In Vitro Methods in Regulatory Toxicology

Abstract

So-called “in vitro” experimentation to be used replacing experiments with whole animals has often been a matter rather of emotion than of data. This is no surprise, and the data thus missing cannot be presented here. In the meantime, however, a whole lot of data has been generated, investigating in detail many aspects of experiments involving biological matter at a level below that of the whole, intact organism. One possibility was the establishment of precise dose- response-relationship comparisons among and between large families of chemical substances. For such comparisons a variety of experimental endpoints is available, often involving acute cytotoxicity. Without further knowledge about the substances to be investigated and compared, e.g. about their physico-chemi- cal attributes, interpretation of such data and comparisons becomes difficult (because of comparing e.g. different lipophilicity rather than different toxicity); this does not contribute to meaningful, risk-benefit assessment and decision as is needed for medicines and other consumer products. Such data, therefore, have become of minor interest to us and will not be presented here.