Cancer-Preventive BBI Clears Maternal/Developmental Safety Hurdle

Bowman-Birk Inhibitor (BBI) - a food-derived substance with potential use as a cancer-preventive agent - has cleared a hurdle in the evaluation of its safety for use by women of child-bearing age.

BBI - a serine protease inhibitor found in soybeans, lima beans, chickpeas, rice and other foodstuffs - when administered to pregnant rats during the period of major organogenesis, was found to induce neither maternal nor developmental toxicity.

IITRI's Dr. Ali Faqi, study director, presented these findings at the Teratology Society meeting June 22-27, 2002, in Scottsdale, AZ.

Methods

Groups of 28 sperm-positive female Sprague-Dawley rats received daily oral (gavage) exposure to BBI (in filtered water) at doses of 0 (control), 250, 500 or 1000 mg/kg/day on gestation days 6 through 15. Litters were delivered by cesarean section on gestation day 20 and underwent a complete Segment II evaluation.

Results

No maternal deaths occurred during the dosing period, and no evidence of BBI-related maternal toxicity was present in any dam. Mean maternal body and organ weights in groups exposed to BBI did not differ from body and organ weights in the vehicle control group.

The number of implantation sites and resorption rates in groups exposed to BBI were comparable to those in vehicle controls. Mean litter size, sex ratio and fetal body weights were similar in all experimental groups. Gross external, visceral, skeletal and cephalic examinations of litters from BBI-treated and control groups failed to identify any teratogenic effects of BBI.

Conclusion

Under these experimental conditions, administration of BBI to pregnant rats during the period of major organogenesis caused no maternal or developmental toxicity. It was concluded that the No Observed Adverse Effect Level (NOAEL) dose for BBI as a developmental toxicant in Sprague-Dawley rats is greater than 1000 mg/kg body weight.