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  • 28-July-2015

    English

    Test No. 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test

    This screening Test Guideline describes the effects of a test chemical on male and female reproductive performance. It has been updated with endocrine disruptor endpoints, in particular measure of anogenital distance and male nipple retention in pups and thyroid examination. The test substance is administered in graduated doses to several groups of males and females. Males should be dosed for a minimum of four weeks. Females should be dosed throughout the study, so approximately 63 days. Matings 'one male to one female' should normally be used in this study. This Test Guideline is designed for use with the rat. It is recommended that each group be started with at least 10 animals of each sex. Generally, at least three test groups and a control group should be used. Dose levels may be based on information from acute toxicity tests or on results from repeated dose studies. The test substance is administered orally and daily. The results of this study include clinical observations, body weight and food/water consumption, oestrous cycle monitoring, offspring parameters observation/measurement, thyroid hormone measurement, as well as gross necropsy and histopathology. The findings of this toxicity study should be evaluated in terms of the observed effects, necropsy and microscopic findings. Because of the short period of treatment of the male, the histopathology of the testis and epididymus should be considered along with the fertility data, when assessing male reproductive effects.

  • 28-July-2015

    English

    Test No. 483: Mammalian Spermatogonial Chromosomal Aberration Test

    This test measures structural chromosomal aberrations (both chromosome- and chromatid-type) in dividing spermatogonial germ cells and is, therefore, expected to be predictive of induction of heritable mutations in these germ cells. The purpose of the in vivo mammalian spermatogonial chromosomal aberration test is to identify those chemicals that cause structural chromosomal aberrations in mammalian spermatogonial cells (1) (2) (3). In addition, this test is relevant to assessing genetoxicity because, although they may vary among species, factors of in vivo metabolism, pharmacokinetics and DNA-repair processes are active and contribute to the response. The original Test Guideline 483 was adopted in 1997. This modified version of the Test Guideline reflects many years of experience with this assay and the potential for integrating or combining this test with other toxicity or genotoxicity studies.

  • 28-July-2015

    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.

  • 15-June-2015

    English, PDF, 184kb

    Draft Updated Test Guideline 232: Collembolan Reproduction Test in Soil

    This Test Guideline is designed for assessing the effects of chemicals on the reproductive output of the collembolans in soil. It is based on existing procedures (1) (2). The parthenogenetic Folsomia candida and sexually reproducing Folsomia fimetaria are two of the most accessible species of Collembola, and they are culturable and commercially available.

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  • 16-February-2015

    English

    Expansion of Brazil's scope under OECD agreement on mutual acceptance of chemical safety data

    In 2011, Brazil joined OECD’s Mutual Acceptance of Data (MAD) system ensuring that its chemical safety test data will be accepted by all 40 countries adhering to MAD. Originally limited to data developed in Brazil on pesticides, biocides and industrial chemicals, it now also includes veterinary products, feed additives, cosmetics, pharmaceutical products, sanitizers, wood preservative and treatments of effluents and natural ecosystems.

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  • 6-February-2015

    English

    Launch of 2 OECD Test Guidelines on human hazard endpoint skin sensitisation

    The OECD has just published two new Test Guidelines on human health hazard endpoint 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).

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  • 5-February-2015

    English

    Test No. 442C: In Chemico Skin Sensitisation - Direct Peptide Reactivity Assay (DPRA)

    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.

  • 13-January-2015

    English

    More about OECD Test Guidelines

    This page explains the background to the OECD Test Guidelines, the reason for their development, their applicability and how they can be accessed.

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  • 18-December-2014

    English

    Guidance Document for Describing Non-Guideline In Vitro Test Methods

    This guidance is intended to harmonise the way non-guideline in vitro test methods are described. This should in future facilitate an assessment of the relevance of test methods for biological activities and responses of interest, of the quality of data produced, irrespective of whether these tests are based on manual protocols or assay protocols adapted for use on automated platforms or high-throughput screening systems (HTS).

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  • 26-September-2014

    English, PDF, 293kb

    OECD Guidance on the GLP Requirements for Peer Review of Histopathology

    This advisory document provides guidance on how pathology peer reviews should be planned, conducted and reported within the context of OECD Good Laboratory Practice.

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