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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.  

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.

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.

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.    

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.

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.  

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.

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).

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.