Latest Documents


  • 7-September-2009

    English

    Test No. 413: Subchronic Inhalation Toxicity: 90-day Study

    This revised Test Guideline has been designed to fully characterize test article toxicity by the inhalation route for a subchronic duration (90 days), and to provide robust data for quantitative inhalation risk assessments. Groups of 10 male and 10 female rodents are exposed 6 hours per day during a 90 day (13 week) period to a) the test article at three or more concentration levels, b) filtered air (negative control), and/or c)

  • 7-September-2009

    English

    Test No. 436: Acute Inhalation Toxicity – Acute Toxic Class Method

    The method described by this Test Guideline provides information that allows hazard assessment for short-term exposure to a test article by inhalation, and allows the substance to be classified according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The test method is based on a stepwise procedure, each step using 3 animals of each sex (the preferred species is rat). Animals are exposed in 

  • 7-September-2009

    English

    Test No. 452: Chronic Toxicity Studies

    The objective of these chronic toxicity studies is to characterize the profile of a substance in a mammalian species (primarily rodents) following prolonged and repeated exposure.
    The Test Guideline focuses on rodents and oral administration. Both sexes should be used. For rodents, at least 20 animals per sex per group should normally be used at each dose level, while for non-rodents a minimum of 4 per sex per group is

  • 7-September-2009

    English

    Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants

    The Bovine Corneal Opacity and Permeability test method (BCOP) is an in vitro test method that can be used to classify substances as 'ocular corrosives and severe irritants'. The BCOP uses isolated corneas from the eyes of cattle slaughtered for commercial purposes, thus avoiding the use of laboratory animals. Each treatment group (test substance, negative/positive controls) consists of a minimum of three eyes where the

  • 7-September-2009

    English

    Test No. 453: Combined Chronic Toxicity/Carcinogenicity Studies

    The objective of a combined chronic toxicity/carcinogenicity study is to identify carcinogenic and the majority of chronic effects, and to determine dose-response relationships following prolonged and repeated exposure.

    The rat is typically used for this study. For rodents, each dose group and concurrent control group intended for the carcinogenicity phase of the study should contain at least 50 animals of each sex,

  • 7-September-2009

    English

    Test No. 231: Amphibian Metamorphosis Assay

    This Test Guideline describes an amphibian metamorphosis assay intended to screen substances which may interfere with the normal functioning of the hypothalamo-pituitary-thyroid axis. The assay was validated with the species Xenopus laevis, which is recommended for use in the Guideline. The assay uses three test chemical concentrations and the necessary controls, including a carrier control if necessary. The assay starts

  • 7-September-2009

    English

    Test No. 232: Collembolan Reproduction Test in Soil

    This Test Guideline is designed for assessing the effects of chemicals on the reproduction of collembolans in soil. The parthenogenetic Folsomia candida is the recommended species for use, but an alternative species such as sexually reproducing Folsomia fimetaria could also be used if they meet the validity criteria. This Guideline can be used for testing both water soluble and insoluble substances but it is not

  • 7-September-2009

    English

    Test No. 230: 21-day Fish Assay - A Short-Term Screening for Oestrogenic and Androgenic Activity, and Aromatase Inhibition

    This Test Guideline describes an in vivo screening assay for certain endocrine active substances where sexually mature male and spawning female fish are held together and exposed to a chemical during a limited part of their life-cycle (21 days). This assay covers the screening of oestrogenic and androgenic activity, and aromatase inhibition. The assay was validated on the fathead minnow (Pimephales promelas), the

  • 7-September-2009

    English

    Test No. 455: The Stably Transfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals

    This Test Guideline describes an in vitro assay, which  provides mechanistical information, and can be used for screening and prioritization purposes. The test system utilises the hERalpha-HeLa-9903 cell line derived from a human cervical tumor and stably transfected. This cell line can measure the ability of a test chemical to induce hERalpha-mediated transactivation of luciferase gene expression. The cells are exposed to

  • 7-September-2009

    English

    Test No. 451: Carcinogenicity Studies

    The objective of a long-term carcinogenicity study is to observe test animals for a major portion of their life span for the development of neoplastic lesions during or after exposure to various doses of a test substance by an appropriate route of administration.

    This Test Guideline is intended primarily for use with rats and mice, and for oral administration. Both sexes should be used. Each dose group and concurrent

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