OECD Guidelines for the Testing of Chemicals, Section 4

Health Effects

Test No. 443: Extended One-Generation Reproductive Toxicity Study
ISSN :
2074-5788 (online)
DOI :
10.1787/20745788
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The OECD Guidelines for the Testing of Chemicals is a collection of about 100 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of new and existing chemical substances, chemical preparations and chemical mixtures. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification and chemical registration. They can also be used for the selection and ranking of candidate chemicals during the development of new chemicals and products and in toxicology research. This group of tests covers health effects.

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    28 July 2011 Test No. 443: Extended One-Generation Reproductive Toxicity Study
OECD
This Test Guideline is designed to provide an evaluation of reproductive and developmental effects that may occur as a result of pre- and postnatal chemical exposure as well as an evaluation of systemic toxicity in pregnant and lactating females and...
    28 July 2011 Test No. 456: H295R Steroidogenesis Assay
OECD
This Test Guideline describes an in vitro screen for chemical effects on steroidogenesis, specifically the production of 17ß-estradiol (E2) and testosterone (T). The human H295R adreno-carcinoma cell line, used for the assay, expresses genes that...
    28 July 2011 Test No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays
OECD
This Test Guideline describes an in vivo assay that detects chemicals that may induce gene mutations. In this assay, transgenic rats or mice that contain multiple copies of chromosomally integrated plasmid or phage shuttle vectors are used. The...
    23 July 2010 Test No. 417: Toxicokinetics
OECD
This Test Guideline describes in vivo studies that provide information on mass balance, absorption, bioavailability, tissue distribution, metabolism, excretion, and basic toxicokinetic parameters [e.g. AUC], as well as supplemental approaches that...
    23 July 2010 Test No. 429: Skin Sensitisation
OECD
The basic principle underlying the Local Lymph Node Assay (LLNA) in mouse is that sensitizers induce a primary proliferation of lymphocytes in the auricular lymph nodes draining the site of chemical application. This proliferation is proportional to...
    23 July 2010 Test No. 439: In Vitro Skin Irritation
OECD
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. ...
    23 July 2010 Test No. 442A: Skin Sensitization
OECD
The Local Lymph Node Assay: DA (LLNA: DA) is a non-radioactive modification to the LLNA method for identifying potential skin sensitizing test substances and measuring the proliferation of lymphocytes they induce in the auricular lymph nodes. The...
    23 July 2010 Test No. 442B: Skin Sensitization
OECD
The Local Lymph Node Assay: BrdU-ELISA (LLNA:BrdU-ELISA) is a non-radioactive modification to the LLNA method for identifying potential skin sensitizing test substances and measuring the proliferation of lymphocytes they induce in the auricular lymph...
    23 July 2010 Test No. 487: In Vitro Mammalian Cell Micronucleus Test
OECD
The in vitro micronucleus test is a genotoxicity test for the detection of micronuclei in the cytoplasm of interphase cells. Micronuclei may originate from acentric chromosome fragments (i.e. lacking a centromere), or whole chromosomes that are...
    08 Sep 2009 Test No. 403: Acute Inhalation Toxicity
OECD
This method provides information on health hazard likely to arise from short-term exposure to a test article (gas, vapour or aerosol/particulate test article) by inhalation. The revised Test Guideline describes two studies: a traditional LC50...
    08 Sep 2009 Test No. 412: Subacute Inhalation Toxicity: 28-Day Study
OECD
This revised Test Guideline 412 (TG 412) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a limited period of time (28 days), and to provide data for quantitative inhalation risk...
    08 Sep 2009 Test No. 413: Subchronic Inhalation Toxicity: 90-day Study
OECD
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.
    08 Sep 2009 Test No. 451: Carcinogenicity Studies
OECD
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 control group should contain at least 50 animals of each sex.
    08 Sep 2009 Test No. 452: Chronic Toxicity Studies
OECD
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.
    08 Sep 2009 Test No. 453: Combined Chronic Toxicity/Carcinogenicity Studies
OECD
The objective of a combined chronic toxicity/carcinogenicity study is to identify the majority of chronic and carcinogenic effects and to determine dose-response relationships following prolonged and repeated exposure.
    08 Sep 2009 Test No. 436: Acute Inhalation Toxicity – Acute Toxic Class Method
OECD
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...
    08 Sep 2009 Test No. 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants
OECD
The BCOP test method 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...
    08 Sep 2009 Test No. 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants
OECD
The ICE method uses eyes collected from chickens obtained from slaughterhouses where they are killed for human consumption, thus eliminating the need for laboratory animals. The eye is enucleated and mounted in an eye holder with the cornea...
