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Environmental Health Criteria 104 Principles for the Toxicological Assessment of Pesticide Residues in Food

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Environmental Health Criteria 104 Principles for the Toxicological Assessment of Pesticide Residues in Food NTERNATIONAL PROGRAMME ON CHEMCAL SAFETY Environmental Health Criteria 104 Principles for the Toxicological Assessment Of Pesticide Residues in Food 0 underthejointaponsorship of the United Nations EnvironmentPrograrnnie, ternational Labour Organrsation, and the World Health Organization 0111CI di es asail:hle iii i he I N VI R( ) N \I I U III' \ I I ( RFIFRIA Other titles available in the ENVIRONMENTAL FIEALTI I eric, include: CRITERIA series (continued): I \ls'rcurv 35. I leptachior 69. Magnetic Fields 2. PnIs ThioL a:iicd ltip]teiis k dOLl I'iiuquia: Lilld I)jtuai 70, Principles for the Safety Assessment of Food Additives lipIucns k I uJouIlaui and Contaminants in Food 3. 1 cild 41 Quiii ii 0/CI1C 71. L'entachlorophenol 4. ()side l Nih audI 42. I L'L I I, I/CI1h 72. Principles of Studies on Diseases of Suspected Chemical Nuhuatc, Nil uhIc, and 43. ( lilni dauic Etiology and Their Prevention N-Nh r0o (. on)ponilik 44 \liicni - . Phosphune and Selected Metal Phosphides 6. l'riIlLi(hlc- :ind \lcilio.1 to! 4 , ( .tinphr'cllloi Diaminotoluenes i- \al u: h :i e lie I i\Iil\c 0 4( o ( uieleiiic t o lid hLirl\ Toluene Diisocvanates (liemicak. 'au I (eilC1ic Ut (Cii. 0 Huiimuii Plioloc}icuiiical ()\i±iiu'. Populuiuis 76, Thiocarbamate Pesticides - A General Introduction S. StulIui ()\iclL' and 5iipnuUs'sI 4. Suiiuihuaru 11_p011 011 ike Man-made Mineral Fibres l'iurticuiiutc Miticu I -' iltiauii'ui at Shari I cruit 1 ck Dithiocarbamate Pesticides, Ethylenethiourea, and 9 1)1)1 duLl ill Dciii iii ii ku (arciIbecn 4C011,'uh01ativc Propylenethiourea - A General Introduction Carhaii Disullijc Slilils on In 111w Icts( Dichlorvos Ii . \laicadia. 45 Dniicuhyl Still aie 80. Pvrrolizidine Alkaloids 12. Noke 49 \r clainude 81, Vanadium Ii. ('at ban \Iaiia.sid Si). Ii lchlmoetht lClic 82. Cvpermethrin 4 t hia%iulcl. k icli it iii 1 ( nick in SIan I I u in I t liii 83 DDT and its Deris'ilis es En ironmental Aspects Ore:iuinhuui ( ,uuli1iuuiIiiJ l)ciccuiii l,itaeciuo_ and l, liii and 84, 24-Dichlorophenoxsacetic Acd - Environmental Aspects 16. Radinlicquuciics and \lueru'ss.u'..'' ( aiciutneeni . ( lienuical' 85. Lead - Environmental Aspects I . - \Ianivauicsc o.. I alueiie 86. Mercury Environmental Aspects I S Arsen ic .Ahc sins ioU Otli Nat oral 87. Allethrins 19. Hvdraecii Sullide Mincial Ii ll CS PolychLorinated Dienzo-parci-dioxins and 21). Slctd Peiriuldhiuli Pu ,iiIiuot S4 \miiioiiiii 88. 21 . (111ou inc and I Is di iuecn 5, 1.:tlivlciie l)\idc Dibenzofurans ('hiot dc 56, l'uops cue ( )\id'• 89. Formaldehyde 22. Ultrasound . 16 inciples a ........cnkiuieuic 90. Dimethoate Lasers and Optical Ruduauiuui Studies . 91. Aldrin and Dieldrjn 1 luaniuni 55. Selenium 92, Resmethrins Selected RadicuuiiucIidc 59. I'riuieip1c tar EvaIiaiing Healih Chlorophenols 26 ,Styr cite Risks front C. lemiecls 1)tirinp Permethrin 2', (iuuiclelines on S111&Cl H luil'ncviiuid Larlv ( }iildhood: 95 Fenvalerate Enrirouimeuuiul Epidcuuiioliais The Need for a Speca Ap- 96 d-Phenothrin .Acrs lonitrile ' proach - . 97. Deltamethrin -.3. * ,4_DieluI(uululielu(uu.\i:uccuic. 6(1. Principles. ar the Assu'ssiucni ol 98. Tetramethrin Acid 12.4-1)) . Neurohelias iouual loxi oLogs Cyhalothrin ft Principles for Iii aliiuiine IIu'luIi (St. Chromium (in preparauoui) 99. Risks in P1012MIN AssaLbated 62. 1 ,2-Diehloroeihane 100. Vinylidene Chloride a jib ldipasure in (11eui5ical'. 63. ()rganophosphoriis Iuisu.eiieudes 101. Methylmercury chin ic Preeiiauiey A (leneral Introduction 102. 1 - Propanol 31. Teuuachloesuethvlene . 64. (burbamauc Pesticides - 103. 2-Propanol 32, Meihylene Chloride A General luuirocltition 33. Epiehlnrolisdriii 65. lluiauiiik . loin soon_os 34. Chlordanc - 66. Kelet an 35. Extremely low F'rcquucuues 67, Teiradifon ([I F) Fields 65. Hydra/i rue 36. ITlhiai inc auid l'liuiuiilcs 37. Aquatic ( Mau lie n5l Frcsliwaiei( Hiiuiaiii ia/iWuiuSJ no dual/n (on1. C (IVi'[ This report contains the lective views of an in- ternatuonal group of experts and does not necessarily represent the decisions or the stated policy of the United Nations Environment Programme, the liii dna- luonal labour Organisation, or the \Vorld Health ()rganii.at Oil Environmental Health Criteria 104 PRINCIPLES FOR THE TOXICO- LOGICAL ASSESSMENT OF PESTICIDE RESIDUES IN FOOD Published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization ? I - World Health Organization Geneva, 1990 The International Programme on Chemical Safety (IPCS) is a joiht venture of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization. The main objec- tive of the EPCS is to carry Out and disse'minate evaluations of the effects of chemicals on human health and the quality of the environ- ment. 