Toward Public Health & Safe Society

Carcinogenicity Test

Carcinogenicity Study
Carcinogenicity test is conducted to predict the carcinogenicity of man by searching for the possibility of tumor initiation using test animal. This test is a mandatory test for long-term administrative drug, drug that is suspected to have genotoxicity or carcinogenicity in the correlation of structure activity, drug that was observed with precancerous change in repeated dose toxicity test.
In 1995, there was an intense discussion about the problem of using many animals and consuming too much time and cost in the traditional method of organ carcinogenicity test at ICH(International Conference on Harmonization), and in 1998, short or mid term alternative carcinogenicity test was approved instead of long term test using mouse, so currently, the long term test using mouse and short, midterm alternative test are both acknowledged.
Field of Test

"Korea Institute of Toxicology is a consigned facility to conduct carcinogenicity test that follows the standard of FDA, OECE and ICh. It has conducted 14 tests that use rodents and 1 short term test using transformant mouse during last 15 years. Currently, the most common test is traditional style long term carcinogenicity test using rat and 2 types of mouse.
Carcinogenicity test using rat and mouse
- Concurrent chronic and carcinogenicity test by feed mixture and forced oral administration
Short term carcinogenicity test using transformant mouse (p53, rasH2 mouse)
Oncogenesis test using nude mouse/rat