OCDE OECD ORGANISATION DE COOPÉRATION ET ORGANISATION FOR ECONOMIC DE DÉVELOPPEMENT ÉCONOMIQUES CO OPERATION AND DEVELOPMENT DIRECTION DE L'ENVIRONNEMENT ENVIRONMENT DIRECTORATE Division de l'Hygiène et de la Sécurité de l'Environment Environmental Health and Safety Division 2, rue André Pascal 75775 PARIS CEDEX 16 Tél. : 45 24 82 00 To: SIDS Contact Points cc: Members of the Steering Group on Existing Chemicals ( letter and Chapter 1 of the Manual only) Members of the Risk Assessment Advisory Body ( RAAB) ( letter only) National Delegations ( letter only)

ENV/ EHS/ DT/ th/ 97.41 Paris, 30 July 1997 Re: SIDS Manual ( Third Revision)

Dear Madam/ Sir,

Please find enclosed the updated SIDS Manual ( third revision) which reflects the state of the art of the OECD SIDS Programme. As only certain chapters have been updated, only copies of those chapters ( i. e. Cover pages, Chapters 1 3 and Annexes 4 6) are enclosed. The other chapters in the May 1996 version are still valid. In addition, a diskette is enclosed, including all the chapters of the latest SIDS Manual ( i. e. updated and unchanged chapters) in Word 6.0 files. 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 the current version, dated July 1997:

1. Chapter 1 ( Description of OECD Work on Investigation of High Production Volume Chemicals) has been updated to reflect the current situation regarding the definition of OECD HPV List, SIDS Review process, procedures for gathering and transmitting exposure information, etc.

2.. Section 2.5 ( Guidance for collection and transmission of exposure information for SIDS Initial Assessment) has been added based on the agreed procedures. Section 2.1 and 2.2 have also been modified and Annex 5 has been simplified.

3. A part of Chapter 3 ( Data Evaluation, Preparation of SIDS Dossiers and Testing Plans) has been revised based on the agreed new SIDS Review process.

4. Information in Annex 4 and 6 has been updated.

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.

If you have any questions or comments, please send them to Kazu Chikazawa ( Tel: 33 1 <IP_ADDRESS>, Fax: 33 1 <IP_ADDRESS>, E mail: kazuhiko. chikazawa@ oecd. org). Kazu will take over the work on the SIDS Manual which was done by Terry Hayamizu to date, after he leaves OECD at the end of August 1997. Additional copies or diskettes are available from Eimear Cantwell ( Tel: 33 1 <IP_ADDRESS>, Fax: 33 1 <IP_ADDRESS>, E mail: eimear. cantwell@ oecd. org).

Yours sincerely, 2 Dian Turnheim Environmental Health and Safety Division Encl.: a set of paper copies ( 7 documents) and a diskette EXCH\ MANUAL\ 97COVER. DOC/ July 1997 SIDS MANUAL ( Third Revision)

SCREENING INFORMATION DATA SET MANUAL OF THE OECD PROGRAMME ON THE CO OPERATIVE INVESTIGATION OF HIGH PRODUCTION VOLUME CHEMICALS July 1997 OECD SECRETARIAT EXCH\ MANUAL\ 97COVER. DOC/ July 1997 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 the OECD Request for Available Data on High Production Volume ( HPV) Chemicals: " Revised OECD HPV Form 1" 2.5 Guidance for collection and transmission of exposure information for SIDS Initial Assessment 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 the SIDS Requirements ( The SIDS Guide) 3.5 Considerations Concerning the Adequacy of Data 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 the Initial Assessment of Environmental Exposure 4.4 Provisional Guidance for the Initial Assessment of Occupational and Consumer Exposure 4.5 Provisional Guidance for the Initial Assessment of Aquatic Effects 4.6 Provisional Guidance for the Initial Assessment of Health Effects 5. Overview of the Post SIDS Work Annex 1 OECD Decision Recommendation of the Council on the Co operative Investigation and Risk Reduction of Existing Chemicals [ C( 90) 163( Final)]

Annex 2 Model SIDS Dossier Annex 3 Synopsis of OECD Test Guidelines for Studies Included in the SIDS Annex 4 OECD's Guidelines for the Testing of Chemicals  Currently Available Guidelines, Draft Guidelines, and Guidance and Review Documents Annex 5 An Example of the Format for Gathering Detailed Exposure Information Annex 6 List of SIDS Contact Points EXCH\ MANUAL\ 97COVER. DOC/ July 1997 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 the 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 reflect 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 Contact Points or from the OECD Secretariat.

In the third revision, made available in July 1997, the following revisions have been made.

1. Chapter 1 ( Description of OECD Work on Investigation of High Production Volume Chemicals) has been updated to reflect the current situation regarding the definition of OECD HPV List, SIDS Review process, procedures for gathering and transmitting exposure information, etc.

2.. Section 2.5 ( Guidance for collection and transmission of exposure information for SIDS Initial Assessment) has been added based on the agreed procedures. Section 2.1 and 2.2 have also been modified and Annex 5 has been simplified.

3. A part of Chapter 3 ( Data Evaluation, Preparation of SIDS Dossiers and Testing Plans) has been revised based on the agreed new SIDS Review process.

4. Information in Annex 4 and 6 has been updated.

The other chapters remain unchanged. A diskette which includes all the latest updated files is available from SIDS Contact Points and from the Secretariat. This Manual will be made available through the OECD Internet Homepage ( http:// www. oecd. org/ ehs/) in near future. EXCH\ MANUAL\ 97 1. DOC/ July 1997 1 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 at levels greater than 1,000 tonnes per year in at least one Member country. 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 management 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 management 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, the 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 on the agreements reached in the OECD Existing Chemicals Programme up to June 1997 EXCH\ MANUAL\ 97 1. DOC/ July 1997 2 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, are 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 ( IRPTC, now called UNEP Chemicals).

This co operative OECD work leads to considerable benefits for many parties:

· Environmental protection and human health will be improved as existing chemicals are 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 the 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. · 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 management actions for those HPV chemicals which have been found to be of concern to man or the environment.

The OECD List of High Production Volume Chemicals EXCH\ MANUAL\ 97 1. DOC/ July 1997 3 The 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 the 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 included all chemicals reported to be produced or imported in excess of 10,000 tonnes per year in any one Member country or in excess of 1,000 tonnes per year in two or more countries.

The List has been modified a couple of times. The 1997 OECD HPV List is currently being compiled by combining the European Union's HPV list ( i. e. Annex I to EC Regulation 793/ 93) and the updated national HPV submissions from non EU OECD Member countries. It was agreed at the 26th Joint Meeting ( i. e. the Joint Meeting of the Chemicals Group and Management Committee of the Special Programme on the Control of Chemicals) that the definition of the HPV chemicals be modified to " all chemicals reported to be produced or imported at levels greater than 1,000 tonnes per year in at least one Member country as of the 1997 List. It is expected to contain about 4,000 entries.

