Subchronic feeding study of high oleic acid soybeans (Event DP-3Ø5423-1) in Sprague–Dawley rats

• Published in: Food and chemical toxicology 2008-12, Vol.46 (12), p.3808-3817
• Main Authors: Delaney, Bryan, Appenzeller, Laura M., Munley, Susan M., Hoban, Denise, Sykes, Greg P., Malley, Linda A., Sanders, Craig
• Format: Article
• Language: English
• Subjects: acetolactate synthase; animal models; Animals; Behavior, Animal - drug effects; biolistics; Biological and medical sciences; Biotechnology; Blood Cell Count; Blood Chemical Analysis; blood chemistry; Blood Coagulation - drug effects; Body Weight - drug effects; Diet; Eating - drug effects; Eye - pathology; feed conversion; Female; food fortification; fortified foods; free fatty acids; genetically modified foods; Genetically-modified; germ cells; Glycine max - chemistry; Glycine max - genetics; Glycine max - toxicity; hematology; High oleic acid oil; histopathology; Male; Medical sciences; neurophysiology; oleic acid; Oleic Acid - analysis; Oleic Acid - toxicity; omega-6 fatty acids; Plants, Genetically Modified; Rat; Rats; Rats, Sprague-Dawley; signs and symptoms (animals and humans); Soybean; soybean oil; soybeans; Subchronic; subchronic toxicity; Toxicology; transgenic plants
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2008.10.003

DP-3Ø5423-1 (305423) is a genetically-modified (GM) soybean that was produced by biolistic insertion of a gm-fad2-1 gene fragment and the gm-hra gene into the germline of soybean seeds. The gm-fad2-1 gene fragment cosuppresses expression of the endogenous FAD2-1 gene encoding the seed-specific omega-6 fatty acid desaturase resulting in higher concentrations of oleic acid (18:1) relative to linoleic acid (18:2). The gm-hra gene encoding a modified acetolactate synthase (ALS) enzyme was used as a selectable marker. In the current study, processed fractions (meal, hulls, and oil) from 305423 soybeans, non-GM soybeans with a similar genetic background (near isoline control) and three commercially-available non-GM varieties were used to formulate diets that were nutritionally comparable to PMI ® Certified Rodent LabDiet ® 5002. Diets were fed to young adult Crl:CD(SD) rats (12/sex/group) for approximately 90 days. Compared with rats fed the non-GM control diet, no biologically relevant differences were observed in rats fed the 305423 diet with respect to body weight/gain, food consumption/efficiency, mortality, clinical signs of toxicity, or ophthalmological observations. No test diet-related effects were observed on neurobehavioral assessments, organ weights, or clinical or anatomic pathology. These results demonstrated that 305423 soybeans are as safe and wholesome as non-GM soybeans.