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

Sarah Adler, David Basketter, Stuart Creton, Olavi Pelkonen, Jan van Benthem, Valerie Zuang*, Klaus Ejner Andersen, Alexandre Angers-Loustau, Aynur Aptula, Anna Bal-Price, Emilio Benfenati, Ulrike Bernauer, Jos G. M. Bessems, Frederic Y. Bois, Alan Boobis, Esther Brandon, Susanne Bremer, Thomas Broschard, Silvia Casati, Sandra CoeckeRaffaella 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 H. Piersma, Albrecht Poth, Pilar Prieto, Guillermo Repetto, Vera Rogiers, Greet Schoeters, Michael Schwarz, Rositsa Serafimova, Hanna Tahti, Emanuela Testai, Joost van Delft, Henk van Loveren, Mathieu Vinken, Andrew Worth, Jose-Manuel Zaldivar

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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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.
Original languageEnglish
Pages (from-to)367-485
JournalArchives of Toxicology
Issue number5
Publication statusPublished - May 2011


  • Alternative methods
  • Toxicokinetics
  • Skin sensitisation
  • Repeated dose toxicity
  • Carcinogenicity
  • Reproductive toxicity

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