OECD Guidelines for the Testing of Chemicals (OECD TG) are a set of internationally accepted specifications for the testing of chemicals decided on by the Organisation for Economic Co-operation and Development (OECD). They were first published in 1981. They are split into five sections:
Guidelines are numbered with three digit numbers, the section number being the first number. Sometimes guidelines are suffixed with a letter.
Guidelines are under constant review, with guidelines being periodically updated, new guidelines being adopted, and guidelines being withdrawn. Previous guidelines are maintained on the website for reference purposes. Animal welfare concerns are dealt with by ensuring that animal tests are only permitted where necessary.
Number | Title |
---|---|
101 | UV-VIS absorption spectra |
102 | Melting point/Melting range |
103 | Boiling point |
104 | Vapour pressure |
105 | Water solubility |
106 | Adsorption – Desorption Using a Batch Equilibrium Method |
107 | Partition coefficient (n-octanol/water): Shake Flask Method |
108 | Complex formation ability in water |
109 | Density of liquids and solids |
110 | Particle size distribution/ fibre length and diameter distributions |
111 | Hydrolysis as a function of pH |
112 | Dissociation constants in water |
113 | Screening test for thermal stability and stability in air |
114 | Viscosity of liquids |
115 | Surface tension of aqueous solutions |
116 | Fat solubility of solid and liquid substances |
117 | Partition coefficient (n-octanol/water), HPLC Method |
118 | Determination of the Number-Average molecular weight and the molecular weight distribution of polymers using Gel Permeation Chromatography |
119 | Determination of the Low Molecular Weight Content of a Polymer Using Gel Permeation Chromatography |
120 | Solution/Extraction Behaviour of Polymers in Water |
121 | Estimation of the adsorption coefficient (KOC) on Soil and on sewage sludge using High Performance Liquid Chromatography (HPLC) |
122 | Determination of pH, Acidity and Alkalinity |
123 | Partition coefficient (1-Octanol/Water): Slow-Stirring Method |
Number | Title |
---|---|
201 | Freshwater Alga and Cyanobacteria, Growth Inhibition Test |
202 | Daphnia sp. Acute Immobilisation Test |
203 | Fish, Acute Toxicity Test |
204 | Fish, Prolonged Toxicity Test: 14-Day Study |
205 | Avian Dietary Toxicity Test |
206 | Avian Reproduction Test |
207 | Earthworm, Acute Toxicity Tests |
208 | Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test |
209 | Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation) |
210 | Fish, Early-life Stage Toxicity Test |
211 | Daphnia magna Reproduction Test |
212 | Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages |
213 | Honeybees, Acute Oral Toxicity Test |
214 | Honeybees, Acute Contact Toxicity Test |
215 | Fish, Juvenile Growth Test |
216 | Soil Microorganisms: Nitrogen Transformation Test |
217 | Soil Microorganisms: Carbon Transformation Test |
218 | Sediment-Water Chironomid Toxicity Using Spiked Sediment |
219 | Sediment-Water Chironomid Toxicity Using Spiked Water |
220 | Enchytraeid Reproduction Test |
221 | Lemna sp. Growth Inhibition Test |
222 | Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) |
223 | Avian Acute Oral Toxicity Test |
224 | Determination of the Inhibition of the Activity of Anaerobic Bacteria |
225 | Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment |
226 | Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil |
227 | Terrestrial Plant Test: Vegetative Vigour Test |
228 | Determination of Developmental Toxicity of a Test Chemical to Dipteran Dung Flies (Scathophaga stercoraria L. (Scathophagidae), Musca autumnalis De Geer (Muscidae)) |
229 | Fish Short Term Reproduction Assay |
230 | 21-day Fish Assay |
231 | Amphibian Metamorphosis Assay |
232 | Collembolan Reproduction Test in Soil |
233 | Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment |
234 | Fish Sexual Development Test |
235 | Chironomus sp., Acute Immobilisation Test |
236 | Fish Embryo Acute Toxicity (FET) Test |
237 | Honey Bee (Apis Mellifera) Larval Toxicity Test, Single Exposure |
238 | Sediment-Free Myriophyllum Spicatum Toxicity Test |
239 | Water-Sediment Myriophyllum Spicatum Toxicity Test |
240 | Medaka Extended One Generation Reproduction Test (MEOGRT) |
241 | The Larval Amphibian Growth and Development Assay (LAGDA) |
Number | Title |
---|---|
301 | Ready Biodegradability |
302A | Inherent Biodegradability: Modified SCAS Test |
302B | Inherent Biodegradability: Zahn-Wellens/ EVPA Test |
302C | Inherent Biodegradability: Modified MITI Test (II) |
303 | Simulation Test – Aerobic Sewage Treatment – A: Activated Sludge Units; B: Biofilms |
304A | Inherent Biodegradability in Soil |
305 | Bioaccumulation in Fish: Aqueous and Dietary Exposure |
