Document dnZ7BMLDywZKERm7MVgy4m4K9

OCDE ORGANISATION DE COOPERATION ET DE DEVELOPPEMENT ECONOMIQUES OECD ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT DIRECTION DE L'ENVTRONNEMENT / ENVIRONMENT DIRECTORATE ENVIRONMENTAL HEALTH AND SAFETY DIVISION To: SIDS Contact Points cc: Members of the Steering Group on Existing Chemicals (letter. Chapter 1 and Chapter 4 ofthe Manual only) Members of the Hazard Assessment Advisory Body (HAAB) (letter and Chapter 4 of the Manual only) National Delegations (letter only) ENV/EHS/DT/th/96.39 Paris, 3 June 1996 Re: SIDS Manual Dear Madam/Sir, Please find enclosed the updated SIDS Manual, which reflects the state-of-the-art of the OECD SIDS Programme. In addition to a paper copy, a diskette including all the files processed in Word 6.0 is enclosed. SIDS Contact Points are expected to make this manual available to people who are involved in the SIDS work. The following revisions have been made in this version dated May 1996: 1. Chapter 1 (Description of OECD Work on Investigation of High Production Volume Chemicals) has been updated to reflect the current situation regarding recommendations in the SIDS Initial Assessment Reports, SIDS Review process, etc. 2. Section 4.S (Provisional Guidance for the Initial Assessment of Aquatic Effects) and Section 4.6 (Provisional Guidance for the Initial Assessment of Health Effects) have been revised to integrate the content of the recently developed EU Technical Guidance Documents in this area. The discussions at SIAM4 in Tokyo in May 1996 and comments on the draft by SIDS Contact Points, Members of die Steering Group and Members of the HAAB have been reflected as well. The most important revisions are: Guidance on determining assessment factors to be used to derive a PNEC for the aquatic environment has been modified in view of international harmonisation. Use of uncertainty factors for the initial assessment of human health has been eliminated from the main text 3. Section 4.2 (Provisional Guidance for the Oudine of the SIDS Initial Assessment Reports) was revised in April 1995 and slightly modified afterwards, recommending that exposure and effects for the environment and those for human health be discussed separately in SIARs. Mailing Address: 2 rue Andre-Pascal 75775 PARIS CEDEX 16 FRANCE CMA 119625 4. Documents reflecting ongoing discussions and proposals for gathering exposure information are included as Annex 5. However, the new proposal for the procedure for gathering exposure information agreed at SLAM4 is not included It will be integrated in the next revision. 5. Annexes have been reorganised and some Annexes have been moved to the main body of the text (e.g. the former Annex 2 has been integrated into Sections 4.3 and 4.4 and the former Annex 3 has been moved to Section 3.4). 6. All the information in the Manual has been updated and the text is now written in Word 6.0. In order to ensure publication of SIDS Initial Assessment Reports and SIDS Dossiers of high quality in a more harmonised way, it is strongly recommended that the reports and the dossiers be prepared according to the guidance set out in this Manual. SIDS Contact Points are encouraged to use the Manual to the greatest extent possible in carrying out SIDS work in their countries/organisations. The next revision is foreseen after SLAM5 to reflect experience in gathering exposure information. Any comments on die content of the Manual are welcome. If you have any questions or comments, please send them to Teruyoshi Hayamizu (Tel: 33-1-45.24.79.07, Fax: 33-1-45.24.16.75). Additional copies or diskettes are available horn Teruyoshi Hayamizu or Cilia Cerredo-Williamson (Tel: 33-1-45.24.16.74, Fax: 33-1-45.24.16.75). Yours sincerely. Dian Tumheim Environmental Health and Safety Division Enel.: a paper copy and a diskette CMA 119626 SIDS MANUAL (Second Revision) SCREENING INFORMATION DATA SET MANUAL OF THE OECD PROGRAMME ON THE CO-OPERATIVE INVESTIGATION OF HIGH PRODUCTION VOLUME CHEMICALS May 1996 OECD SECRETARIAT EXCH\MANUAL\96COVERDOC/Mav 1996 CMA119627 TABLE OF CONTENTS Foreword 1. Description of OECD Work on Investigation of High Production Volume Chemicals 2. SIDS and Data Collection 2.1 Introduction 2.2 Content of the Screening Information Data Set (SIDS) 2.3 Outline of the Harmonized Electronic Data SET (HEDSET) 2.4 Guidance for the Responder to die OECD Request for Available Data on High Production Volume (HPV) Chemicals: "Revised OECD HPV Form 1" 3. Data Evaluation, Preparation of SIDS Dossiers and Testing Plans 3.1 Introduction 3.2 Quality of and Access to Data Used to Prepare SIDS Dossiers 3.3 Considerations for Developing SIDS Testing Plans 3.4 Guidance for Meeting die SIDS Requirements (The SIDS Guide) 3.5 Considerations Concerning the Adequacy ofData in the SIDS 3.6 SIDS Testing of Chemicals with Limited Exposure Potential 4. Preparation of the SIDS Initial Assessment Report 4.1 Introduction 4.2 Provisional Guidance for the Outline of the SIDS Initial Assessment Report 4.3 Provisional Guidance for die Initial Assessment ofEnvironmental Exposure 4.4 Provisional Guidance for the Initial Assessment ofOccupational and Consumer Exposure 4.5 Provisional Guidance for the Initial Assessment ofAquatic Effects 4.6 Provisional Guidance for the Initial Assessment of Health Effects 5. Overview of the Post SIDS Work Annex 1 Annex 2 OECD Decision-Recommendation of the Council on the Co-operative Investigation and Risk Reduction ofExisting Chemicals [C(90)163(Final)] Model SIDS Dossier Annex 3 Synopsis of OECD Test Guidelines for Studies Included in the SIDS Annex 4 OECD Guidelines for Testing of Chemicals - Overview of Currently Available Guidelines Annex 5 Proposed Format and Guidance for Gathering Exposure Information Annex 6 List of SIDS Contact Points EXCH\MANUAL\96COVER.DOC/May 1996 CMA 119628 FOREWORD At the 20th Joint Meeting of the Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals in May 1993, it was agreed that a SIDS Manual would be prepared in order to disseminate information on die OECD activity on the Co-operative Investigation of High Production Volume (HPV) Chemicals and to facilitate the process of gathering information on the Screening Information Data Set (SIDS) elements as well as that of testing and assessing HPV chemicals. This manual, prepared by the OECD Secretariat, presents guidance documents to be used for data evaluation and initial assessment as well as agreements reached in the OECD Existing Chemicals Programme. A Model SIDS Dossier is also included in an Annex. This manual is to be distributed in Member countries through SIDS Contact Points, who should make it available to their industry and scientific community in order to encourage their co-operation in SIDS work. It is strongly recommended that SIDS Dossiers and SIDS Initial Assessments Reports be prepared according to the guidance set out in this manual. The manual has been and will continue to be updated and new documents will be added as appropriate in order to reflea the state-of-the-art of the SIDS Programme, as this programme is essentially carried out on the principle of "learning by doing". In the same context, the programme will continue to be closely co-ordinated with developments in other national, regional and international programmes on existing chemicals. In order to keep the manual compact, some of the rather extensive documents referred to in the manual, such as "Manuals of the Exposure Models", are not included. These documents can be obtained from the SIDS Contaa Points or from the OECD Secretariat In the second revision, made available in May 1996, the following revisions have been made. 1. Chapter 1 (Description of OECD Work on Investigation of High Production Volume Chemicals) has been updated to reflea die current situation regarding recommendations in the SIDS Initial Assessment Reports, SIDS Review process, etc. 2. Section 4.3 (Provisional Guidance for the Initial Assessment of Aquatic Effects) and Section 4.6 (Provisional Guidance for the Initial Assessment of Health Effects) have been revised to integrate the content of the recently developed EU Technical Guidance Documents in this area. The discussion at the 4th SIDS Initial Assessment Meeting (SIAM4) in May 1996 has been reflected as well. Section 4.2 (Provisional Guidance for the Outline of the SIDS Initial Assessment Reports) was revised in April 1995 and slightly modified afterwards. 3. Documents reflecting ongoing discussions and proposals for gathering exposure information are included as Annex 3. 4. Annexes have been reorganised and some Annexes have been moved to die main body of the text (e.g. the former Annex 2 has been integrated into Sections 4.3 and 4.4 and die forma Annex 3 has been moved to Section 3.4). 5. All the information in the Manual has been updated and the text is now written by Word 6.0. In the future, any revisions will take place chapter by chapter, Le. only those chapters for which information has been updated will be distributed to Member countries. A diskette which includes the latest updated files is available from die Secretariat EXCH\MANUAL\96COVER DOC/Mav 1996 CMA 119629 .1 DESCRIPTION OF OECD WORK ON INVESTIGATION OF HIGH PRODUCTION VOLUME CHEMICALS' Summary Through a 1990 OECD Council Decision [C(90)163(Final)] (see Annex 1 to this Manual) Member countries have decided to undertake the investigation of high production volume (HPV) chemicals in a co-operative way. These HPV chemicals include all chemicals reported to be produced or imported in excess of 10,000 tonnes per year in any one Member country, and in excess of 1,000 tonnes per year in two or more countries. The Decision means that Member countries will co-operatively: - select the chemicals to be investigated; - collect effects and exposure information from government and public sources and encourage industry to provide information from their files; - complete the agreed dossier for the Screening Information Data Set (SIDS) by testing; and - make an initial assessment of the potential hazard of each chemical investigated When a full SIDS dossier on a chemical is available, an initial assessment of the information is undertaken and conclusions are drawn according to the potential risks posed by the chemical and recommendations are made on the need for further work. The conclusion might be, for example, that the chemical is of low potential risk and therefore currently of low priority for further work. If a potential risk to man and/or the environment is identified various conclusions might be possible: limited exposure or current risk reduction measures in Member countries could make further action to manage the risk unnecessary at this time; it could be recommended that IPCS (International Programme on Chemical Safety) consider the chemical a candidate for an Environmental Health Criteria or similar document; and/or it could be recommended that risk reduction actions be considered at the national or, as appropriate, international level. In addition, the conclusion might be that further information is required to assess concerns identified in the SIDS process, and that post-SIDS testing is recommended on such chemicals. In the policy bodies of OECD, Member countries discuss and agree on any follow-up actions on chemicals posing a potential risk, and indeed, discuss and confirm all conclusions and recommendations made on all chemicals which have been assessed in the SIDS programme. When full SIDS dossiers and initial assessment reports are finalised, die results are made available world-wide through UN bodies such as IRPTC (UNEP's International Register of Potentially Toxic Chemicals) and IPCS, with whom close co-operation is maintained to this effect The chemical industry fully supports the OECD activities on HPV chemicals because this work avoids duplication of efforts among chemical companies to test chemicals to fulfil various national and regional requirements. This OECD activity is undertaken in close co-ordination with other national, regional and international existing chemicals programmes. This document was prepared by the OECD Secretariat based an the agreements reached in the OECD Existing Chemicals Programme up to April 1996 EXCH\MANUAL\96-1 .DOC/May 1996 1 CMA 119630 Background and Rationale The investigation of the safety of the nearly 100,000 chemicals currently in commerce is a daunting global challenge that can only be met if approached in a systematic way. This enormous task has been undertaken by the OECD and is based on compilation, review and assessment of environmental health and safety data and exposure information on selected existing chemicals. Many existing chemicals are international commodities. Various national governments and chemical companies have independently initiated activities to evaluate their safety, often using the guidance developed by the OECD. Such activities, however, arc time and resource intensive and have led to the duplication of efforts on (groups of) chemicals. In order to tackle this problem, Member countries decided through a Council Decision-Recommendation in 1987 [C(87)90(Final)] to undertake a Systematic Investigation of Existing Chemicals. They agreed to establish or strengthen national programmes to investigate existing chemicals, in order to identify those which pose risks that need to be managed and/or controlled. In 1990, it was recommended in a further Council Decision (on the Co-operative Investigation and Risk Reduction of Existing Chemicals) that Member countries work together and "share the burden" of investigating the potential risks from priority chemicals of mutual concern. By sharing the burden in this manner, and by working towards internationally agreed objectives, governments could avoid wasting resources by duplicative efforts. Industry also benefits by avoiding duplication of information gathering or testing to fulfil various national and regional requirements and international commitments. In order to share the burden of