Abstract
Safety evaluation of pyridoxal-DL-homocysteine (PAL-HCySH) was made by acute-, subacute-, chronic-toxicity and teratological tests. In the acute toxicity test of mice and rats, LD_<50>s of PAL-HCySH were very high levels in any routes. In the oral subacute toxicity test of PAL-HCySH to male and female rats, the results obtained indicated very weak toxicity of the drug. In the chronic toxicity test, PAL-HCySH was administered to male rats orally, in doses of 125,250,500 and 1000mg/kg daily for seven months. With the exception of reduction of body weight gain in the rats given 1000mg/kg of PAL-HCySH, any toxic effects of the drug were not observed in the lower dosed groups. In the teratological test, PAL-HCySH was given orally to pregnant mice and rats every day from the 7th to the 14th day of gestation in doses of 5 and 1000mg/kg for mice and 5 and 500mg/kg for rats. No influence of PAL-HCySH was observed on fetuses obtained from the mother animals.
