Challenges in working towards an internal threshold of toxicological concern (iTTC) for use in the safety assessment of cosmetics: Discussions from the Cosmetics Europe iTTC Working Group workshop.

Cosmetics Cosmetics europe PBPK Physiologically based pharmacokinetic model Risk assessment TTC Thresholds of toxicological concern

Journal

Regulatory toxicology and pharmacology : RTP
ISSN: 1096-0295
Titre abrégé: Regul Toxicol Pharmacol
Pays: Netherlands
ID NLM: 8214983

Informations de publication

Date de publication:
Apr 2019
Historique:
received: 10 10 2018
revised: 02 01 2019
accepted: 07 01 2019
pubmed: 18 1 2019
medline: 21 5 2019
entrez: 18 1 2019
Statut: ppublish

Résumé

The Threshold of Toxicological Concern (TTC) is an important risk assessment tool which establishes acceptable low-level exposure values to be applied to chemicals with limited toxicological data. One of the logical next steps in the continued evolution of TTC is to develop this concept further so that it is representative of internal exposures (TTC based on plasma concentration). An internal TTC (iTTC) would provide threshold values that could be utilized in exposure-based safety assessments. As part of a Cosmetics Europe (CosEu) research program, CosEu has initiated a project that is working towards the development of iTTCs that can be used for the human safety assessment. Knowing that the development of an iTTC is an ambitious and broad-spanning topic, CosEu organized a Working Group comprised a balance of multiple stakeholders (cosmetics and chemical industries, the EPA and JRC and academia) with relevant experience and expertise and workshop to critically evaluate the requirements to establish an iTTC. Outcomes from the workshop included an evaluation on the current state of the science for iTTC, the overall iTTC strategy, selection of chemical databases, capture and curation of chemical information, ADME and repeat dose data, expected challenges, as well as next steps and ongoing work.

Identifiants

pubmed: 30653989
pii: S0273-2300(19)30016-9
doi: 10.1016/j.yrtph.2019.01.016
pmc: PMC6644721
mid: NIHMS1532498
pii:
doi:

Substances chimiques

Cosmetics 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

63-72

Subventions

Organisme : Intramural EPA
ID : EPA999999
Pays : United States

Informations de copyright

Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

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Auteurs

Corie A Ellison (CA)

The Procter & Gamble Company, Cincinnati, OH, United States. Electronic address: Ellison.ca@pg.com.

Karen L Blackburn (KL)

The Procter & Gamble Company, Cincinnati, OH, United States.

Paul L Carmichael (PL)

Unilever Safety and Environmental Assurance Center, Bedfordshire, UK.

Harvey J Clewell (HJ)

ScitoVation, LLC, North Carolina, United States.

Mark T D Cronin (MTD)

School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, England, UK.

Bertrand Desprez (B)

Cosmetics Europe, Brussels, Belgium.

Sylvia E Escher (SE)

Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany.

Steve S Ferguson (SS)

National Institute of Environmental Health Sciences, North Carolina, United States.

Sébastien Grégoire (S)

L'Oréal Research & Innovation, Aulnay-sous-Bois, France.

Nicola J Hewitt (NJ)

Cosmetics Europe, Brussels, Belgium.

Heli M Hollnagel (HM)

Dow Europe GmbH, Horgen, Switzerland.

Martina Klaric (M)

Cosmetics Europe, Brussels, Belgium.

Atish Patel (A)

Research Institute for Fragrance Materials, New Jersey, United States.

Sabrina Salhi (S)

GlaxoSmithKline, Nyon, Switzerland.

Andreas Schepky (A)

Beiersdorf AG, Hamburg, Germany.

Barbara G Schmitt (BG)

Dow Silicones Belgium SPRL, Seneffe, Belgium.

John F Wambaugh (JF)

United States Environmental Protection Agency, National Center for Computational Toxicology, North Carolina, United States.

Andrew Worth (A)

European Commission, Joint Research Centre, Ispra, Italy.

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