investigation, each Member country carries out a specific part of the total work and makes the information it has collected or generated available to other Member countries. Chemical industries in Member countries play a significant role in the conduct of this co operative work. The Business and Industry Advisory Committee to OECD (BIAC) and national chemical industry associations promote the collection of information and help ensure that tests which need to be conducted are undertaken in a timely manner. The work is carried out in collaboration with the International Programme on Chemical Safety (IPCS) and the International Register of Potentially Toxic Chemicals (PTC). This co-operative OECD work leads to considerable benefits for many parties: - Environmental protection and Human health will be improved as existing chemicals arc investigated more effectively. - The financial costs of testing will be substantially reduced as a result of increased co operation and sharing the burden in testing. -- The mutual understanding of national procedures for initial assessment of chemicals will be increased, leading to eventual harmonization of these procedures. -- The use of animals in testing will be reduced, as much duplicative testing will be avoided. Objectives Since 1988, OECD existing chemicals activities have centred primarily on die investigation high production volume (HPV) chemicals, based on the assumption that production volume is an indicator of potential occupational, consumer and environmental exposure. - The first objective of this co-operative work is to ensure that the basic information necessary to undertake a first evaluation of potential hazards associated with HPV chemicals is either available or generated. EXCH\MANUAL\96-1 .DOC/May 1996 2 CMA 119631 ~ A second objective is to undertake an initial assessment of this information and to draw conclusions on the potential risk of the chemicals and make recommendations related to the need for further work. - Finally, when complete data sets and risk assessments are available. Member countries may decide to develop common, consistent or harmonized risk reduction actions for those HPV chemicals which have been found to be of concern to man or the environment. The OECD List ofHigh Production Volume Chemicals The first OECD List of HPV Chemicals is compiled on the basis of submissions by Member countries to the OECD Secretariat These submissions contain industrial chemicals for which a Chemical Abstracts Service (CAS) Registry Number had been assigned. For die first OECD List in 1990, eighteen Member countries (including all major chemical producing countries) provided national inventories of HPV chemicals produced in or imported into their countries. These inventories were merged into the OECD List which includes all chemicals reported to be produced or imported in excess of 10,000 tonnes per year in any one Member country and in excess of 1,000 tonnes per year in two or more countries. The 1995 OECD HPV List was compiled by combining the European Union's HPV list (i.e. Annex 1 to EC Regulation 793/93) and the updated national HPV submissions from non-EU OECD Member countries. It currently contains about 2500 entries. Any chemical on the 1995 OECD HPV list is available for sponsorship by Member countries as their share of the co-operative work on HPV chemicals. Member countries can select either chemicals for which limited data are available, and for which development of SIDS data is needed, or chemicals for which full SIDS information is available and for which an initial assessment can be carried out without delay. In this way the work undertaken in the EU Member States in compliance with the EC Regulation forms their contribution to the OECD programme. Priority Setting The priority setting procedure has evolved since die OECD programme began. At die beginning. Member countries surveyed the 1990 List and by consulting national and/or international databases gathered data that were readily available for the individual chemicals. The annotated List was then reviewed at meetings of experts from Member countries, other international organisations and industry, where it was decided that those substances for which little or no information was available should have highest priority for further work in the phases of the SIDS project As a result of these deliberations, a "working list" of 648 chemicals was developed in 1992, from which Member countries selected chemicals for sponsorship. As of 1993, selection was no longer limited to the "working list". This change was made in order to allow those Member countries with small chemical industries to participate and to follow the evolution of national and regional existing chemicals programmes - some of which are currently aimed less at filling data gaps and more at assessing chemicals of concern for which a great deal of data are available, in order to recommend further action as appropriate. The OECD List of HPV Chemicals serves as the overall priority list from which chemicals are selected for SIDS testing and/or assessment. This gives Member countries greater flexibility in die programme and facilitates the participation of industry. EXCH\MANUAL\96-1 .DOC/May 1996 3 CMA 119632 Selection ofChemicals In order to share the burden, chemicals are selected by Member countries in batches of approximately SO for every "phase" of the programme. In consultation with their chemical industries, they identify chemicals for which, on a voluntary basis, they will act as a Sponsor country in the HPV programme. The overall number of chemicals which any Member country or group of Member countries (through, for example, the EU programme) sponsors should, as a minimum, be proportional to its financial contribution to the OECD Chemicals Programme, which in turn is proportional to its (combined) Gross National Product. The Screening Information Data Set (SIDS) The objective of this OECD activity is to undertake an initial screening of die potential risks of HPV chemicals to man and/or the environment A prerequisite for this generic approach was the identification of the necessary elements, or data set, on which to base an informed judgement as to the potential hazards of the chemicals. The data elements needed for "screening" HPV chemicals were brought together as the Screening Information Data Set, or SIDS, which comprises characterisation and effects data similar to the Minimum Pre-marketing set of Data (MPD) for new chemicals (the OECD Council Decision in 1982 [C(82)196(Final)]), as well as elements of exposure information (see Section 2.2). The SIDS is regarded as die minimum information needed to assess an HPV chemical to determine whether any further work should be carried out or not However, all available data are used to make the assessment. In practice, and especially following the change in scope of the chemicals covered, the available data often goes far beyond SIDS. Responsibilities ofa Sponsor Country Each Sponsor country nominates a SIDS Contact Point who organises the actual work and is available for communication (see Annex 6 to this Manual). The responsibilities of a Sponsor country, again in collaboration with its industry, include: - preparing and managing die collection of effects and exposure data (if necessary, undertaking a further literature search); - identifying a lead organisation, usually a chemical company, for each chemical; - reviewing the data received, assessing their quality, preparing a SIDS Dossier and developing, as appropriate, a SIDS Testing Plan for generating further information by testing; - transmitting die SIDS Dossiers and SIDS Testing Plan to other Member countries; - organising and supervising any agreed SIDS testing; - assisting other national SIDS Contact Points by forwarding exposure information or other requested data on their chemicals; and - making an evaluation of the full SIDS Dossier and preparing a SIDS Initial Assessment Report including proposals for conclusions and recommendations on any follow-up actions to be undertaken on the chemical. Each Member country is responsible for generating and making available SIDS data for those priority HPV chemicals for which it is die Sponsor country. In return, it will benefit from receiving similar data on the other priority HPV chemicals from other Member countries and from the fact that the need for duplicate testing will be eliminated EXCH\MANUAL\96-l.DOC/May 1996 4 CMA 119633 Data Collection, SIDS Dossiers and Testing Plans After selection of chemicals by Sponsor countries, the first activity involves collection of information on the chemicals. In addition to readily available data, industry is also requested to provide Sponsor countries with data and full copies of studies which are in their files and have not so far been published in the open literature. To assist Sponsor countries in the collection of data in a standardised manner, the OECD in co operation with the European Commission has developed a computer format, which can be used by responders when providing information. Not only all information required by the SIDS, but also further information on existing chemicals required within the framework of the EU programme, can be accommodated in the system. Diskettes on which the data elements for the Harmonized Electronic Data Set (HEDSET) may be entered, together with explanatory documents on recording information, are available from the Secretariat, the European Commission and SIDS Contact Points (see Section 2.3). As additional information, beyond SIDS elements, could be helpful to the Sponsor country in formulating its plan for SIDS testing, HEDSET includes a wider range of data elements than those required in the SIDS. Information holders are therefore encouraged to provide information for as many of the data elements on the diskette as possible. Although use of the HEDSET diskette is strongly encouraged, either die paper form, the "Revised OECD HPV Form 1" (see Section 2.4), in Word 6.0 or its diskette equivalent, are acceptable alternatives. The empty form is available from SIDS Contact Points or the OECD Secretariat When no information is available for a given data element, calculation or estimates derived from Quantitative Structure Activity Relationships (QSARs) can sometimes be provided (e.g. for physicalchemical properties or aquatic toxicity), but an indication of the quality of the methods used should be given. For any SIDS element on effects or characterisation for which no data are available or the data are not considered adequate, testing will in principle be carried out Any testing to complete the SIDS should be conducted according to the OECD Test Guidelines and the Principles of Good Laboratory Practice (GLP), in order to ensure that generated data are mutually acceptable among Member countries and that tests carried out in accordance with the OECD Council Decision on the Mutual Acceptance of Data [C(81)30(Final)] need not be repeated. The quality of the collected data is of great importance. In order to harmonize its evaluation and to assist Sponsor countries in preparing the SIDS Dossiers and SIDS Testing Plans for their chosen chemicals, the OECD has prepared guidance for evaluating and documenting the quality of data including a SIDS Guide which addresses details for each SIDS element (see Chapter 3). A Model Dossier has also been prepared to indicate what kind ofdata should be included, how the data should be expressed, etc. (see Annex 2 to this manual). SIDS Review The SIDS Dossiers and SIDS Testing Plans are forwarded by die Sponsor country to all SIDS Contact Points, so that the experts from each OECD country and those fiom non-Member countries nominated by IPCS can study the proposals made by the Sponsor country. Up to 1993, the SIDS Dossiers and Testing Plans were then scrutinised at a meeting of experts of Member countries (SIDS Review Meeting) in order to confirm the adequacy of information and reach agreement on the SIDS Testing Plan. EXCH\MANUAL\96-1.DOC/May 1996 5 CMA 119634 Beginning with phase 4, this SIDS Review is undertaken via a written procedure. Any unresolved problems with SIDS Dossiers or Testing Plans are discussed by the Steering Group on Existing Chemicals, a subsidiary body of the Joint Meeting of the Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals (Joint Meeting). When a SIDS Testing Plan for a chemical is agreed by the other Member countries, the Sponsor country carries out the test(s) and/or continues the collection of information on exposure and effects. When there is already enough information on a chemical, and there is considered to be no need for testing, the Sponsor country prepares the SIDS Initial Assessment Report, if the Testing Plan is not agreed by the other countries, it should be reconsidered by the Sponsor country, with the issue being referred to the Steering Group if necessary. Initial Assessment ofFull SIDS Chemicals When the Sponsor country has obtained all die data elements of die SIDS for the sponsored chemical (a Full SIDS Chemical), it will prepare the SIDS Initial Assessment Report (SIAR) to accompany the full SIDS Dossier on die chemical and make an evaluation including conclusions on the potential risk and recommendations for further action, if appropriate. Recommendations include, for example, further work in the SIDS context, e.g. further testing or analysis of exposure information to assess identified concerns (post-SIDS work), or that the chemical be considered by IPCS as a candidate for an EHC or similar document In certain cases, consideration of risk reduction action at the national or international level might also be recommended. Five provisional guidance documents for Sponsor countries to use in carrying out initial assessments and preparing their recommendations have been developed and reviewed by Member countries, taking into account experience obtained at SIDS Initial Assessment Meetings (SIAM). These documents are included in