Study of the teratogenic potential of FD&C Red No. 40 when given in drinking water

FD&C Red No. 40 in the drinking water at a level of 0, 0.2, 0.4, or 0.7% was available ad libitum to female Osborne-Mendel rats throughout gestation. The treated females consumed 273.6, 545.7, and 939.3 mg FD&C Red No. 40 per kg body weight per day, respectively, for the three dose levels. The animals were sacrificed on gestation day 20. No fetal terata were seen. There were no dose-related changes in maternal findings, number of fetuses, fetal viability, or external or visceral variations. Skeletal development appeared similar to that of the control animals with the exception of the incidence of fetuses with reduced ossification of the hyoid, which was increased significantly at the 0.7% dose level. A dose-related increase occurred in the number of litters containing fetuses with at least two skeletal variations, but the numbers of litters with fetuses with at least one and at least three variations were not different from control values.