), which met in Geneva, Switzerland, 22-31 January 1991. 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-eighth report of JECFA has been published by the
    World Health Oerganization as WHO Technical Report Series No. 815.
    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-eighth meeting of JECFA will be issued separately by FAO
    as FAO Food and Nutrition Paper No. 41/4. 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.

         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.

         Volumes in the WHO Food Additives Series are available from WHO
    except for Numbers 20-24 (prepared by the twenty-ninth through 
    thirty-third Committees), which were published by the Cambridge
    University Press. 

         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 delimitlation 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