Any chemical on the 1997 OECD List of HPV Chemicals can be sponsored 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 ( i. e. " data poor' chemicals), or chemicals for which full SIDS information is available and for which an initial assessment can be carried out without delay ( i. e. " data rich" chemicals). 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 the OECD programme began. At the 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 the programme and facilitates the participation of industry. Chemicals for which SIDS data gap are probable will be identified by searching main databases and these will be marked in the 1997 OECD List of HPV Chemicals for the information of Member countries wishing to sponsor " data poor" chemicals.

Selection of Chemicals In order to share the burden, chemicals are selected by Member countries in batches of approximately 50 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 the 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 EXCH\ MANUAL\ 97 1. DOC/ July 1997 4 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 the 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 of a 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 the 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; · providing the information on SIDS testing/ no testing for the Secretariat; · organising and supervising any agreed SIDS testing; · assisting other national SIDS Contact Points by forwarding exposure information or other requested data on their chemicals; · making an evaluation of the full SIDS Dossier and preparing a SIDS Initial Assessment Report ( SIAR), including proposals for conclusions and recommendations on any follow up actions to be undertaken on the chemical; · circulating the SIAR to other Member countries and presenting it at a SIDS Initial Assessment Meeting ( SIAM); and · finalising the SIAR for publication, taking into account the comments provided and discussions at a SIAM.

Each Member country is responsible for generating and making available SIDS data for those priority HPV chemicals for which it is the 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.

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 the 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. EXCH\ MANUAL\ 97 1. DOC/ July 1997 5 At this stage, information on exposure of the chemical should also be collected. Sponsor countries of the chemicals collect detailed information, whereas other countries also collect easily available information and transmit it to relevant Sponsor countries ( see Section 2.2 and 2.5).

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 physical chemical 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 of data should be included, how the data should be expressed, etc. ( see Annex 2 to this manual).

SIDS Review Up to 1993, the SIDS Dossiers and SIDS Testing Plans had been forwarded by the Sponsor country to all SIDS Contact Points, so that the experts from each OECD country and those from non Member countries nominated by IPCS could study the proposals made by the Sponsor country. The proposals 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.

Beginning with phase 4, this SIDS Review was undertaken via a written procedure by sending the SIDS Dossiers and SIDS Testing Plans to all SIDS Contact Points. However, it was agreed in November 1996 to simplify the procedures by circulating a statement regarding testing needs with relevant information. This is aimed at reducing work for countries but still informing the Secretariat and all Member countries of progress and decisions regarding data quality and testing needs taken by Sponsor countries ( see Section 3.1 for details).

The Secretariat collates the information provided by Sponsor countries and circulates it to all SIDS Contact Points. Any comments are provided to Sponsor countries through SIDS Contact Points within 2 months. If opposing views exist, they will be discussed bilaterally between the individual Member country providing comments and the Sponsor country. Where no consensus can still be reached, discussion and resolution should, in principle, be handled by the Steering Group on Existing Chemicals, a sub group of the Joint Meeting. Sponsor countries can request preliminary discussion of SIDS Dossiers and Testing Plans at a SIDS Initial Assessment Meeting ( SIAM).

Following these SIDS Review procedures, the outcome concerning the data needs for SIDS end points is one of the following:

· existing data are adequate; no testing is needed; · existing data are not adequate; agreed testing will be carried out; or · existing data are not adequate, but there is agreed ( written) scientific justification for not requiring testing.

Initial Assessment of Full SIDS Chemicals When the Sponsor country has obtained all the data elements of the 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 the chemical and make an evaluation including conclusions on the potential risk and recommendations for further action, if appropriate. EXCH\ MANUAL\ 97 1. DOC/ July 1997 6 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 SIAMs. These documents are included in Chapter 4:

 Provisional Guidance for the Outline of the SIDS Initial Assessment Report  Provisional Guidance for the Initial Assessment of Environmental Exposure  Provisional Guidance for the Initial Assessment of Occupational and Consumer Exposure  Provisional Guidance for the Initial Assessment of Aquatic 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).

Peer Review The SIDS Dossiers and Testing Plans as well as the SIDS Initial Assessment Reports ( SIARs) are subject to extensive peer review in two stages. As discussed above, in the first stage, a statement of SIDS testing/ no testing together with relevant information is circulated to SIDS Contact Points who review and comment on the adequacy of the Sponsor country's decision. A two month period is allowed for this review. Sponsor countries receive comments via SIDS Contact Points and complement their data and/ or adjust their Testing Plans as appropriate.

In the second stage, the SIARs, which include evaluations, conclusions and recommendations, are circulated, together with the updated SIDS Dossier, to SIDS Contact Points in a timely 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 SIARs 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 European Commission; · 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 the chemical ( for that part of the discussions which concerns their chemical).

Outcome and public 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 the 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 conclusions and recommendations might state, 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 management 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 a Health and Safety Guide or an Environmental Health Criteria document; and/ or it could be recommended that risk management actions be considered at the national or, as appropriate, international level. In addition, the conclusion EXCH\ MANUAL\ 97 1. DOC/ July 1997 7 might be that further information is required assess concerns identified in the SIDS process, and that post SIDS testing is recommended on such chemicals.

The conclusions and recommendations on the chemicals agreed at a SIAM are reported to the Steering Group on Existing Chemicals and confirmed. They are subsequently transmitted to the Joint Meeting to be endorsed.

Sponsor countries finalise the SIAR taking into account the comments provided by other countries and the discussion at a SIAM, and submit it to the OECD Secretariat together with the SIDS Initial Assessment Profile and the Full SIDS Dossier or the finalised data in the HEDSET. In addition, Sponsor countries are expected to make test reports supporting these data publicly available, wherever possible.

The Secretariat transfers the submitted SIAR and other information to IRPTC for inclusion in their database and publication as a contribution to the International Programme on the Sound Management of Chemicals ( IOMC). These are also made available on Internet. In this way, all information resulting from the OECD SIDS Programme will be available world wide.

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 the 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 of post SIDS work and/ or a revised SIAR 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 management activities by industry for these chemicals.

Certain chemicals of concern might be considered by SIAM to require risk management action, either nationally or internationally. Further consideration of proposed risk management actions will be discussed at the Advisory Group on Risk Management, another sub group of the Joint Meeting.

Overview of the SIDS process including Post SIDS work A synopsis of the stages involved in the OECD work on SIDS is presented below ( also see the flowchart in Annex to this Chapter):

1) development and maintenance of an OECD List of HPV chemicals; EXCH\ MANUAL\ 97 1. DOC/ July 1997 8 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; 5) circulation of the information on SIDS testing/ no testing 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 confirmation at the Steering Group on Existing Chemicals 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 management 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 the results from the first phase of SIDS work, Member countries made a formal commitment, in the form of the 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 the SIDS project, but also disseminate data through its databases. Therefore, SIDS Initial Assessment Reports and all information summarised in the SIDS dossiers or in the HEDSET are transmitted to IRPTC and 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 the 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. ( not modified)

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: EXCH\ MANUAL\ 97 1. DOC/ July 1997 9 · Brydon, James E., Morgenroth III, 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.

