کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5856786 | 1131983 | 2014 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Safety evaluation of the human-identical milk monosaccharide sialic acid (N-acetyl-d-neuraminic acid) in Sprague-Dawley rats
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کلمات کلیدی
N-Acetyl-D-neuraminic acidGLPNOAEL2-NFSIA9-AAMMSFOBOECD2-aminoanthraceneNaN3Neu5AcNeu5GcPND2-AA - 2 AA2-nitrofluorene - 2-نیتروفلوئورن9-Aminoacridine - 9-آمینواکریدینUS FDA - FDA ایالات متحدهArachidonic acid - اسید آراشیدونیکdocosahexaenoic acid - اسید داکوزاگزوائونیکSialic acids - اسید سیالیکhuman milk oligosaccharide - الیگوساکارید شیر انسانFunctional observational battery - باتری مشاهدهی عملکردیGood Laboratory Practice - تمرین خوب آزمایشگاهیARA - در حال حاضرDHA - دوکوساهگزائنوئیک اسیدgestation day - روز بارداریpost-natal day - روز بعد از تولدOrganisation for Economic Co-operation and Development - سازمان همکاری اقتصادی و توسعهsodium azide - سدیم آیزیدSubchronic toxicity - سمیت زیر سونوگرافیGenotoxicity - سمیت ژنتیکیSialic acid - سیالیک اسیدInfant formula - شیر خشکmethyl methanesulfonate - متیل متان سولفوناتICH - منfirst generation - نسل اولno-observed-adverse-effect level - هیچ عارضه ای مشاهده نشدParental - والدینbody weight - وزن بدنinternational conference on harmonization of technical requirements for registration of pharmaceuticals for human use - کنفرانس بین المللی در مورد هماهنگ سازی الزامات فنی ثبت دارویی برای استفاده انسانی
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
N-Acetyl-d-neuraminic acid (Neu5Ac) is the predominant form of sialic acid (Sia) in humans, while other mammals express Sia as a mixture with N-glycolyl-d-neuraminic acid (Neu5Gc). Neu5Ac occurs in highest levels in the brain and in breast milk, and is therefore, coined a human-specific milk monosaccharide, and is thought to play an important nutritional role in the developing infant. Synthesized human-identical milk monosaccharide (HiMM) Neu5Ac is proposed for use in infant formulas to better simulate the free saccharides present in human breast milk. As part of the safety evaluation of HiMM Neu5Ac, a subchronic dietary toxicity study preceded by an in utero phase was conducted in Sprague-Dawley rats. Neu5Ac was without maternal toxicity or compound-related adverse effects on female reproduction and on the general growth and development of offspring at a maternal dietary level of up to 2%, equivalent to a dose of 1895 mg/kg body weight (bw)/day. During the subchronic phase, no compound-related adverse effects were observed in first generation rats at dietary levels of up to 2% (highest level tested), corresponding to doses of 974 and 1246 mg/kg bw/day in males and females, respectively. Neu5Ac also was non-genotoxic in a series of in vitro genotoxicity/mutagenicity tests. These results support the safe use of Neu5Ac both in infant formula and as a food ingredient at levels equivalent to those found naturally in human breast milk.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 70, Issue 2, November 2014, Pages 482-491
Journal: Regulatory Toxicology and Pharmacology - Volume 70, Issue 2, November 2014, Pages 482-491
نویسندگان
Sharon S.H. Choi, Nigel Baldwin, Valentine O. III, Shambhu Roy, Jennifer Rose, Bjorn A. Thorsrud, Phoukham Phothirath, Christoph H. Röhrig,