    08 Sep 2009 Test No. 441: Hershberger Bioassay in Rats
OECD
The Hershberger Bioassay is an in vivo short–term screening test. It evaluates the ability of a chemical to elicit biological activities consistent with androgen agonists, antagonists or 5 á-reductase inhibitors.
    08 Sep 2009 Test No. 455: The Stably Transfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals
OECD
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...
    16 Oct 2008 Test No. 407: Repeated Dose 28-day Oral Toxicity Study in Rodents
OECD
This method provides information on health hazard likely to arise from exposure to test substance via oral administration.
    16 Oct 2008 Test No. 425: Acute Oral Toxicity: Up-and-Down Procedure
OECD
The method permits estimation of an LD50 with a confidence interval and the results allow a substance to be classified for acute toxicity according to the Globally Harmonised System of classification and labelling of chemicals.
    15 Oct 2007 Test No. 426: Developmental Neurotoxicity Study
OECD
A developmental neurotoxicity study will provide information on the effects of repeated exposure to a substance during in utero and early postnatal development.
    15 Oct 2007 Test No. 440: Uterotrophic Bioassay in Rodents
OECD
The Uterotrophic Bioassay is an in vivo short-term screening test. It is based on the increase in uterine weight or uterotrophic response.
    11 Sep 2006 Summary of Considerations in the Report from the OECD Expert Groups on Short Term and Long Term Toxicology
OECD
    17 Aug 2006 Test No. 435: In Vitro Membrane Barrier Test Method for Skin Corrosion
OECD
This Test Guideline is for an in vitro membrane barrier test method that can be used to identify corrosive substances.
    23 Nov 2004 Test No. 427: Skin Absorption: In Vivo Method
OECD
The in vivo percutaneous absorption study set out in this Test Guideline provides the linkage necessary to extrapolate from oral studies when making safety assessments following dermal exposure.
    23 Nov 2004 Test No. 428: Skin Absorption: In Vitro Method
OECD
This Test method has been designed to provide information on absorption of a test substance, (ideally radiolabelled), applied to the surface of a skin sample separating the two chambers (a donor chamber and a receptor chamber) of a diffusion cell.
    23 Nov 2004 Test No. 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER)
OECD
The Globally Harmonised System for the Classification and Labelling of Chemicals defines skin corrosion as the production of irreversible tissue damage in the skin following the application of a test material.
    23 Nov 2004 Test No. 431: In Vitro Skin Corrosion: Human Skin Model Test
OECD
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...
    23 Nov 2004 Test No. 432: In Vitro 3T3 NRU Phototoxicity Test
OECD
This Test Guideline describes a method to evaluate photo-cytotoxicity by the relative reduction in viability of cells exposed to the chemical in the presence versus absence of light.
    24 Apr 2002 Test No. 404: Acute Dermal Irritation/Corrosion
OECD
This method provides information on health hazard likely to arise from exposure to liquid or solid test substance by dermal application.
    24 Apr 2002 Test No. 405: Acute Eye Irritation/Corrosion
OECD
This method provides information on health hazard likely to arise from exposure to test substance (liquids, solids and aerosols) by application on the eye.
    08 Feb 2002 Test No. 420: Acute Oral Toxicity - Fixed Dose Procedure
OECD
A principle of the method is that in the main study only moderately toxic doses are used, and the administration of doses that are expected to be lethal should be avoided.
    08 Feb 2002 Test No. 423: Acute Oral toxicity - Acute Toxic Class Method
OECD
This is a test guideline for testing for Acute Oral Tosxidity using the Acute Toxic Class Method.
    22 Jan 2001 Test No. 414: Prenatal Development Toxicity Study
OECD
This Test Guideline for developmental toxicity testing is designed to provide general information concerning the effects of prenatal exposure on the pregnant test animal and on the developing organism.
    22 Jan 2001 Test No. 416: Two-Generation Reproduction Toxicity
OECD
This Test Guideline for two-generation reproduction testing is designed to provide general information concerning the effects of a test substance on the integrity and performance of the male and female reproductive systems...
    21 Sep 1998 Test No. 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents
OECD
This method provides information on health hazard likely to arise from exposure to test substance via oral administration.
    21 Sep 1998 Test No. 409: Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents
OECD
This method provides information on health hazard likely to arise from short-term exposure to test substance.
    21 July 1997 Test No. 424: Neurotoxicity Study in Rodents
OECD
This Test Guideline has been designed to obtain the information necessary to confirm or to further characterise the potential neurotoxicity of chemicals in adult animals.
    21 July 1997 Test No. 471: Bacterial Reverse Mutation Test
OECD
The bacterial reverse mutation test uses amino-acid requiring at least five strains of Salmonella typhimurium and Escherichia coli to detect point mutations by base substitutions or frameshifts.