· Turnheim, Dian ( 1994); Evaluating Chemical Risks, OECD Observer, 189, August/ September 1994, 12 15. Sponsor Country OECD Testing Plan not agreed Testing Plan agreed No testing Conclusions and Recommendations, ( for example)  requiring further information to assess identified concerns  low potential risk; low priority for further work Joint Meeting  potential risk identified, but adequately controlled; low priority for further action IRPTC IPCS ( data storage ( Preparation of  potential risk identified; priority for further action, publication) EHC, as appropriate ICSC, etc. as appropriate) IOMC SIDS Work Post SIDS Work Conclusions and Recommendations Joint Meeting IRPTC IPCS IOMC Selection of chemicals for sponsorship from HPV chemicals list Collection of data Review of the quality of data, preparation of SIDS Dossiers and SIDS Testing Plans SIDS Testing and/ or collection of information Preparation of SIDS Initial Assessment Report with Conclusions and Recommendations ( Full SIDS Chemical) SIDS Review SIDS initial assessment and agreement on conclusions and recommendations for Full SIDS Chemical at SIDS Initial Assessment Meeting ( SIAM)

Identification of Post SIDS Work by SIAM Further Testing, Data Analysis Assessment at Post SIDS Assessment Meeting EXCH\ MANUAL\ 97 2. DOC/ July 1997 1 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 the OECD Secretariat. Although the choice depends upon the preference of the data submitter, use of the HEDSET diskette 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 information using HEDSET if possible.

In Section 2.5, guidance for collection and transmission of exposure information is described.

* The documents in this chapter were prepared by the OECD Secretariat based on the agreements reached in the OECD Existing Chemicals Programme up to June 1997. EXCH\ MANUAL\ 97 2. DOC/ July 1997 2 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 data are required and how the data are to be described in HEDSET or 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 (*) 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 * · Structural Formula · Quantity ( production ranges expressed as tonnes per year) · Use Pattern ( categories and types of use, see also next page) · Sources of Exposure ( exposure information, see also next page)

2. Physical chemical Data · Melting Point · Boiling Point · Relative Density * · Vapour Pressure · Partition Co efficient: n Octanol/ Water · Water Solubility · Dissociation Constant · Oxidation reduction Potential *

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 procedures for collecting and transmitting exposure information were agreed at the Meeting of the Steering Group on Existing Chemicals and confirmed at the 25th Joint Meeting ( November 1996). EXCH\ MANUAL\ 97 2. DOC/ July 1997 3 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).

Exposure Information It was agreed in May 1993 that certain elements of exposure information be part of the SIDS. Such elements included those which were essential to allow effective application of even simple models and methods. However, despite the decision to encourage collection of exposure information, difficulties arose in actual data collection. Therefore, a Task Force under the Steering Group on Existing Chemicals met in June 1995 and made recommendations for effective and efficient procedures for collection and transmission of exposure information, as well as on exposure data elements to be gathered for the SIDS Initial Assessment.

Taking into account the experiences gained in a pilot study based on the recommendations, another approach was proposed and discussed at the 4th SIDS Initial Assessment Meeting held in Tokyo in May 1996. Finally, the Steering Group agreed at its meeting in November 1996 on the following procedures for collecting and transmitting exposure information, which were subsequently confirmed at the 25th Joint Meeting in November 1996:

First Step ( Beginning with Phase 5 chemicals)

( a) The Secretariat informs Member countries which chemicals are being sponsored and requests them to collect exposure information on these chemicals, i. e. at the information gathering stage. ( Beginning with Phase 6, information giving the rationale for the selection of each chemical is provided for Member countries to easily focus on specific exposure situations.)

( b) Member countries gather easily available exposure information on the elements in the following list on all the chemicals at this stage and forward it to the relevant Sponsor countries within 6 months.

· Produced, imported or used? · Quantity ( production, import and/ or export volume) · General information on use pattern · MAK or equivalent occupational standards · Information on classification and labelling · National regulatory standards or other measures for management of exposure · Other information ( e. g. results of workplace monitoring, other information on occupational exposure, information on release to the environment, results of environmental monitoring, information on consumer exposure, safe handling procedures, etc.)

( c) Sponsor countries gather more detailed national exposure information on their own sponsored chemicals. EXCH\ MANUAL\ 97 2. DOC/ July 1997 4 Second step ( Beginning with specific chemicals identified at SIAM4)

· More detailed information will be gathered later by Member countries for specific chemicals, especially those for which a potential hazard has been identified at a SIAM.

Guidance for collection and transmission of exposure information is given in Section 2.5. EXCH\ MANUAL\ 97 2. DOC/ July 1997 5 2.3 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 3.3 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\ 97 2. DOC/ July 1997 6 Data Collection Process It is recommended that the following be used to collect information on HPV chemicals for Phase 4 onwards, in place of the Revised OECD HPV Form 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 submitters, ( 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 the 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 the 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 of the IUCLID database. EXCH\ MANUAL\ 97 2. DOC/ July 1997 7 2.4 Guidance for the Responder to the OECD Request for Available Data on High Production Volume ( HPV) Chemicals: " Revised OECD HPV Form 1"

1. The attached blank form, 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 the 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 of the 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 Confidential 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)] 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 the 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 the 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", the 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 title 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.

12. Where data for the sponsored chemical are not available, the responders are encouraged to submit existing data on related compounds such as:

· isomers which have similar structure activity profiles; · closely related homologues; · 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 (*) are specifically requested for inorganic chemicals. EXCH\ MANUAL\ 97 2. DOC/ July 1997 8 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\ 97 2. DOC/ July 1997 9 REVISED OECD HPV FORM 1 SIDS DOSSIER ON THE HPV PHASE . . . . . . CHEMICAL . . . . . . . . . . . . . . . . . . . .

CAS No. . . . .  . .  .

Sponsor Country : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DATE: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . EXCH\ MANUAL\ 97 2. DOC/ July 1997 10 CONTENTS Page SIDS PROFILE SIDS SUMMARY 1. GENERAL INFORMATION 1.01 SUBSTANCE INFORMATION * A. CAS NUMBER B. NAME ( IUPAC NAME) * C. NAME ( OECD NAME) * D. CAS DESCRIPTOR E. EINECS NUMBER F. MOLECULAR FORMULA * G. STRUCTURAL FORMULA H. SUBSTANCE GROUP I. SUBSTANCE REMARK J. MOLECULAR WEIGHT 1.02 OECD INFORMATION A. SPONSOR COUNTRY B. LEAD ORGANISATION C. NAME OF RESPONDER ( COMPANY) 1.1 GENERAL SUBSTANCE INFORMATION A. TYPE OF SUBSTANCE B. PHYSICAL STATE C. PURITY 1.2 SYNONYMS 1.3 IMPURITIES 1.4 ADDITIVES 1.5 * QUANTITY 1.6 LABELLING AND CLASSIFICATION ( USE AND/ OR TRANSPORTATION) 1.7 * USE PATTERN A. GENERAL USE PATTERN B. USES IN CONSUMER PRODUCTS 1.8 OCCUPATIONAL EXPOSURE LIMIT VALUE 1.9 * SOURCES OF EXPOSURE 1.10 ADDITIONAL REMARKS A. OPTIONS OF DISPOSAL B. OTHER REMARKS.

