title: The probabilistic aggregate consumer exposure model (PACEM): validation and comparison to a lower-tier assessment for the cyclic siloxane D5.
abstract: Current practice of chemical risk assessment for consumer product ingredients still rarely exercises the aggregation of multi-source exposure. However, focusing on a single dominant source/pathway combination may lead to a significant underestimation of the risk for substances present in numerous consumer products, which often are used simultaneously. Moreover, in most cases complex multi-route exposure scenarios also need to be accounted for. This paper introduces and evaluates the performance of the Probabilistic Aggregate Consumer Exposure Model (PACEM) applied in the context of a tiered approach to exposure assessment for ingredients in cosmetics and personal care products (C&PCPs) using decamethylcyclopentasiloxane (D5) as a worked example. It is demonstrated that PACEM predicts a more realistic, but still conservative aggregate exposure within the Dutch adult population when compared to a deterministic point estimate obtained in a lower tier screening assessment. An overall validation of PACEM is performed by quantitatively relating and comparing its estimates to currently available human biomonitoring and environmental sampling data. Moderate (by maximum one order of magnitude) overestimation of exposure is observed due to a justified conservatism built into the model structure, resulting in the tool being suitable for risk assessment.
authors.affiliation: Institute for Chemical and Bioengineering, ETH Zurich Swiss Federal Institute of Technology, Vladimir-Prelog-Weg 1, 8093 Zurich, Switzerland.
authors.forename: Tatsiana
authors.initials: T
authors.lastname: Dudzina
authors.affiliation: National Institute for Public Health and the Environment (RIVM), P.O. Box 1, Bilthoven, 3720 BA, The Netherlands.
authors.forename: Christiaan J E
authors.initials: CJ
authors.lastname: Delmaar
authors.affiliation: Radboud UMC, Department for Health Evidence (133), P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.
authors.forename: Jacqueline W H
authors.initials: JW
authors.lastname: Biesterbos
authors.affiliation: National Institute for Public Health and the Environment (RIVM), P.O. Box 1, Bilthoven, 3720 BA, The Netherlands.
authors.forename: Martine I
authors.initials: MI
authors.lastname: Bakker
authors.affiliation: National Institute for Public Health and the Environment (RIVM), P.O. Box 1, Bilthoven, 3720 BA, The Netherlands.
authors.forename: Bas G H
authors.initials: BG
authors.lastname: Bokkers
authors.affiliation: Radboud UMC, Department for Health Evidence (133), P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.
authors.forename: Paul T J
authors.initials: PT
authors.lastname: Scheepers
authors.affiliation: National Institute for Public Health and the Environment (RIVM), P.O. Box 1, Bilthoven, 3720 BA, The Netherlands.
authors.forename: Jacqueline G M
authors.initials: JG
authors.lastname: van Engelen
authors.affiliation: Institute for Chemical and Bioengineering, ETH Zurich Swiss Federal Institute of Technology, Vladimir-Prelog-Weg 1, 8093 Zurich, Switzerland.
authors.forename: Konrad
authors.initials: K
authors.lastname: Hungerbuehler
authors.affiliation: Institute for Chemical and Bioengineering, ETH Zurich Swiss Federal Institute of Technology, Vladimir-Prelog-Weg 1, 8093 Zurich, Switzerland. Electronic address: natalie.von.goetz@chem.ethz.ch.
authors.forename: Natalie
authors.initials: N
authors.lastname: von Goetz
mesh_terms: D000328:Adult; D000368:Aged; D003358:Cosmetics / Q000737:chemistry; D004781:Environmental Exposure / Q000009:adverse effects / Q000032:analysis*; D004784:Environmental Monitoring / Q000379:methods*; D005260:Female; D006795:Household Products; D006801:Humans; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D018570:Risk Assessment / Q000379:methods; D012833:Siloxanes / Q000032:analysis*; D055815:Young Adult
chemical_list: D003358:Cosmetics; D012833:Siloxanes; C114768:decamethylcyclopentasiloxane
keywords: Aggregate exposure; Decamethylcyclopentasiloxane; Human biomonitoring; PBPK modeling; Tiered approach