Sensitivity Analysis of Biologically Motivated Model for Formaldehyde-Induced Respiratory Cancer in Humans

analysis of the formaldehyde human model. We show that when the control animals from the National Toxicology Program (NTP) studies are replaced with control animals only from NTP inhalation studies, estimates of human risk are increased by 50-fold. When only concurrent control rats are used, the model does not provide any upper bound (UB) to human risk. No data went into the model on the effectof formaldehyde onthe division rates and deathrates ofinitiated cells. We show that slight numerical perturbations to the Conolly et al. assumptions regarding these rates can be made that are equally consistent with the underlying data used to construct the model, but produce estimates of human risk ranging anywhere from negative up to 10 000 times higher than those deemed by Conolly et al. to be ‘conservative’. Thus, we conclude that estimates of human risk by Conolly et al. (2004) are extremely sensitive to modeling assumptions. This calls into question the basis for the Conolly et al. claim of de minimis human risk and suggests caution in using the model to derive human exposure standards for formaldehyde.