Accuracy is a measure of test performance and describes the proportion of all chemicals tested which are classified as positive and negative for a particular toxicological endpoint and that are predicted respectively as positive and negative by a test being evaluated.
Immediate or short-term adverse reaction of an organism to a single exposure to a chemical substance. References
In the DB-ALM "Adjunct" or "Complementary test" refers to non-animal testing conducted in combination with animal tests to evaluate toxicity, to elucidate mechanisms of toxicity, or to further investigate specific observations without the need to perform additional animal studies. References
An Adverse Outcome Pathway (AOP) is an analytical construct that describes a sequential chain of causally linked events at different levels of biological organisation that lead to an adverse health or ecotoxicological effect. References
Allergic contact dermatitis is a dermal inflammatory response which occurs after a re-exposure to a chemical several weeks, months, or years after the first exposure. Unlike irritation, allergic contact dermatitis takes time to develop and appears only after the second or third exposure.
The term 'alternatives' refers to all the 3Rs (reduction, refinement and replacement) of Russell and Burch (1959).Current focus of the DB-ALM is to provide descriptions of scientific methods and/or non-animal models or test systems used mainly for toxicological evaluations without relying on animal use.
The use of animals as investigational subjects. References
Procedures, such as Tissue Culture Techniques;mathematical models; etc., when used or advocated foruse in place of the use of animals in research ordiagnostic laboratories. References
Index term in use by the EMTREE Thesaurus of Elsevier B.V. (NL). References
Index term in use by the EMTREE Thesaurus of Elsevier B.V. (NL). References
Index term in use by the EMTREE Thesaurus of Elsevier B.V. (NL). References
Alternatives to the use of animals in research, testing, and education. The alternatives may include reduction in the number of animals used, replacement of animals with a non-animal model or with animals of a species lower phylogenetically, or refinement of methods to minimize pain and distress of animals used. References
Classification term in the DB-ALM: Applications and/or policy area of the substances/products for which a given approach is appropriate.
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. References
See: Cytotoxicity, general or basal
Between-laboratory (interlaboratory) assessment establishes whether or not a test can be successfully transferred from one laboratory to another.
A method of measuring the effects of a biologically active substance using a living organism in vivo or in vitro tissue or cell model under controlled conditions. References
A branch of applied ethics that studies the value implications of practices and developments in life sciences, medicine, and health care.(MeSH)The study of the ethical and moral implications of new discoveries and practices in the biological sciences, biomedicine, and health care.(NALT) References
A field of biology concerned with the development of techniques for the collection and manipulation of biological data, and the use of such data to make biological discoveries or predictions. This field encompasses all computational methods and theories applicable to molecular biology and areas of computer-based techniques for solving biological problems including manipulation of models and datasets. References
Organisms or complex pharmaceutical substances, preparations, or agents of organic origin, usually obtained by biological methods or assay. Biological agents are differentiated from biological factors in that the latter are compounds with biological or physiological activity made by living organisms (From Webster’s 3d ed.). References
The term biological endpoint refers to the biological processes, responses or effects assessed by a given test method. The techniques used to assess the biological endpoint are referred to as endpoint measurement.
Endogenously-synthesized compounds that influence biological processes not otherwise classified under enzymes; hormones or hormone antagonists. References
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. References
Measurable and quantifiable biological parameters(e.g., specific enzyme concentration, specific hormone concentration, specific gene phenotype distribution in apopulation, presence of biological substances) which serve as indices for health- and physiology-related assessments, such as disease risk, psychiatric disorders, environmental exposure and its effects, disease diagnosis, metabolic processes, substance abuse, pregnancy, cell line development, epidemiologic studies, etc. References
Drugs, vaccines, growth hormones or other biologics produced by organisms that have been genetically altered to yield these products. References
Chemical Abstract Service (CAS) Registry is a unique numeric identifier that designates only one substance and has no chemical significance.
A technique for maintaining and/or growing dispersed cells from original tissues, primary culture, cell lines or cell strains. References
Techniques to partition various components of the cell into subcellular fractions. References
The study of the effects of chemicals on biological systems, with emphasis on the mechanisms of adverse effects of chemicals and the conditions under which adverse effects occur.
Adverse reaction of an organism to a continuous or repeated exposure to a chemical substance over a long period of time. References
Computer-based representation of physical systems and phenomena such as chemical processes.(MeSH).Computer-calculated representation of a process, device, or concept in mathematical form.(NALT). References
General cytotoxicity (or basal cytotoxicity) is the result of toxic effects on structures and functions common to all cells of the body, such as DNA, chromosomes, mitochondria, the cytoskeleton and various membranes. A large number of general (basal) cytotoxicity tests have been developed for a wide range of purposes. References
Tissue-specific cytotoxicity involves adverse effects on particular types of differentiated cells, in terms of either their tissue-type specific properties (e.g. hormone production, conductivity, contractility) or their modulation of general cytotoxic effects (e.g. via the metabolic activation or detoxification of xenobiotics).For this purpose have been developed: target organ(system)toxicity tests. References
Cytotoxicology is intended as the study of toxic effects and their mechanism of chemicals and other materials at the cellular level and cytotoxicity is the expression of adverse effects on structural and/or functional properties of one or more cell components. References
EURL ECVAM DataBase service on ALternative Methods to animal experimentation.