306 | Biodegradability in Seawater |
307 | Aerobic and Anaerobic Transformation in Soil |
308 | Aerobic and Anaerobic Transformation in Aquatic Sediment Systems |
309 | Aerobic Mineralisation in Surface Water – Simulation Biodegradation Test |
310 | Ready Biodegradability – CO2 in sealed vessels (Headspace Test) |
311 | Anaerobic Biodegradability of Organic Compounds in Digested Sludge: by Measurement of Gas Production |
312 | Leaching in Soil Columns |
313 | Estimation of Emissions from Preservative – Treated Wood to the Environment |
314 | Simulation Tests to Assess the Biodegradability of Chemicals Discharged in Wastewater |
315 | Bioaccumulation in Sediment-dwelling Benthic Oligochaetes |
316 | Phototransformation of Chemicals in Water – Direct Photolysis |
317 | Bioaccumulation in Terrestrial Oligochaetes |
Number | Title |
---|---|
401 | Acute Oral Toxicity |
402 | Acute Dermal Toxicity |
403 | Acute Inhalation Toxicity |
404 | Acute Dermal Irritation/Corrosion |
405 | Acute Eye Irritation/Corrosion |
406 | Skin Sensitisation |
407 | Repeated Dose 28-day Oral Toxicity Study in Rodents |
408 | Repeated Dose 90-Day Oral Toxicity Study in Rodents |
409 | Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents |
410 | Repeated Dose Dermal Toxicity: 21/28-day Study |
411 | Subchronic Dermal Toxicity: 90-day Study |
412 | Subacute Inhalation Toxicity: 28-Day Study |
413 | Subchronic Inhalation Toxicity: 90-day Study |
414 | Prenatal Development Toxicity Study |
415 | One-Generation Reproduction Toxicity Study |
416 | Two-Generation Reproduction Toxicity |
417 | Toxicokinetics |
418 | Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure |
419 | Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study |
420 | Acute Oral Toxicity – Fixed Dose Procedure |
421 | Reproduction/Developmental Toxicity Screening Test |
422 | Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test |
423 | Acute Oral toxicity – Acute Toxic Class Method |
424 | Neurotoxicity Study in Rodents |
425 | Acute Oral Toxicity: Up-and-Down Procedure |
426 | Developmental Neurotoxicity Study |
427 | Skin Absorption: In Vivo Method |
428 | Skin Absorption: In Vitro Method |
429 | Skin Sensitisation |
430 | In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER) |
431 | In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method |
432 | In Vitro 3T3 NRU Phototoxicity Test |
435 | In Vitro Membrane Barrier Test Method for Skin Corrosion |
436 | Acute Inhalation Toxicity – Acute Toxic Class Method |
437 | Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage |
438 | Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage |
439 | In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method |
440 | Uterotrophic Bioassay in Rodents |
441 | Hershberger Bioassay in Rats |
442A | Skin Sensitization |
442B | Skin Sensitization |
442C | In Chemico Skin Sensitisation |
442D | In Vitro Skin Sensitisation |
443 | Extended One-Generation Reproductive Toxicity Study |
451 | Carcinogenicity Studies |
452 | Chronic Toxicity Studies |
453 | Combined Chronic Toxicity/Carcinogenicity Studies |
455 | Draft Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists |
456 | H295R Steroidogenesis Assay |
457 | BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists |
460 | Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants |
471 | Bacterial Reverse Mutation Test |
473 | In Vitro Mammalian Chromosomal Aberration Test |
474 | Mammalian Erythrocyte Micronucleus Test |
475 | Mammalian Bone Marrow Chromosomal Aberration Test |
476 | In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes |
477 | Genetic Toxicology: Sex-Linked Recessive Lethal Test in Drosophila melanogaster |
478 | Rodent Dominant Lethal Test |
479 | Genetic Toxicology: In vitro Sister Chromatid Exchange Assay in Mammalian Cells |
480 | Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation Assay |
481 | Genetic Toxicology: Saacharomyces cerevisiae, Miotic Recombination Assay |
482 | Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells in vitro |
483 | Mammalian Spermatogonial Chromosomal Aberration Test |
484 | Genetic Toxicology: Mouse Spot Test |
485 | Genetic toxicology, Mouse Heritable Translocation Assay |
486 | Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo |
487 | In Vitro Mammalian Cell Micronucleus Test |
488 | Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays |
489 | In Vivo Mammalian Alkaline Comet Assay |
490 | In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene |
491 | Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage |
492 | Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage |
493 | Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity |
Number | Title |
---|---|
501 | Metabolism in Crops |
502 | Metabolism in Rotational Crops |
