title: A 90-day safety study in Wistar rats fed genetically modified rice expressing snowdrop lectin Galanthus nivalis (GNA).
abstract: Genetically modified plants expressing insecticidal traits offer a new strategy for crop protection, but at the same time present a challenge in terms of food safety assessment. The present 90-day feeding study was designed to assess the safety of a rice variety expressing the snowdrop Galanthus nivalis lectin (GNA lectin), and forms part of a EU-funded project where the objective has been to develop and validate sensitive and specific methods to assess the safety of genetically modified foods. Male and female Wistar rats were given a purified diet containing either 60% genetically modified or parental rice for 90 days. This corresponds to a mean daily GNA lectin intake of approximately 58 and 67mg/kg body weight for males and females, respectively. Prior to the animal study comprehensive analytical characterization of both rice materials was performed. The chemical analyses showed a number of statistically significant differences, with the majority being within the ranges reported in the literature. In the animal study a range of clinical, biological, immunological, microbiological and pathological parameters were examined. A number of significant differences were seen between groups fed the two diets, but none of them were considered to be adverse. In conclusion, the design of the present animal study did not enable us to conclude on the safety of the GM food. Additional group(s) where the expressed gene products have been spiked to the diet should be included in order to be able to distinguish whether the observed effects were due to the GNA lectin per se or to secondary changes in the GM rice.
authors.affiliation: Department of Toxicology and Risk Assessment, Danish Institute for Food and Veterinary Research, Mørkhøj Bygade 19, DK-2860 Søborg, Denmark. mop@dfvf.dk
authors.forename: Morten
authors.initials: M
authors.lastname: Poulsen
authors.forename: Stine
authors.initials: S
authors.lastname: Kroghsbo
authors.forename: Malene
authors.initials: M
authors.lastname: Schrøder
authors.forename: Andrea
authors.initials: A
authors.lastname: Wilcks
authors.forename: Helene
authors.initials: H
authors.lastname: Jacobsen
authors.forename: Andreas
authors.initials: A
authors.lastname: Miller
authors.forename: Thomas
authors.initials: T
authors.lastname: Frenzel
authors.forename: Jürgen
authors.initials: J
authors.lastname: Danier
authors.forename: Michael
authors.initials: M
authors.lastname: Rychlik
authors.forename: Qingyao
authors.initials: Q
authors.lastname: Shu
authors.forename: Kaveh
authors.initials: K
authors.lastname: Emami
authors.forename: Duraialagraja
authors.initials: D
authors.lastname: Sudhakar
authors.forename: Angharad
authors.initials: A
authors.lastname: Gatehouse
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Engel
authors.forename: Ib
authors.initials: I
authors.lastname: Knudsen
mesh_terms: D000818:Animals; D001522:Behavior, Animal / Q000187:drug effects; D003257:Consumer Product Safety; D005260:Female; D027801:Galanthus / Q000235:genetics*; D008297:Male; D037241:Mannose-Binding Lectins / Q000235:genetics*; D023421:Models, Animal; D012275:Oryza / Q000737:chemistry / Q000235:genetics* / Q000633:toxicity*; D037121:Plant Lectins / Q000235:genetics*; D030821:Plants, Genetically Modified / Q000737:chemistry / Q000235:genetics / Q000633:toxicity; D051381:Rats; D017208:Rats, Wistar; D018675:Toxicity Tests
chemical_list: D037241:Mannose-Binding Lectins; D037121:Plant Lectins; C063117:snowdrop lectin