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  • 24 Jul 2023
  • OECD
  • Pages: 432

EU Funded Note

Low-emission hydrogen is expected to play an important role in the energy transition to tackle the climate crisis. It can decarbonate “hard-to-abate” sectors still relying on fossil fuels, turn low-carbon electricity into a fuel that can be transported using pipelines and provide a green transport alternative, in particular for heavy-duty and long-distance transport. Given its potential to combat climate change, it can allow for a net reduction in societal risks if managed responsibly. However, while its potential is widely acknowledged, its application is not yet meeting ambitions. Regulation is crucial to facilitate its application and ensure its safety. This report analyses trends, risks, and regulation of hydrogen technologies across economies. It supports the use of low-emission hydrogen as part of the energy transition, by making recommendations for effective risk-based regulation, regulatory delivery and governance.

  • 18 Jul 2023
  • OECD
  • Pages: 204

What are the root causes of gender inequality? Building on the fifth edition of the Social Institutions and Gender Index (SIGI), the SIGI 2023 Global Report provides a global outlook of discriminatory social institutions, the fundamental causes of gender inequality. It reveals how formal and informal laws, social norms and practices limit women’s and girls’ rights and opportunities in all aspects of their lives. Globally, 40% of them continue to live in countries where gender-based discrimination is assessed as high or very high.

The report stresses how discriminatory social institutions curtail women’s and adolescents’ fundamental access to sexual and reproductive health and rights. It also sheds light on the gendered impacts of climate change and underlines how women can play a pivotal role in climate change mitigation and adaptation. To accelerate efforts aimed at achieving SDG 5 and eliminating the underlying and structural factors that hamper women’s empowerment, the report offers concrete policy actions. It calls for a gender-transformative approach to leverage crises and challenges into windows of opportunity to establish women and men as agents of change.

  • 07 Jul 2023
  • African Union Commission, OECD
  • Pages: 252

Africa’s Development Dynamics uses lessons from Central, East, North, Southern and West Africa to develop policy recommendations and share good practices across the continent. Drawing on the most recent statistics, the analysis of development dynamics aims to assist African leaders in reaching the targets of the African Union’s Agenda 2063 at all levels: continental, regional, national and local.

This edition explores how Africa can attract investments that offer the best balance between economic, social and environmental objectives. Its fresh data and analysis aim to help policy makers improve risk assessments, strengthen African-led partnerships, and accelerate regional integration in ways that increase sustainable investments. Two continental chapters examine Africa’s investment landscape and related policy priorities. Five regional chapters offer tailored recommendations in strategic areas including natural ecosystems, renewable energy, climate finance and agri-food value chains.

Africa’s Development Dynamics feeds into a policy debate between the African Union’s governments, citizens, entrepreneurs and researchers. It proposes a new collaboration between countries and regions, focusing on mutual learning and the preservation of common goods. This report results from a partnership between the African Union Commission and the OECD Development Centre.

Portuguese, Italian, French
  • 07 Jul 2023
  • African Union Commission, OECD
  • Pages: 274

La publication Dynamiques du développement en Afrique tire les leçons des expériences des cinq régions du continent – Afrique australe, centrale, de l’Est, du Nord et de l’Ouest – pour élaborer des recommandations en matière de politiques publiques et partager les bonnes pratiques sur l’ensemble du continent. Étayé par les statistiques les plus récentes, son décryptage des dynamiques de développement vise à permettre aux leaders africains de réaliser la vision stratégique de l’Agenda 2063 à tous les niveaux : continental, régional, national et local.

Cette édition explore les différentes manières dont l'Afrique peut attirer les investissements offrant le meilleur équilibre entre ses objectifs économiques, sociaux et environnementaux. Ses nouvelles données et analyses sont mises à la disposition des décideurs dans le but d’améliorer l’évaluation des risques, de renforcer les partenariats pilotés par les Africains et d’accélérer l'intégration régionale de manière à accroître les investissements durables. Deux chapitres dressent l’état des lieux des investissements en Afrique et les priorités connexes en matière de politiques publiques. Les cinq autres chapitres proposent des recommandations adaptées à chaque région dans des domaines stratégiques tels que les écosystèmes naturels, les énergies renouvelables, la finance climatique et les chaînes de valeur agroalimentaires.

Cette publication entend nourrir le débat entre gouvernements de l’Union africaine, citoyens, entrepreneurs et chercheurs. Fruit de la collaboration entre la Commission de l’Union africaine et le Centre de développement de l’OCDE, elle propose une nouvelle coopération entre pays et régions, tournée vers l’apprentissage mutuel et la préservation des biens communs.

