Skin sensitisation – Moving forward with non-animal testing strategies for regulatory purposes in the EU

Basketter, David A.; Alépée, Nathalie; Casati, Silvana; Crozier, Jonathan; Eigler, Dorothea; Griem, Peter; Hubesch, Bruno; Knecht, Joop de; Landsiedel, Robert; Louekari, Kimmo; Manou, Irene; Maxwell, Gavin; Mehling, Annette; Netzeva, Tatiana I.; Petry, Thomas; Rossi, L

doi:10.1016/j.yrtph.2013.10.002

Cited by 38 publications

(13 citation statements)

References 18 publications

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“…Different in vitro models have been validated to evaluate skin corrosion or irritation (Deshmukh et al ., ; Fentem and Botham ; Kidd et al ., ). In contrast, for other parameters, such as the sensitization potential, there is no completely validated in vitro model (Basketter et al ., ; Mehling et al ., ).…”

Section: Introductionmentioning

confidence: 99%

Development of a multiparametric in vitro model of skin sensitization

Guyard‐Nicodème

Gerault

Platteel³

et al. 2014

J of Applied Toxicology

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Most animal experiments on cosmetics safety are prohibited and since March 2013, this obligation includes sensitization tests. However, until now there has been no validated alternative in vitro method. In this work, 400 compounds used in the cosmetic industry were selected to cover the greatest diversity of structures, biological activities and sensitizing potential. These molecules were submitted to a series of tests aimed at reproducing essential steps in sensitization and to distinguish between sensitization and irritations, i.e., transcutaneous permeation (factor A), haptenation (factor B), sensitization cytokines production (factor C) and acute toxicity (factor D). The transcutaneous diffusion was measured on human skin explants using Franz cells. Haptenation was tested in solution on human serum albumin. Sensitization cytokine production was investigated by measurement of interleukin-18 release by keratinocytes. Acute toxicity was determined using an 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide(75) cell viability test. As only sufficiently stable, soluble and detectable compounds are usable, 33, 72, 68 and 68 molecules were finally tested on factors A, B, C and D, respectively, and 32 were completely screened by the four factors. The individual correlation of the four factors with the reference in vivo tests was limited but the combination of these factors led to a correlation between in vivo and in vitro assays of 81.2% and the safety of the test (risk of false negative) reached 96.8%. The techniques employed are simple and inexpensive and this model of four tests appears as a promising technique to evaluate in vitro the skin sensitization potential of unknown molecules.

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Section: Introductionmentioning

confidence: 99%

Development of a multiparametric in vitro model of skin sensitization

Guyard‐Nicodème

Gerault

Platteel³

et al. 2014

J of Applied Toxicology

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“…Some do provide endpoints for potency assessment, as well. Supportive evidence by alternative methods may be included into an integrated testing strategy providing a mechanistic rationale for the Adverse Outcome Pathway for skin sensitization (OECD, 2012;Basketter et al, 2013;Rovida et al 2015). To foster scientific and regulatory acceptance of alternative methods, a number of the validated methods have been tested recently against a data set of 213 substances (151 sensitizers, 62 non-sensitizers).…”

Section: Hazard Identification In the Field Of Consumer Productsmentioning

confidence: 99%

Classification of dermal sensitizers in pharmaceutical manufacturing

Winkler

Perino

Araya

et al. 2015

Regulatory Toxicology and Pharmacology

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“…Jaworska and Hoffmann, 2010;De Wever et al, 2012;Basketter et al, 2013;Rovida et al, 2015 Specifications on the applicability domain, endpoint assessed and regulatory purpose (hazard or potency assessment). Kinsner-Ovaskainen et al, 2009;Krewski et al, 2010;De Wever et al, 2012;Basketter et al, 2013;Tollefsen et al, 2014;Rovida et al, 2015 Transparency regarding all information sources used, including testing costs, animal numbers, uncertainty; data processing, evaluation target (hazard/doseresponse information), endpoint. Lewis et al, 2007;Ahlers et al, 2008;KinsnerOvaskainen et al, 2009;De Wever et al, 2012;OECD, 2016b Flexibility regarding the integration of new information, (e.g.…”

Section: Criteria Related To Generating Informationmentioning

confidence: 99%

“…Kinsner-Ovaskainen et al, 2009;Jaworska and Hoffmann, 2010;De Wever et al, 2012 Final decision based on a weight-of-evidence approach. Jaworska and Hoffmann, 2010;Basketter et al, 2013 Address/document/reduce uncertainty of information generated from individual testing methods and uncertainty of extrapolations to effects in humans. Lewis et al, 2007;Ahlers et al, 2008;Schaafsma et al, 2009;OECD, 2016b Use of mechanistic information; relate construction of DA to mechanistic understanding of an endpoint (e.g.…”

Section: Criteria Related To Generating Informationmentioning

confidence: 99%

“…AOP). Ankley et al, 2010;Dellarco et al, 2010;Basketter et al, 2013;Landesmann et al, 2013;Vinken, 2013;Rovida et al, 2015;OECD, 2016b According to the criteria presented in Table 2.2, information revealed from testing should be reliable, accurate, precise and fit-for-purpose. Uncertainties should be transparently addressed and documented.…”

Section: Criteria Related To Generating Informationmentioning

confidence: 99%

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An economic approach to non-animal toxicity testing for skin sensitisation

Leontaridou¹

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Skin sensitisation – Moving forward with non-animal testing strategies for regulatory purposes in the EU

Cited by 38 publications

References 18 publications

Development of a multiparametric in vitro model of skin sensitization

Development of a multiparametric in vitro model of skin sensitization

Classification of dermal sensitizers in pharmaceutical manufacturing

An economic approach to non-animal toxicity testing for skin sensitisation

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