10/18/2007, Düsseldorf / Germany


Skin sensitization tests in future without animal experiments

BMBF Sponsors Research Project by Phenion and Johann Wolfgang Goethe University

Phenion, the Henkel bio-research company in Düsseldorf, Germany and the Centre for Dermatology and Venerology at Johann Wolfgang Goethe University in Frankfurt am Main, Germany have been awarded a grant worth some 520,000 euros by the German Federal Ministry of Education and Research (BMBF). The goal of the research project is to seek an alternative to animal experiments with which potentially allergenic substances can be assessed.

Phenion GmbH & Co. KG and Johann Wolfgang Goethe University in Frankfurt am Main have joined forces to develop an alternative method to animal testing for the evaluation of chemicals and their sensitizing properties. Animal-free testing methods – known as in-vitro test systems – are urgently needed to assess the safety of raw materials. During the course of the research project, which is being subsidized over three years, Phenion and Frankfurt University will develop and characterize various cell and tissue model systems, based for example on the Phenion® Full Thickness Skin Model.

The Phenion® Full Thickness Skin Model is an artificial model of human skin that consists of the various cell layers of natural skin and which can be cultivated in a test tube (in vitro). “By analyzing  certain biomolecular reactions of the cells that are cultivated in combination with each other or with the artificial skin tissue, our researchers hope to be able to demonstrate the sensitizing properties of a chemical,” says Dr. Andrea Sättler, General Manager at Phenion.

For some substances, the sensitization of the skin is the first step during triggering an allergic reaction, as known from Nickel-containing materials, for example. Currently no alternatives to animal testing exist for the prescribed tests for skin sensitization. The development of the Local Lymph Node Assay a number of years ago has allowed a refinement of animal experiments, meaning that the animals are put under considerably less strain during testing, but it is still an animal experiment.

“In order to demonstrate that the new in-vitro system can replace current animal testing, a wide range of well-known chemicals must be tested during the course of the project,” explains Professor August Bernd, head of biological research projects at the Centre for Dermatology and Venerology at the University of Frankfurt. “We must prove that the new in-vitro systems can distinguish reliably and reproducibly between harmless and sensitizing substances.” After the completion of the research project, the findings must then be subjected to what are termed ‘validation studies’ in collaboration with various independent laboratories to examine their general validity. Finally the validation results will be submitted to the relevant regulatory authorities for approval. The validation process and subsequent approval is very complex and often takes up to ten years. Sättler and Bernd are in full agreement though: “It is only through cooperative projects of this nature that alternative methods can be developed quickly and efficiently.”

Phenion – Henkel’s competence center for skin research and development of alternatives to animal testing – was founded in 2001 as a biotechnology research company in the form of a public-private partnership between Henkel KGaA, the Johann Wolfgang Goethe University in Frankfurt am Main, and six Frankfurt-based professors. In 2006, Phenion was expanded to incorporate the skin and hair research activities and dermatological studies of Henkel Research and is now a 100-percent Henkel research company.