title: Safety testing of GM-rice expressing PHA-E lectin using a new animal test design.
abstract: The 90-day animal study is the core study for the safety assessment of genetically modified foods in the SAFOTEST project. The model compound tested in the 90-day study was a rice variety expressing the kidney bean Phaseolus vulgaris lectin agglutinin E-form (PHA-E lectin). Female Wistar rats were given a nutritionally balanced purified diet with 60% parental rice, 60% PHA-E rice or 60% PHA-E rice spiked with 0.1% recombinant PHA-E lectin for 90 days. This corresponded to a mean daily PHA-E lectin intake of approximately 0, 30 and 100mg/kg body weight for each group, respectively. The spiking was used to increase the specificity and to demonstrate the sensitivity of the study. A range of biological, biochemical, microbiological and pathological parameters were examined and significant differences in weight of small intestine, stomach and pancreas and plasma biochemistry were seen between groups. Included in this paper are also data from the molecular characterisation and chemical analysis of the PHA-E rice, from the construction and production of the PHA-E lectin, and from the preceding 28-day in vivo study where the toxicity of the pure PHA-E lectin was determined. In conclusion, the combined use of information from the compositional analysis, the 28-day study and the characterisation of the PHA-E rice and the PHA-E lectin has improved the design of the 90-day study. The spiking procedure has facilitated the interpretation of the results of the study and transferred it into a valuable tool for the future safety testing of genetically modified foods.
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: Malene
authors.initials: M
authors.lastname: Schrøder
authors.forename: Andrea
authors.initials: A
authors.lastname: Wilcks
authors.forename: Stine
authors.initials: S
authors.lastname: Kroghsbo
authors.forename: Rikke Hvid
authors.initials: RH
authors.lastname: Lindecrona
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: Mark
authors.initials: M
authors.lastname: Taylor
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; D008297:Male; D023421:Models, Animal; D012275:Oryza / Q000737:chemistry / Q000235:genetics* / Q000633:toxicity*; D027805:Phaseolus / Q000235:genetics*; D010835:Phytohemagglutinins / Q000235:genetics*; D030821:Plants, Genetically Modified / Q000737:chemistry / Q000235:genetics / Q000633:toxicity; D051381:Rats; D017208:Rats, Wistar; D018675:Toxicity Tests
chemical_list: D010835:Phytohemagglutinins