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  • 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. 
  • 13-April-2017

    English

    Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests

    Acute toxicity tests are an area of focus for developing alternative assays and approaches to address animal welfare concerns. In the context of this document, acute toxicity studies refer to studies involving a single exposure to a test chemical and include those assessing systemic toxicity as well as those assessing local irritation, corrosion or sensitization. One approach to minimizing the use of animals for acute toxicity testing is to consider waiving a study that may be required based on scientific criteria. Another approach to reducing or eliminating animal testing is to use existing hazard information that is informative for the acute toxicity endpoint for the test chemical; this would include the use of hazard information for one or multiple similar test chemicals to characterize the hazard for another or for mixtures, the use of recognized calculation approaches and bridging concepts. This Document provides clarification on these approaches to ensure that regulatory authorities are provided with the appropriate data required for decision-making and that reduced animal testing can be undertaken without compromising the integrity of the hazard information. 
  • 13-April-2017

    English

    Guidance Document for Describing Non-Guideline In Vitro Test Methods

    The purpose of this guidance is to harmonise the way non-guideline in vitro methods are described and thereby facilitate an assessment of the relevance of test methods for biological activities and responses of interest, and an assessment of the quality of data produced, irrespective of whether these tests are based on manual protocols or assay protocols adapted for use on automated platforms or high-throughput screening systems (HTS). This guidance outlines the elements considered relevant for providing a comprehensive description of an in vitro method to facilitate the interpretation of results and support scientifically defensible fit-for-purpose applications.  
  • 13-April-2017

    English

    OECD Guidance for Characterising Oleochemical Substances 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): oleochemical substances. Many oleochemicals are UVCBs, due to the variability in the composition of the starting materials. The method presented in this document gives guidance on how oleochemical substances can be characterised in a way that their composition is accurately and consistently reflected to ensure 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

    Guidance on Grouping of Chemicals, Second Edition

    This guidance document is part of the OECD effort to provide guidance for assessing the hazards of chemical substances while gaining efficiencies and improving animal welfare. The approach described in this guidance document is to consider closely related chemicals as a group, or category, rather than as individual chemicals. While the first edition was published in 2007, This edition has been augmented with experience and examples encountered in the OECD CooperativeChemicals Assessment Programme, formerly the HPV Chemicals Programme since 2007, the second edition also intends to introduce new or revised guidance on: elaborating the analogue and category approach, quantitative and qualitative read-across, justifying read-across, using bioprofiling results for grouping chemicals, and specific types of category approaches (e.g. chemicals of variable composition, and metals).
  • 13-April-2017

    English

    Guidance on the Incorporation of Bioavailability Concepts for Assessing the Chemical Ecological Risk and/or Environmental Threshold Values of Metals and Inorganic Metal Compounds

    Several models, tools and methods have been published in the past 20 years to include bioavailability in risk assessment and several OECD member countries already have developed frameworks and published guidance documents for taking metal specificities into account in environmental risk assessment. The aim of the current guidance is not to replace the aforementioned frameworks or guidance documents, but rather, to provide an overarching framework on how to apply these tools depending on which data are actually available/needed to assess the bioavailability of the metal under scrutiny. Further harmonisation of these approaches and methodology, where appropriate, over the different OECD countries is recommended and could facilitate a more worldwide application and the Mutual Acceptance of Data since using common assessment approaches may help comparing and exchanging data sets, which could result in significant resource savings. 
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