Italian, English, Portuguese

Located in the mid-Atlantic, the archipelagos of the Azores is an autonomous region of Portugal and an European Union Outermost Region. Once central to global trade routes, the Azores are aspiring to regain a prominent international role by leveraging their unique geographical, natural and historical attributes. To that end, this Production Transformation Policy Review (PTPR) Spotlight identifies priority actions in several areas, including scientific research and collaborations, the ocean economy, agro-food and renewable-energy value chains. It shows the importance for EU Outermost Regions, as well as for Small Island Developing States (SIDS), of building resilient international ties. It benefited from an extensive peer review process involving public and private stakeholders from Brazil, Iceland and the United States.

Environment at a Glance in Latin America and the Caribbean: Spotlight on Climate Change focusses on climate change, looking at trends in greenhouse gas emissions, exposure to climate-related hazards and climate policies. It provides key messages on past progress and remaining efforts to be made in Latin America and the Caribbean. The report draws on the OECD’s expertise in environmental data and indicators, on the work of the International Programme for Action on Climate (IPAC) and is part of the OECD Latin America and the Caribbean Regional Programme. The indicators presented come from OECD and other international databases, and reveal substantive gaps in the availability of data on the environment and climate in the region. This interactive report allows users to play with the data and graphics and to download and share them.

  • 04 Jul 2023
  • OECD
  • Pages: 53

A Defined Approach (DA) consists of a selection of information sources (e.g in silico predictions, in chemico, in vitro data) used in a specific combination, and resulting data are interpreted using a fixed data interpretation procedure (DIP) (e.g. a mathematical, rule-based model). DAs use methods in combination and are intended to overcome some limitations of the individual, stand-alone methods. The first three DAs included in this Guideline use combinations of OECD validated in chemico and in vitro test data, in some cases along with in silico information, to come to a rules-based conclusion on potential dermal sensitisation hazard. The DAs included in this Guideline have shown to either provide the same level of information or be more informative than the murine Local Lymph Node Assay (LLNA; OECD TG 429) for hazard identification (i.e. sensitiser versus non-sensitiser). In addition, two of the DAs provide information for sensitisation potency categorisation that is equivalent to the potency categorisation information provided by the LLNA.

French

Une approche définie (AD) est un ensemble défini de sources d’information (p. ex. prédiction in silico, des données in chemico ou in vitro) utilisées en une combinaison spécifique, dont les résultats sont interprétés selon une procédure établie d’interprétation des données (modèle mathématique ou approche fondée sur des règles, par exemple). Les ADs utilisent des combinaisons de méthodes dans le but de compenser certaines des limites de chacune de ces méthodes lorsqu’elles sont appliquées seules. Les trois premières ADs couvertes par la présente Ligne directrice utilisent des combinaisons de données d’essais in vitro et in chemico validés par l’OCDE, dans certains cas accompgnées d’information in silico, pour arriver à une conclusion basée sur une procédure établie d’interprétation des données concernant le danger potentiel de sensibilisation cutanée. Les ADs comprises sans la présente Ligne directrice ont démontré qu’elles pouvaient générer des informations similaires ou être plus informatives que l’Essai de stimulation locale des ganglions lymphatique (OCDE LD 429) pour l’identificaiton des dangers (c.à.d. sensibilisant versus non sensibilisant). Par ailleurs, deux des ADs fournissent des informations sur la catégorisation de la puissance sensibilisante qui est équivalente à la l’information de catégorisation de la puissance fournie par l’Essai de stimulation locale des ganglions lymphatique.

English

The present 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 provides an in chemico procedure (Direct Peptide Reactivity Assay – DPRA) used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS.

The DPRA is proposed to address the molecular initiating event leading to the skin sensitisation, namely protein reactivity, by quantifying the reactivity of test chemicals towards model synthetic peptides containing either lysine or cysteine. Cysteine and lysine percent peptide depletion values are then calculated and used in a prediction model to categorise a substance in one of four classes of reactivity for supporting the discrimination between skin sensitisers and non-sensitisers.

