The EpiDerm™ Skin Corrosion Test (EpiDerm™ SCT)

  • Helena KandarovaEmail author
  • Manfred Liebsch


Assessment of the skin corrosion potential is an important consideration in establishing procedures for the safe handling, packing and transport of chemicals. Testing for skin corrosion in vivo causes suffering and pain to the test animals. A number of alternative approaches for the assessment of skin corrosion have been developed in the past three decades and some of the assays gained regulatory acceptance as replacements of the rabbit skin corrosion test.

This chapter describes in details the skin corrosion test (SCT) based on the use of in vitro reconstructed human epidermis model EpiDermTM (EpiDermTM SCT). The EpiDermTM SIT is a validated and regulatory adopted test method under the OECD Test Guidelines as TG 431 along with three other tissue models. The chapter focuses on the technical details of this assay, provides information about the performance of the test method during the validation study and discusses the adapted protocol derived from an OECD follow up work to improve the prediction model of RhE models for the sub-categorization of corrosive sub-classes.


  1. 1.
    UN GHS. Harmonised integrated classification system for human health and environmental hazards of chemical substances and mixtures. Sixth revision. 2015. 521 p.
  2. 2.
    Kandárová H, Letasiova S, Milasova T, Hayden P, Klausner M. Analysis of the Validated Epiderm Skin Corrosion Test (EpiDerm SCT) and a Prediction Model for Sub-Categorization According to the UN GHS and EU CLP. ALTEX Proceedings 2, LINZ 2013, p. 47. 2013. Available at:
  3. 3.
    Desprez B, Barroso J, Griesinger C, Kandárová H, Alépée N, Fuchs HW. Two novel prediction models improve predictions of skin corrosive sub-categories by test methods of OECD Test Guideline No. 431. Toxicol In Vitro. 2015;29(8):2055–80.CrossRefPubMedGoogle Scholar
  4. 4.
    OECD. Guidelines for the testing of chemicals No. 431: in vitro skin corrosion: human skin model test. Paris: OECD, . 8 p. Originally adopted in 2004; 2016.Google Scholar
  5. 5.
    Perkins MA, Osborne R, Johnson GR. Development of an in vitro method for skin corrosion testing. Fundam Appl Toxicol. 1996;31:9.18.CrossRefPubMedGoogle Scholar
  6. 6.
    Fentem JH, Archer GEB, Balls M, Botham PA, Curren RD, Earl LK, Esdaile DJ, Holzhutter H-G, Liebsch M. The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the Management Team. Toxicol In Vitro. 1998;12:483–524.CrossRefPubMedGoogle Scholar
  7. 7.
    ECVAM. ESAC statement on the scientific validity of the rat skin transcutaneous electrical resistance (TER) test (an in vitro test for skin corrosivity) dated 3rd April 1998. ATLA. 1998;26(3):275–80.Google Scholar
  8. 8.
    ECVAM. ESAC statement on the scientific validity of the EPISKIN test (an in vitro test for skin corrosivity), dated 3rd April 1998. ATLA. 1998;26(3):275–80.Google Scholar
  9. 9.
    Liebsch M, Traue D, Barrabas C, Spielmann H, Uphill P, Wilkins S, McPherson JP, Wiemann C, Kaufmann T, Remmele M, Holzhütter H-G. The ECVAM prevalidation study on the use of EpiDerm for skin corrosivity testing. ATLA. 2000;28:371–401.PubMedGoogle Scholar
  10. 10.
    ECVAM. ESAC statement on the application of the EPIDERM human skin model for skin corrosivity testing, dated 21st March 2000. ATLA. 2000;28(3):365–7.Google Scholar
  11. 11.
    Kandárová H, Liebsch M, Spielmann H, Genschow E, Schmidt E, Guest R, Whittingham A, Warren N, Gamer A, Remmele M, Kaufmann T, Wittmer E, De Wever B, Rosdy M. Assessment of the SkinEthic reconstituted human epidermis for skin corrosion testing according to OECD guideline 431. Toxicol In Vitro. 2006;20:547–59.CrossRefPubMedGoogle Scholar
  12. 12.
    ECVAM. Statement on the application of the SkinEthicTM human skin model for skin corrosivity testing, issued by the ECVAM Scientific Advisory Committee (ESAC25), 17 November 2006. 2006. Available at: (25) EC-ECVAM (2009).
  13. 13.
    Hoffmann J, et al. Epidermal-skin-test 1000 (EST-1000) – a new reconstructed epidermis for in vitro skin corrosivity testing. Toxicol In Vitro. 2005;19:925–9.CrossRefPubMedGoogle Scholar
  14. 14.
    ECVAM. ESAC statement on the scientific validity of an in-vitro test method for skin corrosivity testing: the EST-1000, issued by the ECVAM Scientific Advisory Committee (ESAC30), 12 June 2009. 2009. Available at:
  15. 15.
    EU. Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 and its updates (2016). 2008.
  16. 16.
    MatTek. EpiDerm SOP, Version MK-24-007-0024 (November 2014). Protocol for: in vitro EpiDerm skin corrosion test (EPI-200-SCT), For use with MatTek Corporation’s reconstructed human epidermal model EpiDerm. 2014.Google Scholar
  17. 17.
    Scheel J, Heppenheimer A, Lehringer E, Kreutz J, Poth A, Ammanna H, Reisinger K, Banduhn N. Classification and labeling of industrial products with extreme pH by making use of in vitro methods for the assessment of skin and eye irritation and corrosion in a weight of evidence approach. Toxicol In Vitro. 2011;25(2011):1435–47.CrossRefPubMedGoogle Scholar
  18. 18.
    Cannon CL, Neal PJ, Southee JA, Kubilus J, Klausner M. New epidermal model for dermal irritancy testing. Toxicol In Vitro. 1994;8:889–91.CrossRefPubMedGoogle Scholar
  19. 19.
    OECD GD No. 203. Guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation. In: Series on testing and assessment. 11-Jul-2014. 2014.
  20. 20.
    Houthoff E, Rugen P, Hart D. Predictability of in vitro dermal assays when evaluating fatty amine derivatives. Toxicol In Vitro. 2015;29(2015):1263–7.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.MatTek In Vitro Life Science LaboratoriesBratislavaSlovakia
  2. 2.Retired Head of Unit “Centre of Alternative Methods to Animal Experiments – ZEBET” at the BfRBerlinGermany

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