To predict and classify the skin corrosivity potential of a chemical by using a three-dimensional human epidermis model. This study is designed based on MatTek protocol “In Vitro EpiDerm™ Skin Corrosion Test”.
A Test substance is dosed topically to a 3D Reconstructed Human Tissue model, comprised of nontransformed, human-derived epidermal keratinocytes, which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. The 3D tissue consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum analogous to those found in vivo.
This reconstructed 3D tissue model is based on the premise that irritating and corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion, and are cytotoxic to the cells in the underlying layers. Enzymatic conversion of the vital dye MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue tetrazolium bromide; CAS number 298-93-1], into a blue formazan salt that is quantitatively measured after extraction from tissues is used to determine cell viability.
3D Reconstructed Human Tissue Model
Skin irritation tests are performed using in vitro 3D human skin tissue models that closely mimic the human epidermis. in vitro 3D human skin tissue models were developed to create an in vitro (non-animal) alternative to the animal-based Draize Skin irritation and corrosivity testing utilized by by many industries including: personal care, household products, chemical, pharmaceutical, and biotech industries.
MB Research offers skin irritation test models that have been endorsed by the ECVAM Scientific Advisory Committee (ESAC) as validated in vitro replacement for the Draize Skin Irritation Test - OECD Test guidelines 439.
- OECD (2016), Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris.
- Draize J.H., Woodard G., and Calvery H.O. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J Pharm Exp Ther 82, 377-390.