Carcinogenicity studies involve exposing rodents to your product for up to a maximum of two years. We collect extensive in-life, survival, and histopathology data, and perform full statistical data analysis to evaluate tumor parameters.
Our carcinogenicity studies comply with EU (CPMP), ICH, FDA, EPA, JMHW, JMAFF and OECD regulations. Requirements are similar for all, though the testing of agrochemicals and industrial chemicals can combine carcinogenicity studies with a long-term chronic toxicity study. Our experts are happy to guide your testing strategy to satisfy regulatory guidelines.
Routine carcinogenicity species include:
Regulatory authorities now accept that carcinogenic potential can be evaluated from data collected in a 2-year rat bioassay, plus a short-term mouse study using a transgenic model. Charles River has actively evaluated these alternative models as part of The International Life Sciences Institute (ILSI) program. A 26-week study in transgenic mouse models (together with a preliminary 4-week toxicity study if necessary) is often selected as a replacement for the standard 78- or 104 week mouse study.
Currently recommended transgenic models are:
- Tg.rasH2 mouse for genotoxic/non-genotoxic compounds
- p53 +/- mouse for known genotoxic compounds
- Tg.AC mouse for dermal drugs
These carcinogenicity models were initially accepted by regulatory agencies as the result of a multinational effort by The ILSI/Health and Environmental Sciences Institute’s Alternatives to Carcinogenicity Testing Project in conjunction with the directives of ICH S1B, from 1996 to 2001. Since then, the rasH2 model has become the model of choice most often used as a replacement for a traditional 2-year mouse carcinogenicity studies.
We’ve conducted more than 60 carcinogenicity studies with the transgenic rasH2 mouse model since 2013 and are happy to offer this alternative to the full 2-year carcinogenicity study.
Learn more about our transgenic mouse and rat model creation.