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The OECD Guidelines for the Testing of Chemicals is a collection of about 150 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. 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 other test guidelines.

The OECD Guidelines for the Testing of Chemicals is a collection of about 150 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. 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 physical-chemical properties.

The OECD Guidelines for the Testing of Chemicals is a collection of about 150 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. 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.

The OECD Guidelines for the Testing of Chemicals is a collection of about 150 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. 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 effects on biotic systems.

The OECD Guidelines for the Testing of Chemicals is a collection of about 150 of the most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. 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 environmental fate and behaviour. In 2017, the section 3 “Degradation and Accumulation” was renamed to “ Environmental fate and behaviour”  to take into account Test Guidelines measuring endpoints such as dispersion, aggregation.

This Monograph describes in detail the process of Test Guideline development, including the structure of the Test Guidelines Programme, the responsibilities of those involved and the procedures which should be followed.

The OECD Guidelines for the Testing of Chemicals are a unique tool for assessing the potential effects of chemicals on human health and the environment. They are split into five sections: Section 1: Physical-Chemical properties; Section 2: Effects on Biotic Systems; Section 3:Environmental fate and behaviour; Section 4: Health Effects and Section 5: Other Test Guidelines. Accepted internationally as standard methods for safety testing, the Guidelines are used by professionals in industry, academia and government involved in the testing and assessment of chemicals (industrial chemicals, pesticides, personal care products, etc.). These Guidelines are continuously expanded and updated to ensure they reflect the state-of-the-art science and techniques to meet member countries regulatory needs. The Guidelines are elaborated with the assistance of experts from regulatory agencies, academia, industry, environmental and animal welfare organisations. OECD Test Guidelines are covered by the OECD Mutual Acceptance of Data (MAD) system. Under this system, laboratory test results related to the safety of chemicals that are generated in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practices are accepted in all OECD countries and adherent countries for the purpose of safety assessment and other uses relating to the protection of human health and the environment.

This document is a tool to support regulatory authorities’ decisions on the hazard of specific chemicals when they receive test results from a Test Guideline (TG) or draft TG for the screening/testing of chemicals for endocrine disrupting properties. The contexts for these decisions will vary, depending on local legislation and practice, so the advice is worded in such a way as to permit flexible interpretation. It provides guidance on how to interpret the outcome of individual tests and how to increase evidence on whether or not a substance may be an endocrine disrupter; to this end, it recommends a test method that may be performed if regulatory authorities need more evidence.

This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals. The document is intended to provide guidance for evaluating chemical using standardised test guidelines. Specific objectives include providing a description of the OECD conceptual framework for evaluating chemicals for endocrine disruption, background on the standardised test methods used, and guidance for interpreting the outcome of individual tests. The general approach taken by the document is primarily to provide guidance on how test results might be interpreted based on the outcome of standardised assays. Key questions addressed in the document concern likely mechanisms of endocrine action and any resulting apical effects that can be attributed to such action. The document is not proscriptive but provides suggestions for possible next steps in testing (if any) which might be appropriate for a regulatory authority to take, given the various data scenarios. The guidance document is focused primarily on endocrine modalities included in the conceptual framework; estrogen, androgen, and thyroid mediated endocrine disruption and chemicals that interfer with steroidogenesis.

The objective of OECD Test Guidelines for the pesticide residue chemistry is to assess pesticide exposure by identifying these residues in food or animal feedstuffs for purposes of dietary risk assessment and setting Maximum Residue Levels. They have been developed and are based on guidelines in use for many years in OECD countries and by the Food and Agriculture Organisation. Because of the unique nature of each study, the pesticide expected use, and the particular methods needed to elucidate the metabolic pathway for each chemical, the description of the test method cannot be as prescriptive as usually required for other OECD Test Guidelines. Pesticide residue studies are complex; guidelines cannot specify all parameters in advance, but each study must be designed individually. Given these characteristics, the guidelines in Part A of Section 5 include elements that differ from those in the other sections (1-4) of the OECD Guidelines for the Testing of Chemicals.

The present Test Guideline addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This Test Guideline (TG) provides an in vitro procedure (the ARE-Nrf2 luciferase test method) used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. The second key event on the adverse outcome pathway leading to skin sensitisation takes place in the keratinocytes and includes inflammatory responses as well as gene expression associated with specific cell signalling pathways such as the antioxidant/electrophile response element (ARE)-dependent pathways. The test method described in this Test Guideline (ARE-Nrf2 luciferase test method) is proposed to address this second key event. The cell line contains the luciferase gene under the transcriptional control of a constitutive promoter fused with an ARE element from a gene that is known to be up-regulated by contact sensitisers. The luciferase signal reflects the activation by sensitisers of endogenous Nrf2 dependent genes. This allows quantitative measurement (by luminescence detection) of luciferase gene induction, using well established light producing luciferase substrates, as an indicator of the activity of the Nrf2 transcription factor in cells following exposure to electrophilic test substances. There are currently two in vitro ARE-Nrf2 luciferase test method covered by this Test Guideline: the KeratinoSensTM test method and the LuSens test method. Performance standards have been developed to enable the validation of similar test methods.

This Test Guideline describes a standardised method to examine the transformation of chemicals in pig and cattle liquid manure under anaerobic conditions. The experiments are performed to determine the rate of transformation of the test chemical, the identity and rates of formation and decline of transformation products and residues). Such studies are relevant for chemicals that are administered to housed animals and are subsequently excreted (e.g. veterinary medicinal products or feed additives) or for chemicals that are applied in buildings for livestock and may also enter the manure collected from these animal housings (e.g. biocides). Pesticides may also be introduced into manure via contaminated animal feed.

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 may provide useful information on toxicokinetics. Information from toxicokinetic studies helps to relate concentration or dose to the observed toxicity and to understand its mechanism of toxicity. The test substance ("unlabelled" or "radiolabelled" forms) is normally administered by an oral route, but other routes of administration may be applicable. Single dose administration of the substance (preferably a minimum of two dose levels) may be adequate, but repeated dose may be needed in some circumstances. Toxicokinetic studies should preferably be carried out in the same species as that used in other toxicological studies performed with the substance (normally the rat, a minimum of 4 animals of one sex for each dose). Initial estimation of absorption can be achieved by mass balance determination, but further investigations such as intravenous (IV) administration and biliary excretion studies might be necessary. Bioavailability can be determined from plasma/blood kinetics of oral and IV groups. The percent of the total dose in tissues should at a minimum be measured at the termination of experiment,but additional time points may also be needed. Metabolites present at 5 % or greater of the administered dose should be identified. The rate and extent of excretion of the administered dose should be determined by measuring the percent recovered dose from urine, faeces and expired air.