RAW MATERIALS / VALIDATED TEST METHOD (under OECD Test Guideline 431)
Our epidermal models and corresponding protocols are designed for regulatory purposes:
- Classification and labelling of chemicals regarding in vitro skin corrosion assessment
- Determination of packaging requirement
- Complementary data to in vitro skin irritation assessment of compound classified as irritant (see OECD Test Guideline 439)
Both EpiskinTM Small Model and SkinEthicTM RHE model can be used for in vitro skin corrosion 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 TG431 version 2015; website news will take you inform of new protocol version availability.
Do not hesitate to get information on our training sessions or to contact our technical support.
The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the management team. J. H. Fentem, G. E. B. Archer, M. Balls, P. A. Botham, R. D. Curren, L K. Earl, D. J. Esdaile, H.-G. Holzhütter, M Liebsch. Toxicology In Vitro, 12: 483-524, 1998.
Sub-categorisation of skin corrosive chemicals by the EpiSkinTM reconstructed human epidermis skin corrosion test method according to UN GHS: revision of OECD Test Guideline 431. N. Alépée, M.-H. Grandidier, J. Cotovio. Toxicology In Vitro, 28: 131-145, 2014.
Assessment of the human epidermis model SkinEthicTM RHE for in vitro skin corrosion testing of chemicals according to new OECD TG 431. H Kandárová, M. Liebsch, H. Spielmann, E. Genschow, E. Schmidt, D. Traue, R. Guest, A. Whittingham, N. Warren, A. O. Gamer, M. Remmele, T. Kaufmann, E. Wittmer, B de Wever, M. Rosdy. Toxicology In Vitro, 20: 547-559, 2006.
Adaptation of the validated SkinEthicTM Reconstructed Human Epidermis (RHE) skin corrosion test method to 0.5 cm² tissue sample. C. Tornier, M. Roquet, A. de Brugerolle de Fraissinette. Toxicology In Vitro, 24 : 1379-1385, 2010.
The usefulness of the validated SkinEthic™ RHE test method to identify skin corrosive UN GHS subcategories. N. Alépée , C. Robert, C. Tornier, J. Cotovio. Toxicology In Vitro, 28: 616-625, 2014.