title: Exposure Factor considerations for safety evaluation of modern disposable diapers.
abstract: Modern disposable diapers are complex products and ubiquitous globally. A robust safety assessment for disposable diapers include two important exposure parameters, i) frequency of diaper use & ii) constituent transfer from diaper to skin from direct and indirect skin contact materials. This article uses published information and original studies to quantify the exposure parameters for diapers. Using growth tables for the first three years of diapered life, an average body weight of 10-11 kg can be calculated, with a 10th percentile for females (8.5-8.8 kg). Data from surveys and diary studies were conducted to determine the frequency of use of diapers. The overall mean in the US is 4.7 diapers per day with a 75th, 90th, and 95th percentile of 5.0, 6.0, and 7.0 respectively. Using diaper topsheet-lotion transfer as a model, direct transfer to skin from the topsheet was 3.0-4.3% of the starting amount of lotion. Indirect transfer of diaper core materials as a measure of re-wetting of the skin via urine resurfacing back to the topsheet under pressure was estimated at a range of 0.32-0.66% averaging 0.46%. As described, a thorough data-based understanding of exposure is critical for a robust exposure based safety assessment of disposable diapers.
authors: The Procter & Gamble Company, Cincinnati, OH, USA. Electronic address: dey.s.3@pg.com.
authors: Swatee
authors: S
authors: Dey
authors: The Procter & Gamble Company, Cincinnati, OH, USA.
authors: Mike
authors: M
authors: Purdon
authors: Procter & Gamble Service GmDH, Schwalbach, Germany.
authors: Taryn
authors: T
authors: Kirsch
authors: Procter & Gamble Service GmDH, Schwalbach, Germany.
authors: HansMartin
authors: H
authors: Helbich
authors: The Procter & Gamble Company, Cincinnati, OH, USA.
authors: Kenny
authors: K
authors: Kerr
authors: The Procter & Gamble Company, Cincinnati, OH, USA.
authors: Lijuan
authors: L
authors: Li
authors: The Procter & Gamble Company, Cincinnati, OH, USA.
authors: Shaoying
authors: S
authors: Zhou
mesh_terms: D002675:Child, Preschool; D041381:Diapers, Infant / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D018570:Risk Assessment; D012449:Safety; D012867:Skin / Q000378:metabolism*; D063465:Skin Cream / Q000008:administration & dosage* / Q000009:adverse effects* / Q000737:chemistry / Q000493:pharmacokinetics; D013499:Surface Properties; D018675:Toxicity Tests
keywords: Baby; Children; Diaper safety; Disposable baby diapers; Exposure; Exposure based safety assessment