PESTICIDE RESIDUES IN FOOD - 1994 JOINT FAO/WHO MEETING ON PESTICIDE RESIDUES EVALUATIONS 1994 PART II - TOXICOLOGY Sponsored jointly by FAO and WHO with the support of the International Programme on Chemical Safety (IPCS) Joint meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues Rome, 19-28 September 1994 This report contains the collective views of two international groups of experts and does not necessarily represent the decisions nor the stated policy of the Food and Agriculture Organization of the United Nations or the World Health Organization. INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY The preparatory work for the toxicological evaluations of pesticide residues carried out by the WHO Expert Group on Pesticide Residues for consideration by the FAO/WHO Joint Meeting on pesticide Residues in Food and the Environment is actively supported by the International Programme on Chemical Safety (IPCS). 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. 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. ISBN 92 4 166510 6 (c) World Health Organization 1995 Publications of the World Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. For rights of reproduction or translation of WHO publications, in part or in toto, application should be made to the Office of Publications, World Health Organization, Geneva, Switzerland. The World Health Organization welcomes such applications. The designations employed and the presentation of the material in this publication do not imply the impression of any opinion whatsoever on the part of the Secretariat of the World Health Organization concerning the legal status of every country, territory, city, or area or of 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 the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. TABLE OF CONTENTS List of participants Abbreviations Introduction The monographs Abamectin (addendum) Chlorfenvinphos Chlormequat Clethodim* Cyhexatin (addendum) Fenpropimorph* Phorate Phosmet Tebuconazole* Tecnazene Teflubenzuron* Tolclofos-methyl* Annex I. Reports and other documents resulting from previous Joint Meetings of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and WHO Expert Groups on Pesticide Residues * First full evaluation 1994 Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues Rome, 19-28 September 1994 PARTICIPANTS WHO Expert Group on Pesticide Residues Dr A.L. Black, Medical Services Adviser in Toxicology, Department of Human Services and Health, Canberra ACT, Australia Professor J.F. Borzelleca, Pharmacology, Toxicology, Medical College of Virginia, Virginia Commonwealth University, Richmond, VA, United States (Vice-Chairman) Dr P. Fenner-Crisp, Acting Deputy Director, Office of Pesticide Programs, US Environmental Protection Agency, Washington DC, United States (Rapporteur) Professor O. Pelkonen, Professor of Pharmacology, Department of Pharmacology and Toxicology, University of Oulu, Oulu, Finland Professor A. Rico, Biochemistry-Toxicology, Physiopathology and Experimental Toxicology Laboratory (INRA), Ecole Nationale Vétérinaire, Toulouse, France Dr P.-P. Yao, Professor of Toxicology, Institute of Occupational Medicine, Ministry of Public Health, Beijing, China FAO Expert Group on Pesticide Residues Dr D.C. Abbott, Ashtead, Surrey, United Kingdom Dr A. Ambrus, Budapest Plant Health and Soil Conservation Station, Budapest, Hungary (Rapporteur) Dr U. Banasiak, Federal Biological Research Centre for Agriculture and Forestry, Kleinmachnow, Germany Mr D.J. Hamilton, Department of Primary Industries, Indooroopilly, Brisbane, Queensland, Australia Mr N.F. Ives, Health Effects Division, US Environmental Protection Agency, Washington DC, United States (Chairman) Ms E. Masoller, Servicios de Laboratorios, Ministerio de Ganaderia, Agricultura y Pesca, Montevideo, Uruguay Mr T. Sakamoto, Assistant Director, Plant Protection Division, Ministry of Agriculture, Forestry and Fisheries, Tokyo, Japan Dr B. Worobey, Chemical Evaluation Division, Bureau of Chemical Safety, Health Canada, Ottawa, Ontario, Canada Secretariat Dr E. Bosshard, Federal Office of Public Health, Division of Food Science, Schwerzenbach, Switzerland (WHO Temporary Adviser) Mrs M. Caris, Bureau of Chemical Hazards, Environmental Health Centre, Health Canada, Ottawa, Ontario, Canada (WHO Temporary Adviser) Dr P. Chamberlain, Veterinary Medical Officer, Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, United States (WHO Consultant) Dr W.H. van Eck, Food and Product Safety Division, Ministry of Health, Welfare and Sport, Rijswijk, Netherlands (Chairman, Codex Committee on Pesticide Residues) Dr K. Fujimori, Division of Pharmacology, Biological Safety Research Center, National Institute of Health Sciences, Ministry of Health and Welfare, Tokyo, Japan (WHO Temporary Adviser) Dr J.L. Herrman, International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland (WHO Joint Secretary) Mrs E. Heseltine, Communication in Science, St Léon-sur-Vézère, France (WHO Temporary Adviser) Mrs P.H. van Hoeven-Arentzen, National Institute of Public Health and Environmental Protection, Bilthoven, Netherlands (WHO Temporary Adviser) Dr J.