AZODICARBONAMIDE - World Health Organization

1 This report contains the collective views of an international group of experts and does notnecessarily represent the decisions or the stated policy of the United Nations EnvironmentProgramme, the international Labour Organisation, or the World Health international Chemical Assessment Document 16 AZODICARBONAMIDEF irst draft prepared byMr R. Cary, Health and Safety Executive, Merseyside, United Kingdom, Dr S. Dobson, Institute of Terrestrial Ecology, Cambridgeshire, United Kingdom, andMrs E. Ball, Health and Safety Executive, Merseyside, United KingdomPlease note that the layout and pagination of thispdf file are not identical to those of theprinted CICADP ublished under the joint sponsorship of the United Nations Environment Programme, theInternational Labour Organisation, and the World Health Organization , and produced within theframework of the Inter- Organization Programme for the Sound Management of Health OrganizationGeneva, 1999 The international Programme on Chemical Safety (IPCS), established in 1980, is a joint ventureof the United Nations Environment Programme (UNEP), the international Labour Organisation (ILO),and the World Health Organization (WHO).

2 The overall objectives of the IPCS are to establish thescientific basis for assessment of the risk to human Health and the environment from exposure tochemicals, through international peer review processes, as a prerequisite for the promotion of chemicalsafety, and to provide technical assistance in strengthening national capacities for the sound managementof Inter- Organization Programme for the Sound Management of Chemicals (IOMC) wasestablished in 1995 by UNEP, ILO, the Food and Agriculture Organization of the United Nations, WHO,the United Nations Industrial Development Organization , the United Nations Institute for Training andResearch, and the Organisation for Economic Co-operation and Development (ParticipatingOrganizations), following recommendations made by the 1992 UN Conference on Environment andDevelopment to strengthen cooperation and increase coordination in the field of chemical safety.

3 Thepurpose of the IOMC is to promote coordination of the policies and activities pursued by the ParticipatingOrganizations, jointly or separately, to achieve the sound management of chemicals in relation to humanhealth and the Library Cataloguing-in-Publication DataAzodicarbonamide.(Concise international chemical assessment document ; 16) compounds exposure Programme on Chemical Safety 92 4 153016 2 (NLM classification: QV 235) ISSN 1020-6167 The World Health Organization welcomes requests for permission to reproduce or translate itspublications, in part or in full. Applications and enquiries should be addressed to the Office of Publications, World Health Organization , Geneva, Switzerland, which will be glad to provide the latest information onany changes made to the text, plans for new editions, and reprints and translations already available. World Health Organization 1999 Publications of the World Health Organization enjoy copyright protection in accordance with theprovisions of Protocol 2 of the Universal Copyright Convention.

4 All rights designations employed and the presentation of the material in this publication do not imply theexpression of any opinion whatsoever on the part of the Secretariat of the World Health Organizationconcerning the legal status of any country, territory, city, or area or of its authorities, or concerning thedelimitation of its frontiers or mention of specific companies or of certain manufacturers products does not imply that they areendorsed or recommended by the World Health Organization in preference to others of a similar naturethat are not mentioned. Errors and omissions excepted, the names of proprietary products aredistinguished by initial capital Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, Germany,provided financial support for the printing of this by Wissenschaftliche Verlagsgesellschaft mbH, D-70009 Stuttgart 10iiiTABLE OF AND PHYSICAL/CHEMICAL OF HUMAN AND ENVIRONMENTAL TRANSPORT, DISTRIBUTION.

5 AND LEVELS AND HUMAN KINETICS AND METABOLISM IN LABORATORY ANIMALS ON LABORATORY MAMMALS AND IN VITRO TEST and exposure and and related and developmental and neurological ON ON OTHER ORGANISMS IN THE LABORATORY AND of Health identification and dose response for setting guidance values for risk Evaluation of environmental EVALUATIONS BY international Health PROTECTION AND EMERGENCY Human Health Health surveillance international Chemical Assessment Document REGULATIONS, GUIDELINES, AND CHEMICAL SAFETY 1 SOURCE 2 CICAD PEER 3 CICAD FINAL REVIEW SUM D DE ORIENTACI international Chemical Assessment Documents(CICADs) are the latest in a family of publications from theInternational Programme on Chemical Safety (IPCS) acooperative programme of the World Health Organization (WHO), the international Labour Organisation (ILO), and theUnited Nations Environment Programme (UNEP).

