ABSTRACT
It is unfortunate that the terms acute lethality testing and acute toxicity have become synonomous. There is indeed a difference that we would like to stress in this book. As described by Zbinden and Flury-Roversi (1981) and Zbinden (1986) the classical LD50 test has several shortcomings, not the least of which is that there is no good correlation between mortality and morbidity. In fact, the FDA expects to see more than lethality data in acute toxicity studies (FDA, 1984). The Pharmaceutical Manufacturers Association has taken a similar position (Le Beau, 1983) in that acute toxicity testing should encompass more than LD50 determi nations. The regulatory requirements for acute toxicity data, including lethality, are included in Tables 23 and 24, Chapter 7 and are also reviewed by Auletta (1988).
