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Dermopharmacy
News
Toxicological Safety
Test
Skin Models
Gaining Ground
For years now it has been designated target in industrial nations to reduce
the number of animal experiments for safety toxicological tests of industry
chemicals, plant protective agents and medicaments. The objective could
be achieved by using alternative methods based on biotechnologically established
human skin models. The development of a method of the type for the testing
of skin penetration nears completion.
The development of novel alternative methods was effected in the scope of
an interdisciplinary joint project started in September 2002 and sponsored
by funds of Bundesministerium für Bildung und Forschung (BMBF) (Federal
Ministry for Education and Research). Dermatologists, pharmacologists, pharmacists
and veterinarians from the following institutions were involved in the project:
- Free University Berlin, Institute for Pharmacy
- University of the Saarland, department Biopharmacy and Pharmaceutical
Technology
- Technical University Brunswick, Institute for Pharmaceutical Technology
- Foundation Veterinarian University Hannover, Institute for Pharmacology,
Toxicology and Pharmacy
- Ludwig-Maximilians-University Munich, Clinic and Polyclinic for Dermatology
and Allergology
- Bundesinstitut für Risikobewertung (BfR) (Federal Institute for
Risk Assessment), Berlin, ZEBET
- Across Barriers GmbH, Saarbrücken
- BASF AG, Ludwigshafen
- Beiersdorf AG, Hamburg
- Cognis Deutschland GmbH, Düsseldorf
- Institut für Grenzflächen- und Bioverfahrenstechnik (Institute
for Interface- and Bio-process Engineering), Fraunhofer, Stuttgart
After first of all test provisions were developed, optimized and compared
in view of their reproducibility, in the end of last year, the one-year
validation of the optimized test method was successfully terminated.
As the speaker of the project, professor Dr. Monika Schäfer-Korting
of the Institut für Pharmazie (Institute for Pharmacy) at Free University
Berlin explained, the results of this study will be furnished in brief
to the Europäische Zentrum zur Validierung von Alternativmethoden
(ECVAM) (European Center for the Validation of Alternative Methods) for
an independent validation of alternative methods.
It is expected that the method can then be employed in the scope of the
OECD-test guideline recently adopted for the determination of the uptake
of foreign bodies.
Concomitant to the process development a training laboratory on bio-technologically
reconstructed human skin models has been installed at the Institut für
Pharmazie (Institute for Pharmacy) of Free University Berlin financed
with EC funds. Since September 2005 scientists from industry and universities
from all over Europe may become acquainted with alternative methods for
animal experiments that are recognized and reached advanced developmental
stages. Further information can be retrieved at the internet-address http://userpage.fu-berlin.de/~invitrot/.
jk
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