BENZOIC ACID AND SODIUM BENZOATE - World Health …

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 Organization, or the World Health International chemical assessment Document 26 BENZOIC ACID AND SODIUM BENZOATENote that the pagination and layout of this pdf file are not identical to those of the printedCICADF irst draft prepared by Dr A. Wibbertmann, Dr J. Kielhorn, Dr G. Koennecker,Dr I. Mangelsdorf, and Dr C. Melber, Fraunhofer Institute for Toxicology and Aerosol Research,Hanover, GermanyPublished under the joint sponsorship of the United Nations Environment Programme, theInternational Labour Organization, and the World Health Organization, and produced within theframework of the Inter-Organization Programme for the Sound Management of Health OrganizationGeneva, 2000 Corrigenda published by 12 April 2005 have been incorporated in this fileThe International Programme on chemical Safety (IPCS), established in 1980, is a joint ventureof the United Nations Environment Programme (UNEP), the International Labour Organization (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 DataBenzoic acid and SODIUM BENZOATE .(Concise international chemical assessment document ; 26) acid - toxicity BENZOATE - toxicity exposure Programme on chemical Safety 92 4 153026 X (NLM Classification: QD ) 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.

4 World Health Organization 2000 Publications of the World Health Organization enjoy copyright protection in accordance with theprovisions of Protocol 2 of the Universal Copyright Convention. 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 sources of BENZOIC Estimated global TRANSPORT, DISTRIBUTION, TRANSFORMATION, and distribution between LEVELS AND HUMAN COMPARATIVE KINETICS AND METABOLISM IN LABORATORY ANIMALS of BENZOIC EFFECTS ON LABORATORY MAMMALS AND IN VITRO TEST exposure.

5 And International chemical assessment Document exposure and of benzyl acetate, benzyl alcohol, and and related and developmental toxicity of benzyl acetate, benzyl alcohol, and EFFECTS ON ON OTHER ORGANISMS IN THE LABORATORY AND of Health identification and dose response for setting tolerable intakes or guidance values for BENZOIC acid and risk of environmental PREVIOUS EVALUATIONS BY INTERNATIONAL 1 SOURCE 2 CICAD PEER 3 CICAD FINAL REVIEW 4 INTERNATIONAL chemical SAFETY SUM D DE ORIENTACI acid and SODIUM benzoate1 FOREWORDC oncise International chemical AssessmentDocuments (CICADs) are the latest in a family ofpublications from the International Programme onChemical Safety (IPCS) a cooperative programme ofthe World Health Organization (WHO), the InternationalLabour Organization (ILO), and the United NationsEnvironment Programme (UNEP).

6 CICADs join theEnvironmental Health Criteria documents (EHCs) asauthoritative documents on the risk assessment are concise documents that providesummaries of the relevant scientific informationconcerning the potential effects of chemicals uponhuman Health and/or the environment. They are basedon selected national or regional evaluation documents oron existing EHCs. Before acceptance for publication asCICADs by IPCS, these documents undergo extensivepeer review by internationally selected experts to ensuretheir completeness, accuracy in the way in which theoriginal data are represented, and the validity of theconclusions primary objective of CICADs ischaracterization of hazard and dose response fromexposure to a chemical . CICADs are not a summary of allavailable data on a particular chemical ; rather, theyinclude only that information considered critical forcharacterization of the risk posed by the chemical .

7 Thecritical studies are, however, presented in sufficientdetail to support the conclusions drawn. For additionalinformation, the reader should consult the identifiedsource documents upon which the CICAD has to human Health and the environment willvary considerably depending upon the type and extentof exposure. Responsible authorities are stronglyencouraged to characterize risk on the basis of locallymeasured or predicted exposure scenarios. To assist thereader, examples of exposure estimation and riskcharacterization are provided in CICADs, wheneverpossible. These examples cannot be considered asrepresenting all possible exposure situations, but areprovided as guidance only. The reader is referred to EHC1701 for advice on the derivation of Health -basedtolerable intakes and guidance every effort is made to ensure that CICAD srepresent the current status of knowledge, newinformation is being developed constantly.

8 Unlessotherwise stated, CICADs are based on a search of thescientific literature to the date shown in the executivesummary. In the event that a reader becomes aware ofnew information that would change the conclusionsdrawn in a CICAD, the reader is requested to contactIPCS to inform it of the new flow chart shows the procedures followed toproduce a CICAD. These procedures are designed totake advantage of the expertise that exists around theworld expertise that is required to produce the high- quality evaluations of toxicological, exposure, and otherdata that are necessary for assessing risks to humanhealth and/or the first draft is based on an existing national,regional, or international review. Authors of the firstdraft are usually, but not necessarily, from the institutionthat developed the original review. A standard outlinehas been developed to encourage consistency in first draft undergoes primary review by IPCS toensure that it meets the specified criteria for second stage involves international peerreview by scientists known for their particular expertiseand by scientists selected from an international rostercompiled by IPCS through recommendations from IPCS national Contact Points and from IPCS ParticipatingInstitutions.

9 Adequate time is allowed for the selectedexperts to undertake a thorough review. Authors arerequired to take reviewers comments into account andrevise their draft, if necessary. The resulting second draftis submitted to a Final Review Board together with thereviewers CICAD Final Review Board has severalimportant functions: to ensure that each CICAD has been subjected toan appropriate and thorough peer review; to verify that the peer reviewers comments havebeen addressed 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 commentsof the reviewers; and to approve CICADs as international members serve in their personal capacity, not asrepresentatives of any organization, government, or 1 International Programme on chemical Safety (1994)Assessing human Health risks of chemicals: derivationof guidance values for Health -based exposure , World Health Organization (EnvironmentalHealth Criteria 170).

10 Concise International chemical assessment Document 262 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) BENZOIC acid and SODIUM benzoate3industry. They are selected because of their expertise inhuman and environmental toxicology or because of theirexperience in the regulation of chemicals. Boards arechosen according to the range of expertise required for ameeting and the need for balanced members, authors, reviewers, consultants,and advisers who participate in the preparation of aCICAD are required to declare any real or potentialconflict of interest in relation to the subjects underdiscussion at any stage of the process.