By Date


  • 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

    Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment

    With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of the components within IATA. Templates are also provided to enable a structured approach to their documentation in order to facilitate their evaluation. A defined approach to testing and assessment consists of a fixed data interpretation procedure (DIP) applied to data generated with a defined set of information sources to derive a result that can either be used on its own, or together with other information sources within an IATA, to satisfy a specific regulatory need. Thus, a defined approach to testing and assessment can be used to support the hazard identification, hazard characterisation and/or safety assessment of chemicals. This guidance is intended to be used alongside similar guidance aimed at harmonising the reporting of other IATA components such as QSARs, grouping and read-across strategies, and non-guideline in vitro methods.

  • 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

    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 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

    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

    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

    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 Cooperative

    Chemicals 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 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

    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.

     

  • 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 > >>