Chapter 4: -- Provisional Guidance for the Outline of the SIDS Initial Assessment Report - Provisional Guidance for the Initial Assessment ofEnvironmental Exposure - Provisional Guidance for the Initial Assessment of Occupational and Consumer Exposure - Provisional Guidance for the Initial Assessment ofAquatic Effects - Provisional Guidance for the Initial Assessment of Health Effects Models used for exposure estimation have been developed based on the results of various OECD workshops and have been distributed to SIDS Contact Points (see Sections 4.3 and 4.4). A recent meeting of a Task Force has begun developing tools to facilitate gathering of international exposure information and a pilot phase is underway (see Section 2.2 and Annex S of this manual). Peer Review The SIDS Dossiers and Testing Plans as well as the SIDS Initial Assessment Reports are subject to extensive peer review in two stages. As discussed above, in the first stage SIDS Dossiers are circulated to SIDS Contact Points who investigate a review of the adequacy and quality of the data therein by experts in their countries. A two-month period is allowed for this review. Sponsor countries receive (wminHin via SIDS Contact Points and complement their data and/or adjust their Testing Plans as appropriate. As required, revised SIDS Dossiers and Testing Plans undergo another SIDS Review, as described above. In the second stage, the SIDS Initial Assessment Reports, which include evaluations, conclusions and recommendations, are circulated with the updated SIDS Dossier, to SIDS Contact Points in a timely EXCH\MANUAL\96-1 .DOC/May 1996 6 CMA 119635 manner prior to the SIDS Initial Assessment Meeting (SIAM). Once again, experts in countries are consulted and comments prepared for discussion at the SIAM. In some cases, initial comments are relayed to the Sponsor country prior to the SIAM, so a revised SIAR can be prepared and circulated, if appropriate. Three months are allowed for this process. At the SIAM itself, the Reports are discussed and consensus reached on the initial assessment and the conclusions and recommendations for each chemical, resulting in an internationally agreed assessment. Participants in the SIAM include: - representatives of the Sponsor countries; - representatives from other Member countries and the Commission of the European Communities; - experts from non-Member countries nominated by IPCS; - secretariat staff from OECD, IPCS and IRPTC; - experts nominated by OECD's Business and Industry Advisory Committee (BIAC) and Trade Union Advisory Committee (TUAC); and - representatives of companies which produce die chemical (for that part of the discussions which concerns their chemical). The Steering Group confirms agreements on the conclusions and recommendations made by the SIAM on the chemicals and transmits them to the Joint Meeting to be endorsed. Outcome andpublic availability For each chemical, the end product of the work, in the framework of the OECD Existing Chemicals activities, should be that all data elements of die SIDS (Full SIDS) are available, their adequacy has been peer reviewed and an initial assessment report prepared. This information will have been evaluated, and conclusions on the potential risk posed by the chemical and recommendations for further actions, if any, agreed among Member countries. [The latter might state, for example, that the chemical is of low potential risk and therefore cunendy of low priority for further work. If a potential risk to man and/or the environment is identified, various conclusions might be possible: limited exposure or current risk reduction measures in Member countries could make further action to manage the risk unnecessary at this time; it could be recommended that IPCS consider the chemical a candidate for one of its documents; and/or it could be recommended that risk reduction actions be considered at the national or, as appropriate, international level. In addition, the conclusion might be that further information is required assess concerns identified in the SIDS process, and that post-SIDS testing is recommended on such chemicals.] In the policy bodies of OECD, Member countries discuss and agree on any follow-up actions on chemicals posing a potential risk, and indeed, discuss and confirm all conclusions and recommendations made on all chemicals which have been assessed in the SIDS programme. The data collected in HEDSET, and summaries of test reports which are provided to support these data, will be publicly available. Full reports supporting the d*n, when no claims for confidentiality are made by the owner, will also be publicly available, as will the data from tests and information on exposure submitted to the SIDS programme. The OECD Secretariat transfers all non-confidential information received from data collection and SIDS testing and the results of initial assessment to IRPTC for inclusion in their database and publication as a contribution to the International Programme on the Sound Management of Chemicals (IOMC). This data is also made available on Internet In this way, all information resulting from the OECD SIDS Programme will be available worldwide. In cases where enough information is available to EXCH\MANUAL\96-1 .DOC/May 1996 7 CMA 119636 prepare a Health and Safety Guide or an Environmental Health Criteria document and where the potential risk posed by the chemicals warrants it, 1PCS is encouraged to consider developing such material based on the results of the SIDS programme. Post-SIDS Activities Where a chemical has been reviewed at the SIAM and it has been recommended that further information is required to assess identified concerns, any follow-up testing or information gathering is regarded as post-SIDS work. The SIAM will give an indication of what data need to be collected, generated and/or analysed, and the priority relative to other chemicals for which post-SIDS work is envisaged. Although a Member country will monitor progress and oversee development of this additional work, the overall responsibility for initiating and undertaking any work rests with industry. Industry has the most knowledge about their chemicals, and is in the best position to negotiate ways and means of sharing the burden of the administrative and operational costs involved. The Member country, in collaboration with industry, supervises the work in order to promote the establishment by producer and user industries of "consortia" to undertake the work, to monitor that any necessary testing is conducted appropriately under the suggested schedule, and to circulate the final report of the work to SIDS Contact Points. Non-Member countries are encouraged to participate in the programme and share die burden. When all the additional information has been collected or generated and analysed, the chemical will be discussed at a Post-SIDS Assessment Meeting, which will have a similar format and participation as the SIAM. The results, including all the reports generated in post-SIDS work, will be provided to IRPTC and IPCS and be publicly available. Some chemicals for which SIAM draws the conclusion that the initial assessment has shown them to pose a potential risk to man and/or the environment may not require any further work in the SIDS context and might be considered candidates for follow-up in IPCS, in order to build on the information provided in the SIAR and to make it more useful in a global context Some chemicals of concern may be considered by SIAM to have a limited potential for exposure and/or to be adequately managed in OECD countries. Recommendations might be made to the effect that BIAC will continue to monitor risk reduction activities by industry for these chemicals. Certain chemicals of concern might be considered by SIAM to require risk reduction action, either national or international. All of the conclusions and recommendations of SIAM are considered first by the Steering Group and then by the Joint Meeting, where modalities of further follow-up activities are discussed. Overview ofthe SIDSprocess including Post-SIDS work A synopsis of the stages involved in die OECD work on SIDS is presented below (also see the flowchart in Annex to this Chapter): 1) development and maintenance of an OECD List ofHPV chemicals; 2) selection of chemicals from the List by Sponsor countries; 3) collection of data; 4) review of the quality of data, preparation of SIDS Dossiers and SIDS Testing Plans; EXCH\MANUAL\96-1 .DOC/May 1996 8 CMA 119637 5) circulation of SIDS Dossiers and SIDS Testing Plans to all SIDS Contact Points; 6) agreement on SIDS Testing Plans through the SIDS Review (by written procedure); 7) SIDS Testing and/or collection of information, as appropriate; 8) preparation of a SIDS Initial Assessment Report by the Sponsor country with conclusions on potential risk and recommendations on further work to be undertaken; 9) co-operative initial assessment and agreement on conclusions and recommendations at the SIAM and coniinnation at the Steering Group and the Joint Meeting; 10) if necessary, further testing and/or data analysis (post-SIDS work) and post-SIDS assessment; recommendation as candidate for development of an IPCS document; or recommendation as a candidate for national or international risk reduction activities. Co-operation with International Organisations In the SIDS programme, it has been demonstrated that Member countries can successfully co operate in gathering data, testing and assessing existing chemicals. It should be noted that in January 1991, after consideration by Environment Ministers of die results from the first phase of SIDS work. Member countries made a formal commitment, in the form of die OECD Council Act on Co-operative Investigation and Risk Reduction of Existing Chemicals [C(90)163(Final)], that they would co-operate in the systematic investigation and assessment of existing chemicals. In this Council Act, particular attention is paid to co-operation with international organisations. In the Council Act, it was decided that Member countries shall make information obtained from the co-operative investigation of existing chemicals publicly available via IRPTC, while respecting legitimate claims for protection of confidential data. IRPTC has agreed that it will not only work as an archive for the data collected or generated in die SIDS project, but also disseminate data through its databases. Therefore all information, including test reports, SIDS dossiers and SIDS Initial Assessment Reports, are transmitted to IRPTC and the information in diem is entered in the IRPTC database. Responding to the request made by UNCED in Agenda 21 to expand and accelerate the international assessment of chemical risks, IRPTC is now issuing a new series of documents including the OECD initial assessments of HPV chemicals, both is paper form and on Internet It is anticipated that in the near future the data collected on HEDSET and the assessment report itself will be able to be transferred directly through electronic means to IRPTC, and from IRPTC to users throughout the world. IPCS was invited, through the Council Act, to use the results of die investigations of existing chemicals by OECD Member countries in preparing its assessments of the health and environmental impacts of existing chemicals. Information collected will be used in the preparation of Environmental Health Criteria or other documents by the IPCS on specific chemicals of concern. EXCH\MANUAL\96-1 .DOC/May 1996 9 CMA 119638 References OECD Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals [C(81)30(Final)], May 1981. OECD Council Decision on the Systematic Investigation of Existing Chemicals (C(87)90(Final)], July 1987. OECD Council Decision-Recommendation on the Co-operative Investigation and Risk Reduction of Existing Chemicals [C(90)163(Final)], January 1991 (see Annex 1 to this manual). Council Regulation (EEC) No. 793/93 on the Evaluation and Control of the Risks of Existing Substances, European Communities, 23 March 1993 The following articles will be of interest: Brydon, James E., Morgenroth IE, Victor H., Smith, Alan M. and Visser, Rob (1990); OECD's Work on Investigation of High Production Volume Chemicals, International Environment Reporter, June 1990,263-270. Smith, Alan M., Arai, Shin-ichi, Tanaka, Katsutoshi and Visser, Rob (1993); Review of the SIDS Project of the OECD Existing Chemicals Programme, International Environment Reporter, November 3, 1993. Tumheim, Dian (1994); Evaluating Chemical Risks, OECD Observer, 189, August'September 1994, 12-15. EXCH\MANUAL\96-1 .DOC/May 1996 10 CMA 119639 Sponsor Country Annex OECD f I^PTC win MBWJnQ CMA119640 IPCS .2 SIDS AND DATA COLLECTION' 2.1 Introduction This chapter describes the Screening Information Data Set (SIDS), including characterisation and effects data, as well as exposure information, to be collected and collated into a SIDS Dossier by a Sponsor country. It describes the various means which have been developed to assure harmonized presentation of the SIDS for use in OECD Existing Chemicals activities. For a Sponsor country, collection of SIDS data from industry and other Member countries is a very important procedure for drawing up both a SIDS Dossier and a SIDS Testing Plan for an assigned chemical. Input of the data collected for SIDS (see Section 2.2) can be done using the HEDSET diskette, a hard copy of "Revised OECD HPV Form 1" or a diskette equivalent in Word 6.0, all of which can be obtained through SIDS Contact Points or die OECD Secretariat Although the choice depends upon the preference of the data submitter, use of the HEDSET diskette in Phase 4 and later phases of the OECD SIDS programme is strongly encouraged. The Harmonized Electronic Data SET (HEDSET), which has been developed in co-operation with the European Commission, has become available, together with its manual and an explanatory note, as a device for data collection in the OECD SIDS procedure. By using IUCLID software developed by the European Commission, data in a HEDSET diskette can be transferred to a database easily. In addition, data will be able to be transferred to IRPTC without manual inputting by means of a conversion program. The HEDSET diskette and requirements for its use are described in Section 2.3. To date, a paper form called "OECD HPV Form 1", which was agreed and distributed in 1990, has been used widely by Member countries. This form was slightly modified in 1993, taking into account the format of HEDSET. The revised form, presented in Section 2.4, can be used instead of HEDSET if necessary. However, it should be noted that it is quite time-consuming to draw up a report from information obtained from various sources using the paper form. Furthermore, inputting the data on the form to computer files will be necessary in the end in order to make the data available to the public through IRPTC. Although it might be slightly easier to edit data by using a PC file of Revised OECD HPV Form 1, it is recommended to collect infoimation using HEDSET ifpossible. The documents in this chapter were prepared by the OECD Secretariat based on the agreements reached in the OECD Existing Chemicals Programme up to April 1996. EXCH\MANUAL\96-2.DOC/May 1996 1 CMA 119641 2.2 Content of the Screening Information Data Set (SIDS) " The following lists the content of the Screening Information Data Set (SIDS). In preparing the SIDS, the "Guidance for Meeting the SIDS Requirements" (see Section 3.4) and a Model SIDS Dossier (see Annex 5 to this manual) will help data submitters and SIDS Contact Points understand what kind of are required and how the data are to be described in HEDSET and the Revised OECD HPV Form 1. Basic Information The following data elements on characterisation, exposure and effects are basically required for preparing the SIDS Dossier. The items marked with a dagger (t) are specifically required for inorganic chemicals. Oxidation-reduction potential should also be required for organic chemicals when deemed necessary. 