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EpiDerm™ Skin Irritation Study

Project Aim

Skin is the largest organ of the human body, and it is permanently exposed to external influences like cosmetics, pharmaceutical products and environmental contaminants. Thus effectiveness and tolerance tests for substances and bioactive ingredients play an essential role during product development cycles in the cosmetics, pharmaceutical and textile industry. Via the humane in vitro skin model EpiDerm^TM, which is categorized according to the EU-classification system (R38 or no identification), a prediction for the skin-irritating potential of 20 defined chemicals will be determined. These chemicals are undisclosed to the investigators. Validation of this in vitro procedure should ultimately result in complete replacement of in vivo rabbit skin-irritation tests which have been used up until now, with one in vitro method.

Project Background

The human skin is more apt to react to chemicals locally and not systematically. The skin-irritating potential of unknown substance can also be predicted with the help of in vitro test systems, like for instance, three-dimensional (3D) skin models, if they are sufficiently complex and can mimic the skins barrier function and emulate the reaction of diverse skin cells. A variety of human 3D skin models and toxicological endpoints have already been investigated in pre-validation studies performed by the ECVAM (European Center for the Validation of Alternative Methods). The revised and optimized test protocol of the 3D skin model is currently being checked in a validation study concerning the reproducibility and predictability in regards to the skin-irritating potential of 20 different chemicals, which are listed in the ECETOC Data Base No. 66 under "Skin Irritation/Corrosion".
zet-LSL is partaking in this international study for the validation of the EpiDerm^TM skin model. The EpiDerm^TM model is an artificial, complete, multilayer epidermis. Testing principle: skin-irritating chemicals penetrate the outer skin layer (starum corneum) and damage subjacent vital cell layers. The cell damage potential can be measured biochemically (MTT-assay). This in vitro 3D skin-model can be used to test liquid, solid, semi-solid and ceraceous substances. It is also irrelevant if the liquids and solids are water soluble or not. Solids are applied as powder. This method is expected to be capable of testing chemicals in diverse categories, with the exception of gases and aerosols. The different classes of substances are taken into account within this validation.

Due to the positive evaluation of the  EpiDerm^TM skin model  can be used today to predict skin irritating properties of test compounds, thus allowing to replace the corresponding animal experiment. The experimental procedure is described in the "OECD Test Guideline 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method".

Participating Laboratories

Central Office for Registration and Evaluation of Substitute and Complimentary Methods of Animal Experiments (German: ZEBET); BASF; Institute for In Vitro Sciences (IIVS); zet-LSL

Financing

Austrian Federal Ministry of Science and Research/BMWF