@article{ad74a1d5efa449b080957c0fe554d017,
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 100 mg/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.",
keywords = "Animal study, GMO, Genetically modified rice, PHA-E lectin, SAFOTEST, Safety assessment, Spiking",
author = "Morten Poulsen and Malene Schr{\o}der and Andrea Wilcks and Stine Kroghsbo and Lindecrona, {Rikke Hvid} and Andreas Miller and Thomas Frenzel and J{\"u}rgen Danier and Michael Rychlik and Qingyao Shu and Kaveh Emami and Mark Taylor and Angharad Gatehouse and Engel, {Karl Heinz} and Ib Knudsen",
note = "Funding Information: This work was financially supported by the European Commission (Contract No. QLK1-1999-00651, New methods for the safety testing of transgenic food). The authors thank Margareta Bertram, Dagmar Fottner, Joan Frandsen, Dorte Hansen, Merete Lykkegaard, Bodil Madsen, Nehad Moradian, Karen Roswall and Ditte S{\o}rensen, and for their excellent technical assistance. Funding Information: In Europe, methodologies for safety assessments of genetically modified (GM) foods and derived products are not harmonized. Recommendations of the EU Commission indicated that the difficulty to use the traditionally designed animal feeding studies like the OECD guideline tests for toxicological assessments remains as a major challenge in the risk assessment strategies of GM foods ( European Commission, 1997 ). Therefore, validated sensitive and specific nutritional-toxicological testing procedures in vivo and in vitro for the safety assessment of GM food were urgently requested. As a consequence, a EU-project entitled “New methods for the safety testing of transgenic food” (SAFOTEST) funded by the Fifth Framework Programme for Research was initiated in February 2000 with the overall objective to develop and to validate the scientific methodology, which is necessary for assessing the safety of food from genetically modified plants. ",
year = "2007",
month = mar,
doi = "10.1016/j.fct.2006.09.003",
language = "English",
volume = "45",
pages = "364--377",
journal = "Food and Chemical Toxicology",
issn = "0278-6915",
publisher = "Elsevier Ltd.",
number = "3",
}