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  • 11-October-2022

    English

    OECD Good Laboratory Practice: Frequently asked questions (FAQ)

    GLP issues raised by testing labs are covered in this comprehensive list of questions and answers, recently updated with questions related to: Test Facility organisation and personnel, Quality Assurance, Equipment and computerized systems, Test items, reference items and samples/specimens (Biologicals, GMOs, etc.), SOPs, Management of the study, Histopathology, Archives and E-Archives and Monitoring Test Facility compliance by GLP CMAs.

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  • 14-September-2022

    English

    Emission Scenario Documents

    This OECD Emission Scenario Document (ESD) is intended to provide information on emissions of metals during primary and secondary smelting and waste incineration, which cover recycling of electrical and electronic waste. It thus aims to derive the relevant emission factors of metals during smelting, waste incineration and from boilers.

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  • 30-June-2022

    English

    Test No. 442D: In Vitro Skin Sensitisation - ARE-Nrf2 Luciferase Test Method

    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 (TG) provides an in vitro procedure (the ARE-Nrf2 luciferase test method) used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. The second key event on the adverse outcome pathway 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. The test method described in this Test Guideline (ARE-Nrf2 luciferase test method) is proposed to address this second key event. The cell line contains the luciferase gene under the transcriptional control of a constitutive promoter fused with an ARE element from a gene that is known to be up-regulated by contact sensitisers. The luciferase signal reflects the activation by sensitisers of endogenous Nrf2 dependent genes. This allows quantitative measurement (by luminescence detection) of luciferase gene induction, using well established light producing luciferase substrates, as an indicator of the activity of the Nrf2 transcription factor in cells following exposure to electrophilic test substances. There are currently two in vitro ARE-Nrf2 luciferase test method covered by this Test Guideline: the KeratinoSensTM test method and the LuSens test method. Performance standards have been developed to enable the validation of similar test methods.
  • 3-May-2022

    English

    Safety Assessment of Transgenic Organisms: OECD Consensus Documents

    The OECD biosafety consensus documents identify elements of scientific information used in the environmental safety and risk assessment of transgenic organisms which are common to OECD member countries.

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  • 16-February-2022

    English

    Risks from Natural Hazards at Hazardous Installations (Natech)

    Natural Hazards Triggering Technological Accidents (Natech) are accidents triggered by the impact of a natural hazard, such as earthquake, flood, or storm, on a hazardous installation, and which involves the release of hazardous substances, fires or explosions. This brochure aims to raise awareness of Natech risks and the challenges associated with their management.

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  • 28-October-2021

    English

    Integrated Approaches to Testing and Assessment (IATA)

    This new case study illustrates an assessment workflow based on various types of non-animal test methods was published in 2021. In addition, an updated document that includes considerations of using methods in IATA was also published following the 6th case study review cycle.

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  • 17-June-2021

    English

    Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists

    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.
  • 2-March-2021

    English, PDF, 2,727kb

    Guidance on Key Considerations for the Identification and Selection of Safer Chemical Alternatives

    As the demand for safer chemicals grows, the field of alternatives assessment is becoming increasingly important in guiding the transition towards safer, less toxic alternatives. A major limitation that can hinder efforts is the lack of consistent criteria for defining “safer" alternatives. This guidance outlines key considerations for the identification and selection of safer alternatives.

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  • 2-March-2021

    English

    Substitution of hazardous chemicals

    As the demand for safer chemicals grows, the field of alternatives assessment is becoming increasingly important in guiding the transition towards safer, less toxic alternatives. A major limitation that can hinder efforts is the lack of consistent criteria for defining “safer" alternatives. This guidance outlines key considerations for the identification and selection of safer alternatives.

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  • 12-November-2020

    English

    OECD Work Related to Endocrine Disrupters

    The OECD has published the Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption 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.

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