In general, further agent-specific and generic rfesearch and testing are needed to be able to describe human carcinogenic potential. Agents whose carcinogenic potential cannot be determined, but for which there is suggestive evidence that raises concern for carcinogenic effects. Agents whose carcinogenic potential cannot be determined because no data are available to perform an assessment. Agents not likely to be carcinogenic to humans when carcinogenicity is dose or route dependent. To qualify, agents will have been appropriately evaluated in animal studies and the only effects show a dose range or route limitation, or a route limitation is otherwise shown by empirical data.
Adequate data are within a spectrum.
Dose-response assessment is not indicated for these agents. Further studies would be needed to determine human carcinogenic potential. This includes a case when there is a lack of pertinent or useful data or when existing evidence is conflicting, e.g., some evidence is suggestive of carcinogenic effects, but other equally pertinent evidence does not confirm a concern. Evidence that carcinogenic effects are not likely by a particular route of exposure. Evidence that carcinogenic effects are not anticipated below a defined dose range.