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Regul Toxicol Pharmacol. 1998 Feb;27(1 Pt 2):3-20.

Human variability and noncancer risk assessment- An analysis of the default uncertainty factor

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Clinical Pharmacology Group, University of Southampton, Biomedical Sciences Building, Bassett Crescent East, Southampton, SO16 7PX, United Kingdom.


A 10-fold uncertainty factor is used for noncancer risk assessments to allow for possible interindividual differences between humans in the fate of the chemical in the body (kinetics) and target organ sensitivity (dynamics). Analysis of a database on the variability in each of these aspects is consistent with an even subdivision of the 10-fold factor into 10(0.5) (3.16) for kinetics and 10(0.5) (3.16) for dynamics. Analysis of the number of subjects in a normally and log-normally distributed population which would not be covered by factors of 3.16 supports this subdivision and also the use of a 10-fold factor to allow for both aspects. Analysis of kinetic data for subgroups of the population indicates that the standard default value of 3.16 for kinetics will not be adequate for all routes of elimination and all groups of the population. A scheme is proposed which would allow the selection of appropriate default uncertainty factors based on knowledge of the biological fate and effects of the chemical under review.


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