    21 July 1997 Test No. 473: In vitro Mammalian Chromosome Aberration Test
OECD
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.
    21 July 1997 Test No. 474: Mammalian Erythrocyte Micronucleus Test
OECD
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...
    21 July 1997 Test No. 475: Mammalian Bone Marrow Chromosome Aberration Test
OECD
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).
    21 July 1997 Test No. 476: In vitro Mammalian Cell Gene Mutation Test
OECD
The in vitro mammalian cell gene mutation test can be used to detect gene mutations induced by chemical substances.
    21 July 1997 Test No. 483: Mammalian Spermatogonial Chromosome Aberration Test
OECD
This test measures chromosome events in spermatogonial germ cells and is, therefore, expected to be predictive of induction of inheritable mutations in germ cells.
    21 July 1997 Test No. 486: Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo
OECD
The purpose of the unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo is to identify substances that induce DNA repair after excision and removal of a stretch of DNA containing a region of damage induced by chemical substances...
    22 Mar 1996 Test No. 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
OECD
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 (approximately 54 days).
    27 July 1995 Test No. 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure
OECD
The test substance is administered orally in a single dose to domestic hens. The animals are observed for 21 days, then the remainder of the hens are killed and histopathological examination is undertaken.
    27 July 1995 Test No. 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study
OECD
This Test Guideline is used in the assessment and evaluation of the toxic effects of organophosporus substances.
    27 July 1995 Test No. 421: Reproduction/Developmental Toxicity Screening Test
OECD
The test substance is administered in graduated doses to several groups of males and females.
    17 July 1992 Test No. 406: Skin Sensitisation
OECD
This method provides information on health hazard likely to arise from exposure to test substance via intradermical injection and/or epidermical application.
    24 Feb 1987 Test No. 401: Acute Oral Toxicity
OECD
The OECD Guidelines for the Testing of Chemicals are a collection of about 100 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of ...
    24 Feb 1987 Test No. 402: Acute Dermal Toxicity
OECD
This method provides information on health hazard likely to arise from a short-term exposure to solid or liquid test substance by the dermal route
    23 Oct 1986 Test No. 479: Genetic Toxicology: In vitro Sister Chromatid Exchange Assay in Mammalian Cells
OECD
The sister chromatid exchange (SCE) assay is a short-term test for the detection of reciprocal exchanges of DNA between two sister chromatids of a duplicating chromosome.
    23 Oct 1986 Test No. 480: Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation Assay
OECD
This assay may be used to measure gene mutation in yeast, a eukaryotic micro-organism.
    23 Oct 1986 Test No. 481: Genetic Toxicology: Saacharomyces cerevisiae, Miotic Recombination Assay
OECD
This assay may be used to measure mitotic recombination (gene conversion or crossingover) in yeast, a eukaryotic micro-organism.
    23 Oct 1986 Test No. 482: Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells in vitro
OECD
The Test Guideline for Unscheduled DNA Synthesis (UDS) in mammalian cells in vitro describes procedures utilizing primary cultures, human lymphocytes or established cell lines...
    23 Oct 1986 Test No. 484: Genetic Toxicology: Mouse Spot Test
OECD
The mouse spot test detects presumed somatic mutations in fetal cells following transplacental absorption of the test substance.
    23 Oct 1986 Test No. 485: Genetic toxicology, Mouse Heritable Translocation Assay
OECD
The mouse heritable translocation test detects structural and numerical chromosome changes in mammalian germ cells as recovered in first generation progeny.
    04 Apr 1984 Test No. 477: Genetic Toxicology: Sex-Linked Recessive Lethal Test in Drosophila melanogaster
OECD
Mutations in the X-chromosome of Drosophila melanogaster are phenotypically expressed in males carrying the mutant gene.
    04 Apr 1984 Test No. 478: Genetic Toxicology: Rodent Dominant Lethal Test
OECD
Dominant lethal (DL) effects cause embryonic or foetal death. Induction of a dominant lethal event after exposure to a test substance...
    26 May 1983 Test No. 415: One-Generation Reproduction Toxicity Study
OECD
This Test Guideline for reproduction testing is designed to provide general information concerning the effects of a test substance (Solid, liquid, gas or vapour) on male and female reproductive performance.
    12 May 1981 Test No. 410: Repeated Dose Dermal Toxicity: 21/28-day Study
OECD
This study relates to the analysis, via dermal application, of the health hazard of solid or liquid test substance.
    12 May 1981 Test No. 411: Subchronic Dermal Toxicity: 90-day Study
OECD
This study relates to the analysis, via dermal application, of the health hazards of solid or liquid test substance.
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