The Big Blue(TM) (lad) and the Muta(TM)Mouse (lacZ/GalE) assays offer
a practical means to generate mutation data from a wide range of tissu
es of treated animals. Our experience with these assays has so far bee
n encouraging, but several fundamental questions require addressing. C
hief among these is whether these assays are to be regarded as replace
ments for standard rodent genotoxicity assays, or if they are to be re
garded as assays for the prediction of potential carcinogenic organotr
opy using a multiple-dose protocol. The interplay between the independ
ent chemical properties of mitogenesis and DNA adduction require also
to be studied. The value and sensitivity of these assays can only be a
ssessed when these questions have been internationally addressed and c
oncluded.