2. PHYSICAL CHEMICAL DATA 2.1 * MELTING POINT 2.2 * BOILING POINT 2.3 * DENSITY ( RELATIVE DENSITY) 2.4 * VAPOUR PRESSURE 2.5 * PARTITION COEFFICIENT n OCTANOL/ WATER 2.6 * WATER SOLUBILITY A. SOLUBILITY B. pH VALUE, pKa VALUE 2.7 FLASH POINT ( LIQUIDS) 2.8 AUTO FLAMMABILITY ( SOLID/ GASES) 2.9 FLAMMABILITY 2.10 EXPLOSIVE PROPERTIES 2.11 OXIDISING PROPERTIES 2.12 * OXIDATION: REDUCTION POTENTIAL 2.13 ADDITIONAL REMARKS A. PARTITION CO EFFICIENT BETWEEN SOIL/ SEDIMENT AND WATER ( Kd) EXCH\ MANUAL\ 97 2. DOC/ July 1997 11 B. OTHER REMARKS 3. ENVIRONMENTAL FATE AND PATHWAYS 3.1 STABILITY 3.1.1 * PHOTODEGRADATION 3.1.2 * STABILITY IN WATER 3.1.3 STABILITY IN SOIL 3.2 * MONITORING DATA ( ENVIRONMENT) 3.3 * TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS 3.3.1 TRANSPORT 3.3.2 THEORETICAL DISTRIBUTION ( FUGACITY CALCULATION) 3.4 MODE OF DEGRADATION IN ACTUAL USE 3.5 * BIODEGRADATION 3.6 BOD 5, COD OR RATIO BOD 5/ COD 3.7 BIOACCUMULATION 3.8 ADDITIONAL REMARKS A. SEWAGE TREATMENT B. OTHER 4. ECOTOXICITY 4.1 * ACUTE/ PROLONGED TOXICITY TO FISH 4.2 ACUTE TOXICITY TO AQUATIC INVERTEBRATES * A. DAPHNIA B. OTHER AQUATIC ORGANISMS 4.3 * TOXICITY TO AQUATIC PLANTS e. g., ALGAE 4.4 TOXICITY TO BACTERIA 4.5 CHRONIC TOXICITY TO AQUATIC ORGANISMS 4.5.1 CHRONIC TOXICITY TO FISH 4.5.2 (*) CHRONIC TOXICITY TO AQUATIC INVERTEBRATES ( e. g., DAPHNIA REPRODUCTION) 4.6 TOXICITY TO TERRESTRIAL ORGANISMS 4.6.1 TOXICITY TO SOIL DWELLING ORGANISMS 4.6.2 TOXICITY TO TERRESTRIAL PLANTS 4.6.3 TOXICITY TO OTHER NON MAMMALIAN TERRESTRIAL SPECIES ( INCLUDING BIRDS) 4.7 BIOLOGICAL EFFECTS MONITORING ( INCLUDING BIOMAGNIFICATION) 4.8 BIOTRANSFORMATION AND KINETICS 4.9 ADDITIONAL REMARKS EXCH\ MANUAL\ 97 2. DOC/ July 1997 12 5. TOXICITY 5.1 * ACUTE TOXICITY 5.1.1 ACUTE ORAL TOXICITY 5.1.2 ACUTE INHALATION TOXICITY 5.1.3 ACUTE DERMAL TOXICITY 5.1.4 ACUTE TOXICITY BY OTHER ROUTES OF ADMINISTRATION 5.2 CORROSIVENESS/ IRRITATION 5.2.1 SKIN IRRITATION/ CORROSION 5.2.2 EYE IRRITATION/ CORROSION 5.3 SKIN SENSITISATION 5.4 * REPEATED DOSE TOXICITY 5.5 * GENETIC TOXICITY IN VITRO A. BACTERIAL TEST B. NON BACTERIAL IN VITRO TEST 5.6 * GENETIC TOXICITY IN VIVO 5.7 CARCINOGENICITY 5.8 * TOXICITY TO REPRODUCTION 5.9 * DEVELOPMENTAL TOXICITY / TERATOGENICITY 5.10 OTHER RELEVANT INFORMATION A. SPECIFIC TOXICITIES ( NEUROTOXICITY, IMMUNOTOXICITY etc.) B. TOXICODYNAMICS, TOXICOKINETICS 5.11 * EXPERIENCE WITH HUMAN EXPOSURE 6. REFERENCES Note: *; Data elements in the SIDS *; Data elements specially required for inorganic chemicals EXCH\ MANUAL\ 97 2. DOC/ July 1997 13 S I D S P R O F I L E DATE:

1.01 A. CAS No.

1.01 C. CHEMICAL NAME ( OECD Name)

1.01 D. CAS DESCRIPTOR 1.01 G. STRUCTURAL FORMULA OTHER CHEMICAL IDENTITY INFORMATION 1.5 QUANTITY 1.7 USE PATTERN 1.9 SOURCES AND LEVELS OF EXPOSURE ISSUES FOR DISCUSSION ( IDENTIFY, IF ANY) SIDS testing required: EXCH\ MANUAL\ 97 2. DOC/ July 1997 14 S I D S S U M M A R Y DATE:

CAS NO: ..................

STUDY Y/ N Y/ N Y/ N Y/ N Y/ N Y/ N Y/ N PHYSICAL CHEMICAL DATA 2.1 2.2 2.3 2.4 2.5 2.6 2.12 Melting Point Boiling Point Density Vapour Pressure Partition Coefficient Water Solubility pH and pKa values Oxidation: Reduction potential OTHER P/ C STUDIES RECEIVED ENVIRONMENTAL FATE and PATHWAY 3.1.1 3.1.2 3.2 3.3 3.5 Photodegradation Stability in water Monitoring data Transport and Distribution Biodegradation OTHER ENV FATE STUDIES RECEIVED ECOTOXICITY 4.1 4.2 4.3 4.5.2 4.6.1 4.6.2 4.6.3 Acute toxicity to Fish Acute toxicity to Daphnia Toxicity to Algae Chronic toxicity to Daphnia Toxicity to Soil dwelling organisms Toxicity to Terrestrial plants Toxicity to Birds OTHER ECOTOXICITY STUDIES RECEIVED TOXICITY 5.1.1 5.1.2 5.1.3 5.4 5.5 5.6 5.8 5.9 5.11 Acute Oral Acute Inhalation Acute Dermal Repeated Dose Genetic Toxicity in vitro . Gene mutation . Chromosomal aberration Genetic Toxicity in vivo Reproduction Toxicity Development / Teratogenicity Human experience OTHER TOXICITY STUDIES RECEIVED EXCH\ MANUAL\ 97 2. DOC/ July 1997 15 1. GENERAL INFORMATION 1.01 SUBSTANCE INFORMATION * A. Cast number . . . . . . . . . . .  . . . . . . . . .  . . . . . . . .

B. Name ( IUPAC name) .......................................................................................................................................

* C. Name ( OECD name) .......................................................................................................................................

* D. CAS Descriptor ( where applicable for complex chemicals)

.......................................................................................................................................