1. General Information Substance Information CAS Number Name (OECD name) CAS Descriptor f Structural Formula Quantity (production ranges expressed as tonnes per year) Use Pattern (categories and types of use, see also next page) Sources ofExposure (exposure information, see also next page) 2. Physical-chemical Data Melting Point Boiling Point Relative Density t Vapour Pressure Partition Co-efficient: n-Octano1/Water Water Solubility Dissociation Constant Oxidation-reduction Potential t 3. Environmental Fate and Pathways Photodegradation (by estimation) Stability in Water (by estimation) Monitoring Data (environmental) Transport and Distribution between Environmental Compartments including Estimated Environmental Concentrations and Distribution Pathways [by estimation, including Henry's Law constant as calculated from data under heading 2, aerosolisation, volatilisation, soil adsorption and desorption calculated using Structure Activity Relationships (SARs)] Aerobic Biodegradability The content of the SIDS was agreed at the 13th Joint Meeting of the Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals (November 1989). The content of the elements of exposure information to be collected as part of the SIDS was agreed at the 20th Joint Meeting (May 1993). EXCH\MANUAL\96-2.DOC/May 1996 2 CMA 119642 4. Ecotoxicity Acute Toxicity to Fish Acute Toxicity to Daphnia (If there is concern for possible long-term effects, prolonged/ chronic toxicity testing should be considered in addition to acute tests.) Toxicity to Algae If significant exposure is expected in the terrestrial environmental compartment, efforts should be made to perform appropriate terrestrial toxicity tests. In addition, when aquatic toxicity testing is not possible (e.g. insolubility of the test chemicals), efforts should also be made to perform terrestrial toxicity tests. 5. Toxicological Data Acute Toxicity Repeated Dose Toxicity Genetic Toxicity (two end points, generally point mutation and chromosomal aberrations) Reproduction Toxicity (including fertility and developmental toxicity) Experience with Human Exposure (if available) It has also been agreed that some data in SIDS are not required for chemicals with limited exposure, such as intermediates (see Section 3.6). Elements ofExposure Information The following exposure elements will improve the quality of the initial exposure assessment of HPV chemicals. It has been agreed that these elements are part of the SIDS. They include information which is essential to allow effective application of even simple models and methods. It is the intention that readily available information be provided, e.g. an indication of use categories and of the order of magnitude of the number of workers involved. It is not expected that detailed reports be provided; whenever estimates are given, however, some background and rationale would be useful. More detailed exposure analyses can be part of any post-SIDS work, as needed. Each National SIDS Contact Point takes the responsibility for collecting information horn the various information providers in his/her country. This information is provided to the Sponsor country so that, for each chemical, a consolidated overview of the exposure situation can be prepared by the National SIDS Contact Point of the Sponsor country. The information needs to be available in time for inclusion in the SIDS Initial Assessment Report ~ Use (identification of occupational or professional uses of the chemical, or products in which it is contained, and of use in consumer products); - for uses in consumer products function of chemical (for each consumer product identified); weight fraction of chemical (actual or recommended); form ofproduct (as marketed, e,g, aerosol, powder, liquid); - Workplace exposure number of workers (in range of situations including manufacture, maintenance and use); frequency and duration of such exposure; EXCH\MANUAL\96-2.DOC/May 1996 3 CMA 119643 - Indications concerning releases to the environment (during manufacturing, processing, use and disposal) identification of media of release; quantities per media [with time dimensions of release, indication of type of release (point source or diffuse), type of estimate, e.g. average or worst case, uncertainties in estimates]; an indication of measured exposure levels (expressed in an appropriate statistical form, e.g. geometric mean and standard deviation); an overview of monitoring data in the environment (with specifications of conditions); - Any other information that will help to focus the assessment of exposure (either qualitative or quantitative in nature). When the use pattern of chemicals is not clear, the amount used for a specific purpose in all Member countries should preferably be estimated. A simple extrapolation can be done from information on use and production volume in one Member country, based on the hypothesis that the population size or GNP might have a correlation with the volume of the national market of chemical products. Despite of the decision to encourage collection of exposure information difficulties have arisen in actual data collection. Therefore, a meeting of a Task Force under the Steering Group on Existing Chemicals was held in June 1995 in order to discuss effective and efficient procedures for collection and transmission of exposure information, as well as exposure data elements to be gathered for the SIDS Initial Assessment which could replace die above items. The Task Force agreed on recommendations to the Steering Group on Existing Chemicals concerning the minimum set of exposure infonnation to be gathered by Member countries for SIDS Initial Assessments and the procedure for collection and transmission of exposure information. Based on the recommendations, the Secretariat has developed a draft format for gathering exposure information as well as draft guidance. A pilot study is currently conducted using the proposed format As a result of the pilot study, it is expected to agree on the format and the procedure for gathering exposure infonnation. These recommendations, the proposed format and guidance are shown as Annex 5 to this Manual, together with a format to gather more detailed infonnation proposed by die US. EXCH\MANUAL\96-2.DOC/May 1996 4 CMA119644 23 Outline of the Harmonized Electronic Data SET (HEDSET) HEDSET (Harmonized Electronic Data SET) HEDSET is a data entry system compiled on diskette with supporting programmes. It has been developed in order to accommodate data on a chemical and allow their transfer to a data export file on diskette, which can then be circulated as necessary. It is written in CLIPPER software and can be run on any type of IBM compatible PC with a minimum of 640 KB memory and MS-DOS version 33 or higher. It is used after installing on a hard disk (with minimum of 10 MB free disk space). Further details are given in a manual. It should be noted that HEDSET does not itself have database or word processor functions. These functions are available through IUCLID software. The HEDSET comprises the following data items, which were identified and agreed to be necessary for the initial assessment of a chemical: - general information on a chemical; - information on producer, importer, etc.; - physical-chemical properties; - information on environmental fate and exposure; - ecotoxicological properties; and - toxicological properties. The data elements in HEDSET are essentially the same as those in the Revised OECD HPV Form 1, but with some differences in the numbering system. For the purpose of promoting user friendliness, HEDSET has many functions for inputting data by means of a glossary, multi-entry facilities, free text data fields, and CAS and EINECS number checking programmes. Although HEDSET will be available in nine EU official languages, only the English version should be used for the OECD work on HPV chemicals. Print files, made by using the printing function, are ASCII files. They can be printed out directly or can be edited using any word processing software. Although data inputted on the hard disk of a PC will automatically be converted to CLIPPER format, the data export programme makes ASCII files for transfer to diskette. These export files can be read and incorporated into another PC using the import programme. Because HEDSET does not have database functions, users cannot electronically compare the data (on two or more chemicals). They may wish to obtain the IUCLID software for this purpose. It should be noted that, for copyright reasons, modification of the HEDSET diskette is prohibited without the prior permission of the European Commission. EXCH\MANUAL\96-2.DOC/May 1996 CMA 119645 Data Collection Process It is recommended that the following be used to collect infonnation on HPV chemicals for Phase 4 onwards, in place of the Revised OECD HPV Foim 1: - a PC with HEDSET installed; - the explanatory note for HEDSET; - the manual for HEDSET; and - an export file on diskette for circulation (only one chemical per diskette!. The diskette and supporting documents will be distributed to data subminers, (i.e. manufacturers or importers of chemicals) through the National SIDS Contact Points. Data submitters will input the data and send export files on diskettes to die National SIDS Contact Points for onward circulation to Member countries and the OECD Secretariat The information in these files will be used nationally for review and/or the initial assessment of the sponsored HPV chemicals, and also at SIDS review procedure and SIDS initial assessment meetings. In addition, the data collected will be made available to IRPTC for wider dissemination. Work is under way on a conversion programme to allow automatic input of HEDSET export file data into the IRPTC database. IUCLID (International Unified ChemicaL Information Database) IUCLID is a database software which has been developed by die European Commission in order to deal specifically with data collected using the HEDSET system. IUCLID is capable to run on different hardware platforms and operating systems. The following operating systems are supported: IBM-AIX (Unix), SCO-UNIX, VMS, DEC-UNIX, SUN SOLARIS and MS-DOS. A corresponding version of the ORACLE database management software is required. To operate IUCLID on a PC with MS-DOS a disk space of 100 Mbytes and a main memory of 16 Mbytes is required. A PC with a PENTIUM processor is recommended. IUCLID can import and compile data from export files made under HEDSET. Database functions such as data search, data sorting, etc., as well as printing functions, are included. ASCII files for exporting data can also be prepared, which could be used for circulation instead of HEDSET diskette. The IUCLID database software and an explanatory manual is available from the European Commission. Recently, a CD-ROM for Windows which includes non-confidential data concerning HPV chemicals in the EU (i.e. chemicals in Annex I of Regulation (EEC) 793/93) has been made available as a low-cost version ofthe IUCLID database. EXCH\MANUAL\96-2.DOC/May 1996 6 CMA 119646 2.4 Guidance f r the Responder to the OECD Request for Available Data on High Production Volume (HPV) Chemicals: "Revised OECD HPV Form 1" 1. The attached blank fora. Revised OECD HPV Form 1, is for the provision of available information on HPV chemicals: i.e. a Screening Information Data Set (SIDS) in the form of a "SIDS Dossier". This original HPV Form 1 was agreed and distributed in 1990, then revised in order to achieve full compatibility with HEDSET in 1993. This "Revised OECD HPV Form 1", now fully compatible with HEDSET, is available both in paper form and on a diskette written in Word 6.0 from the National SIDS Contact Points or the OECD Secretariat 2. Revised OECD HPV Form 1, used for preparing the SIDS Dossier, includes die SIDS Profile and SIDS Summary. These should be filled in after data entry. 