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Test No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
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ISBN: 9264242848 Year: 2021 Publisher: Paris : OECD Publishing,

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This Test Guideline describes an in vitro procedure that may be used for the hazard identification of irritant chemicals (substances and mixtures) in accordance with the UN Globally Harmonized System of Classification and Labelling (GHS) Category 2.  It is based on reconstructed human epidermis (RhE), which in its overall design closely mimics the biochemical and physiological properties of the upper parts of the human skin. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from tissues. Irritant test substances are identified by their ability to decrease cell viability below defined threshold levels (below or equal to 50% for UN GHS Category 2). Coloured chemicals can also be tested by used of an HPLC procedure. There are three validated test methods that adhere to this Test Guideline. Depending on the regulatory framework and the classification system in use, this procedure may be used to determine the skin irritancy of test substances as a stand-alone replacement test for in vivo skin irritation testing, or as a partial replacement test, within a tiered testing strategy.

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Test No. 405: Acute Eye Irritation/Corrosion
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ISBN: 926418533X Year: 2021 Publisher: Paris : OECD Publishing,

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This method provides information on health hazard likely to arise from exposure to test substance (liquids, solids and aerosols) by application on the eye. This Test Guideline is intended preferably for use with albino rabbit. The test substance is applied in a single dose in the conjunctival sac of one eye of each animal. The other eye, which remains untreated, serves as a control. The initial test uses an animal; the dose level depends on the test substance nature. A confirmatory test should be made if a corrosive effect is not observed in the initial test, the irritant or negative response should be confirmed using up to two additional animals. It is recommended that it be conducted in a sequential manner in one animal at a time, rather than exposing the two additional animals simultaneously. The duration of the observation period should be sufficient to evaluate fully the magnitude and reversibility of the effects observed. The eyes should be examined at 1, 24, 48, and 72 hours after test substance application. The ocular irritation scores should be evaluated in conjunction with the nature and severity of lesions, and their reversibility or lack of reversibility. Use of topical anesthetics and systemic analgesics to avoid or minimize pain and distress in ocular safety testing procedures is described.

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Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists
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ISBN: 9264265295 Year: 2021 Publisher: Paris : OECD Publishing,

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This Performance-Based Test Guideline (PBTG) describes in vitro assays, which provide the methodology of Stably Transfected Transactivation to detect Estrogen Receptor Agonists and Antagonists (ER TA assays). It comprises mechanistically and functionally similar test methods for the identification of estrogen receptor agonists and antagonists 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 Stably Transfected TA (STTA) assay using the (h) ERα-HeLa-9903 cell line, derived from a human cervical tumor, and the BG1Luc ER TA assay using the BG1Luc-4E2 cell line, derived from a human ovarian adenocarcinoma. The cell lines used in these assays express ER and have been stably transfected with an ER responsive luciferase reporter gene. The assays are used to identify chemicals that activate (i.e. act as agonists) and also suppress (i.e. act as antagonists) ER- dependent transcription. ER are activated following ligand binding, after which the receptor-ligand complex binds to specific DNA response elements and transactivates the reporter gene, resulting in increased cellular expression of a marker enzyme (e.g. luciferase in luciferase based systems). The enzyme then transforms the substrate to a bioluminescent product that can be quantitatively measured with a luminometer. 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.

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Essai n° 509 : Essais au champ de plantes cultivées
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ISBN: 9264076476 Year: 2021 Publisher: Paris : OECD Publishing,

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Les essais au champ de plantes cultivées ont pour objet de déterminer la quantité de résidus de pesticides présents sur ou dans les produits agricoles bruts, y compris dans les aliments pour animaux. Ils doivent pouvoir mettre en évidence les modes d’utilisation des pesticides qui conduisent à la teneur en résidus maximale. Les essais au champ visent à (1) quantifier la teneur en résidu(s) à laquelle s’attendre après un traitement conforme aux bonnes pratiques agricoles en vigueur ou proposées; (2) déterminer, le cas échéant, le taux de dissipation du ou des résidus de produits phytosanitaires dans les cultures considérées; (3) déterminer des paramètres telles que la « valeur médiane des résidus en essais contrôlés » ou la « valeur de résidu la plus élevée », afin d’évaluer les risques alimentaires; enfin, (4) en déduire les limites maximales de résidus (LMR). La présente ligne directrice pour les essais au champ de plantes cultivées exige un échantillon provenant de parcelles traitées à chaque intervalle d’échantillonnage pour les cultures qui font l’objet de huit essais ou plus. La ou les substances d’essai sont stockées dans des conditions adaptées pendant la durée de l’étude et appliquées rapidement après leur préparation ou leur mélange. La substance d’essai n’est pas appliquée en cas de fort vent, de pluie, ou si des précipitations sont attendues peu après l’application. Pour chaque traitement, le taux d’application est exprimé en quantité de produit et/ou d’ingrédient actif par unité de surface. A la fin de chaque essai au champ de plantes cultivées, les échantillons (entreposés) sont analysés pour mesurer leur teneur en résidu (exprimée par example en mg/kg).

