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  • 7-August-2015

    English

    The chemical accidents programme

    The OECD Programme on Chemical Accidents addresses a subject that concerns everyone who uses or handles hazardous chemicals, works in a chemical plant, or lives near one. This programme helps public authorities, industry, labour and other interested parties prevent chemical accidents and respond appropriately if one occurs.

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  • 31-July-2015

    English

    OECD biotechnology newsletter updates

    OECD major events and activities relating to biotechnologies: latest developments are updated biannually in this Newsletter.

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  • 28-July-2015

    English

    Newly published set of Test Guidelines

    A set of new and updated OECD Test Guidelines was published at the end of July 2015 to test chemicals and identify hazards such as endocrine disruption, serious eye damage, genotoxicity, skin irritation or corrosion.

  • 28-July-2015

    English, PDF, 771kb

    Draft Updated Test Guideline 223: Avian Acute Oral Toxicity Test

    This Test Guideline describes procedures designed to estimate the acute oral toxicity of substances to birds, and it provides three testing options: (1) limit dose test, (2) LD50-slope test, and (3) LD50-only test.

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  • 28-July-2015

    English

    Test No. 241: The Larval Amphibian Growth and Development Assay (LAGDA)

    The test guideline of the Larval Amphibian Growth and Development Assay (LAGDA) describes a toxicity test with an amphibian species (African clawed frog (Xenopus laevis)) that considers growth and development from fertilization through the early juvenile period.  It is an assay (typically 16 weeks) that assesses early development, metamorphosis, survival, growth, and partial reproductive maturation. It also enables measurement of a suite of other endpoints that allows for diagnostic evaluation of suspected endocrine disrupting chemicals (EDCs) or other types of developmental and reproductive toxicants. The LAGDA serves as a higher tier test with an amphibian for collecting more comprehensive concentration-response information on adverse effects suitable for use in hazard identification and characterization, and in ecological risk assessment. The general experimental design entails exposing X. laevis embryos at Nieuwkoop and Faber (NF) stage 8-10 (3) to a minimum of four different concentrations of test chemical and control(s) until 10 weeks after the median time to NF stage 62.  There are four replicates in each test concentration with eight replicates for the control. Endpoints evaluated during the course of the exposure (at the interim sub-sample and final sample at completion of the test) include those indicative of generalized toxicity: mortality, abnormal behaviour, and growth determinations (length and weight), as well as endpoints designed to characterize specific endocrine toxicity modes of action targeting oestrogen, androgen or thyroid-mediated physiological processes.

  • 28-July-2015

    English

    Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method

    The test described in this Test Guideline allows the identification of corrosive chemical substances and mixtures and it enables the identification of non-corrosive substances and mixtures when supported by a weight of evidence determination using other existing information. The test protocol may also provide an indication of the distinction between severe and less severe skin corrosives. This Test Guideline does not require the use of live animals or animal tissue for the assessment of skin corrosivity.

    The test material (solid or liquid) is applied uniformly and topically to a three-dimensional human skin model, comprising at least a reconstructed epidermis with a functional stratum corneum. Two tissue replicates are used for each treatment (exposure time), and for controls. Corrosive materials are identified by their ability to produce a decrease in cell viability below defined threshold levels at specified exposure periods. Coloured chemicals can also be tested by used of an HPLC procedure. The principle of the human skin model assay is based on the hypothesis that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the underlying cell layers.

  • 28-July-2015

    English

    Test No. 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER)

    This Test Guideline addresses the human health endpoint skin corrosion. It is based on the rat skin transcutaneous electrical resistance (TER) test method, which utilizes skin discs to identify corrosives by their ability to produce a loss of normal stratum corneum integrity and barrier function. This Test Guideline was originally adopted in 2004 and updated in 2015 to refer to the IATA guidance document.

  • 28-July-2015

    English

    Test No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

    This Test Guideline describes an in vitro procedure that may be used for the hazard identification of irritant chemicals (substances and mixtures) in accordance with the UN Globally Harmonized System of Classification and Labelling (GHS) Category 2.  It is based on reconstructed human epidermis (RhE), which in its overall design closely mimics the biochemical and physiological properties of the upper parts of the human skin. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from tissues. Irritant test substances are identified by their ability to decrease cell viability below defined threshold levels (below or equal to 50% for UN GHS Category 2). Coloured chemicals can also be tested by used of an HPLC procedure. There are three validated test methods that adhere to this Test Guideline. Depending on the regulatory framework and the classification system in use, this procedure may be used to determine the skin irritancy of test substances as a stand-alone replacement test for in vivo skin irritation testing, or as a partial replacement test, within a tiered testing strategy.

  • 28-July-2015

    English

    Test No. 421: 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. 404: Acute Dermal Irritation/Corrosion

    This method provides information on health hazard likely to arise from exposure to liquid or solid test substance by dermal application. This Test Guideline recommends sequential testing strategies, which include the performance of validated and accepted in vitro or ex vivo tests for corrosion/irritation.

    The albino rabbit is the preferable laboratory animal. The substance to be tested is applied in a single dose to a small area of skin (approximately 6cm²) of an experimental animal; untreated skin areas of the test animal serve as the control. The exposure period is 4 hours. Residual test substance should then be removed. The dose is 0.5ml (liquid) or 0.5g (solid) applied to the test site. The method consists of two tests: the initial test and the confirmatory test (used only if a corrosive effect is not observed in the initial test). All animals should be examined for signs of erythema and oedema during 14 days. The dermal irritation scores should be evaluated in conjunction with the nature and severity of lesions, and their reversibility or lack of reversibility. When responses persist to the end of the 14-day observation period, the test substance should be considered an irritant.

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