E. EINECS Number . . . . . . . . . . . .  . . . . . . . . .  . . . . . . . .

F. Molecular Formula .......................................................................................................................................

* G. Structural Formula ( indicate the structural formula in smiles code, if available)

.......................................................................................................................................

H. Substance Group ( if possible, only for petroleum products, see HEDSET explanatory note)

.......................................................................................................................................

I. Substance Remark ( Indicate the substance remark as prescribed in the EINECS Inventory, if possible)

.......................................................................................................................................

J. Molecular Weight .......................................................................................................................................

1.02 OECD INFORMATION A. Sponsor Country: .......................................................................................................................................

B. Lead Organisation:

Name of Lead Organisation: ..................................................................................................................................... Contact person:.......................................................................................................................................................... Address: Street: .......................................................................................................................................................... Postal code: ................................................................................................................................................. Town:.......................................................................................................................................................... Country:....................................................................................................................................................... Tel:.............................................................................................................................................................. Fax: ............................................................................................................................................................. EXCH\ MANUAL\ 97 2. DOC/ July 1997 16 C. Name of responder ( Information on a responder should be provided when companies respond to Lead Organisation or SIDS Contact Points.)

Name:........................................................................................................................................................................ Address: .................................................................................................................................................................... Street: .......................................................................................................................................................... Postal code: ................................................................................................................................................ Town:.......................................................................................................................................................... Country:....................................................................................................................................................... Tel:.............................................................................................................................................................. Fax: ............................................................................................................................................................. EXCH\ MANUAL\ 97 2. DOC/ July 1997 17 1.1 GENERAL SUBSTANCE INFORMATION A. Type of Substance element [ ]; inorganic [ ]; natural substance [ ]; organic [ ]; organometallic [ ]; petroleum product [ ]

B. Physical State ( at 20 ° C and 1.013 hPa)

gaseous [ ]; liquid [ ]; solid [ ]

C. Purity ( indicate the percentage by weight/ weight)....................................................................................................

1.2 SYNONYMS ...................................................................................................................................................... ...................................................................................................................................................... ...................................................................................................................................................... ...................................................................................................................................................... ......................................................................................................................................................

1.3 IMPURITIES [ Indicate CAS No., chemical name ( IUPAC name is preferable), percentage, if possible EINECS number.]

CAS No: . . . . . . . . . . .  . . . . . . . . .  . . . . . . . . EINECS No: ....................................................................................................................................... Name: ....................................................................................................................................... Value: ....................................................................................................................................... Remarks: .......................................................................................................................................

1.4 ADDITIVES ( e. g. stabilising agents, inhibitors etc. Indicate CAS No., chemical name ( IUPAC name is preferable), percentage, if possible EINECS number), the component of the UVCB ( substance with no defined composition) should be indicated here.)

CAS No: . . . . . . . . . . .  . . . . . . . . .  . . . . . . . . EINECS No: . . . . . . . . . . .  . . . . . . . . .  . . . . . . . . Name: ....................................................................................................................................... Value: ....................................................................................................................................... Remarks: .......................................................................................................................................

* 1.5 QUANTITY [ Information on production or import levels should be provided in figures or ranges ( e. g. 1,000 5,000, 5,000 10,000 tonnes, etc.) per responder or country and the date for which those ranges apply should be given. For EU Member states, only indicate the EU import figure. Give an estimation of the global production quantity in the remarks field. Information on the number of producers in the country and the source of information should also be given in the remarks field.)

Remarks: ( If possible, indicate if the substance was produced and/ or imported during the 12 months following adoption of the EU regulation on existing chemicals.) ..................... ....................................................................................................................................... ....................................................................................................................................... Reference: ....................................................................................................................................... 1.6 LABELLING AND CLASSIFICATION [ If possible, enter information on labelling and classification, such as labelling and classification system, existence of specific limit, symbols, nota, R Phrases and S Phrases of EC Directive 67/ 548/ EEC. See HEDSET Explanatory Note.]

Labelling Type: ....................................................................................................................................... Specific limits: ....................................................................................................................................... Symbols: ....................................................................................................................................... Nota: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 18 R phrases: ....................................................................................................................................... S phrases: ....................................................................................................................................... Text of S phrases: ....................................................................................................................................... Remarks: .......................................................................................................................................

Classification Type: ....................................................................................................................................... Category of danger: ....................................................................................................................................... R phrases: ....................................................................................................................................... Remarks: .......................................................................................................................................

* 1.7 USE PATTERN A. General [ Data on use pattern have to be given by assigning main types according to their exposure relevance ( i. e. non dispersive use, use in closed systems, use resulting in inclusion into or onto matrix and wide dispersive use), industrial categories ( e. g. basic chemical industry, chemical industry, agricultural industry, personal and domestic use) and use categories such as colouring agents, intermediates, solvents, adhesives, cleaning/ washing agents, fertilisers, impregnation agents, surface active, etc. If available, give an estimation of different uses in percentage terms.]

Type of Use: Category:

( a) main ............................................................................................ industrial ............................................................................................ use ............................................................................................

( b) main ............................................................................................ industrial ............................................................................................ use ............................................................................................

Remarks: ( a) ....................................................................................................................................... .......................................................................................................................................

( b) ....................................................................................................................................... .......................................................................................................................................

Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 19 B. Uses in Consumer Products [ If the chemical is present in consumer products as marketed, give details of products' function ( e. g. detergent, etc.), and percentage in product and physical state of product as marketed ( e. g. aerosol, powder or liquid)]

Function Amount present Physical state ............................... ........................................ .....................................

Remarks: . ..................................................................................................................................................... Reference: . .....................................................................................................................................................

1.8 OCCUPATIONAL EXPOSURE LIMIT VALUE ( Indicate the type of occupational exposure limit value including short term exposure limit value. If a value does not exist, give the hygiene standard of the producer company if available. See also 5.11.)

Exposure limit value Type: ...................................................................................................................................................... Value: ......................................................................................................................................................

Short term exposure limit value Value: ...................................................................................................................................................... Length of exposure period:........................................................................................................................................ Frequency: ...................................................................................................................................................... Remarks: ...................................................................................................................................................... Reference: ......................................................................................................................................................

* 1.9 SOURCES OF EXPOSURE Describe sources of potential human [ other than concentration of chemicals in the workplace and indoor environment ( see 5.11)], or environmental exposure, including emission data ( e. g. quantities per media with information such as time dimensions of release, indication of type of release ( e. g. point source or diffuse), type of estimating ( e. g. average or worst case), uncertainties in estimation), for all phases of the life cycle of the chemical, if available, 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.

Also an indication of measured exposure levels ( expressed in an appropriate form, e. g. geometric mean and standard deviation) can be mentioned here. Any information that will help to focus the assessment of exposure ( either quantitative or quantitative in nature) can be mentioned, if available.)

Source: Media of release:........................................................................................................................... Quantities per media:.................................................................................................................... Remarks: ...................................................................................................................................................... Reference: ...................................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 20 1.10 ADDITIONAL REMARKS A. Options for disposal [ Mode of disposal ( e. g. incineration, release to sewage system, etc.) for each category and type of use, if appropriate; recycling possibility]

Remarks: ...................................................................................................................................................... Reference: ......................................................................................................................................................

