[The use of biotechnological recombinant-mice in biological safety research]

Number of transgenic and knock-out mice increased rapidly during the last decade. This review article describes a potential usefulness of transgenic and knock-out mice for biological safety research with respect to each toxicological category for safety evaluations, such as studies for carcinogenicity, general toxicology, genotoxicologic testing, and immuno-toxicological evaluations. In the carcinogenicity, a possible model required for a short-term study in carcinogenicity was discussed. Further, a couple of future subjects were focused specifically on the biotechnology-derived pharmaceuticals and the biotechnical recombinant-mice as a second generation, i.e. experimental mice with double or multiple gene-recombination. Those usefulnesses were also introduced briefly. Establishing the biotechnical recombinant-mice for each safety testing contributes not only to simplify and qualify the on-going evaluation system, but also to the traditional animal studies to be re-evaluated, so that the solutions may lead them to a future in vitro-alternative system much smoothly. For general references, historical reviews on the biotechnical recombination in experimental animals were also briefly introduced to elucidate a new broad area in developmental biology.