By Date


  • 28-July-2015

    English

    Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes

    The in vitro mammalian cell gene mutation test can be used to detect gene mutations induced by chemical substances. In this test, the used genetic endpoints measure mutation at hypoxanthine-guanine phosphoribosyl transferase (HPRT), and at a transgene of xanthineguanine phosphoribosyl transferase (XPRT). The HPRT and XPRT mutation tests detect different spectra of genetic events.

    Cells in suspension or monolayer culture are

  • 28-July-2015

    English

    Test No. 478: Rodent Dominant Lethal Test

    The purpose of the Dominant lethal (DL) test is to investigate whether chemical agents produce mutations resulting from chromosomal aberrations in germ cells. In addition, the dominant lethal test is relevant to assessing genotoxicity because, although they may vary among species, factors of in vivo metabolism, pharmacokinetics and DNA-repair processes are active and contribute to the response. Induction of a DL mutation

  • 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

  • 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

  • 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

  • 28-July-2015

    English

    Test No. 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage

    This Test Guideline describes an in vitro procedure allowing the identification of chemicals (substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage in accordance with UN GHS. It makes use of reconstructed human cornea-like epithelium (RhCE) which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium.

  • 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.

  • 28-July-2015

    English

    Test No. 455: Draft 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

  • 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

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