Uncertainty in toxicological risk assessment for non-carcinogenic health effects

Application of the threshold of toxicological concern approach to ingredients in personal and household care products

“…Following Munro et al (1996), a UF of 3 was used to extrapolate from a NOEL in a subchronic study to a chronic NOEL. An additional UF of 3 was used to extrapolate from a NOEL in a subacute study to a NOEL in a subchronic study (Kalberlah et al, 2003;ILO, 2001). This value is consistent with the use of 3 in the original publication, in that it represents the central tendency of the span of values for ratios of NOAELs from 28-day studies when compared to subchronic studies rather than the extremes of the range.…”

“…The default value most commonly used as a maximum for both the subchronic to chronic extrapolation and the extrapolation from LOAEL to NOAEL is 10, with 3 representing more of a central estimate(Dourson et al, 1996;Kalberlah et al, 2003). LOEL values from 28-day studies were not used due to the excessive uncertainty associated with extrapolating from these values to chronic NOELs.…”

Characterization of risk for general population exposure to perfluorooctanoate

“…Current methods for qualitatively assigning uncertainty factors in a deterministic approach to assessing risk have been recently reviewed by Kalberlah et al (2003). Most methods currently used to assign uncertainty include factors for intraspecies and interspecies extrapolation.…”

Site‐Specific Applications of Probabilistic Health Risk Assessment: Review of the Literature Since 2000

“…Research and Advisory Institute on Hazardous Substances (Germany) Kalberlah et al (2003) Field-based species sensitivity distributions Proposes a method for deriving sediment quality guidelines from field data of benthic communities and contaminant loadings and suggests using the resulting field-based species sensitivity distributions directly in probabilistic risk assessment.…”

“…In general, uncertainty related to toxicity estimates far exceeds the uncertainty of most exposure parameters and thus could significantly affect remedial policy decisions (Kalberlah et al, 2003). As discussed earlier, probabilistic analysis of PBPK models reveals large uncertainties and variabilities in the modeling results (see MacDonald et al, 2002 as an additional example).…”