The action of a drug that may affect the activity, metabolism, or toxicity of another drug. References
Used as a drug subheading to identify a drug or chemicalthat is toxic in animals (including LD50 tests), in animalor human cells and tissues, and in other toxicity studies.In humans, used to signal toxicity at non-therapeuticdose ranges, or when lasting damage is caused at therapeuticdose ranges. References
Any chemical compounds, including nutrients, that are used in the prevention, diagnosis, treatment, or cure of disease, for the relief of pain, or to control or improve any physiological or pathological disorder in humans or animals. References
European Centre for the Validation of Alternative Methods. As of 2011, ECVAM has been established as the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM).
European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM, formerly referred to as ECVAM).
The endpoint measurement refers to the analytical techniques used to assess the endpoints.
Any biological, chemical or physical object whose characteristics will change when in contact with a test compound of given properties. In alternative methods most common experimental systems are organs, 3-dimensional organotypic cultures, cell lines, organelles and biomolecules. Also referred to as Test System in Good Laboratory Practice terminology.
Parts of a living organism, such as cells, tissues, or organs, which are transferred to an artificial medium for culture. References
Globally Harmonized System of Classification and Labeling of Chemicals, an internationally agreed-upon system, created and implemented by the United Nations. References
Is a quantitative expression of the adverse effects elicited by a chemical under defined conditions of exposure. References
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a trilateral (EU-Japan-USA) programme bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. References
The term in silico refers to the computer simulations using mathematical models to predict the properties and behavior of chemical or biological entities without conducting physical experiments.
From the Latin meaning, literally: in glass. Experiments are performed in test tubes or elsewhere outside living organisms.
In vitro systems (subcellular fractions, cell-, tissue- and organ cultures) isolate the system under study from the rest of the organism. New developments in culture technology enable the use of further in vitro systems in the various areas of biomedical sciences, such as the use of monoclonal antibodies.
The opposite to: in vitro. Experiments are performed on a living organism.
The IUPAC International Chemical Identifier, a non-proprietary identifier for chemical substances that can be used in printed and electronic data sources thus enabling easier linking of diverse data compilations.
Integrated Approaches to Testing and Assessment (IATA) are structured approaches that integrate and weigh different types of data for the purposes of performing hazard identification (i.e. the potential to cause a hazard), hazard characterization (e.g. the toxic potency) and/or safety assessment (i.e. the potential/toxicity potency related to exposure) of a chemical or group of chemicals. The IATA is considered a generic approach and may encompass testing strategies such as integrated testing strategies (ITS), sequential testing strategies (STS), as well as weight of evidence (WoE) considerations. References
Integrated Testing Strategy (ITS) is a combination of test batteries covering relevant mechanistic step and organized in a logical, hypothesis-driven decision scheme, which is required to make efficient use of generated data and to gain a comprehensive information basis for making decisions regarding hazard or risk. Unlike in tiered approaches, the sequence of tests is not necessarily prescribed ahead of time but tailored to the chemical-specific situation. References
See 'between-laboratory' assessment.
Irritant contact dermatitis can occur, given an adequate exposure to the toxic material, and unlike allergic dermatitis, it does not require any previous exposure to the same substance.
Lowest Observed Effect Level. In a toxicological study, the lowest dose or exposure level at which a statistically or biologically significant effect is observed in the exposed sample compared with an appropriate unexposed control.
The science and technology dealing with the procurement, breeding, care, health, and selection of animals used in biomedical research and testing. References
Experimental animals used either as the subject of researchor as an experimental tool; For animal models of human diseasesUSE animal models; For mathematical models, e.g.animal genetics, USE mathematical models. References
In the DB-ALM is intended as one of the factors to be taken into account when assessing the value of no-animal toxicity tests and testing strategies and is defined by assessing toxic potential, potency and hazard of a chemical. References
A file format for holding information about the atoms, bonds, connectivity and coordinates of a molecule.
No Observed (Adverse) Effect Level. In a toxicological study: an exposure level at which there are no statistically or biologically significant increases in the frequency or severity of any effect between the exposed sample and its appropriate control.
Maintenance or growth of animal and plant organs in vitro, originating from three-dimensional cultures of undisaggregated cells in a manner that retains some or all of the histological features of the tissue in vivo. References
The study of the origin, nature, properties, and actions of drugs and their effects on living organisms. References
Photoallergy is an acquired immunological reactivity. The skin reaction does not occur on the first treatment with chemical and light. Rather, an induction period of one or two weeks is required before skin reactivity can be demonstrated.
The term photoirritation describes phototoxic reactions in skin which are produced with topically applied substances following exposure to light.
