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CPY Document IA M)(XRAHS ON TH EVATION OF TH CACINIC RISK OF CHCA 'I MA: Sorn Cabartes, Thiocarbates and Carbazides Volur 12 This publication represents the views of an IA Working Group on the Evaluation of the Carcinogenc Risk of Chemcals to .M which net in Lyon, 9- 15 June 1976 lAC WORKING GROU ON TH EVATION OF TH CAINOENIC RISK OF CHCA TO MA: SC CATE, THICCTES AN CAIDES Lyon, 9-15 June 1976 Mernbers1 Dr R.R. Bates, Associate Corssioner for Science, US Foo and Drug Adnistration, 200 C Street SW, Washington IX 20204, USA (Chairman) Professor E. Boyland, TUC Institute of Occupational Health, London School of Hygiene and Tropical l1icine, Keppel Street, London ~LIE 7ll, UK Dr G.J. van Esch, Head, Laratory for Toxicolog, Rijks Instituut voor de Volksgezondheid, Antonie van Leuwenhoelaan 9, Bilthoven, The Netherlands ( Vice-Chairman) Dr D.E. Hathway, Senior Research Scientist, Cetral ToxicolCX.l Laratory, Imial Chercal Industries Lirted, Alderley Park, Cheshire SKIO 4TJ, OK Dr W. Li j insky, Frederick Cacer Research Centre, PO Box B, F'rederick, Maland 21701, USA Professor U. !-hr, Director, Abteilung ftr Exrimtelle Pathologie, Medizinische Hochschule Hanover, Kal Wiechert Allee 9, 3 Haover 61, FRG Dr S. D. Muhy, Assoiate Professor of Toxicolog, School of Pulic Heal th, Depart of Physiolog, Haard University, 665 Huntington Avenue, Boston, Massachusetts 02115, USA Dr V. B. Okulov, N. Petrov Research Insti tute of Oncolog, 68 Leningradskaya Street, Pesochny-2, Leningrad 188646, USSR Dr C. Ral, Stockholm Universitet, Wallenbrglalratoriet, Lilla Frescati, S- 104 05 Stockholm 50, Swden Dr B. Teichr, Akadere der Wissenschaften der DDR, Zentralinstitut ftr Krebsforschung, Lindenbrger Weg 80, 1115 Ber lin- Buch , GOR Dr B. Terracini, Istituto di Anatorna e Istologia Patologica dell 'Università di Torino, Via Santena 7, 10126 Tuin, Italy 1 Unable to attend: Professor F. H. Sobels, Departmt of Radiation Genetics and Chercal Mutagenesis, State University of Leiden, Wassenaarseweg 72, Leiden 2405, Th Netherlands 3 Invited Guests Dr B. Hildebrand, Toxicolog Depat, BASF Aktiengesellschaft, Bruckstrasse 60, D-6700 Ludwigshafen, FRG Dr O.H. Johnson, Senior Industrial Ecnorst, Chcal-Environmtal Prograr, Chercal Industries Center, Staford Research Institute, Menlo Park, ealifornia 94025, USA (Rapporteur sections 2.1 and 2.2) Dr V. von Schuller-Gtzburg, Mager, Chemcal Inforntion Servces - Euope, Stanford Research Institute, Pelikanstrasse 37, 8001 zürich, Swtzerland Mrs M.-T. van der Venne, Conrssion of the Euopean Ccmities, Health and Safety Directorate, Building Jean !-nnet A2jl15, Avenue Alcide-de-Gasperi, Kirchbrg, Luxemurg, Great Duchy of Luxemurg Representative fror the National Cacer Insti tute Dr J .A. Cooper, Deputy Associate Director, Cacinogenesis Prograr, Division of Cancer Cause and Treatrt, National Cacer Institute, Bethesda, Maryland 20014, USA Secretariat Dr C. Agthe, Unit of Chercal Cacinogenesis (Secretary) Dr H. Bartsch, Unit of Checal Cacinogenesis (Rapporteur section 3.2) Dr L. Griciute, Chief, Unit of Environmntal Cacinogens Dr R. Montesano, Unit of Checal Cacinogenesis (Rapporteur section 3.1) Mrs C. Partensky, Unit of Chercal Carcinogenesis (Technical editor) Mrs 1. Peterschmtt, Unit of Checal Carcinogenesis, 'VJHO, Geeva (Bib i iogl'aph1:c yies earcher) Dr V. Ponomarkov, Unit of Chemcal Carcinogenesis Dr R. Saracci, Unit of Epiderolog and Biostatistics (Rapporteur section 3.3) Dr L. Torntis, Chief, Unit of Chercal Cacinogenesis (Head of the Programe) Dr G. Vettorazzi, Foo Additives Unit, WHO, Geeva Mr E.A. Walker, Unit of Environmtal Cacinogens (Rapporteur sections 1 and 2. 3) Mrs E. Ward, Montignac, France (Editor) Mr J .D. Wilbur, Unit of Chercal Carcinogenesis (Co-secretary) 4 Note ta the reader Ever effort is made ta present the rrnogaphs as accuately as possible without unduly delaying their publication. Neverteless, rnstaes have ocurred and are still likel y to occu. ln the interest of all users of the se rrnogaphs, readers are reqested ta coicate any errors observed to the Unit of Chcal Cacinogenesis of the International Agency for Reseach on Cacer, Lyon, France, in order tht these ca be included in corrigenda which will appear in subseqent volurs. Since the rrnogaphs are not intended ta be a review of the literature and contain only data considered relevant by the Working Group, it is not possible for the reader to deterrne whether a certain study was considered or not. However, research v.rkers who are aware of imrtant published data that may chage the evaluation are reqested to mae ther available to the abve-rnntioned address, in order tht they ca be considered for a possible re-evaluation by a future Working Group. 5 cxNl BACKGROU AN PUE OF TH IA PRC ON TH EVATION OF TH CAIN:ENC RISK OF CHCA 'I MA ............. 