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  • 13-April-2017

    English

    Report on Considerations from Case Studies on Integrated Approaches for Testing and Assessment (IATA) - First Review Cycle (2015) - Case Studies on Grouping Methods as a Part of IATA

    OECD member countries have been making efforts to expand the use of alternative methods in assessing chemicals. The OECD has been developing guidance documents and tools for the use of alternative methods such as (Q)SAR, chemical categories and Adverse Outcome Pathways (AOPs) as a part of Integrated Approaches for Testing and Assessment (IATA). There is a need for the investigation of the practical applicability of these methods/tools for different aspects of regulatory decision-making, and to build upon case studies and assessment experience across jurisdictions. The objective of the IATA Case Studies Project is to increase experience with the use of IATA by developing case studies, which constitute examples of predictions that are fit for regulatory use. The aim is to create common understanding of using novel methodologies and the generation of considerations/guidance stemming from these case studies. This document reports the learnings and lessons obtained from the review experience of the four case studies submitted to the 2015 review cycle of the IATA Case Studies project. The topics discussed in this document include the strongest aspects and uncertainties of each case study, and the document identifies areas for developing further guidance on IATA.
  • 13-April-2017

    English

    Guidance on Selecting a Strategy for Assessing the Ecological risk of Organometallic and Organic Metal Salt Substances based on their Environmental Fate

    In this document a strategy is presented to facilitate the ecological risk assessment of organometallic compounds (OM) and organic metal salts (OMS), outlining key steps that are based on elucidation of the fate of these substances in the environment. This document puts forth the recommendation that the initial determination of their fate in the environment is a primary factor for deciding how these substances should be assessed recognising that regulatory and program requirements will vary with each jurisdiction.
  • 13-April-2017

    English

    Fundamental And Guiding Principles For (Q)SAR Analysis Of Chemical Carcinogens with Mechanistic Considerations

    In this document the importance of mechanistic consideration in quantitative structure-activity relationship ((Q)SAR) analysis, the critical role of mechanistic consideration in improving various (Q)SAR approaches and possible integrative approaches of combining chemoinformatics and bioinformatics are discussed, mainly using carcinogenicity as an illustrative toxicity endpoint. The principles and issues described in this document are general and may also be used for various types of chemical assessment. The intended target of readership is for global chemical hazard/risk assessors in regulatory agencies, industries, non-governmental organization and academia who require reliable and scientifically supportable (Q)SAR information and predictions in their assessments as well as for developers/researchers who endeavour to produce scientifically reliable (Q)SAR predictive models and tools.
  • 13-April-2017

    English

    OECD Guidance for Characterising Hydrocarbon Solvents for Assessment Purposes

    This document presents a harmonized method for characterising, for assessment purposes, a specific subcategory of UVCBs (Substances of Unknown or Variable composition, Complex reaction products or Biological materials): hydrocarbon solvent substances. The method presented in this document gives guidance on how hydrocarbon solvent substances can be characterised in a way that their composition is accurately and consistently reflected. This ensures that substances with the same chemical composition, manufactured in different countries, can be characterised with the same description for hazard assessment purposes. A common understanding and approach to characterising UVCBs would enable regulatory authorities to increase cooperation in the field of hazard assessment and help industry deal with regulatory requirements from multiple jurisdictions.
  • 13-April-2017

    English

    New Scoping Document on in vitro and ex vivo Assays for the Identification of Modulators of Thyroid Hormone Signalling

    This scoping document aims at bringing forward relevant in vitro and ex vivo thyroid assays to the attention of OECD member countries, to provide recommendations for their development/use, and also, to identify aspects/blocks of the thyroid signalling pathways that are not covered and would require further development of thyroid assays. 
  • 13-April-2017

    English

    Corporate governance for process safety - Guidance for senior leaders in high hazard industries

    The Guidance on Corporate Governance for Process Safety draws attention to those at the top of industry to the need for high standards of corporate governance in relation to the management of high hazard industries. The Guidance encourages every director, CEO and President of a major hazard company and to check themselves against a set of self-assessment questions and evaluate their awareness and knowledge in process safety.
  • 13-April-2017

    English

    Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Skin Corrosion and Irritation

    This Guidance Document proposes an integrated approach on testing and assessment (IATA) for skin corrosion and irritation. It also provides consistent information on key characteristics of each of the individual information sources of the IATA, and relevant guidance on how to integrate information for decision making (including decisions on the need for further testing) for final decisions for classification and labelling.
  • 13-April-2017

    English

    Overview on genetic toxicology TGs

    Following a general update of the Genetic Toxicology TGs in 2015, the present Document was written to provide succinct and useful information to individuals unfamiliar with genetic toxicology testing, as well as experienced individuals wishing to obtain an overview of the recent changes that were made to the TGs during the recent round of revisions. It provides: 1) general background and historical information on the OECD genetic toxicology TGs; 2) a brief overview of the important types of genetic damage evaluated by these tests; 3) a description of the retained TGs; and 4) the issues and changes addressed therein during the revision process. 
  • 13-April-2017

    English

    Report of the Workshop on a Framework for the Development and Use Of Integrated Approaches to Testing and Assessment

    This document is a report of the Workshop on a framework for the development and use of integrated approaches to testing and assessment which was held on 17-19 November 2014 in Crystal City VA, USA. This framework should provide guiding principles, and technical guidance on how results from alternative approaches (in silico, in chemico, in vitro including high throughput and high content test methods) should be interpreted for characterising (both qualitatively and quantitatively) the adverse effects in animals and humans and/ or the environment, so that they can be used for hazard identification, hazard characterisation and risk assessment. The workshop was organised in close cooperation with the World Health Organisation following a proposal from OECD member countries in June 2013. 
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