3. The information presented should be sufficiently reported and referenced with respect to the substance tested, methods used, endpoints examined and results obtained so as to allow reviewers to make an informed judgement of the quality and suitability ofdie data. 4. In general, the support data and reports will not be kept confidential. [See also OECD Council Act C(83)98(Final) and its OECD List of Non-Confidendal Data on Chemicals.] In exceptional cases, where data are indicated to be confidential, they will be made available for review on a confidential basis by specific experts in each Member country that receives the data. That is, in these cases the OECD Council Act concerning Exchange of Confidential Data on Chemicals [C(83)97(Final)J applies. 5. When a standard test method (e.g. OECD, ISO, DIN, EPA) has been used, it should be identified but it is not necessary to repeat details in die text When a non-standard method has been used, details of the method, equivalent to those in an OECD Test Guideline, should be provided when possible. 6. When the test method allows the use of alternatives for certain test parameters (e.g. species), the alternatives chosen should be indicated. In the case of aquatic toxicity tests, it is important to indicate whether nominal or measured concentrations were used. 7. If more than one set of data is available for a given item, each set should be submitted. The preferred results should be identified as "preferred results" and should come first in the set of data of the item after the data evaluation is over. 8. Under the entry for "Test substance", where possible die purity, percentages of known impurities, and details of any vehicle used should be given. 9. When submitting the test results for any individual data element, the format should, where possible, be based on the corresponding Test Report section described in the relevant OECD Test Guideline. 10. Calculated values must be identified and the calculation method should be cited. 11. Under the section "References", die source of information used to respond to the request should be identified. In general, information should be taken from primary sources and quoting from secondary references such as a book or a review article should be avoided. Indicate the tide of the article; journal where study appears; volume; page numbers; and date of report or publication. Where appropriate, indicate "unpublished report", its authors and their affiliation. Lesser details can be cross-referenced within the appropriate individual data element EXCH\MANUAL\96-2.DOC/May 1996 7 CMA 119647 12. Where data for the sponsored chemical are not available, the responders axe encouraged to submit existing data on related compounds such as: - isomers which have similar structure activity profiles; - closely related bomologues; - relevant precursors and breakdown products, along with information on metabolism and degradation. 13. Data elements marked with an asterisk (*) correspond to those in the Screening Information Data Set (SIDS), and those marked with a dagger (t) are specifically requested for inorganic chemicals. 14. In order to facilitate filling in this form in an appropriate fashion, a Model Dossier has been prepared and is set out in Annex 2 to this Manual. Explanations related to data requested in this form can also be found in the HEDSET Explanatory Note available from the European Commission. EXCH\MANUAL\96-2.DOC/May 1996 8 CMA 119648 3. DATA EVALUATION, PREPARATION OF SIDS DOSSIERS AND TESTING PLANS' 3.1 Introduction This chapter includes documents relevant to both evaluation of data in a SIDS Dossier and developing SIDS Testing Plans. The SIDS Dossiers and the SIDS Testing Plans prepared by the National SIDS Contact Points are circulated to all SIDS Contact Points and reviewed in order to agree on testing plans which have been developed, based on the evaluation of the data by the SIDS Contact Point of the Sponsor country for the chemical. To facilitate orderly review, it is important that the reporting format for the SIDS Dossiers be harmonized and that, as far as possible, similar approaches be used in the assessment of the acceptability and quality of the information received. When submitted, die SIDS Dossiers for each chemical should contain the following to assist in this process: a) SIDS Profile and SIDS Summary which give a snapshot of the status of each chemical on the front page(s); b) the completed HEDSET or Revised OECD HPV Form 1 (hard copy or diskette) for all the data, which includes SIDS elements; c) identification of issues/problems arising from the review of the information which should be flagged for further discussion, and the rationale for accepting, rejecting or setting aside individual studies; d) the plans for SIDS Testing. In the review of available information, some studies/data may be considered particularly controversial or may elicit different responses from SIDS Contact Points as to whether SIDS Testing should be required. In these cases, the SIDS Contact Point of the Sponsor country may wish to provide additional information beyond that requested in HEDSET or the Revised OECD HPV Form 1, and to raise the issue for further discussion. Through the SIDS Review process, adequacy of data in die SIDS Dossiers should be considered based on the "Quality of and Access to Data Used to Prepare SIDS Dossiers" (Section 3.2). "Considerations for Developing SIDS Testing Plans" (Section 3.3) should be taken into account when National SIDS Contact Points develop the testing plan. "Guidance for Meeting the SIDS Requirements (The SIDS Guide)" (Section 3.4) should also be considered. "Considerations Concerning Adequacy of Data in the SIDS" (Section 3.3) should be used for deciding if information in the SIDS Dossier is satisfactory for the use in initial assessment of a chemical by National SIDS Contact Points. The OECD Guidelines for the Testing of Chemicals (overview of currently available guidelines are shown in Annex 4 to this manual) and die Provisional Data Interpretation Guides for Initial Hazard The docummts in this chapto woe prepared by the OECD Secretariat hogfd on agreements reached in the OECD Existing Chemicals Programme up to April 1996. EXCH\MANUAL\96-3.DOC/May 1996 CMA119649 Assessment (DIGS) (OECD, 1984) also provide useful information regarding experimental design, methods and reporting requirements. The "Revised Synopsis of OECD Test Guidelines for Studies Included in the Screening Information Data Set (SIDS)" (Annex 3 to this manual) might be used as a condensed reference to study elements, methods and reporting details when results of the test are reported. In cases of intermediates and other chemicals with limited exposure, "SIDS Testing of Chemicals with Limited Exposure Potential" (Section 3.6) should be used in addition to the documents cited above. EXCH\MANUAL\96-3.DOC/May 1996 CMA 119650 3.2 Quality of and Access to Data Used to Prepare SIDS Dossiers The following principles should be followed in reviewing and documenting the quality of the data in the SIDS Dossier Each National SIDS Contact Point must have had the opportunity to evaluate the quality of important supporting data for chemicals for which they are responsible as a Sponsor country. In principle, their evaluation of the quality, if sufficiently documented, will be able to be relied upon by all OECD Member countries; Data in the SIDS Dossiers should be appropriately summarised and reported and sufficiendy referenced in order to allow reviewers enough information on die substance tested, methods, endpoints and results to make an informed judgement of the quality of the data. The Model Dossier (see Annex 2 to this manual) provides an example on die amount of information which should be reported. Sponsor countries should have hill copies of studies cited in SIDS Dossier so that reviewers from other countries are able to actually examine the studies to independently validate the results and conclusions reported in the SIDS Dossiers if necessary. It should be made clear in describing any endpoints where full studies are not available. In general the support data and reports will not be kept confidential [see also OECD Council Act C(83)98(Final) and its OECD List of Non-Confidential Data on Chemicals]. In the exceptional cases where data are indicated to be confidential they will be made available for review on a confidential basis, i.e. the conditions set out in the OECD Council Act concerning Exchange of Confidential Data on Chemicals [C(83)97(Final)] apply to specific experts in each country that receives the data. In the event that problems still remain with providing support data to SIDS Contact Points other than the Sponsor country's own Contact Point, all efforts should be made to come to a specific solution which will allow progress to be made through the SIDS or Review process (e.g. having a report available on request of the other SIDS Contact Points for review). If the majority of the National SIDS Contact Points are not convinced that a well-informed judgement on the quality of the data can be made then, unless requested additional information is made available by the Sponsor country within a specified time, the relevant SIDS Test to be undertaken and/or exposure information to be collected, should be included in the SIDS Testing Plan. The specific "Considerations for Developing SIDS Testing Plans" (Section 3.3), "Guidance for Meeting the SIDS Requirements (The SIDS Guide)" (Section 3.4) and "Considerations Concerning the Adequacy of Data in the SIDS" (Section 3.S) should be carefully taken into account in preparing the SIDS Testing Plan. EXCHNMANUALN96-3.DOC/May 1996 CMA 119651 33 Considerations for Developing SIDS Testing Plans" General 1. The requirement to complete any individual data element of the SIDS by further testing will depend upon the quality and quantity of data supplied by the responder to the OECD request for available data on High Production Volume (HPV) chemicals (i.e. contained in the Revised OECD HPV Form 1, or preferably, on the HEDSET diskette). As such, it is impossible to give specific guidance which covers every situation. However, it is essential that all data received by the Sponsor country are assessed by suitably qualified personnel and that they, in collaboration with die responder, give the justification for not completing any or all of the SIDS data elements. 2. In deciding which tests should be undertaken, die statement on animal welfare adopted by the Second High Level Meeting of the Chemicals Group [ENV/CHEM/HLM/M/82.1, para. 95] should be taken into account Appropriate infonnation derived from (Quantitative) Structure Activity Relationships can be of assistance in developing the SIDS Testing Plan. 3. Any additional testing that is required should be performed according to internationally acceptable guidelines (e.g. OECD Test Guidelines) and in accordance with the OECD Principles of GLP. Test reports should contain suitable, signed GLP and quality assurance statements. Every attempt should also be made to follow the procedures specified under GLP Principles. 4. Expressing results by phrases such as "insoluble in water'1 is discouraged. A limit test should be performed under such circumstances so that a positive expression, such as "< 0.1 mg/1 (analytical limit)", can be entered. Chemicalsfor Testing 5. When a group of related chemicals is being considered, testing may be conducted on the most appropriate analogue, e.g. the one with die most severe potential effects, and the results extrapolated to the others. 6. Practical reasons for completing less than the SIDS for an individual chemical include the availability of infonnation concerning: isomers which have a similar structure-activity profile; closely related homologues; relevant precursors and breakdown products along with information on metabolism and degradation. As a general approach, for each particular endpoint, the use of range-finding tests may be an appropriate first step to establish relative levels of toxicity between isomers. 7. To avoid interference from additives and impurities, it is recommended that tests for physicalchemical properties be conducted on the purified substance because they are basic infonnation on a specific chemical. The other tests, however, should generally be carried out on the substance with any essential additives (e.g. stabilisers) and impurities it normally contains in order to know the effects of tire The content of this section is based on a document discussed at the 20th Joint Meeting of the Chemicals Group and Management Committee ofthe Special Programme on the Control of Chemicals (May 1993). EXCH\MANUAL\96-3.DOC/May 1996 CMA 119652 marketed product. Ideally, the same batch of substance should be used However, gross amounts of water, mineral oil or other solvents that are sometimes present in the marketed product should be excluded. 8. Highly reactive chemicals may not be stable enough for experiments to be conducted hence testing may not be practical. In these cases, it may be useful to examine breakdown products for possible adverse effects and, where a compound is of limited stability, it may be desirable to design individual ways for testing the potential effect for particular endpoints. For example, in the case of a compound whose breakdown properties have severely irritant properties, it may be possible to test the parent compound at doses below the level at which the irritating effect of the breakdown product occurs. It may also be useful to determine the lowest dose which is tolerated via a limited range finding test using a few animals, and to use these results to determine what toxic effects may be expected to occur as a result of repeated doses. 9. For intermediates, a limited data set rather than a full SIDS might be required Details are provided in "SIDS Testing of Chemicals with Limited Exposure Potential" (Section 3.6). Ecotoxtdty and Toxicity Tests 10. For aquatic effect testing, prolonged/chronic toxicity testing in Daphnia should be considered in addition to acute tests if there is concern for long-term effects. 