BUSINESS

BUSINESSCarcinogenicity Studies

Introduction

Carcinogenicity studies consist of conventional carcinogenicity studies (18 to 24 months) and short-term carcinogenicity studies (6 months) which examine carcinogenicity. The purpose of these studies is to evaluate the carcinogenicity of test substances through long-term administration during a period of the life span of the test subject that is comparable to that of a human. Usually, the test substance is administered for more than six months, or else the test substance is expected to have genotoxic and carcinogenic effects.

In recent years, short-term and medium-term carcinogenicity studies using transgenic mice have gained international recognition, all while considering budget and time frame, as well as the ethical treatment of animals.

With years of experience in long-term and short-term carcinogenicity studies, we provide test results that are recognized internationally, such as in the United States and in Japan.

Biotoxtech, Ltd. has established a peer review group abroad and built a reputation in histopathology.

Our Studies (Applicable to OECD, JMHW, KFDS)

Carcinogenicity Study Using Rats

Wistar Hannover, F344, and SDIGS rats are selected and the test substance administered orally or in the diet over a period of 24 months or more. Histopathological examinations are conducted and the most significant carcinogenic lesions and general toxicity evaluated.

Carcinogenicity Study Using Mice

B6C3F1 or ICR mice are selected and the test substance is administered orally or in the diet over a period of between 18 to 24 months.

Carcinogenicity Study Using Transgenic Mice

RasH2 TG, or p53TG transgenic mice are selected and the test substance is administered orally or in the diet for a relatively short period (generally 6 months), much less than the duration of a standard carcinogenicity study. Histopathological examinations are conducted and the most significant carcinogenic lesions evaluated.

Other Available Studies

  • 01_ Preliminary Carcinogenicity Study
  • 02_ Combined Carcinogenicity/Toxicokinetics Study
  • 03_ Combined Chronic Toxicity/Carcinogenicity StudyDetail