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A positive association between an agent and an effect may be interpreted as implying causality, to a greater or lesser extent, if the following criteria are met: (a) there is not identifiable positive bias; (b) the possibility of positive confounding has been considered; (c) the association is unlikely to be due to chance alone; (d) the association is strong; and (e) there is a dose-response relationship (IARC, 1990).
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It is also recognized that risk management is a complex multidisciplinary procedure that is seldom codified or uniform, frequently unstructured, but which can respond to evolving input from a wide variety of sources (Stern, 1986).
In the case of substances for which the critical effect is not carcinogenicity, it is generally assumed that there is a level of exposure below which the probability for an adverse effect to occur is minimal, if not zero (i.e.
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Hazard identification is based on analyses of a variety of data that may range from observations in humans to analysis of structure-activity relationships.
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Dose-response assessment is the process of characterizing the relationship between the dose of an agent administered or received and the incidence of an adverse health effect.
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organ-specific, neurological/behavioural, immunological, non-genotoxic carcinogenesis, reproductive or developmental), it is generally considered that there is a dose or concentration below which adverse effects will not occur (i.e.
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It is designed to address primarily two questions: (1) whether an agent may pose a health hazard to human beings, and (2) under what circumstances an identified hazard may be expressed.
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If a threshold has been assumed (e.g., for non-neoplastic effects and non-genotoxic carcinogens), traditionally, a level of exposure below which it is believed that there are no adverse effects, based on a no-observed-adverse-effect level (NOAEL) (approximation of the threshold) and uncertainty factors, has been estimated.
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Increasingly, however, the "benchmark dose", a model-derived estimate (or its lower confidence limit) of a particular incidence level (e.g., 5%) for the critical effect, is being proposed for use in quantitative assessment of the dose-response for such effects.
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There is no clear consensus on appropriate methodology for the risk assessment of chemicals for which the critical effect may not have a threshold (i.e.