11. In determining whether significant exposure may be expected in the terrestrial environment, it should be considered whether the chemical has a potential for reaching the terrestrial environment based on use and transport patterns and disposal practices, taking into account all phases of die life cycle; physical-chemical properties indicate that the compound may be persistent, has a potential to bioaccumulate, or that a major portion may partition to the soil; and/or monitoring data indicate residues in soil, sewage sludge or groundwater. 12. In considering which terrestrial testing should be undertaken, the studies selected should be appropriate to the receiving environmental compartment (e.g. in die case of sewage sludge, toxicity to earthworms and plants). In addition, attention should be given to cross-media considerations. 13. For the reproduction toxicity endpoint: when a 90-day repeated dose study is available and is sufficiently documented with respect to studying effects on reproductive organs, and a developmental study is available, the requirements for die reproduction toxicity endpoint are satisfied; when either a 90-day or a 28-day repeated dose study is the only repeated dose study available, it is recommended that a reproduction/developmental toxicity screening test (e.g. OECD Test Guideline 421) be canted out in order to satisfy the requirements for the reproduction toxicity endpoint when a 90-day repeated dose study is available and demonstrates no effects on reproductive organs, in particular the testes, then a developmental study (e.g. OECD Test Guideline 414) can be considered as an adequate test for information on reproduction/ developmental effect EXCH\MANUAL\96-3.DOC/May 1996 CMA 119653 3.4 Guidance for Meeting the SIDS Requirements (The SIDS Guide) In order to assure harmonized responses from Member countries and to ensure consistency on requests for further testing, this guidance document (SIDS guide) has been developed. This documents show data requirements and Test guidelines to be used on each data element Note: Figures in [ ] correspond to the data elements in the HEDSET and in the Revised OECD HPV Form 1. 1. GENERAL INFORMATION [1.01 A.) CAS-number Should always be stated. [1.01 C.] Name of the Substance Should always be stated. Use the name supplied by the OECD. [1.01 D.] CAS-descriptor Should be stated where applicable for complex chemicals. [1.01 G.[ Structural Formula Should be given where possible. [1.5] Quantity Should be given where possible. Information on production and/or import levels should be provided as tonnes per annum (or ranges, e.g., 100-500 tonnes, see Annex to this section) per country and the date for which those figures or ranges apply should be given. [1.7] Use Pattern Should be given where possible. Data on use pattern should be given by assigning main types according to their exposure relevance, industrial categories and use categories. Detailed explanation on categories is given in Annex to this section and die HEDSET explanatory note. If the chemical is present in consumer products as marketed, details should be mentioned on; - function of the products (e.g. detergent etc.), - weight fraction ofthe chemical in products and - physical state ofproducts as marketed (e.g. aerosol, powder or liquid)) EXCH\MANUAL\96-3.DOC/May 1996 CMA 119654 (1.9) Sources of Exposure Should be given where possible. Describe sources of potential human or environmental exposure including emission data if available for all phases of the life cycle of the chemical including manufacturing and user areas. For environmental exposure, indicate the production process briefly, number of sites of manufacture and the basis for concluding that the process is "closed" if applicable. Indication of measured exposure levels can be mentioned here. Any information that will help to focus the assessment of exposure can be mentioned, if available 2. PHYSICAL-CHEMICAL DATA [2.1] Melting Point Should always be stated for substances other than gases (and liquids whose melting point is lower than approximately 0C.) Temperature of decomposition is acceptable. OECD Test Guideline 102 [2.2] Boiling Point Should always be stated for substances other than gases or solids and liquids which either boil above 300C or decompose before boiling (in which cases estimates based on vapour pressure or the boiling point under reduced pressure are necessary). Temperature of decomposition is acceptable. OECD Test Guideline 103 [2.3] Density (Relative Density) Where applicable, indicate the relative density of the substance. This property is generally more important for inorganic chemicals. OECD Test Guideline 109 [2.4] Vapour Pressure [2.5] Should always be stated. Calculations which indicate that the value is probably less than 10 s kPa at 25C, could preclude die need for testing. If a boiling point cannot be quoted due to decomposition or the melting point is above 360C, it may not be necessary to conduct this test If a melting point is < 360C but > 200C, a limit value based on measurement or a recognised calculation method is acceptable. This test is not essential for chemicals with a boiling point of< 30C. OECD Test Guideline 104 Partition Coefficient (n-Octanol/water) Should always be stated. Even for those substances which are extremely soluble/insotuble in either phase, an attempt should be made to provide a limit value (if necessary based on the individual solubilities in EXCH\MANUAL\96-3.DOC/May 1996 CMA 119655 n-Octanol and water). It is recognised that for surface active substances, the measured result may only be approximate. The MedChem database is a good source of data. If the test cannot be performed, a calculated value for Log Pow should be provided. However it should be noted that calculated values which are higher than 6 are, in general, not reliable. For calculation of Pow, see e.g.: - C. Hansch, A.J. Leo in Substituent Constants for Correlation Analysis in Chemistry and Biology, John Wiley, New York, 1979. - W.J. Lyman, W.J. Reehl, D.H. Rosenblatt (ed.), Handbook of Chemical Property Estimation Methods, McGraw-HiU, New York, 1983. - Annex to OECD Test Guideline 117. - Application of Structure Activity Relationships to the Estimation of Properties Important in Exposure Assessment, OECD Environment Monograph No.67, 1993. OECD Test Guidelines 107,117 [2,6. A.] Water Solubility Should always be stated, including gases if necessary, excluding volatile substances and substances unstable in water. Determinations should be made at or near 20C. If solubility/temperature dependence is > 3% per C, further measurements should be made at 10C above and below the initially chosen temperature. If the substance is "insoluble" in water, the detection limit of the analytical method should be indicated. OECD Test Guideline 105 [2.6.B.] pH Value and pKa Value Where applicable, enter values for the dissociation constant(s)and the conditions under which they were measured. Dissociation constants are particularly important for acids, bases and inorganic chemicals (and are normally known calculated or measured). OECD Test Guideline 112 [2.12] Oxidation-Reduction Potential Where applicable, indicate the redox potential and the conditions under which it was measured. This property is generally more important for inorganic chemicals [2.13 A.] Adsorption/ Desorption to Soil Where applicable, indicate the adsorption/ desorption to soil and conditions under which it was measured. This property is particularly important for inorganic chemicals in cases where Log Pow is not useful in view of the expected properties of the chemicals. OECD Test Guideline 106 EXCH\MANUAL\96-3.DOC/May 1996 CMA119656 3. ENVIRONMENTAL FATE AND PATHWAYS [3.1.1] Photodegradation For photodegradation, an estimation is generally sufficient Estimation of photodegradability (and hydrolysis) can be based on reference documents, e.g., "An Assessment of Test Methods for Photodegradation of Chemicals in the Environment" (ECETOC Technical Report No.3) and "Handbook of Chemical Property Estimation Methods" (W.J. Lyman, W.J. Reehl, D.H. Rosenblatt (ed.), Handbook of Chemical Property Estimation Methods, McGraw-Hill, New York, 1983.) OECD Test Guideline 113 [3.1.2] Stability in Water (Hydrolysis) Testing is generally required for hydrolysis unless adequate data is already available. But consideration should be given to the possibility of using estimation methods. Additional testing may be required for hydrolysis even if data have been supplied, given consideration to: - choice of test protocol; - quality of data. When possible, the products of hydrolysis should be identified. OECD Test Guideline 111 [3.2] Monitoring Data (Environment) Where available, indicate an overview of monitoring data in the environment with specifications of conditions. [3.3] Transport and Distribution between Environmental Compartments including Estimated Environmental Concentrations and Distribution Pathways Environmental concentration and important fine and between pathways based on simple models, e.g., those in the "Guidance for Initial Assessment of Environmental Exposure" and "Compendium of Environmental Exposure Assessment Methods for Chemicals" (OECD Environment Monograph No.27) etc. should be described. In particular calculation of distribution of a chemical between environmental compartments by a Fugacity Level I model should be provided. (The diskettes which accommodate global reference model (FUGMOD) and other national models which have been distributed by the Secretariat can be used for this purpose.) [3.5] Biodegradation Testing is generally required, other than for gases, unless adequate data is already available. Additional testing may be required even if data have been supplied, given consideration to: - choice of test protocol; - quality of data. OECD Test Guideline 301A-301F The feasibility of each OECD Test Guideline (301A-301F) may be dependent on the physical-chemical properties (e.g., stability in water), and the structure of the test substance. EXCH\MANUAL\96-3.DOC/May 1996 CMA 119657 4. ECOTOXICITY Where aquatic tests are carried out on poorly soluble substances at nominal concentration above the solubility limit in the test medium, and no mortalities or effects are observed, then the LC30, ECm and NOEC should be indicated as being above the stated solubility limit in the test medium. For poorly soluble substances, it should also be clearly stated whether solvents were used to enhance the solubility. Testing at the solubility limit, without solvent, is preferred. (*) For substances which decompose in water, LC*, ECH and NOEC should be expressed in terms of the nominal concentration of the tested substance. [4.1] Acute/Prolonged Toxicity to Fish Testing is generally required if no adequate data is already available. Additional testing may be required even if data have been supplied, given consideration to: - results from testing and calculations; quality of data. OECD Test Guideline 203 (*) [4.2.A] Acute Toxicity to Aquatic Invertebrates (Daphnia) Acute testing is generally required if no adequate data is already available. Additional testing may be required even if data have been supplied, given consideration to quality of data. OECD Test Guideline 202, Part 1 (*) [4.3] Toxicity to Aquatic plants e.g. Algae Testing is generally required if no adequate data is already available. Additional testing may be required even if data have been supplied, given consideration to quality of data. OECD Test Guideline 201 (*) [4.5.2] Chronic Toxicity to Aquatic Invertebrates (Daphnia) Chronic testing will be required if there is concern about possible long-term effects in the aquatic environment OECD Test Guideline 202, Part 2 (*) [4.6] Toxicity to Terrestrial Organisms If significant exposure is expected in the terrestrial environment compartment, appropriate terrestrial toxicity tests should be performed. In determining whether significant exposure may be expected in the terrestrial environment, the following should be considered: - the chemical has a potential for reaching the terrestrial environment based on use and transport patterns and disposal practices taking into account all phases of the life cycle combined with; - physical-chemical properties indicate the compound may be persistent, has a potential to bioaccumulate or a major portion may partition to the soil; or * measured data indicate residues in soil, waste water sludge or groundwater. EXCH\MANUAL\96-3.DOC/May 1996 CMA 119658  In considering which terrestrial testing should be undertaken, it should be taken into account that studies should be appropriate to the receiving environmental compartment (e.g., in the case of sewage sludge, toxicity to earthworms and plants). In addition, attention should be given to cross media considerations. Initially, a test should be performed on terrestrial invertebrates and/or plants. The results of other tests may indicate the need for avian toxicity tests. OECD Test Guideline 205-208 (*) - 205: Avian Dietary Toxicity Test - 206: Avian Reproduction Test - 207: Earthworms Acute Toxicity Test The artificial soil test is preferred because the paper contact test is not truly representative of the natural habitat. - 208: Terrestrial Plants, Growth Test 5. TOXICITY [5.1] Acute Toxicity Testing is generally required if no adequate data is already available. Consideration should be given to the possibility of using data from analogues or repeated dose toxicity studies on the same substance. Additional testing may be required even if data have been supplied, given consideration to: - test species; - route of exposure; - quality of data. The rat is the preferred species (oral and inhalation). For dermal tests, the rat, rabbit or guinea pig are preferred species. All substances, except gases and vapours, should be tested by the oral route. Dependent upon the physical-chemical properties of the substance and the most important route of human exposure, the dermal or