Manual for Investigation of HPV Chemicals
OECD Secretariat, July 2007
TABLE OF CONTENTS
Introductory Note
This table of contents for the Manual for Investigation of HPV Chemicals is designed to give a quick overview of the guidance developed to support the HPV Chemicals Programme.
Description of OECD Work on Investigation of High Production Volume Chemicals (Date of last update: December 2005)
This section explains the background, scope and key procedures which are followed in the OECD work on the investigation of High Production Volume Chemicals. It covers the relevant Council Decision and the change of emphasis to the work given by the refocus of priority work on initial hazard assessments. The role of the industry initiative in the OECD HPV Chemicals Programme is described.
1. Procedures, including the use of electronic discussion groups and the on-line HPV database [ PDF] (Date of last update: October 2003)
- Annex 1: Synergies with REACH [PDF]
(Date of last update : March 2007)
- Annex 2: Synergies with the US HPV Challenge Programme [PDF]
(Date of last updat: February 2008)
- Annex 3: Synergies with the Canadian Proramme under CEPA 1999 [PDF]
(Date of last update: February 2008)
- Annex 4: Syergies with the Japan HPV Challenge Programme [PDF]
(Date of last update: February 2008)
This chapter lists a number of practical procedures aiming at improving the efficiency of the whole process. The Annexes address synergies between a member of national / regional programmes with the OECD HPV Chemicals Programme.
2. Data Gathering and Testing: SIDS, the SIDS Plan and the SIDS Dossier
- SIDS, the SIDS Plan and the SIDS Dossier [ PDF] (Date of last update: August 2006)
- Annex 1 Guidance for completing a SIDS Dossier [ PDF] (Date of last update: December 2005)
This chapter describes the Screening Information Data Set (SIDS) - the minimum amount of data that is required for making an initial hazard assessment of HPV chemicals which has been agreed upon by OECD. The central role of the SIDS Dossier is described where all relevant study data and information available on an HPV chemical, including that on non-SIDS elements, are collected in a standard manner. The means for initial collation of all available data and determining the need for any additional SIDS testing is discussed. Additional testing is to be performed according to OECD Test Guidelines.
The SIDS Plan lays out the Sponsor's course of action with respect to the use of existing, surrogate or new data. Annex 1 describes how to fill in the SIDS Dossier and provides Robust Study Summary Templates for describing key study results.
The IUCLID software is the preferred software for elaborating SIDS Dossiers.
3. Data Evaluation
- 3.1 Guidance for Determining the Quality of Data for the SIDS Dossier (Reliability, Relevance and Adequacy) [ PDF] (Date of last update: December 2005)
- 3.2 Guidance on the Grouping of Chemicals [ Monograph (2007) 28] (Date of last update: September 2007)
- 3.3 Guidance for the Use of Structure-Activity Relationships (SAR) in the HPV Chemicals Programme [ PDF] (Date of last update: July 2000)
Chapter 3 contains guidance for evaluating the quality of data (section 3.1) as well as guidance for grouping of substances (section 3.2) and the use of structure-activity relationships (section 3.3). The guidance on grouping is published as a separate monograph, due to its wide-ranging use outside of the OECD HPV chemicals Programme.
4. Initial Assessment of Data
- 4.1 Introduction [PDF] (Date of last update: October 2003)
- 4.2 Guidance for the Initial Assessment of Aquatic Effects [PDF] (Date of last update: October 2002)
- 4.3 Guidance for the Initial Assessment of Health Effects [PDF] (Date of last update: October 2003)
Chapter 4 contains guidance for assessing the hazards of chemical substances to man and the environment.
5. Preparation of the SIDS Initial Assessment Report and SIDS Profile [PDF] (Date of last update: December 2005)
This chapter describes how to elaborate the SIDS Initial Assessment Report (SIAR), which is the document through which the key scientific data on a chemical (or category of chemicals) as well as the conclusions regarding its hazards and recommendations for further work are presented for scientific and technical review and discussion by Member countries. Guidance is also provided on how to elaborate the SIDS Initial Assessment Profile (SIDS Profile or SIAP), which is a 1-2 page executive summary that transmits the conclusions and recommendations of the SIAM on a chemical to the Joint Meeting for endorsement.
Furthermore a template for the SIDS Initial Assessment Report is available, together with an explanatory note. The use of this template will ensure a harmonised format between initial assessments drafted by different member countries.
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Template for the SIDS Initial Assessment Report [DOT] (Date of last update: July 2003)
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Explanatory note for the use of the template [Word] (Date of last update: July 2003)
6. Post-SIDS Work
- 6.1 Description of Post-SIDS Activities and Procedures [PDF] (Date of last update: December 2005)
- 6.2 Guidance on reporting summary information on environmental, occupational and consumer exposure [PDF] (Date of last update: December 2003)
- 6.3 Provisional Guidance for the Initial Assessment of Environmental Exposure [PDF] (Date of last update: 1994)
- 6.4 Provisional Guidance for the Initial Assessment of Occupational and Consumer Exposure [PDF] (Date of last update: 1994)
Section 6.1 gives an overview of the Post-SIDS work i.e. essentially any work which follows the endorsement of the conclusions and recommendations of the SIAM. This can include work of a national or regional nature. The Task Force on Existing Chemicals monitors post-SIDS work and can take decisions relating to further work to be carried out in a concerted manner in OECD. Chapter 6 also contains guidance for the collection and reporting of exposure information and guidance documents related to exposure assessment of environmental as well as consumer and occupational exposure.
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