Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment - A case study with parabens.

Autor: Ouedraogo G; L'Oréal, Research & Innovation, 1 Avenue Eugène Schueller, Aulnay Sous-Bois, France., Alexander-White C; MKTox & Co Ltd, 36 Fairford Crescent, Downhead Park, Milton Keynes, Buckinghamshire, MK15 9AQ, UK., Bury D; L'Oréal, Research & Innovation, 9 rue Pierre Dreyfus, 92110, Clichy, France., Clewell HJ 3rd; Ramboll Health Sciences, 3107 Armand Street, Monroe, LA, 71201, USA., Cronin M; School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 AF, UK., Cull T; Unilever, Safety & Environmental Assurance Centre, Colworth House, Sharnbrook, Bedfordshire, MK44 1ET, UK., Dent M; Unilever, Safety & Environmental Assurance Centre, Colworth House, Sharnbrook, Bedfordshire, MK44 1ET, UK., Desprez B; Cosmetics Europe, 40 Avenue Hermann-Debroux, Brussels, Belgium., Detroyer A; L'Oréal, Research & Innovation, 1 Avenue Eugène Schueller, Aulnay Sous-Bois, France., Ellison C; The Procter & Gamble Company, Cincinnati, OH, 45040, USA., Giammanco S; Creme Global, 4th Floor, The Design Tower, Trinity Technology & Enterprise Campus, Grand Canal Quay, Dublin 2, Ireland., Hack E; ScitoVation, Research Triangle Park, Durham, NC, USA., Hewitt NJ; SWS, Wingertstrasse 25, 64390, Erzhausen, Germany., Kenna G; 2 Farmfield Drive, Macclesfield, Cheshire, SK10 2TJ, UK., Klaric M; Cosmetics Europe, 40 Avenue Hermann-Debroux, Brussels, Belgium., Kreiling R; Clariant Produkte (Deutschland) GmbH, Am Unisys-Park 1, 65843, Sulzbach, Germany., Lester C; Procter & Gamble Technical Centres Ltd, Reading, RG2 0RX, UK., Mahony C; Procter & Gamble Technical Centres Ltd, Reading, RG2 0RX, UK., Mombelli E; Institut National de l'Environnement Industriel et des Risques (INERIS), Parc ALATA BP2, 60550, Verneuil en Halatte, France., Naciff J; The Procter & Gamble Company, Cincinnati, OH, 45040, USA., O'Brien J; Creme Global, 4th Floor, The Design Tower, Trinity Technology & Enterprise Campus, Grand Canal Quay, Dublin 2, Ireland., Schepky A; Beiersdorf AG, Global Toxicology, Unnastrasse 48, 20253, Hamburg, Germany., Tozer S; Procter & Gamble Technical Centres Ltd, Reading, RG2 0RX, UK., van der Burg B; BDS, Science Park 406, 1098XH, Amsterdam, the Netherlands., van Vugt-Lussenburg B; BDS, Science Park 406, 1098XH, Amsterdam, the Netherlands., Stuard S; The Procter & Gamble Company, Cincinnati, OH, 45040, USA., Cosmetics Europe; Cosmetics Europe, 40 Avenue Hermann-Debroux, Brussels, Belgium. Electronic address: cosmeticseurope@cosmeticseurope.eu.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2022 Jul; Vol. 132, pp. 105161. Date of Electronic Publication: 2022 May 01.
DOI: 10.1016/j.yrtph.2022.105161
Abstrakt: Parabens are esters of para-hydroxybenzoic acid that have been used as preservatives in many types of products for decades including agrochemicals, pharmaceuticals, food and cosmetics. This illustrative case study with propylparaben (PP) demonstrates a 10-step read-across (RAX) framework in practice. It aims at establishing a proof-of-concept for the value added by new approach methodologies (NAMs) in read-across (RAX) for use in a next-generation risk assessment (NGRA) in order to assess consumer safety after exposure to PP-containing cosmetics. In addition to structural and physico-chemical properties, in silico information, toxicogenomics, in vitro toxicodynamic, toxicokinetic data from PBK models, and bioactivity data are used to provide evidence of the chemical and biological similarity of PP and analogues and to establish potency trends for observed effects in vitro. The chemical category under consideration is short (C1-C4) linear chain n-alkyl parabens: methylparaben, ethylparaben, propylparaben and butylparaben. The goal of this case study is to illustrate how a practical framework for RAX can be used to fill a hypothetical data gap for reproductive toxicity of the target chemical PP.
(Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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