Safety evaluation of a milk basic protein fraction.
Milk products are widely consumed by individuals in the US population in the form of fluid milk and milk-derived products and ingredients. Milk is a good source of calcium, which plays a role in maintaining bone health. In addition to calcium, the whey protein fraction of milk contains basic proteins that have been demonstrated to increase bone metabolism and inhibit bone resorption. A specific basic protein fraction in milk (Milk Basic Protein; MBP) was tested in an acute oral toxicity study, teratology study, subchronic oral toxicity study, and reverse mutation assay and no treatment related adverse effects were found. MBP has been evaluated for its use as an ingredient in food and concluded to be safe for its intended use.
Kruger
C L
CL
ENVIRON International Corporation, 4350 North Fairfax Drive, Suite 300, Arlington, VA 22203, USA. ckruger@environcorp.com
Marano
K M
KM
Morita
Y
Y
Takada
Y
Y
Kawakami
H
H
Kobayashi
T
T
Sunaga
M
M
Furukawa
M
M
Kawamura
K
K
D000284:Administration, Oral; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002458:Cell Fractionation; D003257:Consumer Product Safety; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D047108:Embryonic Development / Q000187:drug effects; D005260:Female; D047109:Fetal Development / Q000187:drug effects; D005523:Food Supply; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D008297:Male; D018811:Maternal Exposure; D008894:Milk Proteins / Q000145:classification / Q000633:toxicity*; D009153:Mutagens / Q000145:classification / Q000633:toxicity*; D019055:No-Observed-Adverse-Effect Level; D011247:Pregnancy; D051381:Rats; D011919:Rats, Inbred Strains; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D013723:Teratogens / Q000145:classification / Q000633:toxicity*; D018675:Toxicity Tests / Q000379:methods*; D000067816:Whey Proteins
D008894:Milk Proteins; D009153:Mutagens; D013723:Teratogens; D000067816:Whey Proteins