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. WHO Library Cataloguing in Publication Data Principles for the toxicological assessment of pesticide residues in food. (Environmental health criteria 104) 1. Pesticide residues - analysis - toxicity 2. Food contamination I. Series ISBN 92 4 157104 7 (NLM Classification: WA 240) ISSN 0250-863X © World Health Organization 1990 Publications of the World Health Organization enjoy copyright pro.- tection in accordance with the provisions of Protocol 2 of the Univer- sal Copyright Convention. For rights of reproduction or translation of WHO publications, in part or in two, 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 expression of any opinion whatsoever on the part of the Secretariat of the World Health Organization con- cerning the legal status of any 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. Prinnd in ELliland 89. 6316 \arnniala CONTENTS PRINCIPLES FOR THE TOXICOLOGICAL ASSESSMENT OF PESTICIDE RESIDUES IN FOOD FOREWORD 10 PREFACE Il INTRODUCTION 13 GENERAL HISTORICAL BACKGROUND 15 JMPR ASSESSMENT PROCESS 17 CONSIDERATIONS OF IDENTITY, PURITY, AND STABILITY 21 21 4.1 Background 4.2 Principles 23 23 4.2.1 Identity 4.2.2 Purity 23 4.2.3 Stability 23 AVAILABILITY AND QUALITY OF DATA 25 5.1 Background 25 5.2 Principles 26 HUMAN DATA 27 6.1 Background 27 6.2 Current position 28 6.3 Principles 29 STRUCTURE-ACTIVITY RELATIONSHIPS 30 7.1 Principle 30 TEST METHODOLOGIES 31 31 8.1 Background 8.2 General considerations 32 8.2.1 Choice of species and strain 32 8.2.2 Group size 33 8.2.3 Selection of dose levels 36 8.2.4 Test duration 38 8.2.5 Pathological procedures 39 8.2.6 Historical control data 40 -4- 8.3 Conduct and evaluation of studies 42 8.3.1 Short- and long-term toxicity studies 42 8.3.2 Carcinogenicity studies 47 8.3.2.1 Background 48 8.3.2.2 Routes of exposure 48 8.3.2.3 Commonly occurring tumours 49 8.3.2.4 Pathological classification of neoplasms 50 8.3.2.5 Evaluation of carcinogenicity studies 51 8.3.2.6 Extrapolation from animals to man 52 8.3.2.7 Principles 53 8.3.3 Reproduction studies 53 8.3.3.1 Multigeneration reproduction studies 53 8.3.3.2 Teratology studies 58 8.3.3.3 Screening studies in teratology 60 8.3.3.4 Principles 60 8.3.4 Neurotoxicity studies 61 8.3.4.1 Delayed neurotoxicity 61 8.3.4.2 Acute neurotoxicity 63 8.3.4.3 Chronic neurotoxicity 65 8.3.4.4 Pyrethroid-induced neurotoxicity 65 8.3.4.5 Neurobehavioural toxicity 66 8.3.4.6 Principles 67 8.3.5 Genotoxicity studies 67 8.3.5.1 Principles 68 8.3.6 Immunotoxicity studies 68 8.3.6.1 Background 68 8.3.6.2 Current position 69 83.63 Principles 70 8.3.7 Absorption, distribution, metabolism, and excretion 71 8.3.7.1 Background 71 8.3.7.2 Current position 72 8.3.7.3 Principles 75 9, EVAIMATION OF DATA 76 9.1 Extrapolation of animal data to humans 76 9.2 Safety factors 76 9.2.1 Background 76 9.2.2 Principles 78 9.3 Allocating the ADI 80 9.3.1 Background 80 9.3.2 Temporary ADIs 81 9.3.3 Present position 82 10. EVALUATION OF MIXTURES 84 10.1 Introduction 84 10,2 Background 84 10.3 Principle 84 -5-. RE-EVALUATION OF PESTICIDES 85 BIOTECI-INOLOGY 86 13, SPECIAL CONSIDERATIONS FOR INDIVIDUAL CLASSES OF PESTICIDES 87 13.1 Organophosphates - ophthalmological effects 87 13.2 Organophosphates - aliesterase (carboxyles te rase) inhibition 87 13.3 The need for carcinogenicity testing of organophosphates 88 13.4 Ocular toxicity of bipyridilium compounds 88 115 Goitrogenic carcinogens 88 REFERENCES 92 ANNEX I: GLOSSARY 109 ANNEX II: APPROXIMATE RELATION OF PARTS PER MILLION IN THE DIET TO MG/KG BODY WEIGHT PER DAY 113 INDEX 114 -6- WHO TASK GROUP ON PRINCIPLES FOR THE TOXICOLOGICAL ASSESSMENT OF PESTICIDE RESIDuES IN FOOD Dr N. Aidridge, The Robens Institute of Industrial & Environmental Health & Safety, University of Surrey, Guildford, Surrey, United Kingdom° Dr G.
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