In-vitro studies

Mechanistic  data might be  supplemented by  data  from in-vitro  studies, like  as information on genotoxicity derived from reversion assays or other same assays. These studies should be conducted following GLP and other widely accepted protocols. Though,  data  from in-vitro studies should not  be  used  as  the  sole source of information to predict the human risk.

-  The results of in-vitro studies can enhance the understanding of mechanisms and phannacokinetics/dynamics.  Though, such information may not be available in many cases and  the  risk assessment process should  not  be delayed pending development of mechanistic and pharmacokineticldynamic data.