B. Other remarks Remarks: ...................................................................................................................................................... Reference: ......................................................................................................................................................

2. PHYSICAL CHEMICAL DATA * 2.1 MELTING POINT ( If more than one, identify the recommended value.)

Value: . . . . . . . . . . . ° C Decomposition: Yes [ ] No [ ] Ambiguous [ ] Sublimation: Yes [ ] No [ ] Ambiguous [ ] Method: [ e. g. OECD, other ( with the year of publication or updated of the method used)] ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 2.2 BOILING POINT ( If more than one, identify the recommended value.)

Value: . . . . . . . . . . . ° C Pressure: at . . . . . . . . . . hPa Decomposition: Yes [ ] No [ ] Ambiguous [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 2.3 DENSITY ( relative density) ( Where applicable, indicate the relative density of the substance.)

Type: Bulk density [ ]; Density [ ]; Relative Density [ ] Value: ....................................................................................................................................... Temperature: . . . . . . . . . . . ° C Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 2.4 VAPOUR PRESSURE ( if more than one, identify the recommended value)

Value: . . . . . . . . . . . hPa Temperature: . . . . . . . . . . . ° C Method: calculated [ ]; measured [ ] [ e. g. OECD, other ( with the year of publication or updated of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] EXCH\ MANUAL\ 97 2. DOC/ July 1997 21 Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 2.5 PARTITION COEFFICIENT log10Pow ( if more than one, identify the recommended value)

Log Pow: . . . . . . . . . . . Temperature: . . . . . . . . . . . ° C Method: calculated [ ]; measured [ ] [ e. g. OECD, other ( with the year of publication or updating of the ..................... method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 2.6 WATER SOLUBILITY ( if more than one, identify the recommended value)

A. Solubility Value: . . . . . . . . . . . Temperature: . . . . . . . . . . . ° C Description: Miscible [ ]; Of very high solubility [ ]; Of high solubility [ ]; Soluble [ ]; Slightly soluble [ ]; Of low solubility [ ]; Of very low solubility [ ]; Not soluble [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

B. pH Value, pKa Value pH Value: . . . . . . . . . . . Concentration: . . . . . . . . . . . Temperature: . . . . . . . . . . . ° C Method: [ e. g. OECD, other ( with the year of publication or updating of the method used). ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] ( Where applicable, enter values for the dissociation constant( s) and the conditions under which they were measured.) pKa value . . . . . . . . . . . at 25 ° C Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... 2.7 FLASH POINT ( liquids)

Value: . . . . . . . . . . . ° C Type of test: Closed cup [ ]; Open cup [ ]; Other [ ] Method: ( with the year of publication or updating of the method used). ..................................... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

2.8 AUTO FLAMMABILITY ( solid/ gases)

Value: . . . . . . . . . . . ° C Pressure: . . . . . . . . . . . hPa Method: ( with the year of publication or updating of the method used). ..................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 22 ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

2.9 FLAMMABILITY Results: Extremely flammable [ ]; Extremely flammable  liquified gas [ ]; Highly Flammable [ ]; Flammable [ ]; Non flammable [ ]; Spontaneously flammable in air [ ]; Contact with water liberates highly flammable gases [ ]; Other [ ] Method: ( with the year of publication or updating of the method used). ..................................... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

2.10 EXPLOSIVE PROPERTIES Results: Explosive under influence of a flame[ ]; More sensitive to friction than m dinitrobenzene [ ]; More sensitive to shock than m dinitrobenzene [ ]; Not explosive [ ]; Other [ ] Method: ( with the year of publication or updating of the method used). ..................................... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 23 2.11 OXIDISING PROPERTIES Results: Maximum burning rate equal or higher than reference mixture [ ]; Vigorous reaction in preliminary test [ ]; No oxidising properties [ ]; Other [ ]

Method: ( with the year of publication or updating of the method used). ..................................... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 2.12 OXIDATION: REDUCTION POTENTIAL ( Where applicable, indicate the redox potential and the conditions under which it was measured.)

Value: . . . . . . . . . . . mV Method: ( with the year of publication or updating of the method used) ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

2.13 ADDITIONAL DATA A. Partition co efficient between soil/ sediment and water ( Kd)

Value: . . . . . . . . . . . Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

B. Other data ( e. g. Henry's Law constant, fat solubility, surface tension ( of aqueous solution), adsorption/ desorption on soil, particle size distribution, etc.)

Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 24 3. ENVIRONMENTAL FATE AND PATHWAYS [ Reporting of studies should give the test method, test conditions ( laboratory versus field studies), test results ( e. g. % degradation in specified time period) and reference. Information on breakdown products ( transient and stable) should be provided when available.]

3.1 STABILITY * 3.1.1 PHOTODEGRADATION Type: Air [ ]; Water [ ]; Soil [ ]; Other [ ] Light source: Sunlight [ ]; Xenon lamp [ ]; Other [ ] Light spectrum: . . . . . . . . . . . nm Relative intensity: . . . . . . . . . . . ( based on intensity of sunlight) Spectrum of substance: [ e. g. lambda ( max.)(> 295nm) and epsilon ( max) or epsilon ( 295nm)] . . . . . . . . . . . nm Concentration of Substance: . . . . . . . . . . . Temperature: . . . . . . . . . . . ° C Direct photolysis: Half life: . . . . . . . . . . . Degradation: . . . . . . . . . . . % ( weight/ weight) after . . . . . . . . . . . ( exposure time) Quantum yield: . . . . . . . . . . . Indirect Photolysis: Type of sensitizer: . . . . . . . . . . . Concentration of sensitizer: . . . . . . . . . . . Rate constant ( radical): . . . . . . . . . . . cm 3/ molecule* sec Degradation: . . . . . . . . . . . Method: calculated [ ]; measured [ ] [ e. g. OECD, other ( with the year of publication or updating of the method used)] ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity:. . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 3.1.2 STABILITY IN WATER Type: Abiotic ( hydrolysis) [ ]; biotic ( sediment)[ ] Half life: . . . . . . . . . . . at pH . . . . . . . . . . . at . . . . . . . . . . . ° C Degradation: . . . . . . . . . . . at pH . . . . . . . . . . . at . . . . . . . . . . . ° C after . . . . . . . . . . . ( exposure time) Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)] ...... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ( e. g. CAS number, name and percentage of degradation products) ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 25 3.1.3 STABILITY IN SOIL Type : Field trial [ ]; Laboratory [ ]; Other [ ] Radiolabel: Yes [ ] No [ ] ? [ ] Concentration: . . . . . . . . . . . Soil temperature: . . . . . . . . . . . ° C Soil humidity: . . . . . . . . . . . Soil classification: DIN19863 [ ]; NF X31 107 [ ]; USDA [ ]; Other [ ] year . . . . . . . . Content of clay etc.: Clay . . . . . . %, Silt . . . . . . . %, Sand . . . . . . % Organic Carbon: . . . . . . . . . . . Soil pH: . . . . . . . . . . . Cation exchange capacity: . . . . . . . . . . . Microbial biomass: . . . . . . . . . . . Dissipation time: DT 50 : . . . . . . . . . . . DT 90 : . . . . . . . . . . . Dissipation : . . . . . . . . . . . % after . . . . . . . . . . ( time) Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)] ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 3.2 MONITORING DATA ( ENVIRONMENTAL)

Note that data on biological effects monitoring, including biomagnification, and biotransformation and kinetics in environmental species are to be reported in section 4.7 and 4.8, respectively. Nonetheless, concentration in various biota should be reported here. Data on concentration in the workplace or indoor environment should be reported under item 5.11.

