Safety assessment of transgenic maize CC-2 by 90-day feeding study in Sprague-Dawley rats.

ABSTRACT

Objective: The purpose of this study was to assess the safety of transgenic maize CC-2 through a 90-day feeding study in Sprague-Dawley rats. Methods: Transgenic maize CC-2 and its parental counterpart maize Zhengdan 958 were respectively incorporated into diets at levels of 70%, 35% or 17.5% (w/w) and were administrated to rats (n = 10/sex/group) for 90 days. An additional control group of rats (n = 10/sex/group) were fed with the AIN93 breeding diet. All formulated diets were nutritionally balanced. Results: There was no death and obvious toxic symptom in all rats. Food consumption, body weight, total food consumption rate, hematology, urinalysis, organ weight and organ coefficient were comparable between transgenic groups and the corresponding dose parental groups. There were significant differences of food consumption rate on some timepoint between high dose transgenic group and high dose parental group; male rats in high dose transgenic group showed significantly higher ALT/AST than high dose parental group on the middle or end of the experiment; but the differences showed no biological significance. There were no significant differences of other serum biochemistry parameters and pathological changes. Conclusion: The results in this study demonstrated that the transgenic maize CC-2 didn't cause any related toxicity in rats.