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• W2017133676 abstract "ABSTRACT The Reference Dose (RfD) is used in the risk assessment of non-carcinogenic chemicals. It is derived by dividing a point of departure by the product of the uncertainty (UFs) and modifying factors (MFs). Separate UFs are used for different variables, e.g., intraspecies variation and, in general, each UF is an order of magnitude (10-fold). On the other hand, the MF is usually based on some known variable such as differences in absorption of a chemical from food and water and its default value is one. The USEPA's Integrated Risk Information System (IRIS) has 14 chemicals that have RfDs based on human studies. We examined those IRIS files to determine the rationale for setting human intraspecies uncertainty factors (UFH). The first consideration was that the chemical had an adequate peer-reviewed human database. Without such, it would not be possible to derive an RfD based on human data. Ten of the 14 chemicals had an UFH of 1 or 3; four of these were essential trace elements (ETEs). The rationales for using less than a 10-fold UFH for the ETEs included; 1) nutritional data, 2) large human exposure groups, 3) minimal effect levels and/or 4) several studies with similar effect levels. For the other compounds, reasons included; 1) large human exposure groups, 2) a critical effect that was not adverse (cosmetic), 3) the most sensitive population was exposed, 4) the compound was on the FDA's “generally regarded as safe” (GRAS) list, 5) database uncertainties and 6) less-than-lifetime exposure adjusted for 70 years exposure. It is important to understand the reasons for selecting a UFH of 1, or 3 as they will apply to future chemicals considered by the USEPA and other agencies." @default.
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• W2017133676 date "2004-02-01" @default.
• W2017133676 modified "2023-09-27" @default.
• W2017133676 title "Some Comments on the Selection of Human Intraspecies Uncertainty Factors" @default.
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• W2017133676 doi "https://doi.org/10.1080/10807030490280936" @default.
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