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The EpiDerm™ Skin Irritation Test (EpiDerm™ SIT)

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Alternatives for Dermal Toxicity Testing

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Abstract

Assessment of the skin irritation belongs to the basic battery of toxicology tests. Due to the enormous efforts from test methods developers, validation centers and regulators, several in vitro test methods have been developed, validated and regulatory adopted as potential replacements of the rabbit skin irritation test.

This chapter describes in details the skin irritation test (SIT) based on the use of the in vitro reconstructed human epidermis model EpiDerm™ (EpiDerm™ SIT). The EpiDerm™ SIT is a validated and regulatory adopted method under the OECD Test Guidelines 439 along with three other tissue models. The chapter focuses on the technical details of this assay and also provides information about the performance of this test method obtained during the validation study. Part of this chapter also describes other EpiDerm™ skin irritation protocols that can be used for the safety assessment of final cosmetic products and for testing extracts from Medical Devices in line with the ISO 10993.

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Author information

Authors and Affiliations

  1. MatTek In vitro Life Science Laboratories, Mlynske Nivy 73, 821 05, Bratislava, Slovakia

    Helena Kandarova

  2. Retired Head of Unit “Centre of Alternative Methods to Animal Experiments–ZEBET” at the BfR, Berlin, Germany

    Manfred Liebsch

Authors
  1. Helena Kandarova
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  2. Manfred Liebsch
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Corresponding author

Correspondence to Helena Kandarova .

Editor information

Editors and Affiliations

  1. SeCAM, Magliaso, Switzerland

    Chantra Eskes

  2. Innovitox Consulting & Services, Houten, The Netherlands

    Erwin van Vliet

  3. Department of Dermatology, University of California School of Medicine, San Francisco, California, USA

    Howard I. Maibach

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Kandarova, H., Liebsch, M. (2017). The EpiDerm™ Skin Irritation Test (EpiDerm™ SIT). In: Eskes, C., van Vliet, E., Maibach, H. (eds) Alternatives for Dermal Toxicity Testing. Springer, Cham. https://doi.org/10.1007/978-3-319-50353-0_3

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  • DOI: https://doi.org/10.1007/978-3-319-50353-0_3

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-50351-6

  • Online ISBN: 978-3-319-50353-0

  • eBook Packages: MedicineMedicine (R0)

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