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Essai n° 406: Sensibilisation de la peau
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ISBN: 9264070672 Year: 2021 Publisher: Paris : OECD Publishing,

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Cette méthode fournit des informations sur les dangers pour la santé qui peuvent résulter d’une exposition à une substance d’essai par injection intradermique et/ou une application épidermique. Dans cette Ligne directrice, les méthodes préférées sont le test de maximisation chez le cobaye (GPMT) de Magnusson et Kligman, qui utilise un adjuvant, et le test de Buehler (sans adjuvant). Cette Ligne directrice utilise principalement des cobayes, mais récemment des modèles de souris ont été développés pour évaluer le potentiel de sensibilisation. Pour le GPMT, au moins 10 animaux pour le groupe traité et 5 pour le contrôle doivent être utilisés. Pour le test de Buehler, 20 animaux minimum sont employés dans le groupe traité et au moins 10 pour le contrôle. Les animaux testés sont premièrement exposés à la substance d’essai. Après une période de repos, la période d’induction (10-14 jours), pendant laquelle une réponse immunitaire peut être développée, les animaux sont exposés à une dose déclenchante. Le GPMT dure environ 23-25 jours, le test de Buehler pendant environ 30-32 jours. La concentration de la substance d’essai employée pour chaque induction doit être systématiquement bien tolérée et doit être la plus élevée à causer une irritation moyenne à modérée de la peau ; pour la dose déclenchante la dose non irritante la plus élevée doit être employée. Toutes les réactions cutanées et les résultats inhabituels doivent être observés et notés (d'autres procédures peuvent suivre pour clarifier des réactions douteuses).

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Customisation Opportunities of IUCLID for the Management of Chemical Data - 2nd edition
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ISBN: 926488338X Year: 2021 Publisher: Paris : OECD Publishing,

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IUCLID (International Uniform Chemical Information Database) is a software application designed to record, store, maintain and exchange data on chemicals. It is a key software application for both regulatory bodies and the chemical industry where it is used in the implementation of various regulatory programmes. IUCLID can be customised and configured to manage chemical data in different contexts and is a platform employing globally harmonised data elements pertinent to chemicals. It is continuously updated to provide greater customisation, extension and integration with other tools. This second edition provides the latest updates on IUCLID features and processes, including visual "working" contexts for the preparation and management of data according to regulatory contexts or data processes, possibilities for data entry in multiple languages, and a matrix view of the use of IUCLID in OECD countries.

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Use of aqueous film-forming foams in firefighting
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ISBN: 9264837159 Year: 2021 Publisher: Paris : OECD Publishing,

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This OECD Emission Scenario Document (ESD) is intended to provide information on the sources, use patterns, and potential release and exposure pathways of non-volatile chemicals used in Aqueous Film-Forming Foams (AFFFs) in firefighting applications. The document presents standard approaches for estimating the environmental releases of and occupational exposures to chemicals used in AFFF.

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A Chemicals Perspective on Designing with Sustainable Plastics : Goals, Considerations and Trade-offs
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ISBN: 9264375511 Year: 2021 Publisher: Paris : OECD Publishing,

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The development of plastic products does not systematically take sustainability, particularly from a chemicals perspective, into account. This report seeks to enable the creation of inherently sustainable plastic products by integrating sustainable chemistry thinking in the design process. By applying a chemicals lens during the plastic material selection process, designers and engineers can make informed decisions to incorporate sustainable plastic during the conceptualisation phase of their products. The report provides an integrated approach to sustainable plastic selection from a chemicals perspective, and identifies a set of generalisable sustainable design goals, life cycle considerations and trade-offs. At a more granular level, considerations are identified for each life-cycle phase, which are brought together as a whole-product assessment and optimisation taking the full life cycle into account. The report also considers trade-offs that will need to be carefully balanced in the design phase and reflection on implications of design choices. Ultimately, the report helps to equip designers and engineers with knowledge of relevant chemical considerations when selecting sustainable plastic, supporting better outcomes and a more transparent process.

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Observateur annuel de l'action climatique : Aider les pays à progresser vers le zéro net
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Year: 2021 Publisher: Paris, France : Organisation for Economic Co-operation and Development Publishing,

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Observateur annuel de l'action climatique : Aider les pays à progresser vers le zéro net
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Year: 2021 Publisher: Paris, France : Organisation for Economic Co-operation and Development Publishing,

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