Print Email Facebook Twitter Sub-chronic (13-week) oral toxicity study in rats with recombinant human lactoferrin produced in the milk of transgenic cows Title Sub-chronic (13-week) oral toxicity study in rats with recombinant human lactoferrin produced in the milk of transgenic cows Author Appel, M.J. van Veen, H.A. Vietsch, H. Salaheddine, M. Nuijens, J.H. Ziere, B. de Loos, F. TNO Kwaliteit van Leven Publication year 2006 Abstract The oral toxicity of recombinant human lactoferrin (rhLF) produced in the milk of transgenic cows was investigated in Wistar rats by daily administration via oral gavage for 13 consecutive weeks, 7 days per week. The study used four groups of 20 rats/sex/dose. The control group received physiological saline and the three test groups received daily doses of 200, 600 and 2000 mg of rhLF per kg body weight. Clinical observations, growth, food consumption, food conversion efficiency, water consumption, neurobehavioural testing, ophthalmoscopy, haematology, clinical chemistry, renal concentration test, urinalysis, organ weights and gross examination at necropsy and microscopic examination of various organs and tissues were used as criteria for detecting the effects of treatment. Overall, no treatment-related, toxicologically significant changes were observed. The few findings that may be related to the treatment (lower cholesterol in high-dose females, lower urinary pH in high-dose males and females and very slightly higher kidney weight in high-dose females) were considered of no toxicological significance. Based on the absence of treatment-related, toxicologically relevant changes, the no-observed-adverse-effect level (NOAEL) was considered to be at least 2000 mg/kg body weight/day. © 2005 Elsevier Ltd. All rights reserved. Subject BiologyToxicology and Applied PharmacologyOral administrationRatsRecombinant human lactoferrinRepeated dose toxicity studylactoferrinanimal cellanimal experimentanimal modelanimal tissuearticlebody growthbody weightcognitioncontrolled studyfemalefluid intakefood intakekidney concentrating capacitynonhumanophthalmoscopypH measurementrattoxicity testingtransgenic animalAnimalsAnimals, Genetically ModifiedBehavior, AnimalBlood Cell CountBlood Chemical AnalysisCattleDrinkingFemaleHumansLactoferrinMilkMotor ActivityNo-Observed-Adverse-Effect LevelOrgan SizeRatsRats, WistarRecombinant ProteinsSex CharacteristicsRattus norvegicus To reference this document use: http://resolver.tudelft.nl/uuid:8a3fb4f2-2021-45b3-8ff7-58c082f638ef DOI https://doi.org/10.1016/j.fct.2005.11.012 TNO identifier 239328 ISSN 0278-6915 Source Food and Chemical Toxicology, 44 (7), 964-973 Document type article Files To receive the publication files, please send an e-mail request to TNO Library.