Guidance Document on the In Vitro Syrian Hamster Embryo (SHE) Cell Transformation Assay

This document presents guidance for conducting the Syrian Hamster Embryo Cells Transformation Assay (SHE CTA). The purpose of this Guidance document is to allow the regulatory community to use the described method as part of a weight of evidence approach in the testing of substances for carcinogenic potential. There are a number of issues which...