Systematic evaluation of non-animal test methods for skin sensitisation safety assessment

被引：96

作者：

Reisinger, Kerstin ^{[1
]}

Hoffmann, Sebastian ^{[2
]}

Alepee, Nathalie ^{[3
]}

Ashikaga, Takao ^{[4
]}

Barroso, Joao ^{[5
]}

Elcombe, Cliff ^{[6
]}

Gellatly, Nicola ^{[7
]}

Galbiati, Valentina ^{[8
]}

Gibbs, Susan ^{[9
]}

Groux, Herve ^{[10
]}

Hibatallah, Jalila ^{[11
]}

Keller, Donald ^{[12
]}

Kern, Petra ^{[13
]}

Klaric, Martina ^{[5
]}

Kolle, Susanne ^{[14
]}

Kuehnl, Jochen ^{[15
]}

Lambrechts, Nathalie ^{[16
]}

Lindstedt, Malin ^{[17
]}

Millet, Marion ^{[18
]}

Martinozzi-Teissier, Silvia ^{[3
]}

Natsch, Andreas ^{[19
]}

Petersohn, Dirk ^{[1
]}

Pike, Ian ^{[20
]}

Sakaguchi, Hitoshi ^{[21
]}

Schepky, Andreas ^{[15
]}

Tailhardat, Magalie ^{[22
]}

Templier, Marie ^{[18
]}

van Vliet, Erwin ^{[23
]}

Maxwell, Gavin ^{[7
]}

机构：

[1] Henkel AG & CO KGaA, D-40191 Dusseldorf, Germany

[2] Seh Consulting Serv, D-33098 Paderborn, Germany

[3] LOreal Res Ea Innovat, F-93600 Aulnay Sous Bois, France

[4] Shiseido Co Ltd, Qual Assurance Ctr, Kanagawa, Japan

[5] Cosmet Europe, B-1160 Brussels, Belgium

[6] OCR Biosci Ltd, Dundee DD1 5JJ, Scotland

[7] Unilever Safety & Environm Assurance Ctr, Sharnbrook MK44 1LQ, Beds, England

[8] Univ Milan, Toxicol Lab, I-20133 Milan, Italy

[9] Vrije Univ Amsterdam, Med Ctr, Dept Dermatol, NL-1081 HV Amsterdam, Netherlands

[10] ImmunoSearch, F-06130 Le Plan De Grasse, France

[11] Chanel, F-92521 Neuilly Sur Seine, France

[12] Cyprotex LLC, Kalamazoo, MI USA

[13] Procter & Gamble Technol Beijing Co Ltd, Global Product Stewardship, KongGang Dev Area Area B, Beijing 101312, Peoples R China

[14] BASF SE, Expt Toxicol & Ecol, D-67056 Ludwigshafen, Germany

[15] Beiersdorf AG, D-20245 Hamburg, Germany

[16] VITO NV, B-2400 Mol, Belgium

[17] Lund Univ, Dept Immunotechnol, S-22381 Lund, Sweden

[18] Inst Rech Pierre Fabre, CEPC, F-81106 Castres, France

[19] Givaudan Schweiz AG, CH-8600 Dubendorf, Switzerland

[20] Proteome Sci Plc, Cobham KT11 3EP, England

[21] Kao Corp, Ichikai, Tochigi, Japan

[22] LVMH Rech, F-45804 St Jean De Braye, France

[23] SeCAM, CH-6982 Agno, Switzerland

来源：

TOXICOLOGY IN VITRO | 2015年 / 29卷 / 01期

关键词：

Skin sensitisation; Testing strategy; Safety assessment; Non-animal test methods; Adverse Outcome Pathways; EPIDERMAL EQUIVALENT ASSAY; PEPTIDE REACTIVITY; CELL-LINE; CONTACT ALLERGENS; IL-18; PRODUCTION; POTENCY; REPRODUCIBILITY; ACTIVATION; SIGNATURE; STRATEGY;

D O I：

10.1016/j.tiv.2014.10.018

中图分类号：

R99 [毒物学（毒理学）];

学科分类号：

100405 ;

摘要：

The need for non-animal data to assess skin sensitisation properties of substances, especially cosmetics ingredients, has spawned the development of many in vitro methods. As it is widely believed that no single method can provide a solution, the Cosmetics Europe Skin Tolerance Task Force has defined a three-phase framework for the development of a non-animal testing strategy for skin sensitisation potency prediction. The results of the first phase systematic evaluation of 16 test methods are presented here. This evaluation involved generation of data on a common set of ten substances in all methods and systematic collation of information including the level of standardisation, existing test data, potential for throughput, transferability and accessibility in cooperation with the test method developers. A workshop was held with the test method developers to review the outcome of this evaluation and to discuss the results. The evaluation informed the prioritisation of test methods for the next phase of the non-animal testing strategy development framework. Ultimately, the testing strategy combined with bioavailability and skin metabolism data and exposure consideration is envisaged to allow establishment of a data integration approach for skin sensitisation safety assessment of cosmetic ingredients. (C) 2014 The Authors. Published by Elsevier Ltd.

引用

页码：259 / 270

页数：12

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