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  • 16-July-2021

    English

    Section 4: Health Effects

    Interested parties are invited to send their comments on the Mammalian Erythrocyte Pig-a Gene Mutation Assay draft Test Guideline on the. Comments should be sent by 16 July 2021.

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  • 18-June-2021

    English

    Draft Guidance and Review Documents/Monographs

    Interested parties are invited to send their comments on the Draft Guidance Document for the Scientific Review of Adverse Outcome Pathways by 18 June 2021.

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  • 17-June-2021

    English

    Test No. 405: Acute Eye Irritation/Corrosion

    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.
  • 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.
  • 10-June-2021

    English

    Series on Testing and Assessment: publications by number

    This Series includes publications related to testing and assessment of chemicals; some of them support the development of OECD Test Guidelines (e.g. validation reports, guidance documents, detailed review papers).

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  • 2-June-2021

    English

    Safety of novel foods and feeds and on the harmonisation of regulatory oversight in biotechnology

    These two documents compile information on activities related to the assessment of the safety of products derived from modern biotechnology, environmental safety (biosafety) and the safety of novel foods and feeds, at the international level between April 2020 and March 2021. The information was provided by OECD Members, partner countries and observer organisations participating in the work.

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  • 1-June-2021

    English

    Chemical Safety and Biosafety Progress Report

    The Chemical Safety and Biosafety Progress Report is released every eight months. Its purpose is to provide an update on the projects, events and activities. Information on new publications as well as dates and venues of upcoming events and meetings are given.

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  • 17-May-2021

    English

    Webinar Series on Testing and Assessment Methodologies

    On 10 May 2021, the OECD presented the recently published Guidance Document on the Characterisation, Validation and Reporting of Physiologically Based Kinetic (PBK) Models for Regulatory Purposes. The webinar introduced the assessment framework for PBK models and the scientific workflow for characterising and validating PBK models. Watch the webinar video recording and access the presentation.

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  • 29-March-2021

    English

    Occupational Biomonitoring

    Occupational Biomonitoring allows to measure internal exposure or effect. It is especially efficient in assessing exposures from multiple routes, i.e. inhalation, oral and dermal exposure pathways. This project is focused on improving methods for deriving health based human biomarker values (BMGV, BLV, DNELbiomarker).

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  • 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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