The epiCS® Skin Irritation Test (SIT) Method

  • Oliver Engelking
  • Horst W. Fuchs
  • Dirk Weisensee
Chapter

Abstract

The epiCS® skin irritation test (SIT) method is based on epiCS®, a reconstructed human epidermis, produced with normal human keratinocytes. During production, these cells differentiate in a multilayered epidermis that serves as a model for human in vivo epidermis. For the epiCS® SIT method, the tissues are exposed to test substances for 20 min followed by a 42 h post-incubation period. Subsequently, the relative viability of the tissues is determined by an MTT assay and is used to differentiate between irritants and non-irritants. A me-too validation study of the epiCS® SIT method was conducted involving EURL ECVAM and the independent scientific peer reviewing by the EURL ECVAM Scientific Advisory Committee. With the positive ESAC opinion, the epiCS® SIT method will be proposed for incorporation into the OECD Test Guideline 439.

References

  1. 1.
    OECD. New guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation, Series on Testing and Assessment, No. 203. 2014.Google Scholar
  2. 2.
    UN. United Nations globally harmonized system of classification and labelling of chemicals (GHS), UN New York and Geneva. 2015. Available at: http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html
  3. 3.
    Hoffmann J, Heisler E, Karpinski S, Losse J, Thomas D, Siefken W, Ahr H-J, Vohr HW, Fuchs HW. Epidermal-skin-test 1000 (EST-1000)—a new reconstructed epidermis for in vitro skin corrosivity testing. Toxicol In Vitro. 2005;19:925–9.CrossRefGoogle Scholar
  4. 4.
    Welss T, Basketter DA, Schröder KR. In vitro skin irritation: fact and future. State of the art review of mechanisms and models. Toxicol In Vitro. 2004;18:231–43.CrossRefGoogle Scholar
  5. 5.
    OECD. OECD guidelines for the testing of chemicals. In Vitro skin irritation: reconstructed human epidermis test method. 2015.Google Scholar
  6. 6.
    EC-ECVAM. Performance standards for in vitro skin irritation test methods based on Reconstructed human Epidermis (RhE). 2009. available online at: https://eurl-ecvam.jrc.ec.europa.eu/validation-regulatory-acceptance/docs-skin-irritation-1/DOC8-updated_ECVAM_PS_2009.pdf
  7. 7.
    OECD. Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment, OECD series on testing and assessment No. 34, OECD, Paris. 2005. Available at: http://www.oecd.org/env/testguidelines
  8. 8.
    OECD. Document No. 220: Performance Standards for the Assessment of Proposed Similar or Modified In Vitro Reconstructed Human Epidermis (RHE) Test Methods for Skin Irritation Testing as Described in TG 439. OECD Environmental Health and Safety Publications, Series on Testing and Assessment. 2015. Available at: http://www.oecd.org/env/ehs/testing/series-testing-assessment-publications-number.htm.
  9. 9.
    Basketter DA, York M, McFadden JP, Robinson MK. Determination of skin irritation potential in the human 4-h patch test. Contact Dermatitis. 2004;51:1–4.CrossRefGoogle Scholar
  10. 10.
    Jírová D, Basketter D, Liebsch M, Bendová H, Kejlová K, Marriott M, Kandarova H. Comparison of human skin irritation patch test data with in vitro skin irritation assays and animal data. Contact Dermatitis. 2010;62:109–16.CrossRefGoogle Scholar
  11. 11.
    Jirova D, Liebsch M, Basketter D, Spiller E, Kejlova K, Bendova H, Marriott M, Kandarova H. Comparison of human skin irritation and photo-irritation patch test data with cellular in vitro assays and animal in vivo data. ALTEX. 2007;14:359–65.Google Scholar
  12. 12.
    CellSystems. epiCS® SKIN IRRITATION TEST, standard operating procedure (SOP epiCS SIT) version 5.1, 2017. Available online at: http://reconstructed-human-epidermis.com/user-data/downloads/manuels-sops/SOP-epiCS-skin-irritation.pdf

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Oliver Engelking
    • 1
  • Horst W. Fuchs
    • 1
  • Dirk Weisensee
    • 1
  1. 1.CellSystems GmbHTroisdorfGermany

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