Photosensitisation is defined as a process in which reactions to normally ineffective radiation doses are induced in a system by the introduction of a specific, radiation-absorbing substance (photosensitiser) which causes another substance (substrate) to be changed by radiation. When used to describe the reaction of skin to an exogenous chemical or UV or visible radiation, the term includes both phototoxic and photoallergic reactions. Chemical photosensitisation as an adverse reaction may be induced by a broad spectrum of industrial or therapeutic agents, which may enter the body by ingestion, inhalation or injection, or by topical application to the skin. Photosensitisation reactions are mostly associated with absorption of UVA (or, with dyes, absorption of visible light).
Phototoxicity is an acute reaction which can be caused by single treatment with a chemical and UV or visible radiation. In vivo, the reaction can be evoked in all subjects in which both the concentration of the chemical and the dose of light are appropriate. 'Acute' includes both immediate and delayed (e.g. after 48 hours) reactions.
Procedure refers to a test, test battery or testing strategy.
Protocol refers to a precise step-by-step description of a test that allows the performance of that test in the laboratory.
In the DB-ALM is intended as one of the factors to be taken into account when assessing the value of no-animal toxicity tests and testing strategies and it gives information on whether the test is used for general classification and labelling or specifically for workers and patients protection. References
Any decrease in the numbers of animals used to obtain information of a given amount and precision.
Any decrease in the incidence or severity of procedures applied to animals necessarily used.
Relevance of a procedure describes whether it is meaningful and useful for a particular purpose.
Reliability of a procedure describes whether it can be performed reproducibly within and between laboratories and over time.
Replacement describes those methods/models which permit a given purpose to be achieved without conducting experiments or other scientific procedures on whole animals. The substitution of conscious living higher animals by the use of non-sentient material.
In the context of experimental methods, robustness is the insensitivity of test results to departures from the specified test conditions when conducted in different laboratories or over a range of conditions under which the test method might normally be used. If a test is not robust, it will be difficult to use in a reproducible manner within and between laboratories. References
In the DB-ALM "screening" is a preliminary testing activity, which implies that there will subsequently be more definitive testing. Screening tests are normally used for preliminary decision making and priority setting. References
Sensitivity is a measure of test performance and describes the proportion of all chemicals tested which are classified as positive for a particular toxicological endpoint and that are predicted as positive by a test being evaluated.
Skin corrosion refers to the full-thickness necrosis of the skin, caused by the direct contact with a chemical substance. References
Skin irritation refers to the inflammation of the skin, visible as erythema and/or edema, caused by the direct contact with a chemical substance. Symptoms will disappear after the substance is removed but some morphological changes may remain visible after healing: alopecia, scaling, hyperkeratosis and hyperplasia. References
Specificity is a measure of test performance, and describes the proportion of all chemicals tested which are classified as negative for a particular toxicological endpoint and that are predicted as negative by a test being evaluated.
Components of a cell produced by various separation techniques which, though they disrupt the delicate anatomy of a cell, preserve the structure and physiology of its functioning constituents for biochemical and ultrastructural analysis. (From Alberts et al., Molecular Biology of the Cell, 2d ed, p163) References
Threshold of Toxicological Concern. The term is used to describe a human exposure threshold value, below which there is a very low probability of any adverse effect to human health. Mostly used for chemicals for which no direct toxicological data are available and predictions are made based on chemical structure and toxicity data of structurally related chemicals.
See: Cytotoxicity, tissue-specific
Test refers to the combination of the experimental system used, exposure conditions, endpoint, endpoint measurement and data analysis method.
Test development is the process by which the components of a protocol (for example, experimental system, exposure conditions, endpoint, endpoint measurement and data analysis procedures) are defined for a specific purpose, and is normally carried out in the laboratory of origin.
A thesaurus is an alphabetically and systematically ordered collection of all terms, synonyms and other semantically related expressions for a given topic area.
It refers to in vitro systems in which the loss of cell-cell interactions is avoided by the use of fragments or slices of tissue in which the normal architecture of the normal tissue is maintained.
Classification term in the DB-ALM: Field of application of a given method (e.g. area of toxicology, cancer research or production and quality control of biologicals).
Is a measure of the relative toxicity of a chemical and can be used for the ranking of chemicals and/or their classification. References
Refers to the inherent toxicological properties of a chemical, i.e. the possibility that toxicity can occur, with no concern for its likelihood or severity. References
An array of tests used to determine the toxicity of a substance to living systems. These include tests on clinical drugs, foods, and environmental pollutants. References
The science concerned with the detection, chemical composition, and biological action of toxic substances or poisons and the treatment and prevention of toxic manifestations. References
In the DB-ALM is intended as one of the factors to be taken into account when assessing the value of no-animal toxicity tests and testing strategies; it specifies whether the test is used for screening, adjunct or replacement purposes. References
The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration. References
Suspensions of killed or attenuated microorganisms (bacteria, viruses, fungi, protozoa), antigenic proteins, synthetic constructs, or other bio-molecular derivatives, administered for the prevention, amelioration, or treatment of infectious and other diseases. References
Validation is the process by which the reliability and relevance of a procedure are established for a specific purpose.
Within-laboratory assessment establishes whether or not a test can be successfully established in one laboratory.
A chemical foreign to the biological system, structurally distinct from endogenous compounds present within.