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

Ouédraogo, G, Alexander-White, C, Bury, D, Clewell, HJ, Cronin, MTD, Cull, T, Dent, M, Desprez, B, Detroyer, A, Ellison, C, Giammanco, S, Hack, E, Hewitt, NJ, Kenna, G, Klaric, M, Kreiling, R, Lester, C, Mahony, C, Mombelli, E, Naciff, J , O'Brien, J, Schepky, A, Tozer, S, van der Burg, B, van Vugt, B, Stuard, S and Cosmetics Europe, (2022) Read-across and new approach methodologies applied in a 10-step framework for cosmetics safety assessment – A case study with parabens. Regulatory Toxicology and Pharmacology. p. 105161. ISSN 0273-2300

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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.

Item Type: Article
Uncontrolled Keywords: Toxicology; 1115 Pharmacology and Pharmaceutical Sciences
Subjects: R Medicine > RS Pharmacy and materia medica
Divisions: Pharmacy & Biomolecular Sciences
Publisher: Elsevier BV
SWORD Depositor: A Symplectic
Date Deposited: 09 May 2022 12:10
Last Modified: 09 May 2022 12:15
DOI or Identification number: 10.1016/j.yrtph.2022.105161
URI: https://researchonline.ljmu.ac.uk/id/eprint/16785

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