Probabilistic Monte Carlo estimation for quantitative exposure assessment of lotion transfer via baby wipes usage

• Published in: Regulatory toxicology and pharmacology 2016-08, Vol.79, p.54-63
• Main Authors: Dey, Swatee, Carr, Gregory J., Li, Lijuan, Brink, Susanna, Zhou, Shaoying
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Adolescent; Adult; Age Factors; Baby wipes; Child, Preschool; Children; Computer Simulation; Consumer Product Safety; Consumer products; Diapers, Infant; Europe; Exposure based risk assessment; Female; Habits and practices; Humans; Infant; Infant Care - methods; Infant, Newborn; Lotion transfer; Male; Middle Aged; Models, Statistical; Monte Carlo Method; Monte Carlo simulation; Probability; Risk Assessment; Skin - metabolism; Skin Absorption; Skin Cream - administration & dosage; Skin Cream - adverse effects; Skin Cream - metabolism; United States; Young Adult
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2016.05.006

Unique aspects of childhood exposure to products need childs specific exposure data. This study developed a probabilistic exposure model for lotion transfer to diapered skin through normal use of baby wipes in children up to 48 months of age. Monte Carlo simulations used baby wipe diary data from the US, Germany and the UK, body weight data from the US, and lotion transfer data from single and multiple wipes adjusting for separate diaper changes. The models predicted a declining number of wipes used/day with a reduction in lotion transfer as age and body weight increased. Experimental testing on multiple sequential wipes used on an overlapping area showed a reduction in lotion deposition by 23.9% after the first wipe. Overall, the weighted population average over the approximate diapering period of 0–36 months across the three geographies at 50th, 90th, & 95th percentiles, were between 130, 230, 260 mg/kg/day, respectively, and 150, 270, 310 mg/kg/day depending on whether a reduction due to overlap is implemented. The statistical model represents an effective strategy to determine exposure to baby wipes lotion for exposure based risk assessment. •Monte Carlo simulations estimate daily exposures to lotion in baby wipes.•Lotion transfer is reduced after first wipe during subsequent multiple wipe usage.•Lotion exposure at 90th & 95th percentiles was 230 & 260 mg/kg/day respectively.