Archives of Toxicology

, Volume 85, Issue 5, pp 367–485

Alternative (non-animal) methods for cosmetics testing: current status and future prospects—2010

Authors

  • Sarah Adler
    • Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET)Federal Institute for Risk Assessment (BfR)
  • David Basketter
    • DABMEB Consultancy Ltd
  • Stuart Creton
    • NC3Rs
  • Olavi Pelkonen
    • Department of Pharmacology and ToxicologyUniversity of Oulu
  • Jan van Benthem
    • Laboratory for Health Protection ResearchNational Institute for Public Health and the Environment (RIVM)
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Klaus Ejner Andersen
    • Department of Dermatology and Allergy Centre, Odense University HospitalUniversity of Southern Denmark
  • Alexandre Angers-Loustau
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Aynur Aptula
    • SEAC, UnileverColworth Science Park
  • Anna Bal-Price
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Emilio Benfenati
    • Laboratory of Environmental Chemistry and ToxicologyInstituto di Ricerche Farmacologiche “Mario Negri”
  • Ulrike Bernauer
    • Federal Institute for Risk Assessment (BfR)
  • Jos Bessems
    • Centre for Substances and Integrated Risk AssessmentNational Institute for Public Health and the Environment (RIVM)
  • Frederic Y. Bois
    • Chair of Mathematical Modelling for Systems Toxicology, Compiegne and INERIS, DRC/VIVA/METOCompiegne University of Technology
  • Alan Boobis
    • Imperial College London
  • Esther Brandon
    • Centre for Substances and Integrated Risk AssessmentNational Institute for Public Health and the Environment (RIVM)
  • Susanne Bremer
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Thomas Broschard
    • Merck KGaA
  • Silvia Casati
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Sandra Coecke
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Raffaella Corvi
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Mark Cronin
    • School of Pharmacy and Chemistry LiverpoolJohn Moores University
  • George Daston
    • Miami Valley Innovation CenterThe Procter and Gamble Company
  • Wolfgang Dekant
    • Department of ToxicologyJulius-Maximilians-Universität Würzburg
  • Susan Felter
    • Procter and Gamble CompanyCentral Product Safety
  • Elise Grignard
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Ursula Gundert-Remy
    • Department ToxicologyMedical School (Charité)
  • Tuula Heinonen
    • FICAM, School of MedicineUniversity of Tampere
  • Ian Kimber
    • University of Manchester
  • Jos Kleinjans
    • Department of Health Risk Analyses and Toxicology, Faculty of Health, Medicine and Life SciencesMaastricht University
  • Hannu Komulainen
    • Department of Environmental HealthNational Institute for Health and Welfare (THL)
  • Reinhard Kreiling
    • Clariant Produkte (Deutschland) GmbH
  • Joachim Kreysa
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Sofia Batista Leite
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
    • Instituto Tecnologia Química Biológica (ITQB)/Instituto Biologia Experimental (IBET)
  • George Loizou
    • Health and Safety Laboratory, Mathematical Sciences UnitHealth Improvement Group
  • Gavin Maxwell
    • SEAC, UnileverColworth Science Park
  • Paolo Mazzatorta
    • Nestlé Research CenterVers-chez-les-Blanc
  • Sharon Munn
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Stefan Pfuhler
    • Procter and Gamble CompanyCentral Product Safety
  • Pascal Phrakonkham
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Aldert Piersma
    • Laboratory for Health Protection ResearchNational Institute for Public Health and the Environment (RIVM)
  • Albrecht Poth
    • Harlan Cytotest Cell Research GmbH
  • Pilar Prieto
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Guillermo Repetto
    • University Pablo de Olavide
  • Vera Rogiers
    • Department of ToxicologyVrije Universiteit Brussel
  • Greet Schoeters
    • Department of Biomedical SciencesUniversity of Antwerp
  • Michael Schwarz
    • Institute of Pharmacology und ToxicologyUniversity of Tuebingen
  • Rositsa Serafimova
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • Hanna Tähti
    • FICAM, School of MedicineUniversity of Tampere
  • Emanuela Testai
    • Istituto Superiore di Sanità
  • Joost van Delft
    • Department of Health Risk Analyses and Toxicology, Faculty of Health, Medicine and Life SciencesMaastricht University
  • Henk van Loveren
    • Department of Health Risk Analyses and Toxicology, Faculty of Health, Medicine and Life SciencesMaastricht University
    • National Institute for Public Health and the Environment (RIVM), Laboratory for ToxicologyPathology and Genetics
  • Mathieu Vinken
    • Department of ToxicologyVrije Universiteit Brussel
  • Andrew Worth
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
  • José-Manuel Zaldivar
    • ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research Centre
Review Article

DOI: 10.1007/s00204-011-0693-2

Cite this article as:
Adler, S., Basketter, D., Creton, S. et al. Arch Toxicol (2011) 85: 367. doi:10.1007/s00204-011-0693-2

Abstract

The 7th amendment to the EU Cosmetics Directive prohibits to put animal-tested cosmetics on the market in Europe after 2013. In that context, the European Commission invited stakeholder bodies (industry, non-governmental organisations, EU Member States, and the Commission’s Scientific Committee on Consumer Safety) to identify scientific experts in five toxicological areas, i.e. toxicokinetics, repeated dose toxicity, carcinogenicity, skin sensitisation, and reproductive toxicity for which the Directive foresees that the 2013 deadline could be further extended in case alternative and validated methods would not be available in time. The selected experts were asked to analyse the status and prospects of alternative methods and to provide a scientifically sound estimate of the time necessary to achieve full replacement of animal testing. In summary, the experts confirmed that it will take at least another 7–9 years for the replacement of the current in vivo animal tests used for the safety assessment of cosmetic ingredients for skin sensitisation. However, the experts were also of the opinion that alternative methods may be able to give hazard information, i.e. to differentiate between sensitisers and non-sensitisers, ahead of 2017. This would, however, not provide the complete picture of what is a safe exposure because the relative potency of a sensitiser would not be known. For toxicokinetics, the timeframe was 5–7 years to develop the models still lacking to predict lung absorption and renal/biliary excretion, and even longer to integrate the methods to fully replace the animal toxicokinetic models. For the systemic toxicological endpoints of repeated dose toxicity, carcinogenicity and reproductive toxicity, the time horizon for full replacement could not be estimated.

Keywords

Alternative methodsToxicokineticsSkin sensitisationRepeated dose toxicityCarcinogenicityReproductive toxicity

Supplementary material

204_2011_693_MOESM1_ESM.doc (201 kb)
Supplementary material 1 (DOC 201 kb)

Copyright information

© Springer-Verlag 2011