[OECD ist accepting test guidelines for validated in vitro toxicity tests in 1996]
Since 1990 in Europe a scientific concept for the validation of in vitro toxicity tests has been developed to facilitate regulatory acceptance of the new methods at the international level. ERGATT and ECVAM have promoted the concept of validation on two workshops in 1990 and 1994. A pre-validation stage is an essential part of this validation concept to achieve a better standardisation of in vitro tests before entering formal validation. Within the NTP in 1995/96 Federal Agencies of the USA represented by the validation center ICCVAM have accepted a validation concept, which basically agrees with the essentials of ECVAM"s European validation concept. Subsequently, in January of 1996 the major industrial nations have at the OECD level agreed to the European/US validation concept. This will at the international level allow mutual acceptance of data obtained with in vitro toxicity tests rather than with animal tests. It seems very likely that in 1996 in vitro testing for skin penetration with human skin will be the first in vitro toxicity test accepted by the OECD. Several in vitro tests for local irritancy testing will follow in 1997/98, since they are currently undergoing validation according to OECD criteria.
Spielmann
Horst
H
ZEBET (Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch) im BgVV (Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin), D-Berlin.
Reinhardt
Christoph
C