503 | Metabolism in Livestock |
504 | Residues in Rotational Crops (Limited Field Studies) |
505 | Residues in Livestock |
506 | Stability of Pesticide Residues in Stored Commodities |
507 | Nature of the Pesticide Residues in Processed Commodities – High Temperature Hydrolysis |
508 | Magnitude of the Pesticide Residues in Processed Commodities |
509 | Crop Field Trial |
In vitro studies are performed with microorganisms, cells, or biological molecules outside their normal biological context. Colloquially called "test-tube experiments", these studies in biology and its subdisciplines are traditionally done in labware such as test tubes, flasks, Petri dishes, and microtiter plates. Studies conducted using components of an organism that have been isolated from their usual biological surroundings permit a more detailed or more convenient analysis than can be done with whole organisms; however, results obtained from in vitro experiments may not fully or accurately predict the effects on a whole organism. In contrast to in vitro experiments, in vivo studies are those conducted in living organisms, including humans, known as clinical trials, and whole plants.
In toxicology, the median lethal dose, LD50 (abbreviation for "lethal dose, 50%"), LC50 (lethal concentration, 50%) or LCt50 is a toxic unit that measures the lethal dose of a given substance. The value of LD50 for a substance is the dose required to kill half the members of a tested population after a specified test duration. LD50 figures are frequently used as a general indicator of a substance's acute toxicity. A lower LD50 is indicative of higher toxicity.
The Draize test is an acute toxicity test devised in 1944 by Food and Drug Administration (FDA) toxicologists John H. Draize and Jacob M. Spines. Initially used for testing cosmetics, the procedure involves applying 0.5 mL or 0.5 g of a test substance to the eye or skin of a restrained, conscious animal, and then leaving it for set amount of time before rinsing it out and recording its effects. The animals are observed for up to 14 days for signs of erythema and edema in the skin test, and redness, swelling, discharge, ulceration, hemorrhaging, cloudiness, or blindness in the tested eye. The test subject is commonly an albino rabbit, though other species are used too, including dogs. The animals are euthanized after testing if the test renders irreversible damage to the eye or skin. Animals may be re-used for testing purposes if the product tested causes no permanent damage. Animals are typically reused after a "wash out" period during which all traces of the tested product are allowed to disperse from the test site.
Transfer pricing refers to the rules and methods for pricing transactions within and between enterprises under common ownership or control. Because of the potential for cross-border controlled transactions to distort taxable income, tax authorities in many countries can adjust intragroup transfer prices that differ from what would have been charged by unrelated enterprises dealing at arm’s length. The OECD and World Bank recommend intragroup pricing rules based on the arm’s-length principle, and 19 of the 20 members of the G20 have adopted similar measures through bilateral treaties and domestic legislation, regulations, or administrative practice. Countries with transfer pricing legislation generally follow the OECD Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations in most respects, although their rules can differ on some important details.
Aquatic toxicology is the study of the effects of manufactured chemicals and other anthropogenic and natural materials and activities on aquatic organisms at various levels of organization, from subcellular through individual organisms to communities and ecosystems. Aquatic toxicology is a multidisciplinary field which integrates toxicology, aquatic ecology and aquatic chemistry.
Fatty alcohols (or long-chain alcohols) are usually high-molecular-weight, straight-chain primary alcohols, but can also range from as few as 4–6 carbons to as many as 22–26, derived from natural fats and oils. The precise chain length varies with the source. Some commercially important fatty alcohols are lauryl, stearyl, and oleyl alcohols. They are colourless oily liquids (for smaller carbon numbers) or waxy solids, although impure samples may appear yellow. Fatty alcohols usually have an even number of carbon atoms and a single alcohol group (–OH) attached to the terminal carbon. Some are unsaturated and some are branched. They are widely used in industry. As with fatty acids, they are often referred to generically by the number of carbon atoms in the molecule, such as "a C12 alcohol", that is an alcohol having 12 carbons, for example dodecanol.