Type of Measurement: Background [ ]; At contaminated site [ ]; Other [ ] Media: ....................................................................................................................................... Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

3.3 TRANSPORT AND DISTRIBUTION BETWEEN ENVIRONMENTAL COMPARTMENTS INCLUDING ESTIMATED ENVIRONMENTAL CONCENTRATIONS AND DISTRIBUTION PATHWAYS ( e. g. during the chemical life cycle. The information should indicate whether the calculation is on a global basis or is site specific, and whether it is based on laboratory measurements or field observations.) EXCH\ MANUAL\ 97 2. DOC/ July 1997 26 * 3.3.1 TRANSPORT Type: Adsorption [ ]; Desorption [ ]; Volatility [ ]; Other [ ] Media: ....................................................................................................................................... Method: ....................................................................................................................................... Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 3.3.2 THEORETICAL DISTRIBUTION ( FUGACITY CALCULATION)

Media: Air biota [ ]; Air biota sediment soil water [ ]; Soil biota [ ]; Water air [ ]; Water biota [ ]; Water soil [ ]; Other [ ] Method: Fugacity level I [ ]; Fugacity level II [ ]; Fugacity level III [ ]; Fugacity level IV [ ]; Other ( calculation) [ ]; Other ( measurement)[ ] ....................................................................................................................................... Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

3.4 IDENTIFICATION OF MAIN MODE OF DEGRADABILITY IN ACTUAL USE Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 3.5 BIODEGRADATION Type: aerobic [ ]; anaerobic [ ] Inoculum: adapted [ ]; non adapted [ ]; ...................................................................................... Concentration of the chemical: . . . . . . . . related to COD [ ]; DOC [ ]; test substance [ ] Medium: water [ ]; water sediment [ ]; soil [ ]; sewage treatment [ ] Degradation: ( percentage reduction/ exposure time) . . . . . . . . . . % after . . . . . . . . . . . ( time) Results: ( see OECD Guidelines) readily biodeg. [ ]; inherently biodeg. [ ]; under test condition no biodegradation observed [ ], other [ ] Kinetic ( e. g. Zahn Wellens Test) . . . . . . . . . . % in . . . . . . . . . . . . ( time) Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: [ In the case of poorly soluble chemicals, treatment given ( nature, concentration, CAS number, name and percentage of degradation products etc.)]:. .................................... ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 27 3.6 BOD5, COD OR RATIO BOD5/ COD BOD5 Method: . . . . . . . . . . . Concentration: . . . . . . . . . . . related to COD [ ]; DOC [ ]; Test substance [ ] Value: . . . . . . . . . . . mg O2/ l GLP: Yes [ ] No [ ] ? [ ]

COD Method: . . . . . . . . . . . Value: . . . . . . . . . . . mg O2/ g GLP: Yes [ ] No [ ] ? [ ]

Ratio BOD5/ COD: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

3.7 BIOACCUMULATION Species: ....................................................................................................................................... Exposure period: ....................................................................................................................................... Temperature: . . . . . . . . . . . ° C Concentration: . . . . . . . . . . . BCF: . . . . . . . . . . . Elimination: Yes [ ] No [ ] ? [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... Type of test: calculated [ ]; measured [ ] static [ ]; semi static [ ]; flow through [ ]; other ( e. g. field test) [ ] GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity:. . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

3.8 ADDITIONAL REMARKS A. Sewage treatment ( information on treatability of the substance)

Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

B. Other information [ information that will help to focus the exposure assessment ( either qualitative or quantitative)]

Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 28 4. ECOTOXICITY * 4.1 ACUTE/ PROLONGED TOXICITY TO FISH Type of test: static [ ]; semi static [ ]; flow through [ ]; other ( e. g. field test) [ ] open system [ ]; closed system [ ] Species: ....................................................................................................................................... Exposure period: ....................................................................................................................................... Results: LC50 ( 24h) = . . . . . . . mg/ l LC50 ( 48h) = . . . . . . . mg/ l LC50 ( 72h) = . . . . . . . mg/ l LC50 ( 96h) = . . . . . . . mg/ l NOEC = . . . . . . . . . mg/ l LOEC = . . . . . . . . . mg/ l Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

4.2 ACUTE TOXICITY TO AQUATIC INVERTEBRATES * A. Daphnia Type of test: static [ ]; semi static [ ]; flow through [ ]; other ( e. g. field test) [ ]; open system [ ]; closed system [ ] Species: ....................................................................................................................................... Exposure period: ....................................................................................................................................... Results: EC50 ( 24h) = . . . . . . . . mg/ l EC50 ( 48h) = . . . . . . . . mg/ l ECxx (.. h) = . . . . . . . . mg/ l NOEC = . . . . . . . . . . . mg/ l Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

B. Other aquatic organisms Type of test: static [ ]; semi static [ ]; flow through [ ]; other ( e. g. field test) [ ]; open system [ ]; closed system [ ] Species: ....................................................................................................................................... Exposure period: ....................................................................................................................................... Results: EC50 ( 24h) = . . . . . . . . mg/ l EC50 ( 48h) = . . . . . . . . mg/ l ECxx (.. h) = . . . . . . . . . mg/ l NOEC = . . . . . . . . . . mg/ l Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . EXCH\ MANUAL\ 97 2. DOC/ July 1997 29 Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

* 4.3 TOXICITY TO AQUATIC PLANTS, e. g. algae Species: ....................................................................................................................................... Endpoint: Biomass [ ]; Growth rate [ ]; Other [ ] Exposure period: ....................................................................................................................................... Results: . . . . . . . . . . . . EC50 (. . . . . . . h) = . . . . . . . mg/ l ( Endpoint) ECxx (. . . . . . . h) = . . . . . . . mg/ l NOEC = . . . . . . . mg/ l LOEC = . . . . . . . mg/ l Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... open system [ ]; closed system [ ] GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

4.4 TOXICITY TO BACTERIA ( Single species tests and tests on overall processes such as nitrification or soil respiration are included in this item.)

Type: Aquatic [ ]; Field [ ]; Soil [ ]; Other [ ] Species: ....................................................................................................................................... Exposure Period: ....................................................................................................................................... Results: EC50 (. . . h) = . . . . . . . mg/ l ECxx (. . . h) = . . . . . . . mg/ l Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

4.5 CHRONIC TOXICITY TO AQUATIC ORGANISMS 4.5.1 CHRONIC TOXICITY TO FISH ( effects on reproduction, embryo/ larva, etc.)

Type of test: static [ ]; semi static [ ]; flow through [ ]; other ( e. g. field test) [ ]; open system [ ]; closed system [ ] Species: ....................................................................................................................................... Endpoint: Length of fish [ ]; Weight of fish [ ]; Reproduction rate [ ]; Other [ ] Exposure period: ....................................................................................................................................... Results: . . . . . . . . . . EC50 (.. d) = . . . . . . . mg/ l ( Endpoint) ECxx (.. d) = . . . . . . . mg/ l NOEC = . . . . . . . . . mg/ l LOEC = . . . . . . . . mg/ l Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 30 Reference: .......................................................................................................................................

