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The present Key Event based Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with a tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This Test Guideline is proposed to address a Key Event leading to skin sensitisation, namely keratinocyte activation. This Key Event on the Adverse Outcome Pathway (AOP) leading to skin sensitisation takes place in the keratinocytes and includes inflammatory responses as well as gene expression associated with specific cell signalling pathways such as the antioxidant/electrophile response element (ARE)-dependent pathways. This Test Guideline provides three in vitro test methods addressing the same Key Event on the AOP for skin sensitisation: (i) the ARE-Nrf2 luciferase KeratinoSens™ test method, (ii) the ARE-Nrf2 luciferase LuSens test method and (iii) the Epidermal Sensitisation Assay – EpiSensA. The KeratinoSens and the Lusens are in vitro ARE-Nrf2 luciferase-based test methods and the EpiSensA is based on gene expression quantification using Reverse Transcription- quantitative PCR in reconstructed human epidermis models. The proposed test methods are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. Performance standards have been developed to enable the validation of similar test methods.
This Test Guideline proposes defined approaches (DA) combining data generated in vitro methods, with information sources such as physicochemical properties. The prediction from a DA may be used alone to determine eye hazard potential according to the hazard classes of the UN GHS (Categories 1, 2, or not classified). A DA consists of a fixed data interpretation procedure (DIP) (i.e. a mathematical model, a rule-based approach) applied to data (e.g in silico predictions, in chemico, in vitro data) generated with a defined set of information sources to derive a prediction without the need for expert judgment. The DAs use method combinations intended to overcome some of the limitations of the individual, stand-alone methods in order to provide increased confidence in the overall obtained result.
The in vitro macromolecular test method is a biochemical in vitro test method that can be used to identify chemicals (substances and mixtures) that have the potential to induce serious eye damage as well as chemicals not requiring classification for eye irritation or serious eye damage. The in vitro macromolecular test method contains a macromolecular reagent composed of a mixture of proteins, glycoproteins, carbohydrates, lipids and low molecular weight components, that when rehydrated forms a complex macromolecular matrix which mimics the highly ordered structure of the transparent cornea. Corneal opacity is described as the most important driver for classification of eye hazard. Test chemicals producing protein denaturation, unfolding and changes in conformation will lead to the disruption and disaggregation of the highly organised macromolecular reagent matrix, and produce turbidity of the macromolecular reagent. Such phenomena is quantified, by measuring the changes in light scattering (at a wavelength of 405 nm using a spectrometer), which is compared to the standard curve established in parallel by measuring the increase in OD produced by a set of calibration substances.
The present Key Event based Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This Test Guideline is proposed to address the Molecular Initiating Event leading to skin sensitisation, namely protein reactivity, by quantifying the reactivity of test chemicals towards model synthetic peptides or amino acid derivatives containing either lysine or cysteine. This Test Guideline provides three in chemico test methods addressing the same Key Event on the Adverse Outcome Pathway for Skin Sensitisation: (i) the Direct Peptide Reactivity Assay – DPRA, (ii) the Amino Acid Derivative Reactivity Assay – ADRA and (iii) the kinetic Direct Peptide Reactivity Assay – kDPRA. The DPRA and ADRA are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. In contrast, the kDPRA allows discrimination of UN GHS subcategory 1A skin sensitisers from those not categorised as subcategory 1A, i.e. subcategory 1B or no category but does not allow to distinguish sensitisers from non-sensitisers.
The Hyalella azteca Bioconcentration Test (HYBIT) provides a non-vertebrate test for bioconcentration in aquatic environments. The test consists of two phases: the exposure (uptake) and post-exposure (depuration) phases. During the uptake phase, a group of H. azteca is exposed to the test chemical at one or more chosen concentrations. They are then transferred to a medium free of the test chemical for the depuration phase. The concentration of the test chemical in the analysed H. azteca is followed through both phases of the test. Parameters which characterise the bioaccumulation potential include the uptake rate constant (k1), the depuration rate constant (k2), the steady-state bioconcentration factor (BCFSS) and the kinetic bioconcentration factor (BCFK).
This Test Guideline describes an in vitro procedure the identification on its own of chemicals (substances and mixtures) not requiring classification (No Cat), requiring classification for eye irritation (Cat 2) and requiring classification for serious eye damage (Cat 1) according to the UN GHS ocular hazard categories. It makes use of reconstructed human cornea-like epithelium (RhCE) which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium. The test evaluates the ability of a test chemical to induce cytotoxicity in a RhCE tissue construct, as measured by the MTT assay. RhCE tissue viability following exposure to a test chemical is measured by enzymatic conversion of the vital dye MTT by the viable cells of the tissue into a blue MTT formazan salt that is quantitatively measured after extraction from tissues. Cytotoxicity is measured at different time points of exposure; this is one of the methodological differences with the original TG 492.
