RAW MATERIALS / VALIDATED TEST METHOD (under OECD Test Guidelines 439)
Our epidermal models and corresponding protocols are designed for regulatory purposes to classify and label chemicals regarding in vitro skin irritation assessment.
In case of irritant test substance, an additional run using in vitro skin corrosion test method may be required when data are generated in the context of OECD TG 439.
Both EpiskinTM Small Model and SkinEthicTM RHE model can be used for in vitro skin irritation assessment but they should be used with their respective protocol.
DETAILED ASSAY PROCEDURE
NB: please note that this protocol is currently under revision in order to meet OECD TG439 version 2015; website news will will keep you informed of new updated protocol version. Do not hesitate to get information on our training sessions or to contact our technical support.
A catch-up validation study on reconstructed human epidermis (SkinEthicTM RHE) for full replacement of the Draize skin irritation test. N. Alépée, C. Tornier, C. Robert, C. Amsellem, M.-H. Roux, O. Doucet, J. Pachot, M. Meloni, A. de Brugerolle de Fraissinette. Toxicology In Vitro, 24: 257-266, 2010.
Use of HPLC/UPLC-spectrophotometry for detection of formazan in in vitro Reconstructed human Tissue (RhT)-based test methods employing the MTT-reduction assay to expand their applicability to strongly coloured test chemicals. N. Alépée, J. Barroso, A. De Smedt, B. De Wever, J. Hibatallah, M. Klaric, K. R. Mewes, M. Millet, U. Pfannenbecker, M. Tailhardat, M. Templier, P. McNamee. Toxicology In Vitro, 29: 741-761, 2015.
The ECVAM international validation study on in vitro tests for acute skin irritation: report on the validity of the EPISKIN and EpiDerm Assays and on the Skin Integrity Function Test. H. Spielmann, S. Hoffmann, M. Liebsch, P. Botham, J. H. Fentem, C. Eskes, R. Roguet, J. Cotovio, T. Cole, A. Worth, J. Heylings, P. Jones, C. Robles, H. Kandárová, A. Gamer, M. Remmele, R. Curren, H. Raabe, A. Cockshott, I. Gerner, V. Zuang. Alternatives To Laboratory Animals, 35: 559-601, 2007.