INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION TOXICOLOGICAL EVALUATION OF CERTAIN VETERINARY DRUG RESIDUES IN FOOD WHO FOOD ADDITIVES SERIES 23 Prepared by: The 32th meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) World Health Organization, Geneva 1988 (c) World Health Organization 1988 First published 1988 Printed in Great Britain at the University Press, Cambridge Library of Congress cataloguing in publication data available. British Library cataloguing in publication data Joint FAO/WHO Expert Committee on Food Additives. Meeting (32nd: 1987: Rome, Italy). Toxicological evaluation of certain veterinary drug residues in food. (WHO food additives series; 23). 1. Food. Additives & contaminants. Toxic effects. I. Title II. World Health Organization III. Series ISBN 0 521 37916 4 The preparation of this document was supported by the International Programme on Chemical Safety (IPCS), Geneve, Switzerland. CONTENTS Preface Chloramphenicol Trenbolone acetate Zeranol 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 1987 JECFA participants Annex 4 Acceptable daily intakes, other toxicological recommendations and information on specifications PREFACE The monographs contained in this volume were prepared by the thirty-second Joint FAO/WHO Expert Committee on Food Additives (JEFCA), which met in Rome, Italy, 15-23 June 1987. 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-second report of JECFA has been published by the World Health Organization as WHO Technical Report Series, No. 763. 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. Specifications established at the thirty-second meeting of JEFCA will be issued separately by FAO under the title, Specifications for the identity and purity of certain veterinary drug residues in the FAO Food and Nutrition Paper Series. These toxicological monographs should be read in conjunction with the specifications 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 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 in advance of the thirty-first JECFA meeting. A special acknowledgement is given to those who prepared these working papers, Dr S. Fitzpatrick, Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD, USA; Dr C.L. Galli, Professor of Experimental Toxicology, University of Milan, Milan, Italy; Dr S.I. Shibko, Associate Director for Regulatory Evaluation, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC, USA; and Dr K.N. Woodward, Division of Toxicology and Environmental Protection, Department of Health and Social Security, 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 FAO/WHO Expert Committees on Food Additives were published in the WHO Food Additives Series; after 1975 this series became available only in the form of unpublished WHO documents provided upon request by the Organization. Beginning with the 1985 monographs, they are published by the Cambridge University Press, which should ensure that these monographs are more widely known and available. 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.
See Also: Toxicological Abbreviations