This Performance-Based Test Guideline (PBTG) describes in vitro assays, which provide the methodology for human recombinant in vitro assays to detect substances with estrogen receptor binding affinity (hrER binding assays). It comprises two mechanistically and functionally similar test methods for the identification of estrogen receptor (i.e. ERα) binders and should facilitate the development of new similar or modified test methods. The two reference test methods that provide the basis for this PBTG are: the Freyberger-Wilson (FW) In Vitro Estrogen Receptor (ER) Binding Assay Using a Full Length Human Recombinant ERα, and the Chemical Evaluation and Research Institute (CERI) In Vitro Estrogen Receptor Binding Assay Using a Human Recombinant Ligand Binding Domain Protein. This assay measures the ability of a radiolabeled ligand ([3H]17β-estradiol) to bind with the ER in the presence of increasing concentrations of a test chemical (i.e. competitor). Test chemicals that possess a high affinity for the ER compete with the radiolabeled ligand at a lower concentration as compared with those chemicals with lower affinity for the receptor. This assay consists of two major components: a saturation binding experiment to characterise receptor-ligand interaction parameters and document ER specificity, followed by a competitive binding experiment that characterises the competition between a test chemical and a radiolabeled ligand for binding to the ER. These test methods are being proposed for screening and prioritisation purposes, but also provide mechanistic information that can be used in a weight of evidence approach.
This Test Guideline describes a Rapid Estrogen ACTivity In Vivo (REACTIV) Assay in an aquatic assay that utilises transgenic Oryzias latipes (Japanese medaka) eleutheroembryos at day post hatch zero, in a multi-well plate format to identify chemicals active on the estrogen axis. The REACTIV assay was designed as a screening assay to provide a medium throughput and short-term assay to measure the response of eleutheroembryos to chemicals potentially active on the estrogen axis.
Given the important role of strategic foresight in policymaking and resilience, the Government of Flanders has been taking steps to improve its capabilities in this area. This report outlines the main findings and recommendations of the OECD assessment of the strategic foresight system of the Government of Flanders. It includes a blueprint and roadmap for incorporating strategic foresight into the public administration of Flanders over the next five years.
This report looks back at 15 years of tax and development work at the OECD charting the evolution of the OECD’s engagement with, and inclusion of, developing countries in its tax work from 2009 to 2024. Beginning with the restructuring of the Global Forum on Transparency and Exchange of Information for Tax Purposes in 2009, through the BEPS Actions, the establishment of the Inclusive Framework on BEPS and negotiations on the Two Pillar Solution to Address the Tax Challenges of the Digitalising Economy, it shows how OECD initiatives have combined the momentum for multilateral tax co-operation with the increased focus on taxation in international development, to develop a range of tools, instruments and forums with wide participation from developing counties. Accompanying the move to multilateralism in tax matters, the OECD has also sought to increase the availability of data on taxation, for example through the Global Revenue Statistics Database, and support more integrated tax and development policy thinking, for example on the taxation of development assistance. Concurrently there has been a continuous growth in the OECD capacity building activities, now reaching over 30,000 officials in over 100 countries annually. Notable among these initiatives is the groundbreaking joint OECD/UNDP Tax Inspectors Without Borders initiative. The report features several case studies highlighting the impacts across various countries, as well as the wide range of partnerships forged by the OECD to harness taxation’s potential in advancing sustainable development.
The transport sector currently faces a number of disruptions related to geopolitics, climate change and energy security. Transport system resilience refers to the sector’s capacity to deal with, adapt to and recover from such disruptions. This report sets out the main disruptions to transport systems worldwide. It explores ways to reduce uncertainty by assessing vulnerabilities, and the main mitigation and adaptation measures required to ensure transport systems function in times of crisis.
Violence against women (VAW) and girls exists in all countries and across all socio-economic groups, with around one in three women experiencing sexual and physical violence in their lifetime worldwide. This issue was exacerbated by the COVID-19 pandemic, intensifying the need for urgent action to eradicate it. Many governments, including in the MENA region, have enacted policies and programmes to tackle VAW. However, limited strategic planning, long-term investment in services, and co-ordinated responses among public institutions and actors involved in the implementation of VAW strategies have made it difficult to break the VAW cycle. Drawing on data collected through the 2022 OECD Survey on Strengthening Governance and Victim/survivor-centric Approaches to end Violence Against Women in MENA Countries, this report provides an overview of MENA countries’ efforts to develop whole-of-government VAW responses, especially during the COVID-19 pandemic and with a view to help anticipate future crises. It assesses the gaps that hinder progress towards achieving lives free from violence for all women and girls and provides recommendations to enhance the efficiency and effectiveness of the policy and institutional frameworks across MENA countries in addressing VAW.
Lobbying and influence activities are legitimate acts of democratic participation and enable different groups to provide input and expertise to the policymaking process. This report looks at Chile’s existing framework to ensure equity, integrity and transparency in public decision-making processes, and assesses its resilience to the risks of undue influence by special interest groups. The report also explores how to improve transparency and facilitate the disclosure of lobbying and influence activities. Finally, it discusses complementary reforms of the legal framework on integrity and transparency that could help strengthen the lobbying framework.
This report looks back at TIWB’s achievements from July 2022 to December 2023. Chapter 1 describes TIWB in the evolving international taxation and development context. Chapter 2 discusses TIWB programmes and operations. Chapter 3 provides information on current and future areas of TIWB technical assistance. Chapter 4 highlights results obtained over the past year. Chapter 5 describes TIWB participation at international events and the initiative’s communication efforts. Finally, Chapter 6 sets out the work plan for the year and provides an overview of the previous year’s objectives and performance.
