A Tg-rasH2 mouse is an innovative transgenic mouse, developed in Central Institute for Experimental Animals (CIEA), carrying the three copies of human prototype c-Ha-ras oncogenes with endogenous promoter and enhancer in tandem.[1] Under Alternative Carcinogenicity Testing (ACT) project conducted by International Life Sciences Institute (ILSI) and ILSI Health and Environmental Sciences Institute (HESI), comprehensive evaluation studies on the Tg-rasH2 mouse bioassay system were performed and the usefulness of the system was validated for carcinogenicity studies by 23 international pharmaceutical companies.[2] In the studies, it was confirmed that Tg-rasH2 mice are sensitive to both genotoxic and non-genotoxic human carcinogens and show no response to non-carcinogens.[3] As a consequence, the Tg-rasH2 mice have been accepted as a short-term carcinogenicity study system enabling to reduce the conventional two-year study period to 26 weeks.
History
edit- 1989: Tg-rasH2 mice were first developed in CIEA.
- 1992: CIEA started development of carcinogenicity bioassay system using Tg-rasH2 mice.
- 1996: Policy to replace the 2-year study on mice with the short-term study decided at ICH4.
- 1996-2000: Usefulness of rasH2 mice validated by ILSI/HESI international research.
- 2001: Production and sales of Tg-rasH2 mice.