Toxicological evaluation of the new calcium antagonist VULM 993

The tolerance of the new calcium antagonist VULM 993 was investigated in a series of toxicological studies. The following results were obtained: the m aximum tolerated oral dose in acute toxicity was 10,000 mg/kg for mice and 6600 mg/kg for rats, for venous administration it was 26.1 mg/kg in mice an d 32.2 mg/kg in rats. In subacute oral toxicity test in rats, VULM 993 show ed no toxic effect up to 300 mg/kg/d. The drug was not teratogenic in rats (5, 50 or 250 mg/kg/d, p.o.). VULM 993 did not show any positive response i n tests for genotoxicity in vitro. Transplacental study of VULM 993 in rabb its indicated active placental barrier function in the late stage of pregna ncy. The toxicological profile of VULM 993 is characterised by a high toler ance in all relevant species of experimental animals, and no biologically s ignificant mutagenic potential was recorded.