die inhalation route could also be considered. Gases should be tested by the inhalation route alone. OECD Test Guideline 401-403,420 [5.4] Repeated dose Toxicity Testing is generally required if no adequate data is already available. Additional testing may be required even if data have been supplied, given consideration to: - test species; - route of exposure; - duration of exposure; - quality of data. The rat is the preferred species but consideration should be given to the species used in the acute test Oral, dermal and inhalation routes should be considered. The oral route is normally preferred. The appropriate route should be selected dependent on physical-chemical properties of the substance, the results of the acute toxicity tests and the most important route ofhuman exposure. OECD Test Guideline 407,410 and 412 The "Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test" (OECD Test Guideline 422) is also acceptable. EXCHYMANUAL\96-3.DOC/May 1996 CMA 119659 (5.5) [5.61 Genetic Toxicity in vitro and in vivo Testing is generally required if no adequate data is already available. Additional testing may be required even if data have been supplied, given consideration to: - test organism, strain and/or cell system; - if metabolic activation has been used; - quality of data. Two different endpoints should be tested: gene mutation and chromosomal aberration. These endpoints may be evaluated by using the following tests: - Gene mutation in prokaryotic cells, should be performed preferably in Salmonella typhimurium (OECD Test Guideline 471). The chemical class of the test substance may determine which test organism and whether modified procedures may be needed. The test should be earned out with and without metabolic activation. - Chromosomal aberration in mammalian cells grown in vitro (OECD Test Guideline 473) or in vivo methods such as the micronucleus test or metaphase analysis of bone marrow cells (OECD Test Guidelines 474, 475). For chemicals which are in vitro mutagens and are handled and used as if they were in vivo mutagens, then any further in vivo tests may be considered for post SIDS assessment [5.7] Toxicity to Reproduction Testing is generally required if no adequate data is already available. Additional testing may be required even if data have been supplied, given consideration to: - test species; - duration of exposure; - quality of data. For the reproduction toxicity endpoint - when a 90-day repeated dose study is available and is sufficiently documented with respect to studying effects on the reproductive organs and a developmental study is available, the requirements for the reproduction toxicity endpoint are satisfied; - when either a 90-day or 28-day repeated-dose study is the only repeated dose study available, it is recommended that the reproduction/developmental toxicity screening test (e.g. OECD Test Guideline 421) be carried out in order to satisfy the requirements for the reproduction toxicity endpoint; and - when a 90-day repeated dose study is available and demonstrates no effect on reproductive organs, in particular the testes, then a developmental study (e.g. OECD Test Guidelines 414) can be considered as an adequate test to complete information on reproduction/developmental effect OECD Test Guideline 415 - 416. The screening tests [OECD Test Guideline 422: Combined Repeated Dose Toxicity Study with die Reproduction/Developmental Toxicity Screening Test, (for when repeated dose toxicity is not available) and OECD Test Guideline 421: Reproduction/Developmental Toxicity Screening Test (for when repeated dose toxicity is available)] are also acceptable. [5.8] Developmental Toxicity/Teratogenicity Endpoint of developmental toxicity is generally required if no adequate data i$ already available. See Toxicity to Reproduction. OECD Test Guideline 414 EXCH\MANUAL\96-3.DOC/May 19% CMA119660 [5.11] Experiences with Human Exposure (Work Place Exposure) Information on work place exposure such as; - concentration of chemicals in the workplace (manufacturing, maintenance and professional use) and indoor environment, - number of workers (in range or situations including manufacture, maintenance and use), - frequency, duration and level of exposure should be mentioned if available. Effects of accidental or occupational exposure, epidemiological and clinical studies, case reports, etc. can be described. EXCH\MANUAL\96-3.DOC/May 1996 CAM 119661 Annex Expressions for Quantity and Categories of Use Pattern 1. Quantity Following range of quantity produced or imported are recommended to be used. 10 50 50 100 100 500 500 1 000 1 000 5 000 5 000 10 000 10 000 50 000 50 000 100 000 100 000 500 000 500 000 - 1 000 000 more than 1 000 000 tonnes per annum tonnes per annum tonnes per annum tonnes per annum tonnes per annum tonnes per annum tonnes per annum tonnes per annum tonnes per annum tonnes per annum tonnes per annum Note: indicate the year when these quantities were produced or imported. If the annual figure is not for a calendar year, specify it in comment field. 2. Use Pattern Data on use pattern have to be given by assigning them to 4 main groups according to their exposure relevance, IS industrial categories and 55 use categories. If information for other countries is available, input it by using the multi-entry programme with the name of the country in the comments field. If available, give an estimation of different uses in percentage terms. Type of Use - use EACH of following terms Contents Main Industrial Use A. Main Categories - use one of die following glossary codes Contents Use in closed systems Use resulting in inclusion into or onto matrix Non dispersive use Wide dispersive use EXCH\MANUAL\96-3 .DOC/May 19% CMA 119662 Use in dosed systems A substance should be assigned only to this category if it remains within a reactor or is transferred from vessel to vessel through closed pipework and therefore accidental spillage is the only likely cause for human exposure or environmental contamination. These intermediates are classified in one of the following 3 categories: - non-isolated intermediates (restricted to the reaction vessel and its dedicated equipment) - isolated intermediates stored on-site under controlled conditions - isolated intermediates with controlled transport A typical example is phosgene which will be used only under these conditions. Substances that are used in closed systems but might be released into the environment after use, sometimes in considerable quantities, or where significant discharges into the environment cannot be excluded during production and use, should be assigned to the "Non dispersive use" or even "Wide dispersive use" categories. Typical examples in the latter case are CFC's used as cooling agents or hydraulic fluids. Use resulting in inclusion into or onto matrix Use consisting of inclusion into or onto matrices means all processes where chemicals are incorporated into products or articles from which they would not be released into the environment. Examples are the inclusion of plasticizers in plastics, additives such as pigments or dyes in plastics or fibres and catalysts in coating materials. Non dispersive use Non dispersive use refers to chemicals which are used in such a way that only certain groups of workers, with the knowledge of the processes, come into contact with these chemicals. Workers are normally aware of the procedures to protect themselves through the use of personal or technical protective measures. The employer should also take the necessary steps to protect the environment against exposure. Thus, exposure to these chemicals will be limited. These chemicals may also be discharged into the environment from point sources. Quantities discharged will be limited due to protective measures such as waste water sewage treatment plants or air filters. Wide dispersive use The term "wide dispersive use" should be used for a wide range of activities particularly where end users come into contact with the products. Examples are detergents, cosmetics, disinfectants, solvents in household paints EXCH\MANUAL\96-3.DOC/May 1996 CMA 119663 B. Industrial Categories - use the following glossary codes Contents Agricultural industry e.g. Pesticides, fertilisers Basic chemical industry: basic chemicals e.g. Solvents, pH-regulating agents (acids, alkalis) Chemical industry: chemicals used in synthesis e.g. Intermediates (including monomers), process regulators Electrical/electronic engineering industry e.g. Electrolytes, semiconductors. Not: galvanics, electroplating agents Fuel industry e.g. Gasoline, colouring agents, fuel additives, antiknock agents Leather processing industry e.g. Dyestuffs, tanning auxiliaries Metal extraction, refining and processing industry e.g. Heat transferring agents, electroplating agents Paints, lacquers and varnishes industry e.g. Solvents, viscosity adjusters, dyestuffs Paper, pulp and board industry e.g. Dyestuffs, toners Personal and domestic use e.g. Consumer products such as detergents (including additives), cosmetics, non-agricultural pesticides for domestic use Photographic industry e.g. Antifogging agents, sensitisers Polymers industry e.g. Stabilisers, softeners, antistatic agents, dyestuffs Public domain e.g. Professional products used in public areas such as non-agricultural pesticides, cleaning agents Textile processing industry e.g. Dyestuffs, flame retardants Other (indicate the this category) These IS categories represent almost all industrial uses for chemicals and could serve for setting up exposure scenarios with regard to the designated use of a substance. C. Use Categories - use die following glossary codes Contents Absorbents and Adsorbents Adhesive, binding agents Aerosol propellants Anti-condensation agents Anti-freezing agents Anti-set-off and anti-adhesive agents Anti-static agents Bleaching agents Cleaning/washing agents and disinfectants Colouring agents Complexing agents Conductive agents Construction materials additives Corrosion inhibitors Cosmetics Dustbinding agents Electroplating agents EXCH\MANUAL\96-3.DOC/May 1996 CMA119664  Explosives Fertilisers Fillers Fixing agents Flame retardants and fire preventing agents Flotation agents Flux agents for casting Foaming agents Food/foodstuff additives Fuel Fuel additives Heat transferring agents Hydraulic fluids and additives Impregnation agents Insulating materials Intermediates (give description in the remarks field) Laboratory chemicals Lubricants and additives Non-agricultural pesticides, Odour agents Oxidising agents pH-reguladng agents Pesticides Pharmaceuticals Photochemicals Process regulators Reducing agents Reprographic agents Semiconductors Softeners Solvents Stabilisers Surface-active agents Tanning agents Viscosity adjusters Vulcanising agents Welding and soldering agents Others (indicate the this category) EXCH\MANUAL\96-3.DOC/May 1996 CMA 119665 3.5 Considerations Concerning the Adequacy of Data in the SIDS*** General 1. Each National SIDS Contact Point must have had the opportunity to evaluate the quality of data in the SIDS for chemicals with complete studies available for which they are responsible as a Sponsor country. 2. OECD Test Guidelines and GLP Principles are generally used to produce studies of acceptable quality. However, data may be considered adequate for the purposes of screening even if not totally acceptable by international standards (e.g. OECD Test Guidelines, GLP Principles). This is best determined by expert judgement on a case-by-case basis. 3. It may not be necessary to conduct certain studies in cases when: other studies, for example on analogues, are available and the results are consistent - e.g., acute toxicity studies, biodegradation studies; there are other relevant studies or calculations available, and the results are consistent, which diminishes the need for retesting; and/or an approximate value is adequate for screening purposes, e.g. acute toxicity studies. 4. If studies have been carried out according to guidelines other than those of the OECD, these test methods should be clearly described. Also if calculated data are reported, the method of calculation and its justification should be described. 5. In the same way, if studies have not been carried out under the OECD GLP Principles, an explanation for not doing so must be provided. 6. If some SIDS data are inadequate or missing, there will be a bias for testing unless a rationale for not testing is provided and is accepted in the international context Again, bearing in mind animal welfare considerations, internationally acceptable methods of in vitro testing should be considered as a first line of approach. 7. Studies should be referenced as clearly as possible so that, when data are prepared for transfer to IRPTC and IPCS, they can be properly identified and coded. Physical-chemical Data 8. Physical-chemical data for boiling point and melting point when taken from reliable references (i.e. from handbooks) rather than taken from actual test reports can generally be accepted because there is good confidence in these data based on experience. Information on related compounds may be useful in affirming physical-chemical parameters. 9. For vapour pressure, octanol/water partition coefficients (P,,J and water solubility studies, more scrutiny may be required as such data are more critical to the initial assessment of potential hararrk e.g. The content of this section is based on a document discussed at the 20th Joint Meeting of the Chemicals Group and Management Committee of the Special Programme an the Control of Chemicals (May 1993). EXCH\MANUAL\96-3.DOC/May 1996 CMA 119666 bioaccumulation. In particular, calculated values of log P,, are not reliable if greater than 6. The American MedChem database could be used as a good source of data for these endpoints. 