-J. Larsen, Head, Department of General Toxicology, Institute of Toxicology, National Food Agency of Denmark, Soborg, Denmark (WHO Temporary Adviser) Mr A.F. Machin, London, United Kingdom (FAO Consultant) Dr D. McGregor, Unit of Carcinogen Identification and Evaluation, International Agency for Research on Cancer, Lyon, France Dr A. Moretto, Università di Padova, Istituto di Medicina del Lavoro, Padova, Italy (WHO Temporary Adviser) Dr G. Moy, Food Safety Unit, Division of Food and Nutrition, World Health Organization, Geneva, Switzerland Mr W. Murray, Plant Protection Service, Plant Production and Protection Division, Food and Agriculture Organization of the United Nations, Rome, Italy (FAO Joint Secretary) Dr. B. Röstel-Peters, Detached National Expert, DG III/E/3, Pharmaceuticals, Commission of the European Communities, Brussels, Belgium (WHO Temporary Adviser) Dr G. Vettorazzi, International Toxicology Information Centre, San Sebastian, Spain (WHO Temporary Adviser) Mr M. Walsh, Principal Administrator, European Commission, Législation des produits végétaux et de nutrition animale, VI/B/II.1, Brussels, Belgium Mr M. Watson, Head, Risk Evaluation Branch, Pesticides Safety Directorate, Ministry of Agriculture, Fisheries and Food, York, United Kingdom (WHO Temporary Adviser) Dr Y. Yamada, Food Standards Officer, Joint FAO/WHO Food Standards Programme, Food and Nutrition Division, Food and Agriculture Organization of the United Nations, Rome, Italy Abbreviations used in these monographs ADI acceptable daily intake ATP adenosine triphosphate bw body weight CCPR Codex Committee on Pesticide Residues CHO Chinese hamster ovary CI confidence interval CMC carboxymethylcellulose DMSO dimethyl sulfoxide DNA deoxyribonucleic acid F female F0 parental generation F1 first filial generation F2 second filial generation HPLC high-performance liquid chromatography hprt hypoxanthine-guanine phosphoribosyl transferase gene IPCS International Programme on Chemical Safety JECFA Joint FAO/WHO Expert Committee on Food Additives JMPR Joint FAO/WHO Meeting on Pesticide Residues LC50 median lethal concentration LD50 median lethal dose LOAEL lowest-observed-adverse-effect level M male NADPH reduced nicotinamide adenine dinucleotide phosphate NOAEL no-observed-adverse-effect level NR not reported ppm parts per million SD standard deviation TLC thin-layer chromatography Tween 80 polyoxyethylenesorbitan monooleate v/v volume per volume w/w weight per weight Introduction The toxicological monographs and monograph addenda contained in this volume were prepared by a WHO Expert Group on Pesticide Residues that met with the FAO Panel of Experts on Pesticide Residues in Food and the Environment in a Joint Meeting on Pesticide Residues (JMPR) in Rome, Italy, on 19-28 September 1994. These monographs summarize the safety data on those pesticide residues for which sufficient information was provided to the WHO Expert Group for it to make decisions about acceptable daily intakes. Five of the compounds considered by the WHO Expert Group at this Meeting had been evaluated at earlier meetings. For two of these, abamectin and cyhexatin, only information received since the previous evaluation is summarized, in 'monograph addenda'. The appropriate earlier documents should be consulted in order to obtain a full toxicological profile of these chemicals. In the cases of chlorfenvinphos, chlormequat, phorate, phosmet and tecnazene, toxicological monographs were prepared, summarizing new data and incorporating information from previous monographs and addenda. Reports and other documents resulting from previous Joint Meetings of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and WHO Expert Groups on Pesticide Residues are listed in Annex I. The report of the Joint Meeting has been published by the FAO as FAO Plant Production and Protection Paper No. 127. The report contains brief comments on the compounds considered, acceptable daily intakes established by the WHO Expert Group, and maximum residue limits or guideline levels established by the FAO Panel of Experts. Monographs on residues prepared by the FAO Panel of Experts are published as a companion volume, as Evaluations 1994, Part I, Residues, in the FAO Plant Production and Protection Paper series. The toxicological monographs and addenda contained in this volume are based on working papers that were prepared by temporary advisers before the 1994 Joint Meeting. A special acknowledgement is made to those advisers. The monographs were edited by Mrs E. Heseltine, St Léon-sur-Vézère, France. The preparation and editing of this volume were made possible by the technical and financial contributions of the lead institutions of the International Programme on Chemical Safety (IPCS), which supports the activities of the JMPR. 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 Central Unit of the IPCS concerning the legal status of any country, territory, city or area or of its authorities, nor 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 the IPCS in preference to others of a similar nature that are not mentioned. Any comments or new information on the biology or toxicology of the compounds included in this volume should be addressed to: Joint WHO Secretary of the Joint FAO/WHO Meeting on Pesticide Residues, International Programme on Chemical Safety, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland.
See Also: Toxicological Abbreviations