6 CICAD sjoin the Environmental Health Criteria documents (EHCs) asauthoritative documents on the risk assessment of are concise documents that provide summariesof the relevant scientific information concerning the potentialeffects of chemicals upon human Health and/or theenvironment. They are based on selected national or regionalevaluation documents or on existing EHCs. Before acceptancefor publication as CICADs by IPCS, these documents undergoextensive peer review by internationally selected experts toensure their completeness, accuracy in the way in which theoriginal data are represented, and the validity of theconclusions primary objective of CICADs is characterization ofhazard and dose response from exposure to a are not a summary of all available data on a particularchemical; rather, they include only that information consideredcritical for characterization of the risk posed by the critical studies are, however, presented in sufficient detailto support the conclusions drawn.

7 For additional information,the reader should consult the identified source documents uponwhich the CICAD has been to human Health and the environment will varyconsiderably depending upon the type and extent of authorities are strongly encouraged to characterizerisk on the basis of locally measured or predicted exposurescenarios. To assist the reader, examples of exposureestimation and risk characterization are provided in CICADs,whenever possible. These examples cannot be considered asrepresenting all possible exposure situations, but are providedas guidance only. The reader is referred to EHC 1701 for adviceon the derivation of Health -based guidance every effort is made to ensure that CICAD srepresent the current status of knowledge, new information isbeing developed constantly. Unless otherwise stated, CICAD sare based on a search of the scientific literature to the dateshown in the executive summary. In the event that a readerbecomes aware of new information that would change theconclusions drawn in a CICAD, the reader is requested tocontact IPCS to inform it of the new flow chart shows the procedures followed toproduce a CICAD.

8 These procedures are designed to takeadvantage of the expertise that exists around the World expertise that is required to produce the high-qualityevaluations of toxicological, exposure, and other data that arenecessary for assessing risks to human Health and/or first draft is based on an existing national, regional,or international review. Authors of the first draft are usually,but not necessarily, from the institution that developed theoriginal review. A standard outline has been developed toencourage consistency in form. The first draft undergoesprimary review by IPCS to ensure that it meets the specifiedcriteria for second stage involves international peer review byscientists known for their particular expertise and by scientistsselected from an international roster compiled by IPCS throughrecommendations from IPCS national Contact Points and fromIPCS Participating Institutions. Adequate time is allowed forthe selected experts to undertake a thorough review.

9 Authorsare required to take reviewers comments into account andrevise their draft, if necessary. The resulting second draft issubmitted to a Final Review Board together with thereviewers CICAD Final Review Board has several importantfunctions: to ensure that each CICAD has been subjected to anappropriate and thorough peer review; to verify that the peer reviewers comments have beenaddressed appropriately; to provide guidance to those responsible for thepreparation of CICADs on how to resolve anyremaining issues if, in the opinion of the Board, theauthor has not adequately addressed all comments of thereviewers; and to approve CICADs as international members serve in their personal capacity, not asrepresentatives of any Organization , government, or are selected because of their expertise in human andenvironmental toxicology or because of their 1 international Programme on Chemical Safety (1994)Assessing human Health risks of chemicals: derivationof guidance values for Health -based exposure , World Health Organization (Environmental HealthCriteria 170).

10 Concise international Chemical Assessment Document 162 SELECTION OF HIGH QUALITYNATIONAL/REGIONALASSESSMENT DOCUMENT(S)CICAD PREPARATION FLOW CHARTFIRST DRAFTPREPAREDREVIEW BY IPCS CONTACT POINTS/SPECIALIZED EXPERTSFINAL REVIEW BOARD 2 FINAL DRAFT 3 EDITINGAPPROVAL BY DIRECTOR, IPCSPUBLICATIONSELECTION OF PRIORITY CHEMICAL1 Taking into account the comments from The second draft of documents is submitted to the Final Review Board together with the reviewers Includes any revisions requested by the Final Review OF COMMENTS (PRODUCER/RESPONSIBLE OFFICER),PREPARATIONOF SECOND DRAFT 1 PRIMARY REVIEW BY IPCS (REVISIONS AS NECESSARY)Azodicarbonamide3experience in the regulation of chemicals. Boards are chosenaccording to the range of expertise required for a meeting andthe need for balanced geographic members, authors, reviewers, consultants, andadvisers who participate in the preparation of a CICAD arerequired to declare any real or potential conflict of interest inrelation to the subjects under discussion at any stage of theprocess.