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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.

  • 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

    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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  • 26-September-2014

    English

    Test No. 473: In Vitro Mammalian Chromosomal Aberration Test

    The purpose of the in vitro chromosome aberration test is to identify agents that cause structural chromosome aberrations in cultured mammalian somatic cells. Structural aberrations may be of two types: chromosome or chromatid. The in vitro chromosome aberration test may employ cultures of established cell lines, cell strains or primary cell cultures. Cell cultures are exposed to the test substance (liquid or solid) both with and without metabolic activation during about 1.5 normal cell cycle lengths. At least three analysable concentrations of the test substance should be used. At each concentration duplicate cultures should normally be used. At predetermined intervals after exposure of cell cultures to the test substance, the cells are treated with a metaphase-arresting substance, harvested, stained. Metaphase cells are analysed microscopically for the presence of chromosome aberrations.

  • 26-September-2014

    English

    Test No. 474: Mammalian Erythrocyte Micronucleus Test

    The mammalian in vivo micronucleus test is used for the detection of damage induced by the test substance to the chromosomes or the mitotic apparatus of erythroblasts, by analysis of erythrocytes as sampled in bone marrow and/or peripheral blood cells of animals, usually rodents (mice or rats). The purpose of the micronucleus test is to identify substances (liquid or solid) that cause cytogenetic damage which results in the formation of micronuclei containing lagging chromosome fragments or whole chromosomes. An increase in the frequency of micronucleated polychromatic erythrocytes in treated animals is an indication of induced chromosome damage. Animals are exposed to the test substance by an appropriate route (usually by gavage using a stomach tube or a suitable intubation cannula, or by intraperitoneal injection). Bone marrow and/or blood cells are collected, prepared and stained. Preparations are analyzed for the presence of micronuclei. Each treated and control group must include at least 5 analysable animals per sex. Administration of the treatments consists of a single dose of test substance or two daily doses (or more). The limit dose is 2000 mg/kg/body weight/day for treatment up to 14 days, and 1000 mg/kg/body weight/day for treatment longer than 14 days.

  • 26-September-2014

    English

    Test No. 475: Mammalian Bone Marrow Chromosomal Aberration Test

    The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese hamsters). Structural chromosome aberrations may be of two types: chromosome or chromatid. Animals are exposed to the test substance (liquid or solid) by an appropriate route of exposure (usually by gavage using a stomach tube or a suitable intubation cannula, or by intraperitoneal injection) and are sacrificed at appropriate times after treatment. Prior to sacrifice, animals are treated with a metaphase-arresting agent. Chromosome preparations are then made from the bone marrow cells and stained, and metaphase cells are analysed for chromosome aberrations. Each treated and control group must include at least 5 analysable animals per sex. The limit dose is 2000 mg/kg/body weight/day for treatment up to 14 days, and 1000 mg/kg/body weight/day for treatment longer than 14 days.

  • 3-September-2014

    English

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

    This document is a tool to support regulatory authorities’ decisions on the hazard of specific chemicals when they receive test results from a Test Guideline (TG) or draft TG for the screening/testing of chemicals for endocrine disrupting properties. The contexts for these decisions will vary, depending on local legislation and practice, so the advice is worded in such a way as to permit flexible interpretation. It provides guidance on how to interpret the outcome of individual tests and how to increase evidence on whether or not a substance may be an endocrine disrupter; to this end, it recommends a test method that may be performed if regulatory authorities need more evidence.

  • 18-July-2014

    English

    Guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation

    This guidance document proposes an integrated approach on testing and assessment for skin corrosion and irritation, in view of replacing the "testing and evaluation strategy" provided in the supplement to OECD TG404 (to be updated), provides information on key performance characteristics of each information source comprising the IATA, and guidance on how to integrate information for decision making for classification and labeling.

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  • 1-August-2013

    English

    Guidance for Assessment of the Efficacy of Baits Against Garden Ants

    This biocide document provides guidance on the conduct of laboratory and field tests aimed to assess the efficacy of anti-ants baits for indoor use. A bait contains one or more insecticidal active ingredients combined with food for garden ants.

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  • 16-January-2013

    English

    Guidance Document on Assays for Testing The Efficacy of Baits against Cockroaches

    This document provides guidance on conducting laboratory tests to determine and assess the efficacy of test substances and/or the effectiveness of test products used as baits for the control of cockroach species in indoor environments.

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