(*) 4.5.2 CHRONIC TOXICITY TO AQUATIC INVERTEBRATES ( e. g. daphnia reproduction. The need to conduct tests for this endpoint will depend inter alia upon possible concern for long term effects.)

Type of test: static [ ]; semi static [ ]; flow through [ ]; other ( e. g. field test) [ ]; open system [ ]; closed system [ ] Species: ....................................................................................................................................... Endpoint: Mortality [ ]; Reproduction rate [ ]; Other [ ] Exposure period: . . . . . . . . . . . . Results: . . . . . . . . . . . EC50 (. . . . . h) = . . . . . . . mg/ l ( Endpoint) ECxx (. . . . . . d) = . . . . . . . mg/ l NOEC = . . . . . . . . mg/ l LOEC = . . . . . . . . mg/ l Analytical monitoring: Yes [ ] No [ ] ? [ ] Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 31 4.6 TOXICITY TO TERRESTRIAL ORGANISMS 4.6.1 TOXICITY TO SOIL DWELLING ORGANISMS Type : Artificial soil [ ]; Filter paper [ ]; Other [ ] Species: ....................................................................................................................................... Endpoint: Mortality [ ]; Weight [ ]; Other [ ] Exposure period: ....................................................................................................................................... Results: . . . . . . . . . . EC50 (. . . . . d) = . . . . . . . mg/ kg ( Endpoint) EC50 (. . . . . d) = . . . . . . . mg/ kg ECxx (. . . . . d) = . . . . . . . mg/ kg NOEC = . . . . . . . . . . . mg/ kg LOEC = . . . . . . . . . . . mg/ kg Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]. ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

4.6.2 TOXICITY TO TERRESTRIAL PLANTS ( a) Species: ....................................................................................................................................... Endpoint: Emergence [ ]; Growth [ ]; Other [ ] Exposure period: ....................................................................................................................................... Results: EC50 and/ or LC50 ( 7d) = . . . . . . . . mg/ l EC50 and/ or LC50( 14d) = . . . . . . . . mg/ l ECxx and/ or LCxx ( xxd) = . . . . . . . . mg/ l NOEC = . . . . . . . . . . . . . . . . . . . mg/ l LOEC = . . . . . . . . . . . . . . . . . . . mg/ l Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

( b) Species: ....................................................................................................................................... Endpoint: Emergence [ ]; Growth [ ]; Other [ ] Exposure period: ....................................................................................................................................... Results: EC50 and/ or LC50 ( 7d) = . . . . . . . mg/ l EC50 and/ or LC50( 14d) = . . . . . . . . mg/ l ECxx and/ or LCxx ( xxd) = . . . . . . . . mg/ l NOEC = . . . . . . . . . . . . . . . . . . mg/ l LOEC = . . . . . . . . . . . . . . . . . . mg/ l Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

( c) Species: ...................................................................................................................................... . Endpoint: Emergence [ ]; Growth [ ]; Other [ ] Exposure period: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 32 Results: EC50 and/ or LC50 ( 7d) = . . . . . . . mg/ l EC50 and/ or LC50( 14d) = . . . . . . . . mg/ l ECxx and/ or LCxx ( xxd) = . . . . . . . . mg/ l NOEC = . . . . . . . . . . . . . . . . . . mg/ l LOEC = . . . . . . . . . . . . . . . . . . mg/ l Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

4.6.3 TOXICITY TO OTHER NON MAMMALIAN TERRESTRIAL SPECIES ( INCLUDING AVIAN)

Species: ....................................................................................................................................... Endpoint: Mortality [ ]; Reproduction rate [ ]; Weight [ ]; Other [ ] Exposure period: ....................................................................................................................................... Results: LDxx or LCxx ( xxd) = . . . . . . . mg/ kg NOEC = . . . . . . . mg/ kg LOEC = . . . . . . . mg/ kg Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]

GLP: Yes [ ] No [ ] ? [ ] Test substance: .........., purity: .......... Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

4.7 BIOLOGICAL EFFECTS MONITORING ( INCLUDING BIOMAGNIFICATION) ( Studies on variation of predominant species in certain ecosystems ( e. g. mesocosm) and monitoring of biological effects are included.)

Results: Substance:...................................................................................................................... Species or ecosystem studied:........................................................................................ Effects monitored: ......................................................................................................... Results:.......................................................................................................................... Chemical analysis:......................................................................................................... Remarks: ( Information on environmental conditions ( e. g. water characteristics: suspended matter, pH, temperature, hardness; soil/ sediment characteristics: % organic matter, clay content) ....................................................................................................................................... Reference: .......................................................................................................................................

4.8 BIOTRANSFORMATION AND KINETICS ( Under this item, studies on absorption, distribution, metabolism and excretion etc. should be given.)

Type: Animal [ ]; Aquatic [ ]; Plant [ ]; Terrestrial [ ]; Other [ ] Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

4.9 ADDITIONAL REMARKS Results: ....................................................................................................................................... Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 33 EXCH\ MANUAL\ 97 2. DOC/ July 1997 34 5. TOXICITY ( Where observations on humans are available, these should be entered in the appropriate " Comments" section or under section 5.11.)

* 5.1 ACUTE TOXICITY 5.1.1 ACUTE ORAL TOXICITY Type: LD0 [ ]; LD100 [ ]; LD 50 [ ]; LDL0 [ ]; Other [ ] Species/ strain: ....................................................................................................................................... Value: . . . . . . . . . mg/ kg b. w.: Discriminating dose: ..................................................................................................... Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

5.1.2 ACUTE INHALATION TOXICITY Type: LC0 [ ]; LC100 [ ]; LC50 [ ]; LCL0 [ ]; Other [ ] Species/ strain: ....................................................................................................................................... Exposure time: ....................................................................................................................................... Value: ....................................................................................................................................... Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: .......................................................................................................................................

5.1.3 ACUTE DERMAL TOXICITY Type: LD0 [ ]; LD100 [ ]; LD 50 [ ]; LDL0 [ ]; Other [ ] Species/ strain: ....................................................................................................................................... Value: . . . . . . . . . . . . . . mg/ kg b. w. Method: [ e. g. OECD, other ( with the year of publication or updating of the method used)]....... ....................................................................................................................................... GLP: Yes [ ] No [ ] ? [ ] Test substance: . . . . . . . . . . . , purity: . . . . . . . . . . . Remarks: ....................................................................................................................................... Reference: ....................................................................................................................................... EXCH\ MANUAL\ 97 2. DOC/ July 1997 35 5.1.4 ACUTE TOXICITY, OTHER ROUTES OF ADMINISTRATION ( e. g. subcutaneous, intravenous, etc.)