Archives of Toxicology

, Volume 85, Issue 5, pp 367–485

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

  • Sarah Adler
  • David Basketter
  • Stuart Creton
  • Olavi Pelkonen
  • Jan van Benthem
  • Valérie Zuang
  • Klaus Ejner Andersen
  • Alexandre Angers-Loustau
  • Aynur Aptula
  • Anna Bal-Price
  • Emilio Benfenati
  • Ulrike Bernauer
  • Jos Bessems
  • Frederic Y. Bois
  • Alan Boobis
  • Esther Brandon
  • Susanne Bremer
  • Thomas Broschard
  • Silvia Casati
  • Sandra Coecke
  • Raffaella Corvi
  • Mark Cronin
  • George Daston
  • Wolfgang Dekant
  • Susan Felter
  • Elise Grignard
  • Ursula Gundert-Remy
  • Tuula Heinonen
  • Ian Kimber
  • Jos Kleinjans
  • Hannu Komulainen
  • Reinhard Kreiling
  • Joachim Kreysa
  • Sofia Batista Leite
  • George Loizou
  • Gavin Maxwell
  • Paolo Mazzatorta
  • Sharon Munn
  • Stefan Pfuhler
  • Pascal Phrakonkham
  • Aldert Piersma
  • Albrecht Poth
  • Pilar Prieto
  • Guillermo Repetto
  • Vera Rogiers
  • Greet Schoeters
  • Michael Schwarz
  • Rositsa Serafimova
  • Hanna Tähti
  • Emanuela Testai
  • Joost van Delft
  • Henk van Loveren
  • Mathieu Vinken
  • Andrew Worth
  • José-Manuel Zaldivar
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 methods Toxicokinetics Skin sensitisation Repeated dose toxicity Carcinogenicity Reproductive toxicity 

Supplementary material

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

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Sarah Adler
    • 1
  • David Basketter
    • 2
  • Stuart Creton
    • 3
  • Olavi Pelkonen
    • 4
  • Jan van Benthem
    • 5
  • Valérie Zuang
    • 6
  • Klaus Ejner Andersen
    • 7
  • Alexandre Angers-Loustau
    • 6
  • Aynur Aptula
    • 8
  • Anna Bal-Price
    • 6
  • Emilio Benfenati
    • 9
  • Ulrike Bernauer
    • 10
  • Jos Bessems
    • 11
  • Frederic Y. Bois
    • 12
  • Alan Boobis
    • 13
  • Esther Brandon
    • 11
  • Susanne Bremer
    • 6
  • Thomas Broschard
    • 14
  • Silvia Casati
    • 6
  • Sandra Coecke
    • 6
  • Raffaella Corvi
    • 6
  • Mark Cronin
    • 15
  • George Daston
    • 16
  • Wolfgang Dekant
    • 17
  • Susan Felter
    • 18
  • Elise Grignard
    • 6
  • Ursula Gundert-Remy
    • 19
  • Tuula Heinonen
    • 20
  • Ian Kimber
    • 21
  • Jos Kleinjans
    • 22
  • Hannu Komulainen
    • 23
  • Reinhard Kreiling
    • 24
  • Joachim Kreysa
    • 6
  • Sofia Batista Leite
    • 6
    • 26
  • George Loizou
    • 27
  • Gavin Maxwell
    • 8
  • Paolo Mazzatorta
    • 25
  • Sharon Munn
    • 6
  • Stefan Pfuhler
    • 18
  • Pascal Phrakonkham
    • 6
  • Aldert Piersma
    • 5
  • Albrecht Poth
    • 28
  • Pilar Prieto
    • 6
  • Guillermo Repetto
    • 29
  • Vera Rogiers
    • 30
  • Greet Schoeters
    • 31
  • Michael Schwarz
    • 32
  • Rositsa Serafimova
    • 6
  • Hanna Tähti
    • 20
  • Emanuela Testai
    • 33
  • Joost van Delft
    • 22
  • Henk van Loveren
    • 22
    • 34
  • Mathieu Vinken
    • 30
  • Andrew Worth
    • 6
  • José-Manuel Zaldivar
    • 6
  1. 1.Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET)Federal Institute for Risk Assessment (BfR)BerlinGermany
  2. 2.DABMEB Consultancy LtdSharnbrookUK
  3. 3.NC3RsLondonUK
  4. 4.Department of Pharmacology and ToxicologyUniversity of OuluOuluFinland
  5. 5.Laboratory for Health Protection ResearchNational Institute for Public Health and the Environment (RIVM)BilthovenThe Netherlands
  6. 6.ECVAM, Institute for Health & Consumer ProtectionEuropean Commission Joint Research CentreIspraItaly
  7. 7.Department of Dermatology and Allergy Centre, Odense University HospitalUniversity of Southern DenmarkOdenseDenmark
  8. 8.SEAC, UnileverColworth Science ParkSharnbrookUK
  9. 9.Laboratory of Environmental Chemistry and ToxicologyInstituto di Ricerche Farmacologiche “Mario Negri”MilanItaly
  10. 10.Federal Institute for Risk Assessment (BfR)BerlinGermany
  11. 11.Centre for Substances and Integrated Risk AssessmentNational Institute for Public Health and the Environment (RIVM)BilthovenThe Netherlands
  12. 12.Chair of Mathematical Modelling for Systems Toxicology, Compiegne and INERIS, DRC/VIVA/METOCompiegne University of TechnologyVerneuil en HalatteFrance
  13. 13.Imperial College LondonLondonUK
  14. 14.Merck KGaADarmstadtGermany
  15. 15.School of Pharmacy and Chemistry LiverpoolJohn Moores UniversityLiverpoolUK
  16. 16.Miami Valley Innovation CenterThe Procter and Gamble CompanyCincinnatiUSA
  17. 17.Department of ToxicologyJulius-Maximilians-Universität WürzburgWürzburgGermany
  18. 18.Procter and Gamble CompanyCentral Product SafetyCincinnatiUSA
  19. 19.Department ToxicologyMedical School (Charité)BerlinGermany
  20. 20.FICAM, School of MedicineUniversity of TampereTampereFinland
  21. 21.University of ManchesterManchesterUK
  22. 22.Department of Health Risk Analyses and Toxicology, Faculty of Health, Medicine and Life SciencesMaastricht UniversityMaastrichtThe Netherlands
  23. 23.Department of Environmental HealthNational Institute for Health and Welfare (THL)KuopioFinland
  24. 24.Clariant Produkte (Deutschland) GmbHSulzbachGermany
  25. 25.Nestlé Research CenterVers-chez-les-BlancLausanneSwitzerland
  26. 26.Instituto Tecnologia Química Biológica (ITQB)/Instituto Biologia Experimental (IBET)OeirasPortugal
  27. 27.Health and Safety Laboratory, Mathematical Sciences UnitHealth Improvement GroupHarpur Hill, BuxtonUK
  28. 28.Harlan Cytotest Cell Research GmbHRoßdorfGermany
  29. 29.University Pablo de OlavideSevillaSpain
  30. 30.Department of ToxicologyVrije Universiteit BrusselBrusselsBelgium
  31. 31.Department of Biomedical SciencesUniversity of AntwerpAntwerpBelgium
  32. 32.Institute of Pharmacology und ToxicologyUniversity of TuebingenTuebingenGermany
  33. 33.Istituto Superiore di SanitàRomeItaly
  34. 34.National Institute for Public Health and the Environment (RIVM), Laboratory for ToxicologyPathology and GeneticsBilthovenThe Netherlands