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Glossary

  EU-NETVAL
EU-NETVAL is the European Union Network of Laboratories for the Validation of Alternative Methods.
EU-NETVAL's mission is to provide support for EURL ECVAM validation studies that serve to assess the reliability and relevance of alternative methods that have a potential to replace, reduce, or refine the use of animals for scientific purposes.
EU-NETVAL was set up by EURL ECVAM in response to the provision of Directive 2010/63/EU on the protection of animals used for scientific purposes which requests that EU Member States assist the European Commission in the validation of alternative methods. Currently there are a total of26 members of EU-NETVAL, selected against pre-defined eligibility criteria(including 25 test facilities from EU Member States plus the European Commission's ownin vitroGLP test facility operated by EURL ECVAM, which coordinates the network) and approved by the National Contact Points.
Source: EURL ECVAM.
 'Three Rs' principle (Replace, Reduce, Refine)
Increasing concern about the use of laboratory animals for toxicity studies and other effects of substances has led to widespread support of, and adherence to, the principle of the 3Rs of animal use in alternative test method development [Replacement, Reduction and Refinement], first defined by the scientists William Russell and Rex Burch in 'The Principles of Humane Experimental Technique' (1959).
Regulatory authorities have endorsed the principle of the 3Rs. As a consequence, alternative test methods have been developed to replace the use of animals with non-animal systems, reduce the number of animals in a test, or refine the procedures to make them less painful or stressful to the animals under study.
TheDirective 2010/63/EU on the protection of animals used for scientific purposes (published on 20 October 2010) includes an explicit reference to the 3Rs principle.
Sources: (see IHCP's disclaimer on linked sites)

- OECD, Guidance Document No. 34 on the Validation and International Acceptance of new or Updated Test Methods for Hazard Assessment
- Altweb (the Alternatives to Animal Testing Web Site) for Russel and Burch's article
 'Two Rs' principle
(Reduction and Refinement)
Reduce the number of animals in a test, or refine the procedures to make them less painful or stressful to the animals under study.
See: 'Three Rs' principle
 3T3-NRU in vitro phototoxicity test
This assay consists of the immortalized mouse fibroblast cell line, Balb/c 3T3 and is based on a comparison of the cytotoxicity of a chemical when tested in the presence and in the absence of exposure to a non-cytotoxic dose of simulated solar light. Cytotoxicity in this test is expressed as a concentration-dependent reduction of the uptake of the vital dye Neutral Red when measured 24 hours after treatment with the test chemical and irradiation.The test chemical together with the irradiation may alter the cell surface and in effect may result in a decreased uptake and binding of the Neutral Red Dye. Differences in this uptake can be measured with a spectrophotometer, which allows in essence the distinction and quantification between viable, damaged or dead cells.
The 3T3-NRU-PT-assay gained regulatory acceptance in all EU Member States in 2000 and in the OECD Member States in 2004 as Test Guideline (TG) 432. It is now widely used in the chemical and cosmetics industries.
Source: IHCP, Phototoxicity.
 Accreditation
From REGULATION (EC) No 765/2008 of the European Parliment and Council:
10. ‘accreditation’ shall mean an attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity
12.‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled
13.‘conformity assessment body’ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection
Source: European Commission's REGULATION (EC) No 765/2008
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 acute dermal toxicity test
For the OECD TG 402, Acute Dermal Toxicity, a test substance is applied to no less than 10% of the area of the skin of rats, rabbits, or guinea pigs, followed by 14 days of observation. Death of the animals is used to determine an LD50 value.
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.
This Test Guideline is intended primarily for use with rodents (rat, rabbit or guinea pig may be used). For each dose at least 5 animals (of the same sex) are used. The test substance is applied to the skin (not less than 10 per cent of the body surface area) in graduated doses to several groups of experimental animals, one dose being used per group. At least three dose levels should be used, appropriately spaced to produce a dose-response curve. A limit test of at least 2000 mg/kg could be made. The observation period should be at least 14 days. During the first day the animals should be observed frequently and then the observations should be made daily. Necropsy of all animals should be carried out and all gross pathological changes should be recorded. A study of acute toxicity by the dermal route and determination of a dermal LD provides an estimate of the relative toxicity of a substance by the dermal route of exposure and they may serve as a basis for classification and labeling. It is an initial step in establishing a dosage regimen in subchronic and other studies and may provide information on dermal adsorption and the mode of toxic action of a substance by this route.
