A 90-day safety study of genetically modified rice expressing Cry1Ab protein ( Bacillus thuringiensis toxin) in Wistar rats
An animal model for safety assessment of genetically modified foods was tested as part of the SAFOTEST project. In a 90-day feeding study on Wistar rats, the transgenic KMD1 rice expressing Cry1Ab protein was compared to its non-transgenic parental wild type, Xiushui 11. The KMD1 rice contained 15 m...
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| Veröffentlicht in: | Food and chemical toxicology 2007-03, Vol.45 (3), p.339-349 |
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| creator | Schrøder, Malene Poulsen, Morten Wilcks, Andrea Kroghsbo, Stine Miller, Andreas Frenzel, Thomas Danier, Jürgen Rychlik, Michael Emami, Kaveh Gatehouse, Angharad Shu, Qingyao Engel, Karl-Heinz Altosaar, Illimar Knudsen, Ib |
| description | An animal model for safety assessment of genetically modified foods was tested as part of the SAFOTEST project. In a 90-day feeding study on Wistar rats, the transgenic KMD1 rice expressing Cry1Ab protein was compared to its non-transgenic parental wild type, Xiushui 11. The KMD1 rice contained 15
mg Bt toxin/kg and based on the average feed consumption the daily intake was 0.54
mg Bt toxin/kg body weight.
No adverse effects on animal behaviour or weight gain were observed during the study. Blood samples collected one week prior to sacrifice were analyzed and compared for standard haematological and biochemical parameters. A few parameters were significantly different, but all within the normal reference intervals for rats of this breed and age and not in relation to any other findings, thus not considered treatment related. Upon sacrifice a large number of organs were weighed, macroscopic and histopathological examinations were performed with only minor changes to report.
The aim of the study was to use a known animal model in performance of safety assessment of a GM crop, in this case KMD1 rice. The results show no adverse or toxic effects of KMD1 rice when tested in the design used in this 90-day study. Nevertheless the experiences from this study lead to the overall conclusion that safety assessment for unintended effects of a GM crop cannot be done without additional test group(s). |
| doi_str_mv | 10.1016/j.fct.2006.09.001 |
| format | Article |
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mg Bt toxin/kg and based on the average feed consumption the daily intake was 0.54
mg Bt toxin/kg body weight.
No adverse effects on animal behaviour or weight gain were observed during the study. Blood samples collected one week prior to sacrifice were analyzed and compared for standard haematological and biochemical parameters. A few parameters were significantly different, but all within the normal reference intervals for rats of this breed and age and not in relation to any other findings, thus not considered treatment related. Upon sacrifice a large number of organs were weighed, macroscopic and histopathological examinations were performed with only minor changes to report.
The aim of the study was to use a known animal model in performance of safety assessment of a GM crop, in this case KMD1 rice. The results show no adverse or toxic effects of KMD1 rice when tested in the design used in this 90-day study. Nevertheless the experiences from this study lead to the overall conclusion that safety assessment for unintended effects of a GM crop cannot be done without additional test group(s).</description><identifier>ISSN: 0278-6915</identifier><identifier>EISSN: 1873-6351</identifier><identifier>DOI: 10.1016/j.fct.2006.09.001</identifier><identifier>PMID: 17050059</identifier><identifier>CODEN: FCTOD7</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Animal study ; Animals ; Bacillus thuringiensis ; Bacillus thuringiensis - genetics ; Bacterial Proteins - genetics ; Bacterial Toxins - genetics ; Behavior, Animal - drug effects ; Biological and medical sciences ; Consumer Product Safety ; Cry1Ab protein ; Endotoxins - genetics ; Feeding trial ; Female ; Food safety ; Genetically modified rice ; Hemolysin Proteins - genetics ; Male ; Medical sciences ; Models, Animal ; Oryza - chemistry ; Oryza - genetics ; Oryza - toxicity ; Oryza sativa ; Plants, Genetically Modified - chemistry ; Plants, Genetically Modified - genetics ; Plants, Genetically Modified - toxicity ; Rats ; Rats, Wistar ; SAFOTEST ; Toxicity Tests ; Toxicology ; Wistar rats</subject><ispartof>Food and chemical toxicology, 2007-03, Vol.45 (3), p.339-349</ispartof><rights>2006 Elsevier Ltd</rights><rights>2007 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c509t-8265df10177bf1f71a4e4c2968bfada5a05b5d20d28bb423e33266e0b5d6cca83</citedby><cites>FETCH-LOGICAL-c509t-8265df10177bf1f71a4e4c2968bfada5a05b5d20d28bb423e33266e0b5d6cca83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0278691506002535$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18522214$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17050059$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schrøder, Malene</creatorcontrib><creatorcontrib>Poulsen, Morten</creatorcontrib><creatorcontrib>Wilcks, Andrea</creatorcontrib><creatorcontrib>Kroghsbo, Stine</creatorcontrib><creatorcontrib>Miller, Andreas</creatorcontrib><creatorcontrib>Frenzel, Thomas</creatorcontrib><creatorcontrib>Danier, Jürgen</creatorcontrib><creatorcontrib>Rychlik, Michael</creatorcontrib><creatorcontrib>Emami, Kaveh</creatorcontrib><creatorcontrib>Gatehouse, Angharad</creatorcontrib><creatorcontrib>Shu, Qingyao</creatorcontrib><creatorcontrib>Engel, Karl-Heinz</creatorcontrib><creatorcontrib>Altosaar, Illimar</creatorcontrib><creatorcontrib>Knudsen, Ib</creatorcontrib><title>A 90-day safety study of genetically modified rice expressing Cry1Ab protein ( Bacillus thuringiensis toxin) in Wistar rats</title><title>Food and chemical toxicology</title><addtitle>Food Chem Toxicol</addtitle><description>An animal model for safety assessment of genetically modified foods was tested as part of the SAFOTEST project. In a 90-day feeding study on Wistar rats, the transgenic KMD1 rice expressing Cry1Ab protein was compared to its non-transgenic parental wild type, Xiushui 11. The KMD1 rice contained 15
mg Bt toxin/kg and based on the average feed consumption the daily intake was 0.54
mg Bt toxin/kg body weight.
No adverse effects on animal behaviour or weight gain were observed during the study. Blood samples collected one week prior to sacrifice were analyzed and compared for standard haematological and biochemical parameters. A few parameters were significantly different, but all within the normal reference intervals for rats of this breed and age and not in relation to any other findings, thus not considered treatment related. Upon sacrifice a large number of organs were weighed, macroscopic and histopathological examinations were performed with only minor changes to report.
The aim of the study was to use a known animal model in performance of safety assessment of a GM crop, in this case KMD1 rice. The results show no adverse or toxic effects of KMD1 rice when tested in the design used in this 90-day study. Nevertheless the experiences from this study lead to the overall conclusion that safety assessment for unintended effects of a GM crop cannot be done without additional test group(s).</description><subject>Animal study</subject><subject>Animals</subject><subject>Bacillus thuringiensis</subject><subject>Bacillus thuringiensis - genetics</subject><subject>Bacterial Proteins - genetics</subject><subject>Bacterial Toxins - genetics</subject><subject>Behavior, Animal - drug effects</subject><subject>Biological and medical sciences</subject><subject>Consumer Product Safety</subject><subject>Cry1Ab protein</subject><subject>Endotoxins - genetics</subject><subject>Feeding trial</subject><subject>Female</subject><subject>Food safety</subject><subject>Genetically modified rice</subject><subject>Hemolysin Proteins - genetics</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Models, Animal</subject><subject>Oryza - chemistry</subject><subject>Oryza - genetics</subject><subject>Oryza - toxicity</subject><subject>Oryza sativa</subject><subject>Plants, Genetically Modified - chemistry</subject><subject>Plants, Genetically Modified - genetics</subject><subject>Plants, Genetically Modified - toxicity</subject><subject>Rats</subject><subject>Rats, Wistar</subject><subject>SAFOTEST</subject><subject>Toxicity Tests</subject><subject>Toxicology</subject><subject>Wistar rats</subject><issn>0278-6915</issn><issn>1873-6351</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcFu1DAQhi0EotvCA3BBvoDgkDB21k4sTsuqQKVKvRRxtBx7XLzKJovtoEZ9eVztSr3BaWTrm_H4_wh5w6BmwOSnXe1trjmArEHVAOwZWbGubSrZCPacrIC3XSUVE2fkPKUdALSslS_JGWtBAAi1Ig8bqqByZqHJeMyl5NktdPL0DkfMwZphWOh-csEHdDQGixTvDxFTCuMd3caFbXp6iFPGMNIP9IuxYRjmRPOvORYi4JhCOU33YfxIC_IzpGwijSanV-SFN0PC16d6QX58vbzdfq-ub75dbTfXlRWgctVxKZwvH27b3jPfMrPGteVKdr03zggDoheOg-Nd3695g03DpUQol9Ja0zUX5P1xblnz94wp631IFofBjDjNSXPgjVLs_yBTHWMl0wKyI2jjlFJErw8x7E1cNAP9qEbvdFGjH9VoULqoKT1vT8Pnfo_uqePkogDvToBJJXYfzWhDeuI6wTln68J9PnJYMvsTMOpkS8wWXYhYHnVT-McafwFbfqxL</recordid><startdate>20070301</startdate><enddate>20070301</enddate><creator>Schrøder, Malene</creator><creator>Poulsen, Morten</creator><creator>Wilcks, Andrea</creator><creator>Kroghsbo, Stine</creator><creator>Miller, Andreas</creator><creator>Frenzel, Thomas</creator><creator>Danier, Jürgen</creator><creator>Rychlik, Michael</creator><creator>Emami, Kaveh</creator><creator>Gatehouse, Angharad</creator><creator>Shu, Qingyao</creator><creator>Engel, Karl-Heinz</creator><creator>Altosaar, Illimar</creator><creator>Knudsen, Ib</creator><general>Elsevier Ltd</general><general>Elsevier Science</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QO</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>RC3</scope></search><sort><creationdate>20070301</creationdate><title>A 90-day safety study of genetically modified rice expressing Cry1Ab protein ( Bacillus thuringiensis toxin) in Wistar rats</title><author>Schrøder, Malene ; 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In a 90-day feeding study on Wistar rats, the transgenic KMD1 rice expressing Cry1Ab protein was compared to its non-transgenic parental wild type, Xiushui 11. The KMD1 rice contained 15
mg Bt toxin/kg and based on the average feed consumption the daily intake was 0.54
mg Bt toxin/kg body weight.
No adverse effects on animal behaviour or weight gain were observed during the study. Blood samples collected one week prior to sacrifice were analyzed and compared for standard haematological and biochemical parameters. A few parameters were significantly different, but all within the normal reference intervals for rats of this breed and age and not in relation to any other findings, thus not considered treatment related. Upon sacrifice a large number of organs were weighed, macroscopic and histopathological examinations were performed with only minor changes to report.
The aim of the study was to use a known animal model in performance of safety assessment of a GM crop, in this case KMD1 rice. The results show no adverse or toxic effects of KMD1 rice when tested in the design used in this 90-day study. Nevertheless the experiences from this study lead to the overall conclusion that safety assessment for unintended effects of a GM crop cannot be done without additional test group(s).</abstract><cop>Oxford</cop><cop>New York, NY</cop><pub>Elsevier Ltd</pub><pmid>17050059</pmid><doi>10.1016/j.fct.2006.09.001</doi><tpages>11</tpages></addata></record> |
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| ispartof | Food and chemical toxicology, 2007-03, Vol.45 (3), p.339-349 |
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| subjects | Animal study Animals Bacillus thuringiensis Bacillus thuringiensis - genetics Bacterial Proteins - genetics Bacterial Toxins - genetics Behavior, Animal - drug effects Biological and medical sciences Consumer Product Safety Cry1Ab protein Endotoxins - genetics Feeding trial Female Food safety Genetically modified rice Hemolysin Proteins - genetics Male Medical sciences Models, Animal Oryza - chemistry Oryza - genetics Oryza - toxicity Oryza sativa Plants, Genetically Modified - chemistry Plants, Genetically Modified - genetics Plants, Genetically Modified - toxicity Rats Rats, Wistar SAFOTEST Toxicity Tests Toxicology Wistar rats |
| title | A 90-day safety study of genetically modified rice expressing Cry1Ab protein ( Bacillus thuringiensis toxin) in Wistar rats |
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