Use of an aggregate exposure model to estimate consumer exposure to fragrance ingredients in personal care and cosmetic products
B. Safford, A.M. Api, C. Barratt, D. Comiskey, E.J. Daly, G. Ellis, C. McNamara, C. O’Mahony, S. Robison, B. Smith, R. Thomas, S. Tozer
B-Safe Toxicology Consulting, Northants United Kingdom; Research Institute for Fragrance Materials, Woodcliff Lake, United States; Unilever, Safety and Environmental Assurance Centre, Beds, United Kingdom; Creme Global Ltd, The Tower, Dublin , Ireland; Givaudan International S.A., Vernier, Switzerland; The Procter and Gamble Company, Mason, United States; Firmenich Inc., Princeton, United States; Procter&Gamble, Surrey United Kingdom)
Regulatory Toxicology and Pharmacology (72, Issue 3, August 2015), pp 673–682
• A probabilistic model to estimate aggregate exposure to fragrances is described.
• The model can determine both systemic and dermal aggregate exposure.
• 2-Phenylethanol is used as an example to demonstrate the use of the model.
• Output is shown which illustrates the utility of the model.
• The model provides valuable information for risk assessment and risk management.
Ensuring the toxicological safety of fragrance ingredients used in personal care and cosmetic products is essential in product development and design, as well as in the regulatory compliance of the products.
This requires an accurate estimation of consumer exposure which, in turn, requires an understanding of consumer habits and use of products. Where ingredients are used in multiple product types, it is important to take account of aggregate exposure in consumers using these products.
This publication investigates the use of a newly developed probabilistic model, the Creme RIFM model, to estimate aggregate exposure to fragrance ingredients using the example of 2-phenylethanol (PEA). The output shown demonstrates the utility of the model in determining systemic and dermal exposure to fragrances from individual products, and aggregate exposure.
The model provides valuable information not only for risk assessment, but also for risk management. It should be noted that data on the concentrations of PEA in products used in this article were obtained from limited sources and not the standard, industry wide surveys typically employed by the fragrance industry and are thus presented here to illustrate the output and utility of the newly developed model. They should not be considered an accurate representation of actual exposure to PEA.(…)”
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