Case studies using the probabilistic aggregate consumer exposure model (PACEM) for cosmetics ingredient safety
Camilla Alexander-White1, Catherine Barratt2, Dagmar Bury3
1MKTox & Co Ltd, c/o LB Group, 80 Compare Crescent, Ipswich, IP2 0EH, UK.
Regulatory Toxicology and Pharmacology : RTP
|May 2, 2025
Summary
The Probabilistic Aggregate Consumer Exposure Model (PACEM) tool helps assess cosmetic ingredient safety. Case studies show PACEM provides credible data for regulatory submissions, aiding consumer safety assessors.
Area of Science:
- Cosmetic Science
- Toxicology
- Risk Assessment
Background:
- Consumer safety assessment requires robust exposure data for cosmetic ingredients.
- Existing tools may not adequately capture aggregate exposure from multiple products.
- Probabilistic modeling offers a sophisticated approach to exposure estimation.
Purpose of the Study:
- To evaluate the functionality and performance of the PACEM webtool.
- To assess PACEM's utility for cosmetic ingredient exposure assessment.
- To determine the credibility of PACEM outputs for regulatory dossiers.
Main Methods:
- Utilized case studies with cosmetic ingredients: propyl paraben, salicylic acid, methyl salicylate, D5, and methylisothiazolinone.
- Employed probabilistic mathematical modeling incorporating European consumer habits and practices data.
- Focused evaluation on cosmetic product exposure assessment within the PACEM framework.
Main Results:
- PACEM successfully estimated aggregate consumer exposure to cosmetic ingredients.
- The tool generated key exposure metrics: external dose, internal systemic exposure dose (SED), and dermal load.
- Case studies demonstrated PACEM's ability to handle ingredient exposure across multiple product types.
Conclusions:
- PACEM is a valuable and free online tool for cosmetic safety assessors.
- The webtool generates credible exposure data suitable for regulatory dossier submissions.
- PACEM enhances the accuracy of consumer safety assessments for cosmetic products.

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