9 SCOPE OF TH MONOHS 9 MEISM FOR PROOUCING TH MONCRAHS 10 GE PRIIPLES FOR TH EVATION 11 EXIA'IRY NOIS ON TH M)HS 14 GE RE ON CATES, THIcxTES AN CAIDES 23 TH M)HS Cabal 37 Chloroprophar 55 Diallate ..................................................... 69 Dimthy lcabay 1 chloride 77 Disulf iram ....... .... ......... ..... .... ... ..... .......... .... 85 Dulcin ....... 97 Ethy 1 selenac ........ ........ ...... ... ......... ........... ... 107 Etyl tellurac ... ... ..... .... .......... .......... ......... ... 115 Ferbam ..... ........ ........ .... ...... ......... ......... ... ... 121 Ledate ... .......... ....... ... ......... ................... .... 131 .Meb ........... ..... ..... ... ........ ............ ... ......... 137 Methyl carbate ....... ....... ........ ... .... .... .......... ..... 151 Methyl selenac ...... ......... ...... ....... ..... .......... .... 161 !-nuron ......... ... .... ...... ...... .... .......... ........ .... 167 Phenicabazide 177 Potassium bis (2-hydroxyethyl) dithocarbate ................. 183 Propha ...................................................... 189 n- Propy 1 carba te ........................................... 201 Secarbazide (hydrochloride) . .....oo.. ........... ......... ... 209 Soum diethyldithocbate ...oo.....oo.oo...............oo... 217 Thirar ....................................................... 225 Zectran . .. .". .. 237 7 Zineb .......................... ........ ... ........... ........ 245 ziram ... ... ... ..... .... ........ ................ ........... ... 259 SUPPLEAR CORRGENA 'I VOLUMS 1-11 ..... ..... .... .... .... .... 271 CUTIV INEX 'I MONcxHS ........ ............ ... ... ... ....... 273 8 BACKGROU AND PUSE OF TH IA PRCRA-l ON TH EVALATION OF TH CAINCIC RISK OF CHCA 'I MA The International Agency for Research on Cacer (lAC) initiated in 1971 a program to evaluate the carcinogenic risk of chercals to ma. This program was supported by a Resolution of the Governing Council at i ts Ninth Session concerning the role of IA in providing goverrnt authorities with exrt, independent scientific opinion on environrtal carcinogenesis. ln view of the ÌIrtce of the project and in order to expdite production of ITnogaphs, the National Cancer Insti tute of the United States has provided IAC with additional funds for this purse. The objective of th program is to elalrate and publish in the forr of Ilnographs critical reviews of cacinogenicity and related data in the light of the present state of knowledge, with the final am of evaluating the data in terr of possible hum risk, and at the saine tir to indicate where additional research efforts are needed. SCOPE OF TH M)NOGRAHS The TInographs sunize the evidence for the carcinogenicity of indi vidual chercals and other relevant inforrtion on the basis of data coriled, reviewd and evaluated by a Working Group of experts. i' recom- rnndations are given concerning preventive neasures or legislation, since these rntters depend on risk-benefit evaluations, which seer best made by individual governnts and/or interntional agencies such as v\1O and IID. Since 1971, when the program was started, eleven volums have been published1-11. As new data on chercals for which rrnographs have already ben prepared and new principles for evaluation becoin available, re- evaluations will be made at future meetings, and revised monographs will be published as necessary. The ITnogaphs are distributed to international and governrntal agencies, are available to industries and scientists dealing with these chercals an are offeredto any interested reader through their world-wide 9 distribution as ~VH publications. They also fonn the basis of advice fror IA on carcinogenesis fror these subtances. MEHAISM FOR PRODUCING TH M)N(HS As a first step, a list of chemcals for possible consideration by the Working Group is estalished. IAC then collects pertinent references regarding physico-chercal characteristics, production and use*, occurrence and analysis and biological data** on the se cornunds. The material is surized by an exprt consultant or an IA staff lTr, who prepares the first draft, which in sorn cases is sent to another exprt for corrts. The drafts are circulated to all lTrs of the ~'brking Group abut one IInth before the ireting. Duing the neeting, further additions to and de let ions from the data are agreed upon, and a final version of comrts and evaluation on each comund is adopted. Priority for the prepaation of IInographs Priori ty is gi ven rninl y to chercals belonging to paticular chemcal groups and for which there is at least sorn suggestion of carcinoenici ty from observations in animIs and/or ma and evidence of human expsure. However, the inclusion of a particular compound in a volume does not necessarily mean that
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