When should the results of cancer bioassay studies that show significant increases over controls in benign but not in malignant tumors be submitted to the Agency under TSCA §8(e)?
A.17. Benign tumors should be reported when either statistically or biologically significant increases over controls are observed. The observation of such increases in many cases is made at interim sacrifices performed during long-term exposure studies in animals. Benign tumors may eventually become malignant, and benign tumors themselves may pose serious health hazards.