Sources:

- ALT Tox web site
- OECD(1987), Test No. 402: Acute Dermal Toxicity, OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects, OECD Publishing. doi: 10.1787/9789264070585-en
See IHCP's disclaimer on linked sites
 acute dermal toxicity test
For the OECD TG 402, Acute Dermal Toxicity, a test substance is applied to no less than 10% of the area of the skin of rats, rabbits, or guinea pigs, followed by 14 days of observation. Death of the animals is used to determine an LD50 value.
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.
This Test Guideline is intended primarily for use with rodents (rat, rabbit or guinea pig may be used). For each dose at least 5 animals (of the same sex) are used. The test substance is applied to the skin (not less than 10 per cent of the body surface area) in graduated doses to several groups of experimental animals, one dose being used per group. At least three dose levels should be used, appropriately spaced to produce a dose-response curve. A limit test of at least 2000 mg/kg could be made. The observation period should be at least 14 days. During the first day the animals should be observed frequently and then the observations should be made daily. Necropsy of all animals should be carried out and all gross pathological changes should be recorded. A study of acute toxicity by the dermal route and determination of a dermal LD provides an estimate of the relative toxicity of a substance by the dermal route of exposure and they may serve as a basis for classification and labeling. It is an initial step in establishing a dosage regimen in subchronic and other studies and may provide information on dermal adsorption and the mode of toxic action of a substance by this route.
Sources:

- ALT Tox web site
- OECD(1987), Test No. 402: Acute Dermal Toxicity, OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects, OECD Publishing. doi: 10.1787/9789264070585-en
See IHCP's disclaimer on linked sites
 acute systemic toxicity testing
Acute systemic toxicity testing is the estimation of the human hazard potential of a substance by determining its systemic toxicity in a test system (currently animals) following an acute exposure. Its assessment has traditionally been based on the median lethal dose (LD50) value - an estimate of the dose of a test substance that kills 50% of the test animals. For a substance to have systemic toxic effects it must be absorbed by the body and distributed by the circulation to sites in the body where it exerts toxic effects. The liver may transform a circulating drug or chemical to another form (biotransformation), and this new metabolite may be the one causing the observed toxicity.
Acute systemic toxicity is assessed following oral, dermal, and/or inhalation exposure(s) - depending upon the anticipated routes of human exposure to the substance.
Source: ALT Tox web site
See IHCP's disclaimer on linked sites
 acute toxicity
The term acute toxicity is used to describe the adverse effects, which may result from a single exposure (i.e. a single exposure or multiple exposures within 24 hours) to a substance. Exposure relates to the oral, dermal or inhalation routes.
Source: ECHA, Guidance on information requirements and chemical safety assessment - Chapter R.7a: Endpoint specific guidance
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 ADME
ADME is an acronym in pharmacokinetics and pharmacology for absorption, distribution, metabolism, and excretion, and describes the disposition of a pharmaceutical compound within an organism.
Source: Wikipedia
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 AFFSET
AFSSET (Agence française de sécurité sanitaire de l'environnement et du travail - French Agency for Environmental and Occupational Health Safety), now ANSES (following its merging, on 1st July 2010, with the former French Food Safety Agency - AFSSA).
Source: ANSES web site
 AgBB
AgBB (Ausschuss zur gesundheitliche Bewertung von Bauprodukten) is the German Committee for Health-related Evaluation of Building Products.
 Alternative test methods
The term "alternative" is generally associated with the Principles of the 3Rs, - Replacement, Reduction and Refinement - of animal testing. In this context an alternative method serves to fully replace an animal test, to reduce the number of animals needed in a test, or to refine an animal testing procedure in order to reduce pain and suffering.
Alternative test methods that are developed to reduce or replace animal experiments are typically based on either in vitro systems or on computer-based models.
In vitro test methods use (reconstructed) tissues, whole cells or parts of cells. Recent advances in cell-based research include the development of two-dimensional and three-dimensional cell (co)-cultures which mimic very closely cells and tissues in the human body.
