Safety evaluation of zinc threoninate chelate.
The acute toxicity of zinc threoninate chelate was assessed. The oral lethal dose 50% (LD(50)) was 2710 mg/kg in female rats and 3160 mg/kg in male rats. Genotoxicity was assessed by Ames test in Salmonella typhimurium strains TA97, TA98, TA100, and TA102, by bone marrow mouse micronucleus test and a sperm abnormality test with mice. Thirty-day repeat dose toxicity study was conducted at oral daily doses of 0, 42, 169, and 675 mg/kg in rats. Teratogenicity was assessed at the same daily dose in pregnant rats by gavage. No significant changes in body weight, food consumption, organ weight, relative organ weight, hematology, blood biochemistry, histopathology, behavior, mortality, sperm abnormality, mutagenicity, and micronucleus formation were observed and no clinical signs or adverse effects were detected. Zinc threoninate chelate had no significant teratogenic effect at a daily dose of 42 mg/kg.
Hu
Xiao-bo
XB
State Key Laboratory of Food Science and Technology, Nanchang University, Jiangxi 330047, China. xmync@sina.com.cn
Gong
Yi
Y
Li
Lei
L
Nie
Shao-ping
SP
Wang
Yuan-xing
YX
Xie
Ming-yong
MY
D000818:Animals; D002614:Chelating Agents / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D005260:Female; D007928:Lethal Dose 50; D008297:Male; D051379:Mice; D008813:Mice, Inbred ICR; D015162:Micronucleus Tests; D009152:Mutagenicity Tests; D051381:Rats; D012486:Salmonella typhimurium / Q000235:genetics; D013094:Spermatozoa / Q000187:drug effects; D013723:Teratogens / Q000633:toxicity; D013912:Threonine / Q000031:analogs & derivatives* / Q000633:toxicity*; D015032:Zinc / Q000633:toxicity*
D002614:Chelating Agents; D013723:Teratogens; D013912:Threonine; D015032:Zinc