French
  • 04 Jul 2023
  • OECD
  • Pages: 28

This Test Guideline (TG) describes the IL-2 Luc Assay test method to evaluate the potential immunotoxic effects of chemicals on T lymphoblastic cell line. This cell line allows quantitative measurement of luciferase gene induction by detecting luminescence from well-established light producing luciferase substrates as indicators of the activity of IL-2, IFN-γ and GAPDH in cells following exposure to immunotoxic chemicals. The method is intended to be used as a part of a battery to determine immunotoxic potential of chemicals.

French
  • 04 Jul 2023
  • OECD
  • Pages: 30

The in vitro micronucleus test is a genotoxicity test for the detection of micronuclei in the cytoplasm of interphase cells. Micronuclei may originate from acentric chromosome fragments (i.e. lacking a centromere), or whole chromosomes that are unable to migrate to the poles during the anaphase stage of cell division. The assay detects the activity of clastogenic and aneugenic test substances in cells that have undergone cell division during or after exposure to the test substance. This Test Guideline allows the use of protocols with and without the actin polymerisation inhibitor cytochalasin B. Cytochalasin B allows for the identification and selective analysis of micronucleus frequency in cells that have completed one mitosis, because such cells are binucleate. This Test Guideline also allows the use of protocols without cytokinesis block provided there is evidence that the cell population analysed has undergone mitosis.   

French

This Test Guideline describes in vitro assays, which use Androgen Receptor TransActivation (ARTA) to detect Androgen Receptor Agonists and Antagonists. The ARTA assay methods are mechanistically and functionally similar test methods that provide information on the transcription and translation of a reporter gene following the binding of a chemical to the androgen receptor and subsequent transactivation. The cell lines used in these assays express AR and have been stably transfected with an AR-responsive luciferase reporter gene, and are used to identify chemicals that activate (i.e. act as agonist) or inhibit (i.e. act as antagonists) AR-dependent transcription. Some chemicals may, in a cell type-dependent manner, display both agonist and antagonist activity and are known as selective AR modulators. The AR is activated following ligand binding, after which the receptor-ligand complex binds to specific DNA responsive elements and transactivates the receptor gene, resulting in an increase cellular expression of the luciferase enzyme. The enzyme then transforms the substrate to a bioluminescent product that can be quantitatively measured with a luminometer. This Test Guideline includes ARTA assays using the AR-EcoScreenTM cell line, the AR-CALUX® cell line, and 22Rv1/MMTV_GR-KO cell line.

French

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.

French

The present Key Event based Test Guideline (TG) addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. More specifically, it addresses the activation of dendritic cells, which is one Key Event on the Adverse Outcome Pathway (AOP) for Skin Sensitisation. 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 TG provides three in vitro test methods addressing the same Key Event on the AOP: (i) the human cell Line Activation Test or h-CLAT method, (ii) the U937 Cell Line Activation Test or U-SENS and (iii) the Interleukin-8 Reporter Gene Assay or IL-8 Luc assay. All of them are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. Test methods described in this TG either quantify the change in the expression of cell surface marker(s) associated with the process of activation of monocytes and DC following exposure to sensitisers (e.g. CD54, CD86) or the changes in IL-8 expression, a cytokine associated with the activation of DC. In the h-CLAT and U-SENS assays, the changes of surface marker expression are measured by flow cytometry following cell staining with fluorochrome-tagged antibodies. In the IL-8 Luc assay, the changes in IL-8 expression are measured indirectly via the activity of a luciferase gene under the control of the IL-8 promoter. The relative fluorescence or luminescence intensity of the treated cells compared to solvent/vehicle control are calculated and used in the prediction model, to support the discrimination between sensitisers and non-sensitisers.

French

This Test Guideline describes an in vitro procedure allowing the identification of chemicals (substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage in accordance with UN GHS. 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. Coloured chemicals can also be tested by used of an HPLC procedure. 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. The viability of the RhCE tissue is determined in comparison to tissues treated with the negative control substance (% viability), and is then used to predict the eye hazard potential of the test chemical. Chemicals not requiring classification and labelling according to UN GHS are identified as those that do not decrease tissue viability below a defined threshold (i.e., tissue viability > 60%, for UN GHS No Category).

French

This Test Guideline describes an in vitro assay that may be used for identifying water soluble ocular corrosives and severe irritants as defined by the UN Globally Harmonized System of Classification and Labelling, Category 1. The assay is performed in a well where a confluent monolayer of Madin-Darby Canine Kidney (MDCK) is used as a separation between two chambers. It uses a fluorescein dye as marqueur. The test substance has the potential to impair the junctions of the MDCK cells and thus to increase the monolayer¡¯s permeability. Consequently the fluorescein passes through the monolayer and the fluorescein leakage (FL) increases. The FL is calculated as a percentage of leakage relative to both a blank control and a maximum leakage control. The concentration of test substance that causes 20% FL (FL20, in mg/mL) is calculated and used in the prediction model for identification of ocular corrosive and severe irritants. The cut-off value of FL20 to identify water soluble chemicals as ocular corrosives/severe irritants is ¡Ü 100mg/mL. The FL test method should be part of a tiered testing strategy.