The growing use of 'omics' technologies (e.g. transcriptomics, proteomics and metabonomics) in combination with in vitro test systems allows a comprehensive analysis of the impact of a chemical at the molecular level and can indicate potential toxicity pathways that may lead to adverse health effects.
Computer-based approaches (often termed in silico or non-testing methods) are becoming increasingly powerful and can be used effectively to predict the toxicity of a chemical from its basic properties. Computer models are also an important tool for efficiently integrating toxicological information derived from complimentary in vitro and in silico methods.
A non-testing approach frequently used in the safety assessment of industrial chemicals, for example, is called 'read-across' technique where toxicological effects for one chemical are predicted using data for the same toxicological effect from another chemical, which is considered to be similar in terms of chemical structural, physico-chemical properties, or bioactivity.
Source: EURL ECVAM.
 Ames test
The Ames test is a biological assay to assess the mutagenic potential of chemical compounds. A positive test indicates that the chemical might act as a carcinogen (although a number of false-positives and false-negatives are known). As cancer is often linked to DNA damage, the test also serves as a quick assay to estimate the carcinogenic potential of a compound since it is difficult to ascertain whether standard carcinogen assays on rodents were successful. The procedure is described in a series of papers from the early 1970s by Bruce Ames and his group at the University of California, Berkeley.
Source: Wikipedia.
See IHCP's disclaimer on linked sites.
 ANSES
ANSES (Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail - French National Agency on Food Safety, Environment, and Workplace Security) is a French public authority reporting to the Ministries of Health, Agriculture, the Environment, Labour and Consumer Affairs.
It was founded on 1st July 2010 following the merger of two French health agencies, the French Food Safety Agency (AFSSA) and the French Agency for Environmental and Occupational Health Safety (AFSSET).
Source: ANSES web site
 AOP
AOPs (adverse outcome pathways) delineate the documented, plausible, and testable processes by which a chemical induces molecular perturbations (Molecular Initiating Events) and the associated biological responses that describe how the molecular perturbations cause effects at the subcellular, cellular, tissue, organ, whole animal, and population levels of observation.
Source: T.W. Schutz (OECD), What is the Adverse Outcome Pathway (AOP) concept?
An adverse outcome pathway (AOP) is the sequence of events from the chemical structure of a targetchemical or group of similar chemicals through the molecular initiating event to an in vivo outcome ofinterest. Each AOP represents the existing knowledge concerning the linkage(s) between a molecularinitiating event, intermediate events and an adverse outcome at the individual or population level.
Source: OECD,The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins -Part 1: Scientific Evidence -Series on Testing and AssessmentNo.168,2012, page 18.
 ARTA
Androgen Receptor Transactivation Assays
 assay
An assay or test method is a definitive procedure that produces a test or assay result.
A test can be considered as technical operation that consists of determination of one or more characteristics of a given product, process or service according to a specified procedure. Often a test is part of an experiment.
The test result can be qualitative (yes/no), categorical, or quantitative (a measured value). It can be a personal observation or the output of a precision measuring instrument.
Usually the test result is the dependent variable, the measured response based on the particular conditions of the test or the level of the independent variable. Some tests, however, involve changing the independent variable to determine the level at which a certain response occurs: in this case, the test result is the independent variable.
Freely elaborated from: Wikipedia
See IHCP's disclaimer on linked sites
 BALB/3T3 cells
This cell line is able, using the test called 'cell transformation assay', to identify the carcinogenic potential of chemicals in vitro.
The BALB/3T3 is one of several cell lines developed by S.A. Aaronson and G.T. Todaro in 1968 from BALB/c mouse embryos.
BALB/c is an albino, laboratory-bred strain of the House Mouse originated in New York in 1920, from which a number of common substrains are derived.
The '3T3' designation refers to the abbreviation of "3-day transfer, inoculum 3 x 105 cells." This cell line was originally established from the primary mouse embryonic fibroblast cells that were cultured by the designated protocol, so-called '3T3 protocol'. The primary mouse embryonic fibroblast cells were transferred (the "T") every 3 days (the first "3"), and inoculated at the rigid density of 3 x 105 cells per 20-cm² dish (the second "3") continuously. The spontaneously immortalized cells with stable growth rate were established after 20-30 generations in culture, and then named '3T3' cells.
