Latest Documents

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.

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.

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): 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.

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.

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.

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.  

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.  

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.