French

Skin phototoxicity (photoirritation) is defined as an acute toxic response elicited by topically or systemically administered photoreactive chemicals after the exposure of the skin to environmental light. The in vitro reconstructed human epidermis phototoxicity test (RhE PT) is used to identify the phototoxic potential of a test chemical after topical application in reconstructed human epidermis (RhE) tissues in the presence and absence of simulated sunlight. Phototoxicity potential is evaluated by the relative reduction in viability of cells exposed to the test chemical in the presence as compared to the absence of simulated sunlight. Chemicals identified as positive in this test may be phototoxic in vivo following topical application to the skin, eyes, and other external light-exposed epithelia.

French

Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

The Isolated Chicken Eye  (ICE) test method is an in vitro test method that can be used to classify substances as causing serious eye damagae (UN GHS Category 1) or as not requiring classification (UN GHS No catgory). The ICE method uses eyes collected from chickens obtained from slaughterhouses where they are killed for human consumption, thus eliminating the need for laboratory animals. The eye is enucleated and mounted in an eye holder with the cornea positioned horizontally. The test substance and negative/positive controls are applied to the cornea. Toxic effects to the cornea are measured by a qualitative assessment of opacity, a qualitative assessment of damage to epithelium based on fluorescein retention, a quantitative measurement of increased thickness (swelling), and a qualitative evaluation of macroscopic morphological damage to the surface. The endpoints are evaluated separately to generate an ICE class for each endpoint, which are then combined to generate an Irritancy Classification for each test substance. Optionally, histopathology of the eye can be evaluated to improve the predictivity of the test for chemicals causing serious eye damage. 

French

This Test guideline describes studies on phototransformation in water to determine the potential effects of solar irradiation on chemicals in surface water, considering direct photolysis only.

It is designed as a tiered approach. The Tier 1 is based on a theoretical screen. The rate of decline of a test chemical in a direct photolysis study is generally assumed to follow pseudo first-order kinetics. If the maximum possible losses is estimated to be superior or equal to 50% of the initial concentration over a 30-day period, an experimental study is proceeded in Tier 2. The direct photolysis rate constants for test chemicals in the laboratory is determined using preferably a filtered xenon arc lamp capable of simulating natural sunlight in the 290 to 800 nm, or sunlight irradiation, and extrapolated to natural water. If estimated losses are superior or equal to 20%, the transformation pathway and the identities, concentrations, and rate of formation and decline of major transformation products are identified. An optional task is the additional determination of the quantum yield for various types of water bodies, seasons, and latitudes of interest.

The test chemical should be directly dissolved in the aqueous media saturated in air at a concentration which should not exceed half its solubility. For linear and non-linear regressions on the test chemical data in definitive or upper tier tests, the minimum number of samples collected should be 5 and 7 respectively. The exact number of samples and the timing of their collection is determined by a preliminary range-finding. Replicates (at least 2) of each experimental determination of kinetic parameters are recommended to determine variability and reduce uncertainty in their determination.

French

This Test Guideline describes the Medaka Extended One Generation Test (MEOGRT), which exposes fish over multiple generations to give data relevant to ecological hazard and risk assessment of chemicals, including suspected endocrine disrupting chemicals (EDCs).  Exposure in the MEOGRT starts with spawning fish (P or F0 generation) and continues until hatching (until two weeks post fertilization, wpf) in the second (F2) generation. This Test Guideline measures several biological endpoints.  Primary emphasis is given to potential adverse effects on population relevant parameters including survival, gross development, growth and reproduction (fecundity).  Secondarily, in order to provide mechanistic information and provide linkage between results from other kinds of field and laboratory studies, where there is a posteriori evidence for a chemical having potential endocrine disrupter activity (e.g. androgenic or oestrogenic activity in other tests and assays) then other useful information is obtained by measuring vitellogenin (vtg) mRNA (or vitellogenin protein, VTG), phenotypic secondary sex characteristics (SSC) as related to genetic sex, and evaluating histopathology.

French
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