From worst-case to reality - Case studies illustrating tiered refinement of consumer exposure to cosmetic ingredients.

Autor: Tozer S; Procter & Gamble Technical Centres Ltd, Reading, RG2 0QE, UK., Alexander-White C; MKTox & Co Ltd, c/o LB Group, 80 Compare Crescent, Ipswich, IP2 0EH, UK. Electronic address: ckaw@mktoxconsult.com., Amin R; Avon Products International, 1 Avon Place, Suffern, NY, 10901, USA., Audebert F; FEBEA, 137 Rue de l'Universite 75007, Paris, France., Barratt C; Unilever Safety & Environmental Assurance Centre (SEAC), Colworth Science Park, Sharnbrook, Bedfordshire, MK44 1LQ, UK., O'Brien J; Creme Global, 4th Floor, The Tower, Trinity Technology & Enterprise Campus, Grand Canal Quay, Dublin 2, Ireland., Burke T; Reckitt, Hull, UK., Bury D; Worldwide Safety Evaluation Department, L'Oreal Research and Innovation, 9 Rue Pierre Dreyfus, 92110, Clichy, France., Nguea HD; Worldwide Safety Evaluation Department, L'Oreal Research and Innovation, 9 Rue Pierre Dreyfus, 92110, Clichy, France., Dimopoulou M; Reckitt, Hull, UK., Farahmand S; Edgewell Personal Care, 75 Commerce Drive, Allendale, NJ, 07401, USA., Fritz S; Kao Germany GmbH, Pfungstädter Straße 98-100, 64297, Darmstadt, Germany., Gerber E; Beiersdorf AG, Unnasrasse 48, D-20245, Hamburg, Germany., Giusti A; Cosmetics Europe - The Personal Care Association, Avenue Herrmann-Debroux 40, B-1160, Brussels, Belgium., Goodwin W; Creme Global, 4th Floor, The Tower, Trinity Technology & Enterprise Campus, Grand Canal Quay, Dublin 2, Ireland., Kirsch T; Procter & Gamble, Sulzbacher Str. 40, 65824, Schwalbach am Taunus, Germany., Oreffo V; Unilever Safety & Environmental Assurance Centre (SEAC), Colworth Science Park, Sharnbrook, Bedfordshire, MK44 1LQ, UK., McNamara C; Creme Global, 4th Floor, The Tower, Trinity Technology & Enterprise Campus, Grand Canal Quay, Dublin 2, Ireland.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Sep; Vol. 143, pp. 105436. Date of Electronic Publication: 2023 Jul 08.
DOI: 10.1016/j.yrtph.2023.105436
Abstrakt: Consumer exposure to cosmetic ingredients is estimated in a tiered manner. Simple Tier1 deterministic aggregate exposure modelling generates a worst case estimate of exposure. Tier1 assumes that a consumer uses all cosmetic products concomitantly daily, at maximum frequency, and products always contain the ingredient at the maximum allowed % w/w concentration. Refining exposure assessment from worst case to more realistic estimates uses evidence from surveys of actual use levels of ingredients and Tier2 probabilistic models, where distributions of consumer use data can be applied. In Tier2+ modelling, occurrence data provides evidence of products on the market actually containing the ingredient. Three case studies are presented using this tiered approach to illustrate progressive refinement. The scale of refinements from Tier1 to Tier2+ modelling for the ingredients, propyl paraben, benzoic acid and DMDM hydantoin were: 0.492 to 0.026; 1.93 to 0.042 and 1.61 to 0.027 mg/kg/day exposure dose. For propyl paraben, moving from Tier1 to Tier2+ represents a refinement from 49-fold to 3-fold overestimate of exposure when compared to a maximum estimate of 0.01 mg/kg/day exposure seen in human studies. Such refinements from worst case to realistic levels of exposure estimation can be critical in the demonstration of consumer safety.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: All authors are employed by the Cosmetics Industry. C Alexander-White is an independent consultant in chemicals safety assessment who was commissioned by Cosmetics Europe specifically for this project as a specialist in cosmetics safety evaluation and scientific writer.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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