CellSystems

Human reconstructed skin has become increasingly important during the last few years in different fields

Chemical testing on reconstructed human epidermis already replaces animals for skin corrosion and skin irritation testing. These skin models are used for substance testing in the regulatory context of the cosmetics directive and under the REACH legislation.

 Skin Corrosion

Skin corrosion refers to the production of irreversible tissue damage in the skin following the application of a test material (as defined by GHS). Their classification into corrosives and non-corrosives by in vitro tests is described in detail by the OECD Test Guideline 431 „OECD Guideline for the testing of chemicals – In Vitro Skin Corrosion: Human Skin Model Test“.

EST1000 has been validated for skin corrosion testing in the context of the OECD TG 431 in a multicenter validation study. The data have been submitted to ECVAM (European Centre for the Validation of Alternative Methods) and ESAC – the ECVAM Scientific Advisory Committee – endorsed the statement on the scientific validity of the EST1000 method for skin corrosion testing (June 2009).

 Skin Irritation

Skin irritation is the production of reversible inflammatory changes in the skin following the application of a test chemical.
Chemical classification – in accordance with UN-GHS and EU-CLP is described in detail by the OECD Test Guideline 439 „OECD Guideline for the testing of chemicals – In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method“.

CellSystems has carried out a multi - centre validation study for the EST1000 Skin Irritation Test (according to OECD Test Guideline 439) and has submitted a dossier in 2011 to ECVAM. The endorsement by ESAC– the ECVAM Scientific Advisory Committee – is expected in 2012.

 Skin Phototoxicity

Phototoxicity is defined as a toxic response that is elicited after exposure of the skin to certain chemicals and subsequent exposure to light. The approved 3T3 NRU phototoxicity test (OECD Test Guideline 432) is based on submersed BALB/c 3T3 fibroblasts. Hence, the method is limited to testing of soluble chemicals.

As the use of EST1000 enables to apply test items topically the use of reconstructed epidermis reflects better the physiological situation and is used as a second tier approach to gather more information about the test items. This strategy is widely established in the cosmetics industry.