Author(s): Gallagher, L.
Article Type: Report
Record ID: 734
Abstract: This evaluation of Bt brinjal studies is based on requirements for a rigorous evaluation of food safety for the people of India and their health. Departures from Indian and international published standards for the 14-day and 90-day studies are a cause for concern 1.
The current food safety studies for Bt brinjal were not conducted in accordance with published standards, did not accurately summarize results, and ignored toxic endpoints for rats fed Bt brinjal: in particular, rats fed Bt brinjal for 78 out of 90 days (only one dose level) experienced: organ and system damage: ovaries at half their normal weight, enlarged spleens with white blood cell counts at 35 to 40 percent higher than normal with elevated eosinophils, indicating immune function changes; toxic effects to the liver as demonstrated by elevated bilirubin and elevated plasma acetylcholinesterase.
Major health problems among test animals were ignored in these reports. The single test dose used was lower than recommended by the Indian protocols. Release of Bt brinjal for human consumption cannot be recommended given the current evidence of toxicity to rats in just 90 days and the studies’ serious departures from normal scientific standards.
Citation: Gallagher, L., 2016. Bt Brinjal Event EE1—the scope and adequacy of the GEAC toxicological risk assessment: review of oral toxicity studies in rats.
