Exposure Factor considerations for safety evaluation of modern disposable diapers

- Disposable diapers are 3D products with varied 'in use' constituent exposure scenarios.
- Understanding habits and practices of diapers is critical for a robust exposure based safety assessment.
- Average diaper frequency of use is 4.7 per day.
- Default direct and indirect skin contact constituent transfer is 3-4.3% and 0.32-0.66% respectively.

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.