The developmental toxicity of tetramethylurea (TMU) was assessed in rats by
inhalation exposure of the test material over days 6-20 of gestation. Grou
ps of 25 mated female Crl:CD (R) BR rats were exposed whole-body for 6 hour
s/day to concentrations of either 0, 2, 20 or 100 ppm TMU. The dams were eu
thanized on day 21 and the offspring were weighed, sexed, and examined for
external, visceral, and skeletal alterations. Maternal toxicity was demonst
rated at both 20 and 100 ppm. Maternal body weights, weight changes, and fo
od consumption were statistically significantly reduced at these concentrat
ions: effects were more pronounced at 100 ppm. There was evidence of develo
pmental toxicity only at 100 ppm. The only finding was a decrease in mean f
etal weight. No fetal malformations or variations occurred in fetuses deriv
ed from rats exposed to all 3 test concentrations (up to 100 ppm). The mate
rnal no-observed-effect-level (NOEL) was 2 ppm. the fetal NOEL was 20 ppm.
Thus, TMU was not considered to be uniquely toxic to the rat conceptus.