Exposure considerations in human safety assessment: Report from an EPAA Partners' Forum.

Autor: Cronin MTD; School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, United Kingdom. Electronic address: m.t.cronin@ljmu.ac.uk., Ball N; Dow Europe GmbH, Bachtobelstrasse, 8810, Horgen, Switzerland. Electronic address: nball@dow.com., Beken S; Federal Agency for Medicines and Health Products (FAMHP), Avenue Galilée 5/03, 1210, Brussels, Belgium. Electronic address: sonja.beken@fagg-afmps.be., Bender H; Peter Schwingen 6, D 53177, Bonn, Germany. Electronic address: bender.hj@hotmail.de., Bercaru O; European Chemicals Agency, Telakkakatu 6, Helsinki, Finland. Electronic address: Ofelia.BERCARU@echa.europa.eu., Caneva L; Zoetis Belgium, Veterinary Medicine Research & Development, Mercuriusstraat 20, B-1930, Zaventem, Belgium. Electronic address: laura.caneva@zoetis.com., Corvaro M; Corteva Agriscience Italia S.r.l, Rome, Italy. Electronic address: marco.corvaro@corteva.com., Currie RA; Syngenta Jealott's Hill International Research Centre, Bracknell, RG42 6EY, UK. Electronic address: richard.currie@syngenta.com., Dawson JL; United States Environmental Protection Agency, 1200 Pennsylvania Ave NW, Washington DC, 20004, USA. Electronic address: dawson.jeff@epa.gov., Desert P; Sanofi, 1541 avenue Marcel Mérieux, 69280, Marcy l'Etoile, France. Electronic address: Paul.Desert@sanofi.com., Escher SE; Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany. Electronic address: sylvia.escher@item.fraunhofer.de., Franco A; European Commission, Joint Research Centre (JRC), Ispra, Italy. Electronic address: antonio.franco@ec.europa.eu., Irizar A; The International Fragrance Association (IFRA), Geneva, Switzerland. Electronic address: airizar@ifrafragrance.org., Mehta JM; ADAMA Agricultural Solutions Ltd., Reading, United Kingdom. Electronic address: tina.mehta@adama.com., Rogiers V; Faculty of Medicine and Pharmacy, In Vitro Toxicology and Dermato-Cosmetology, Vrije Universiteit Brussel, Laarbeeklaan 103, B-1090, Brussels, Belgium. Electronic address: vera.rogiers@vub.be., Tremblay RT; Procter & Gamble Services Company, Temselaan 100, 1853 Strombeek-Bever, Belgium. Electronic address: tremblay.r.2@pg.com., Westmoreland C; Safety & Environmental Assurance Centre (SEAC), Unilever, Colworth Science Park, Sharnbrook, Bedford, MK44 1LQ, United Kingdom. Electronic address: carl.westmoreland@unilever.com., Maxwell G; Safety & Environmental Assurance Centre (SEAC), Unilever, Colworth Science Park, Sharnbrook, Bedford, MK44 1LQ, United Kingdom. Electronic address: gavin.maxwell@unilever.com.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Oct; Vol. 144, pp. 105483. Date of Electronic Publication: 2023 Aug 26.
DOI: 10.1016/j.yrtph.2023.105483
Abstrakt: Understanding and estimating the exposure to a substance is one of the fundamental requirements for safe manufacture and use. Many approaches are taken to determine exposure to substances, mainly driven by potential use and regulatory need. There are many opportunities to improve and optimise the use of exposure information for chemical safety. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a Partners' Forum (PF) to explore exposure considerations in human safety assessment of industrial products to agree key conclusions for the regulatory acceptance of exposure assessment approaches and priority areas for further research investment. The PF recognised the widescale use of exposure information across industrial sectors with the possibilities of creating synergies between different sectors. Further, the PF acknowledged that the EPAA could make a significant contribution to promote the use of exposure data in human safety assessment, with an aim to address specific regulatory needs. To achieve this, research needs, as well as synergies and areas for potential collaboration across sectors, were identified.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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