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134User Guide for Thresholds and ClassificationsTermDefinitionSee United Nations (2007).sufficient evidence in animalsIn relation to a substance, data that indicate a causal relationship betweenexposure to the substance and:a. an increased incidence of malignant tumours, or of a combination ofbenign and malignant tumours, in:i. two or more species of animal; orii. two or more independent studies in one species carried out at differenttimes, in different laboratories, or under different protocols; orb. malignant tumours that occur to an unusual degree, having regard toincidence, site, type of tumour, or age at onset in a single study in onespecies.See Schedule 4 to the Hazardous Substances (Classification) Regulations2001.sufficient evidence in humansIn relation to a substance, a causal relationship that has been establishedbetween exposure to the substance and the development of human cancer,from which chance, bias, and confounding can be ruled out with reasonableconfidence.See Schedule 4 to the Hazardous Substances (Classification) Regulations2001.target organ, systemic toxicityToxicologically significant effects on the function or morphology of an organ oron the biochemistry or haematology of a human.See Schedule 4 to the Hazardous Substances (Classification) Regulations2001.TD LOThe lowest toxic dose, that is, the minimum amount of a substance that is toxicto a specified type of animal.teratogenicitytoxicodynamicstoxicokineticsThe potential to cause the production of non-heritable structural malformationsor defects in offspring.See IUPAC (2007).The process of interaction of potentially toxic substances with target sites, andthe biochemical and physiological consequences leading to adverse effects.See IUPAC (2007).Generally, the overall process of the absorption (uptake) of potentially toxicsubstances by the body, the distribution of the substances and their metabolitesin tissues and organs, their metabolism (biotransformation), and the eliminationof the substances and their metabolites from the body.See IUPAC (2007).μmurticariamicron(s)A vascular reaction of the skin marked by the transient appearance of smooth,slightly elevated patches (for example, wheals and hives) that are redder orpaler than the surrounding skin and often attended by severe itching.January 2012 EPA0109
135User Guide for Thresholds and ClassificationsTermDefinitionSee IUPAC (2007).In relation to a study, means the:a. design of the study methodology accurately reflects the matters the studyseeks to measure; andvalidb. study findings can be extrapolated from the sample used in the study to abroader population.See Schedule 4 to the Hazardous Substances (Minimum Degrees of Hazard)Regulations 2001.ReferencesEMEA 2002. Committee for Proprietary Medicinal Products Note for Guidance on Photosafety Testing,CPMP/SWP/398/01. European Medicines Agency, London.http://www.emea.europa.eu/pdfs/human/swp/039801en.pdfIUPAC (International Union of Pure and Applied Chemistry) 2007. Glossary of terms used in toxicology, 2ndedition (IUPAC Recommendations 2007). Pure and Applied Chemistry 79(7): 1153–1344.United Nations 2007. Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 2ndrevised edition. United Nations, Geneva.January 2012 EPA0109
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