title: Subchronic feeding study of DAS-59122-7 maize grain in Sprague-Dawley rats.
abstract: 59122 is a transgenic maize line containing event DAS-59122-7 that expresses the corn rootworm (CRW) specific pesticidal Cry34Ab1 and Cry35Ab1 proteins from Bacillus thuringiensis (Bt) Berliner strain PS149B1 and the phosphinothricin-N-acetyltransferase (PAT) protein from Streptomyces viridochromogenes for tolerance to the herbicidal ingredient glufosinate-ammonium. For the current study, 59122 maize grain, non-transgenic near-isogenic maize grain (091), and a commercially available non-transgenic reference maize grain (33R77) were grown under conditions simulating commercial farming practices. Adult Sprague-Dawley rats (12/sex/group) were fed diets formulated with 35% maize grain from either 59122, 091, or 33R77, or one of two separate lots of commercially available rodent chow prepared with commercially available corn (35%) in accordance with the standards of Purina Mills Labdiet 5002 for approximately 90 days. All diets possessed similar nutritional and contaminant profiles. The transgenic proteins were detected only in diets prepared with 59122 maize grain and were stable over the course of the study. Compared to control groups, no adverse diet-related differences were observed in rats fed diets formulated with 59122 maize grain with respect to body weight/gain, food consumption/efficiency, clinical signs of toxicity, mortality, ophthalmology, neurobehavioral (FOB and motor activity) assessments, clinical pathology (hematology, clinical chemistry, coagulation, and urinalysis), and pathology (organ weights and gross and microscopic pathology). Results from this study indicate that 59122 maize grain is nutritionally equivalent to and as safe as conventional maize grain.
authors.affiliation: DuPont Haskell Laboratory, Newark, DE, United States.
authors.forename: Linda A
authors.initials: LA
authors.lastname: Malley
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Everds
authors.forename: Julia
authors.initials: J
authors.lastname: Reynolds
authors.forename: Peter C
authors.initials: PC
authors.lastname: Mann
authors.forename: Ian
authors.initials: I
authors.lastname: Lamb
authors.forename: Tracy
authors.initials: T
authors.lastname: Rood
authors.forename: Jean
authors.initials: J
authors.lastname: Schmidt
authors.forename: Raymond J
authors.initials: RJ
authors.lastname: Layton
authors.forename: Lee M
authors.initials: LM
authors.lastname: Prochaska
authors.forename: Mark
authors.initials: M
authors.lastname: Hinds
authors.forename: Mary
authors.initials: M
authors.lastname: Locke
authors.forename: Chok-Fun
authors.initials: CF
authors.lastname: Chui
authors.forename: Fred
authors.initials: F
authors.lastname: Claussen
authors.forename: Joel L
authors.initials: JL
authors.lastname: Mattsson
authors.forename: Bryan
authors.initials: B
authors.lastname: Delaney
mesh_terms: D000818:Animals; D000083722:Bacillus thuringiensis Toxins; D001426:Bacterial Proteins / Q000235:genetics*; D001427:Bacterial Toxins / Q000235:genetics*; D001522:Behavior, Animal / Q000187:drug effects; D004032:Diet; D004435:Eating / Q000187:drug effects; D004731:Endotoxins / Q000235:genetics*; D004734:Energy Metabolism / Q000187:drug effects; D005260:Female; D006403:Hematologic Tests; D006460:Hemolysin Proteins / Q000235:genetics*; D007306:Insecticides; D008136:Longevity / Q000187:drug effects; D008297:Male; D009929:Organ Size / Q000187:drug effects; D010572:Pest Control, Biological; D030821:Plants, Genetically Modified / Q000235:genetics / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D018675:Toxicity Tests / Q000379:methods*; D015430:Weight Gain / Q000187:drug effects; D003313:Zea mays / Q000235:genetics*
chemical_list: D000083722:Bacillus thuringiensis Toxins; D001426:Bacterial Proteins; D001427:Bacterial Toxins; D004731:Endotoxins; D006460:Hemolysin Proteins; D007306:Insecticides; C030956:insecticidal crystal protein, Bacillus Thuringiensis