Reports

The IUCLID (International Uniform ChemicaL Information Database) can be customised to manage chemical data in different contexts and is a platform employing globally harmonised data elements pertinent to chemicals. The version 6 of IUCLID software released in 2016 allows for greater customisation of IUCLID and for extension and integration with other tools. For example, the standard IUCLID data elements can be extended to capture specific information for specific legislative data needs before they are added to the OHTs. This document describes four main elements related to the customisation of IUCLID including how the IUCLID format can be configured and customised, the main IUCLID features and add-ons, integration with other systems and development of alternative user interfaces. The document also outlines how customisation of these different elements requires different expertise and resources. It incorporates user stories regarding customisation of and data migration to IUCLID from ECHA, Australia, and Canada. Following an update of the IUCLID 6 software, a second edition of the report was released in June 2021 to reflect the most recent features and processes.

The chemical industry is one of the largest industrial sectors in the world and is expected to grow fourfold by 2060. Indeed modern life without chemicals would be inconceivable. Given the potential environmental and human health risks from exposure to chemicals, governments and industry have a major responsibility to ensure that chemicals are produced and used safely. The OECD assists countries in developing and implementing policies and instruments that protect human health and the environment, and in making their systems for managing chemicals as efficient as possible. To eliminate duplication of work and avoid non-tariff barriers to trade, emphasis has been on developing shared frameworks for gathering and assessing information on potential chemical risks. The time-tested OECD Mutual Acceptance of Data (MAD) system provides a major basis for generating savings to governments and industry. This report provides an overview of the benefits and estimates the total savings from OECD work to be more than EUR 309 million per year.

On 20 February 2019, OECD Council adopted the Recommendation on Countering the Illegal Trade of Pesticides to strengthen cooperation between countries and inspectors. A Best Practice Guidance was developed to provide guidance for inspectors and regulatory authorities on best practices for identifying and tackling illegal pesticides throughout the complete lifecycle of a pesticide, from manufacture, through formulation, trade and use to destruction.

In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context.  To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible.  Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions.  GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.

The report outlines the technical aspects of the various approaches and methodologies available with respect to the assessment of risks from combined exposures to multiple chemicals. The document draws from approaches applied and experience gained in the regulatory context and will therefore be most relevant to the regulatory authorities addressing chemicals, the regulated community and other interested stakeholders. The considerations are not presented as strict guidance but rather elements to recognise in assessing combined exposures to multiple chemicals.

This working document has been prepared to address the assessment of secondary metabolites of microbial biocontrol agents. The main focus of this working document is the assessment of the hazards and risk of secondary metabolites produced during the manufacturing of microbial pest control products and after their application in the field. This document addresses a number of important topics for secondary metabolites, including concerns that microbial pest control products could be associated with known or as yet uncharacterised ‘new’ secondary metabolites. A background document is available as an annex to help provide clarity on issues and terminology related to secondary metabolites of microbial biocontrol agents. This document may also form the basis of a future OECD Guidance Document on the subject.

This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals. The document is intended to provide guidance for evaluating chemical using standardised test guidelines. Specific objectives include providing a description of the OECD conceptual framework for evaluating chemicals for endocrine disruption, background on the standardised test methods used, and guidance for interpreting the outcome of individual tests. The general approach taken by the document is primarily to provide guidance on how test results might be interpreted based on the outcome of standardised assays. Key questions addressed in the document concern likely mechanisms of endocrine action and any resulting apical effects that can be attributed to such action. The document is not proscriptive but provides suggestions for possible next steps in testing (if any) which might be appropriate for a regulatory authority to take, given the various data scenarios. The guidance document is focused primarily on endocrine modalities included in the conceptual framework; estrogen, androgen, and thyroid mediated endocrine disruption and chemicals that interfer with steroidogenesis.

The Test Guideline (TG) describes the use of cryopreserved rainbow trout (Oncorhynchus mykiss) hepatocytes (RT-HEP) as a metabolising system to determine the clearance (CL, IN VITRO, INT) of a test chemical using a substrate depletion approach. Introduction of the test chemical to the RT-HEP suspension initiates the reaction. In order to collect samples at various time points, the reaction is terminated by transferring an aliquot of the suspension to a stopping solution. The decrease of the test chemical concentration from the incubation vial is measured with a validated analytical method and used to determine the CL, IN VITRO, INT.  The value obtained can then be used to improve in silico predictions of the test chemical bioaccumulation in fish.