title: A 90-day safety study in Sprague-Dawley rats fed milk powder containing recombinant human lactoferrin (rhLF) derived from transgenic cloned cattle.
abstract: Transgenic cloned animals expressing beneficial human nutritional traits offer a new strategy for large-scale production of some kinds of functional substances. In some cases, the required safety testing for genetically modified (GM) foods do not seem appropriate for human food safety, though regulations do not seem to provide alternatives. A 90-day rat feeding study is the core study for the safety assessment of GM foods. The test material in this 90-day study was prepared nonfat milk powder containing recombinant human lactoferrin (rhLF), which was expressed in transgenic cloned cattle. Groups of 10 male and female Sprague-Dawley rats were given a nutritionally balanced purified diet containing 7.5, 15, or 30% transgenic or conventional milk powder for 90 days. A commercial AIN93G diet was used as an additional control group. Clinical, biological, and pathological parameters were compared between groups. The only significant effect of treatment was higher mean ferritin and Fe(+) concentrations for both male and female rats fed the transgenic milk powder diets, as compared to rats fed nontransgenic milk diets or the commercial diet. The results of the present study are consistent with previous research, which indicates that milk powder containing rhLF derived from healthy transgenic cloned cattle is as safe as conventional milk powder.
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.
authors.forename: Cui
authors.initials: C
authors.lastname: Zhou
authors.forename: Jian Wu
authors.initials: JW
authors.lastname: Wang
authors.forename: Kun Lun
authors.initials: KL
authors.lastname: Huang
authors.forename: XiaoYun
authors.initials: X
authors.lastname: He
authors.forename: Xiu Ping
authors.initials: XP
authors.lastname: Chen
authors.forename: Hong
authors.initials: H
authors.lastname: Sun
authors.forename: Tian
authors.initials: T
authors.lastname: Yu
authors.forename: Hui Lian
authors.initials: HL
authors.lastname: Che
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D002417:Cattle / Q000235:genetics*; D019976:Cloning, Organism / Q000662:veterinary*; D003257:Consumer Product Safety; D005260:Female; D030841:Food, Genetically Modified / Q000009:adverse effects*; D006801:Humans; D007781:Lactoferrin / Q000032:analysis* / Q000235:genetics; D008297:Male; D008892:Milk / Q000737:chemistry / Q000633:toxicity*; D011208:Powders; D051381:Rats; D017207:Rats, Sprague-Dawley; D013997:Time Factors; D036401:Toxicity Tests, Chronic
chemical_list: C490098:LTF protein, human; D011208:Powders; D007781:Lactoferrin