User Guide to Thresholds and Classification - Environmental ...

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