10. Key information which affects the value of physical-chemical properties such as temperature and methods used must be provided. Environmental Fate Data 11. As for biodegradation data on a chemical, the most important issue at the level of the SIDS is whether a compound is readily biodegradable or not Therefore, in any ready biodegiadability test, the following figures should be provided: the number of micro-organisms present; the time window for 10 per cent degradation; and the test results at the end ofthe test It is necessary to present these data for tests which are comparable with ready biodegradation tests. Other biodegradation data that are available, especially data obtained using natural media such as soil or river water, should also be included in the SIDS dossier. 12. Distribution of a chemical between environmental compartments can be calculated by the Fugacity Level I Model in the FUGMOD computer program, which has been distributed by the OECD Secretariat and can be obtained horn SIDS Contact Points. Primarily partition coefficients such as soil/water Koc, Henry's constant and BCF's are required for inputting into the fugacity model when it is used. Ecotoxicity and Toxicity Data 13. If any of the required ecotoxicity or toxicity studies are lacking, consideration may be given to waiving some testing endpoints where there are adequate data for closely related analogues. This should be closely scrutinised on a case-by-case basis. 14. For a proper evaluation of ecotoxicity and toxicity studies, detailed information should be reported in addition to those explicitly required in the Revised OECD HPV Form 1 or the HEDSET. Lack of detail in reporting toxicity or ecotoxicity data does not automatically lead to die need to re-test, but this will delay a decision on the acceptability and adequacy of toxicity and ecotoxicity studies mentioned in the SIDS Dossiers. Availability of detailed information for all tests make the review by other countries much easier and more efficient Examples of details on the information on die aquatic toxicity tests which could be reported, if available, recommended by the Netherlands and the US respectively, are attached as an Annex to this section. 15. If the data presented horn studies not fully in compliance with GLP Principles and/or not conducted according to internationally acceptable test guidelines suggest a very low concern for the desired endpoints, i.e. a high and acceptable NOEL, then the test may be considered aHoqnam for screening purposes. EXCH\MANUAL\96-3.DOC/May 1996 CMA 119667 Annex Information to be Used in the Evaluation of Aquatic Toxidty Test Results, if available 1. Items and Contents Recommended by the Netherlands A. Organism B. Method C. Test-system: static; semi-static; continuous flow D. Test result: - fish: 24 + 48 + 72 + 96 hour - daphnia/acute: 24 + 48 hour - algae: 24-72 hr EC*, + NOEC + parameters used; biomass or growth rate - daphnia/chronic: NOEC, LCM(21d), ECM(21d) (in cases where chronic data are needed) E. Purity of test compound F. Whether analysis has been carried out and if so: - Is die result based on the nominal or measured concentration? - If the result is based on the measured concentration, an indication of the discrepancies should be given. G. Additional information for special compounds: (This information also is required for biodegradation tests.) - volatile substance: was an open or closed system used? - insoluble substance: if a solvent is used, how much has been added and has a solvent control been carried out? 2. Items and Contents Recommended by the US A. Organism: Age, mean length and mean weight, as appropriate; loading. B. Test System: For semi-static, time period between renewal; for continuous flow, number of replacements per day. C. Fish Test Result: 24, 48, 72 and 96 hr results; discriminate between intrinsic (chemical) toxicity and physical toxicity; sub-lethal effects observed. D. Daphnia Test Result (acute): 24 and 48 hr result; discriminate between intrinsic (chemical) toxicity and physical toxicity; sub-lethal effects observed. E. Algae Test Result: 24-72 hr (96 hr EC50, if available); NOEC and LOEC; parameter used (biomass or growth rate). F. Analytical Method: EXCH\MANUAL\96-3.DOC/May 1996 CMA119668 Detection limit, mean per cent recovery, table of nominal concentrations and measured concentrations with time interval(s) indicated, mean measured concentrations, statement as to how concentrations below the detection limit were bandied in the calculation of mean measured concentrations; concentration values should be reported as "100% active ingredient" G. Dilution Water Source, hardness, pH, total organic carbon (TOC), total suspended solids (TSS). H. Algae Growth Medium: Composition; final concentrations of nutrients in medium; TOC; hardness. I. pH of Test Solution: pH of test solution at t=0 hr and 48 hr or 96 hr as appropriate. J. Purity: Impurities; physical state. K. Aeration: Was aeration used during test; if yes, how much and by what method? L. Volatile: For closed systems, presence of head space; size of any head space; modifications of closed test system relative to open test system, e.g. adjustments in algal growth medium of bicarbonate concentration. M. Stock Solution Preparation: (1) If a stock solution was prepared, this procedure must be carefully evaluated using considerations such as the following: check all calculations from test material to stock solution; concentration to treatment concentrations; indicate clearly if stock solution concentration was based on test material "as is" or on 100 percent active ingredients; solvents or carriers used and their possible effects; concentration of solvents or carriers used; pH of stock solution; pH adjustment, if any; time between stock solution preparation and addition of organisms to exposure vessels; observations of physical appearance of stock solution: clear, milky dispersions as observed for detergents and charged polymers, dispersed solids, precipitate, oily slick or phase separation, etc.; if precipitates are present, how were they handled: mixed and distributed to exposure vessels of filtered out; if filtered out, what type of filter, were all solids filtered or only part of solids; was only the water soluble fraction (WSF) removed from the stock solution; methods used to dissolve test material: sonication (how long), mixing time heating, etc. (2) If no stock solution was prepared, the direct dilution of test material was employed. What was the time between direct dilution of the test material to the exposure vessel and the addition of organisms? [Note: Not all of these points are of equal relevance to the evaluation of tests, depending on the nature of the specific chemical. Guidance could be developed as to when certain information is critical to interpreting study results on a given class of chemicals in later phases of the HPV programme.] EXCHYMANUAL\96-3.DOC/May 1996 CMA119669 3.6 SIDS Testing of Chemicals with Limited Exposure Potential"** 1. This document is intended to give exposure criteria in relation to SIDS Testing, with regard to both intermediates and chemicals for which other claims for limited exposure can be made. Definition ofIntermediates 2. With respect to intermediates, any chemical which is intended to undergo a further deliberate reaction to produce another industrial substance is considered an intermediate. 3. In the context of the SIDS work, the following types of intermediates which are contained in closed systems and therefore have a limited potential for exposure can be identified: a) non-isolated intermediates, i.e. those chemicals whose life-cycle is restricted to the reaction vessel and its specific equipment; b) isolated intermediates which are stored in controlled on-site facilities; c) isolated intermediates with controlled transport, Le. to a limited number of locations within the same company or second parties which use the chemical in a controlled way as an intermediate with a well-known technology. Reduced SIDS 4. For these intermediates of categories 3a), b) and c), a reduced SIDS package reflecting the information needed to evaluate die hazards in case of an accident could be used. This consists of the Screening Information Data Set (SIDS) minus the tests for repeated dose toxicity and reproduction toxicity. 5. For intermediates in categories 3b) and 3c), mentioned above, inclusion of tests for reproduction/developmental toxicity included in the reduced SIDS package should be considered on a case-by-case basis. 6. In view of their limited exposure potential, intermediates currently have a lower priority in the context of the SIDS work and, consequently, the choice of these chemicals by Sponsor countries is discouraged. 7. It was agreed that if in spite of the above-mentioned discouragement, an intermediate in categories 3b) or 3c) was chosen in one of the early phases of the SIDS work, then the Sponsor countty must be prepared to undertake a developmental toxicity study. 8. The contribution to the overall sharing of the burden and fulfilling of die SIDS testing commitments by Sponsor countries is only partially satisfied when a reduced SIDS is performed. In order to conduct the initial phases in a practical and equitable maimer, it was agreed that when reduced SIDS are conducted for intermediates, (an) additional chemical(s) should be taken up by the Sponsor country The content of this Section is based an a document discussed at an Expert Meeting an Exposure Criteria and SIDS Testing, held in Paris in March 1991. EXCH\MANUAL\96-3.DOC/May 1996 CMA 119670 concerned. For example, when SIDS testing for a nonisolated intermediate is undertaken, SIDS testing for a second nonisolated intermediate would be appropriate to make up a full commitment Other Chemicalsfor which Limited Potentialfor Exposure can be Claimed 9. For chemicals other than intermediates, the possibility of reduced SIDS testing exists based on considerations of limited potential for exposure. It was felt that adequate experience was not yet available to develop suitable criteria to define such considerations in sufficient detail. 10. Consequently, it was agreed that, except for the first phase, a Sponsor country would not choose a chemical for which a claim for limited potential for exposure could be made. International Aspects 11. Whenever a Sponsor country claims reduced SIDS testing requirements for any of its chemicals such chemicals should be considered carefully by other Member countries. If they have substantiated evidence of existing or potential exposure in their country, they should forward this information to the Secretariat and the Sponsor country so that it can be used in a possible revision of the proposed SIDS Testing Plan for the chemical concerned. A non-response or null return by any Member country will be assumed to signify no exposure in that country. By following this procedure the Sponsor country, which will undertake the necessary testing, can ensure that the international dimensions which are inherent in the SIDS work are encompassed. Those chemicals for which reduced SIDS Testing has been internationally agreed will be periodically re-assessed for any changes in the exposure parameters. 12. The international character of the SIDS work suggests that exposure should not be viewed solely from a national standpoint Hence, it has been agreed that when a Sponsor country claims reduced SIDS testing based on considerations of limited potential for exposure, and receives substantiated evidence for existing or potential exposure from another Member country, then the Sponsor country should undertake the full SIDS Testing, and an extensive fine and pathway assessment should be conducted. 13. For chemicals considered to have limited potential for exposure, it is recommended that a procedure and time-table be defined for collecting use information from other Member countries, when a chemical moves into an initial assessment phase. Quality ofData 14. The principles concerning the quality of and access to data in the SIDS Dossier, which are mentioned in the documents such as "Considerations Concerning Adequacy of Data in the SIDS" (Section 3.5), etc., should obviously also apply to the information concerning exposure, in the case of claims for exemptions based on limited exposure as well as in the case of substantiated evidence to indicate existing or potential exposure. 15. It was agreed that, when a claim for reduced SIDS testing is maria based on considerations of limited potential for exposure, in addition to completing the HEDSET and/or the Revised OECD HPV Form 1, further information will need to be provided to support that claim Details of the type of such information have been agreed. They include number of sites, process, monitoring, presence in products, and transport (see Annex to this Section). EXCH\MANUAL\96-3.DOC/May 1996 CMA 119671 Annex Information Requirements Supporting Exemption Claims for Reduced SIDS Testing Based on Exposure Considerations I. Information on sites A. Number of sites B. Basis for "closed process" conclusion at each site: 1) process description in enough detail to clarify the basis for claiming that the process is closed; 2) if available, monitoring data showing no detection in any media, including the limits of detection; 3) if monitoring data are not available, statement that no monitoring has taken place and basis for believing, in the absence of data, that the chemical has not been released and that exposure does not occur. [Note: Distinguishing between no data and no detection is important] C. Data on "presence in distributed product" or, in the absence of data, die basis for believing it is not present II. Information on transport If transport also occurs, then in addition to the above, the following should be provided: Mode of transport (e.g. water, truck, rail, pipeline) Volume (annual) Types of consignments (e.g. bulk or drums) Controls during transport and transfer at despatching and receiving sites (placards, labels, etc.) III. Supporting evidence from a data search showing that the chemical is not present in other end-products EXCH\MANUAL\96-3.DOC/May 1996 CMA119672