Ecotoxicology is the study of the effects of toxic chemicals on biological organisms, especially at the population, community, ecosystem, and biosphere levels. Ecotoxicology is a multidisciplinary field, which integrates toxicology and ecology.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is an internationally agreed-upon standard managed by the United Nations that was set up to replace the assortment of hazardous material classification and labelling schemes previously used around the world. Core elements of the GHS include standardized hazard testing criteria, universal warning pictograms, and safety data sheets which provide users of dangerous goods relevant information with consistent organization. The system acts as a complement to the UN numbered system of regulated hazardous material transport. Implementation is managed through the UN Secretariat. Although adoption has taken time, as of 2017, the system has been enacted to significant extents in most major countries of the world. This includes the European Union, which has implemented the United Nations' GHS into EU law as the CLP Regulation, and United States Occupational Safety and Health Administration standards.
Alternatives to animal testing are the development and implementation of test methods that avoid the use of live animals.
A micronucleus test is a test used in toxicological screening for potential genotoxic compounds. The assay is now recognized as one of the most successful and reliable assays for genotoxic carcinogens, i.e., carcinogens that act by causing genetic damage and is recommended by the OECD guideline for the testing of chemicals. There are two major versions of this test, one in vivo and the other in vitro.
High production volume chemicals are produced or imported into the United States in quantities of 1 million pounds or 500 tons per year. In OECD countries, HPV chemicals are defined as being produced at levels greater than 1,000 metric tons per producer/importer per year in at least one member country/region. A list of HPV chemicals serves as an overall priority list, from which chemicals are selected to gather data for a screening information dataset (SIDS), for testing and for initial hazard assessment.
The Guinea pig maximisation test (GPMT) is an in vivo test to screen for substances that cause human skin sensitisation. It was first proposed by B. Magnusson and Albert Kligman in 1969 and described in their 1970 book Allergic Contact Dermatitis in the Guinea Pig.
The Buehler test is an in vivo test to screen for substances that cause human skin sensitisation. It was first proposed by Edwin Vernon Buehler in 1965 and further explained in 1980.
The murine local lymph node assay (LLNA) is an in vivo test for skin sensitisation.
The Test Methods Regulation is a Regulation No. 440/2008 of May 30, 2008. It, and its subsequent amendments, define tests, testing of chemicals for the REACH Regulation. They are based on the OECD Guidelines for the Testing of Chemicals.
The maximum acceptable toxicant concentration (MATC) is a value that is calculated through aquatic toxicity tests to help set water quality regulations for the protection of aquatic life. Using the results of a partial life-cycle chronic toxicity test, the MATC is reported as the geometric mean between the No Observed Effect Concentration (NOEC) and the lowest observed effect concentration (LOEC).
An early life stage (ELS) test is a chronic toxicity test using sensitive early life stages like embryos or larvae to predict the effects of toxicants on organisms. ELS tests were developed to be quicker and more cost-efficient than full life-cycle tests, taking on average 1–5 months to complete compared to 6–12 months for a life-cycle test. They are commonly used in aquatic toxicology, particularly with fish. Growth and survival are the typically measured endpoints, for which a Maximum Acceptable Toxicant Concentration (MATC) can be estimated. ELS tests allow for the testing of fish species that otherwise could not be studied due to length of life, spawning requirements, or size. ELS tests are used as part of environmental risk assessments by regulatory agencies including the U.S. Environmental Protection Agency (EPA) and Environment Canada, as well as the Organisation for Economic Co-operation and Development (OECD).
E-SCREEN is a cell proliferation assay based on the enhanced proliferation of human breast cancer cells (MCF-7) in the presence of estrogen active substances. The E-SCREEN test is a tool to easily and rapidly assess estrogenic activity of suspected xenoestrogens. This bioassay measures estrogen-induced increase of the number of human breast cancer cell, which is biologically equivalent to the increase of mitotic activity in tissues of the genital tract. It was originally developed by Soto et al. and was included in the first version of the OECD Conceptual Framework for Testing and Assessment of Endocrine Disrupters published in 2012. However, due to failed validation, it was not included in the updated version of the framework published in 2018.
In the realms of toxicology and pathology, the Irwin screen is utilised to determine whether the subject(s) show adverse effects from a course of pharmaceutical treatment or environmental pollution. It is an observational methodology.