Guiding principles for the implementation of non-animal safety assessment approaches for cosmetics: Skin sensitisation

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• 作者：Carsten Goebel^a ; Pierre Aeby^b ; Nadè ; ge Ade^c ; Nathalie Alé ; pé ; e^c ; Aynur Aptula^d ; Daisuke Araki^e ; Eric Dufour^c ; Nicola Gilmour^d ; Jalila Hibatallah^f ; Detlef Keller^g ; Petra Kern^h ; Annette Kirstⁱ ; Monique Marrec-Fairley^j ; Gavin Maxwell^d ; Joanna Rowland^k ; Bob Safford^d ; Florian Schellauf^j ; Andreas Schepky^l ; Chris Seaman^m ; Thomas Teichert^l ; Nicolas Tessierⁿ ; Silvia Teissier^o ; Hans Ulrich Weltzien^p ; Petra Winkler^q ; Julia Scheel^g ; ^{julia.scheel@henkel.com}
• 关键词：ACD ; allergic contact dermatitis ; AEL ; acceptable exposure level ; APC ; antigen presenting cells ; CEL ; consumer exposure level ; CIR ; cosmetic ingredient review ; COLIPA ; the European Cosmetics Association ; DC ; dendritic cells ; DPRA ; direct peptide reactivit
• 刊名：Regulatory Toxicology and Pharmacology
• 出版年：2012
• 期刊代码：57_02732300
• 类别：pha
• 出版时间：June, 2012
• 卷：63
• 期：1
• 页码：40-52
• 文件大小：627 K

摘要

Characterisation of skin sensitisation potential is a key endpoint for the safety assessment of cosmetic ingredients especially when significant dermal exposure to an ingredient is expected. At present the mouse local lymph node assay (LLNA) remains the 鈥榞old standard鈥?test method for this purpose however non-animal test methods are under development that aim to replace the need for new animal test data. COLIPA (the European Cosmetics Association) funds an extensive programme of skin sensitisation research, method development and method evaluation and helped coordinate the early evaluation of the three test methods currently undergoing pre-validation. In May 2010, a COLIPA scientific meeting was held to analyse to what extent skin sensitisation safety assessments for cosmetic ingredients can be made in the absence of animal data. In order to propose guiding principles for the application and further development of non-animal safety assessment strategies it was evaluated how and when non-animal test methods, predictions based on physico-chemical properties (including in silico tools), threshold concepts and weight-of-evidence based hazard characterisation could be used to enable safety decisions. Generation and assessment of potency information from alternative tools which at present is predominantly derived from the LLNA is considered the future key research area.