Source: Wikipedia.
SeeIHCP's disclaimer on linked sites
 BCS
Breast Cancer Services
 Behavioural Economics (BE)
Behavioural Economics (BE) essentially studies the effects of social, cognitive and emotional factors on the economic decisions of individuals and institutions and the consequences for market prices, returns, resource allocations and public policy.
Using experimental and advanced empirical techniques, BE identifies individual and group behaviours and social phenomena that are not adequately explained by traditional economical analysis. As a result, new models can be developed that are better able to explain "irrational" economic behaviour.
These models draw on the basic principles of game theory and incorporate aspects of emotions, reciprocity, fairness, social capital, bounded rationality, etc.
BE is cross-disciplinary by its nature as it combines research findings across a wide range of scientific fields including psychology, sociology, medicine, and neuroscience.
Source: IHCP.
 Best practice
A method or technique that has consistently shown results superior to those achieved with other means, and that is used as a benchmark. The term is also used to describe the process of developing and following a standard way of doing things that multiple organizations can use.
Source: Bogan, C.E. and English, M.J., 1994: Benchmarking for best practices: winning through innovative adaptation. McGraw-Hill, New York
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 BEVABS
European Office for Wine, Alcohol and Spirit Drinks -
Bureau Européen des Vins, Alcohols et des Boissons Spiritueuses
 bioaccumulation
According to international guidelines, “bioaccumulation” is defined as the process where the chemical concentration in an aquatic organism achieves a level that exceeds that in the water as a result of chemical uptake through all routes of chemical exposure (e.g. dietary absorption, transport across the respiratory surface, dermal absorption). Bioaccumulation typically takes place under field conditions and is a combination of chemical bioconcentration and biomagnification (the process by which lipid normalized chemical concentrations increase with trophic level in a food-chain). The extent of chemical bioaccumulation is usually expressed in the form of a bioaccumulation factor (BAF), which is the ratio of the chemical concentration in the organism (CB) and the water (CW), including the uptake in the diet.
Source: CAESAR project
SeeIHCP's disclaimer on linked sites
 bioassay
Bioassay (biological assay), or biological standardization is a type of scientific experiment. Bioassays are typically conducted to measure the effects of a substance on a living organism and are essential in the development of new drugs and in monitoring environmental pollutants. Both are procedures by which the potency or the nature of a substance is estimated by studying its effects on living matter.
Source: Wikipedia
See IHCP's disclaimer on linked sites.
 Biocidal Products Directive
Directive 98/8/EC of the European Parliament and of the Council on the placing on the market of biocidal products was adopted in 1998. According to the Directive, Member States had to transpose the rules before 14 May 2000 into national law. The Commission adopted the original proposal for the Directive in 1993. Directive 91/414/EEC on plant protection products, adopted in 1991, served as a model for the new Directive.
The Biocidal Products Directive aims to harmonise the European market for biocidal products and their active substances. At the same time it aims to provide a high level of protection for humans, animals and the environment.
Source: Europa, Environment web site
 biokinetics
Time-course of a chemical in a living organism, i.e., increase or decrease of substance at site of measurement due to transport or due to formation or breakdown. The term "toxicokinetics" is also often used synonymously.
Source: AA. VV.,Toxicity Testing for Human Health Risk Assessment,in Risk Assessment of Chemicals,2007, 227-280, DOI: 10.1007/978-1-4020-6102-8_6
 biological pathway
A biological pathway is a number of biochemical steps, linked together, with a start and an end. The activity within a pathway should is a flow of molecules. Some typical types of biochemical pathways are metabolic pathways and signaling pathways. The Reactome is a curated information source, with information about specific pathways.
Source: Wikipedia.
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 biologics
Biologics (or biologicals) include a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins created by biological processes (as distinguished from chemistry).
Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other technologies.
Source: Wikipedia
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 Bionomics
Bionomics (Greek: bio = life; nomos = law) is the comprehensive study of an organism and its relation to its environment.
Source: Wikipedia.
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