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  • 18-February-2019

    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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  • 13-February-2019

    English

    Mutual Acceptance of Data (MAD)

    The OECD has developed the Mutual Acceptance of Data (MAD), a multilateral agreement which allows participating countries (including non members) to share the results of various non-clinical tests done on chemicals using OECD methods and principles. MAD reduces duplicative testing, allows governments to work together when assessing chemicals, and saves government and industry resources.

  • 30-January-2019

    English

    Substitution of hazardous chemicals

    The first report is a synthesis from a Workshop on Approaches to Support Substitution and Alternatives Assessment, which discussed approaches used to support alternative assessments and substitution. The second report is a Cross Country Analysis of Approaches to Support Alternatives Assessment and Substitution of Chemicals of Concern that describes a list of approaches developed across countries and by different stakeholders.

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  • 28-January-2019

    English

    Saving Costs in Chemicals Management - How the OECD Ensures Benefits to Society

    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.
  • 10-December-2018

    English

    Series on Testing and Assessment: Testing for Endocrine Disrupters

    The series on endocrine disrupters provides common tools and guidances for testing the effects of endocrine disrupting chemicals on the oestrogen, androgen and thyroid hormone systems. Using these validated methodologies, regulatory authorities can use internationally harmonised tools to evaluate chemicals of concern for human health and/or the environment as well as testing costs.

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  • 4-September-2018

    English

    Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

    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.

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  • 4-September-2018

    English

    Guidance Document on Good In Vitro Method Practices (GIVIMP)

    GIVIMP aims to reduce the uncertainties in cell and tissue-based in vitro method derived predictions by applying good scientific, technical and quality practices from method development to implementation for regulatory use. Test method developers and test guideline users will find best practices for designing guideline in vitro methods, carrying out safety tests and assuring quality and scientific integrity of the resulting data

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  • 27-June-2018

    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.
  • 27-June-2018

    English

    Test No. 442B: Skin Sensitization - Local Lymph Node Assay: BrdU-ELISA or –FCM

    The Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA) is a non-radioactive modification to the LLNA method for identifying potential skin sensitizing test substances and measuring the proliferation of lymphocytes they induce in the auricular lymph nodes. The method described in mouse  is based on the use of measuring 5-bromo-2-deoxyuridine (BrdU) content, an analogue of thymidine, as an indicator of this proliferation. A minimum of four animals is used per dose group, with a minimum of three concentrations of the test substance, plus a concurrent negative control group and a positive control group. The experimental schedule is during 6 days. Thereafter, the animals are killed and a single cell suspension of lymph node cells (LNC) is prepared. The procedure for preparing the LNC is crucial, in particular for the small lymph nodes in NC animals. Then the BrdU content in DNA of lymphocytes is measured by ELISA using a commercial kit of by Flow Cytometry (FCM). This study includes: measurements (weighing, BrdU) and clinical daily observations. The results are expressed as the Stimulation Index (SI) obtained by calculation from the mean BrdU labelling index. The SI should be ≥1.6 for the ELISA method or ≥2.7 for the FCM method for identifying the test material as a potential skin sensitizer. 
  • 27-June-2018

    English

    Test No. 412: Subacute Inhalation Toxicity: 28-Day Study

    This revised Test Guideline 412 (TG 412) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a limited period of time (28 days), and to provide data for quantitative inhalation risk assessments.  It was updated in 2017 to enable the testing and characterisation of effects of nanomaterials tested.Groups of at least 5 male and 5 female rodents are exposed 6 hours per day for 28 days to a) the test chemical at three or more concentration levels, b) filtered air (negative control), and/or c) the vehicle (vehicle control). Animals are generally exposed 5 days per week but exposure for 7 days per week is also allowed. Males and females are always tested, but they may be exposed at different concentration levels if it is known that one sex is more susceptible to a given test article. This guideline allows the study director the flexibility to include satellite (reversibility) groups, bronchoalveolar lavage (BAL), lung burden (LB) for particles, neurologic tests, and additional clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test chemical.
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