Since joining the EU in 2013, Croatia’s macroeconomic performance has improved significantly. At the same time, large demographic and socio-economic disparities across Croatian regions persist. These trends provide the backdrop against which Croatia has reformed its legislative and strategic planning framework for regional development. Such reforms culminated in the adoption of the National Development Strategy 2030, which includes balanced regional development among its main long-term objectives. They have also led to the creation of regional development agencies, and the design of development plans at the county and local levels.
This report assesses the extent to which Croatia’s multi-level governance system is supporting its regional development objectives. In particular, it provides an overview of the country’s regional development performance on several demographic, economic and well-being indicators. From there, it considers how the regional development reforms adopted since 2014 affect the ability of national and subnational governments to design, implement, fund, monitor and evaluate place-based regional development plans. Finally, this report provides practical recommendations to help national and subnational policy makers develop and implement strategic frameworks to meet their territorial development objectives and deliver tangible results to communities across the country.
A key part of the OECD/G20 BEPS Project is addressing the tax challenges arising from the digitalisation of the economy. In October 2021, over 135 jurisdictions joined a ground-breaking plan to update key elements of the international tax system which is no longer fit for purpose in a globalised and digitalised economy. The Global Anti-Base Erosion (GloBE) Rules are a key component of this plan and ensure large multinational enterprise pay a minimum level of tax on the income arising in each of the jurisdictions where they operate. More specifically, the GloBE Rules provide for a co-ordinated system of taxation that imposes a top-up tax on profits arising in a jurisdiction whenever the effective tax rate, determined on a jurisdictional basis, is below the minimum rate. The Commentary to the GloBE Rules was originally released by the Inclusive Framework in March 2022. The Commentary explains the intended outcomes under the GloBE Rules, clarifies the meaning of certain terms and illustrates the application of the rules to certain fact patterns. This Consolidated Commentary incorporates Agreed Administrative Guidance that has been released by the Inclusive Framework since March 2022 up until December 2023. It provides tax administrations and taxpayers with guidance on the interpretation and application of the GloBE Rules in order to promote a consistent and common interpretation and application of those that will facilitate coordinated outcomes for both tax administrations and MNE Groups.
This annual publication provides details of taxes paid on wages in OECD countries. This year’s edition focuses on fiscal incentives for second earners in the OECD and how tax policy might contribute to gender gaps in labour market outcomes. For the year 2023, the report also examines personal income taxes and social security contributions paid by employees, social security contributions and payroll taxes paid by employers, and cash benefits received by workers. It illustrates how these taxes and benefits are calculated in each member country and examines how they impact household incomes. The results also enable quantitative cross-country comparisons of labour cost levels and the overall tax and benefit position of single persons and families on different levels of earnings. The publication shows average and marginal effective tax rates on labour costs for eight different household types, which vary by income level and household composition (single persons, single parents, one or two earner couples with or without children). The average tax rates measure the part of gross wage earnings or labour costs taken in tax and social security contributions, both before and after cash benefits, and the marginal tax rates the part of a small increase of gross earnings or labour costs that is paid in these levies.
The blue economy is a major driver of urban and regional development, creating millions of local jobs in water-dependent sectors such as fisheries, tourism, and shipping. However, it can also contribute to carbon emissions and ecosystem degradation, while its reliance on freshwater, coastal and marine ecosystems exposes it to the impacts of climate change. As the places where the blue economy takes place, creates value and provides jobs, cities and regions play a key role in unlocking the potential of a resilient blue economy that preserves the ecosystems that sustain it. Building on a global survey of 80+ cities, regions and basins, this report highlights the costs and benefits of the blue economy at subnational level, shedding light on the link between the blue economy and water security. This analysis provides an overview of the multi-level governance of the blue economy and related gaps. It calls on cities and regions to develop resilient, inclusive, sustainable and circular (RISC-proof) blue economies by establishing the right governance conditions related to policy making, policy coherence and policy implementation. The report concludes with a RISC Assessment Framework that offers a self-evaluation tool for subnational governments.
Ireland has shown a strong commitment to addressing child poverty and improving outcomes for children and young people. Responding to the needs of children and young people, particularly those most vulnerable, requires integrated policies and services. This report is part of a joint project between the OECD and the European Commission to strengthen policy and governance arrangements for tackling child poverty and improving outcomes for children and young people based on a whole-of-government approach.
The report assesses recent policy, institutional and legislative developments in Ireland and compares outcomes for children and young people with those in other EU and OECD countries. It finds that despite progress, Ireland still has room for improvement on child poverty reduction, and more can be done to address the trust gap between young people in Ireland and their government. The report recommends Ireland to adopt measures to enhance inter-departmental and inter-agency co-operation, strengthen evidence-informed approaches, reinforce policy monitoring tools, and improve accountability mechanisms. It also recommends measures to support the effective implementation of Young Ireland, the National Policy Framework for Children and Young People (2023-28), and to ensure policy coherence.