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Abstract

The questions of why and when specific in vitro tests should be accepted into regulatory toxicology are addressed. In vitro tests should be accepted into regulatory toxicology for at least five reasons: scientific; humanitarian; legislative; logistical; and economic. In particular, in vitro tests have the potential to provide a mechanistic basis for toxicity testing, and they may permit the use of tissues from more appropriate target species and individuals, including humans. However, there are many barriers to the acceptance of alternative methods, including: the validation barrier, the scientific barrier, the legislative barrier, the development barrier, the psychological barrier, the fear of litigation barrier, and the regulatory barrier. Attention is focused, in particular, on validation as a barrier to regulatory acceptance. The relevance and reliability of the in vitro test, with regard to its use for a particular purpose and with particular types of chemical, should have been adequately demonstrated (i.e. it should have been validated) prior to its promotion for regulatory acceptance.

Additional information

Authors: BALLS M, JRC Ispra (IT);FENTEM J H, FRAME, Nottingham (GB)
Bibliographic Reference: Article: The World Congress on Alternatives and Animal Use in the Life Sciences : Education, Research, Testing (1996), pp. 683-689
Record Number: 199610554 / Last updated on: 1996-05-27
Category: PUBLICATION
Original language: en
Available languages: en
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