GRAS FAO/WHO JECFA ADI 1982 MTDI mg/kg ADI not specified. Zinc Gluconate -1- 5),6)

Transcription

1 ) GRAS 2) EU 3) 4) FAO/WHO JECFA ADI 1982 MTDI 5),6) mg/kg ) ADI not specified Zinc Gluconate -1-

2 C12H22O14Zn nho 2 n= ) Cmax 9) 10),11) 12),13) 14) LD50 3,420 mg/kg 1) LD50 2,630 mg/kg ,000 ppm 21 1),15) 500 1,000 ppm ,000 30,000 ppm 13 30,000 ppm 16) 17) 18),19) 100 mg/ 18) 18) 100 mg/ -2-

3 17) mg 17 20) mg/ / 10 21) ESOD mg/ / ) ESOD 6 30 mg/ / 14 23),24) 25 53mg/ / 90 ESOD SOD 25) mg/ / 90 26) mg/ / mg/ / 19) ) UL 30 mg/ / UL JECFA ADI mg 200 mg 5),6) MTDI mg/kg EPA mg/ / 10 ESOD 10 mg/ / 60 mg/ / 1.0 mg/kg / LOAEL UF 3 LOAEL 28) 1 RfD 20 mg/ / -3-

4 CRN mg/ / NOAEL 60 mg/ / SOD 29) LOAEL IOM 2001 LOAEL 60 mg/ / UF 1.5 LOAEL UL 40 30) mg/ / 18 UL EU 2003 NOAEL 50 mg/ / UF 2 UL 25 mg/ / 17 UL 31) UL JECFA EU 6) 31) 27) 28) 29) 30) 1982 EPA CRN IOM (1997) (2001) LOAELmg/ / NOAELmg/ / MTDI mg/kg ULmg/ / RfDmg/ mg 13 32) mg 15 mg 1 24 mg 33) 12 5,525 5, % 0.1 mg/l 1 3L 0.3 mg 1-4-

5 1998 JECFA ADI UL LOAEL EPA CRN IOM 60 mg/ / 1.0 mg/kg / 53 mg/ / 40 mg/ / 10 mg/ / EU NOAEL 50 mg/ / JECFA ADI 1982 MTDI mg/kg UL 30 mg/ / 30 mg/ / UL 30 mg/ / UL 1,,, : CFR Ch.I Edition Food and Drug Administration, HHS EEC 89/107/EEC, Council Directive of 21 December 1988 on the Approximation of the Laws of the Member States Concerning Food Additives Authorized for Use in Foodstuffs Intended for Human Consumption. -5-

6 4 EEC 91/321/EEC, 14 May 1991, on Infant Formulae and Follow-on Formulae. 5World Health Organization: Evaluation of Certain Food Additives and Contaminants, 26th Report of the Joint FAO/WHO Expert Committee on Food Additives, World Health Organization, Geneva World Health Organization: Toxicological Evaluation of Certain Food Additives, 26th Report of the Joint FAO/WHO Expert Committee on Food Additives, World Health Organization, Geneva World Health Organization: 51st Meeting for Joint FAO/WHO Expert Committee on Food Additives, Geneva, 9-18 June Dreno B, Stalder JF, Pecquet C, Boiteau HL, Barri`ere H. Variations in cutaneous zinc concentrations after oral administration of zinc gluconate. Acta Derm. Venereol : N`eve J, Hanocq M, Peretz A, Khalil FA, Pelen F. Absorption and metabolism of oral zinc gluconate in humans in fasting state, during, after ameal, Biol. Trace Elem. Res : Couzy F., C. Keen, M. E. Gershwin, and J. P. Mareschi. Nutritional implications of the interactions between minerals : Progress in Food and Nutrition Science. 11O'Dell BL. Mineral interactions relevant to nutrient requirements, upper limits of nutrients in infantformulas. Symposium,November 7-8, 1988, Iowa, IA, USA. 12 Petering HG. Some observations on the interaction of zinc, copper, and iron metabolism in lead and cadmium toxicity, Environ. Health Perspect : Chowdhury BA, Chandra RK. Biological and health implications of toxic heavy metal and essential trace element interactions. Prog. Food Nutr. Sci : Flodin NW. Micronutrient supplements: Toxicity and drug interactions. Nutr. Sci : Prog. Food 15Hagen EC, Radomski JL, Nelson AA. Blood and bone marrow effects offeeding zinc sulfate to rats and dogs. J. Am. Pharm. Assoc. Scient. Ed : Maita K, Hirano M, Mitsumori K, Takahashi K, Shirasu Y. Subacute toxicity studies with zinc sulfate in mice and rats. J. Pestic. Sci : : , : Botash AS, Nasca J, Dubowy R, Weinbeger L, Oliphant M. Zinc-induced copper deficiency in an infant. Am. J. Dis. Childr :

7 20Matthew RL, Lada K. Zinc gluconate: Acute ingestion. Clin. Toxicol : Yadrick MK, Kenney MA, Winterfeldt EA. Iron, copper, and zinc status: Response to supplementation with zinc or zinc and iron in adult females : Am. J. Clin. Nutr. 22Fischer PWF, Giroux A, L'Abbe MR. Effect ofzincsupplementation on copper status in adult man. Am. J. Clin. Nutr : Bonham M, O'Connor JM, McAnena LB, Walsh PM, Downes CS, Hannigan BM, Strain JJ. Zinc supplementation has no effect on lipoprotein metabolism, hemostasis and putative indices of copper status in healthy men. Biol. Trace Elem. Res : Bonham M, O'Connor JM, Alexander HD, Coulter J, Walsh PM, McAnena LB, Downes CS, Hannigan BM, Strain JJ. Zinc supplementation has no effect on circulating levels of peripheral blood leucocytes and lymphocyte subsets in healthy adultmen. Br. J. Nutr : Davis CD, Milne DB, Nielsen FH. Changes in dietary zinc and copper affect zinc-status indicators of postmenopausal women, notably, extracellular superoxide dismutase and amyloid precursor proteins. Am. J. Clin. Nutr : Milne DB, Davis CD, Nielsen FH. Low dietary zinc alters indices of copper function and status in postmenopausal women. Nutrition : Zinc and Compounds CASRN , IRIS, Environmental Protection Agency. 29 CRN JAPAN John N. Hathcock ed., Vitamin andmineral Safety, Council for Responsible Nutrition, Washington DC AReport of the panel on micronutrients, subcommittees on upper reference levels of nutrients and of interpretation and use of dietary reference intakes, and the standing committee on the scientific evaluation of dietary reference intakes, Food and Nutrition Board, Chapter 12, Institute of Medicine, Washington D.C Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Zinc, Health and Consumer Production Directorate-General, European Commission, 19 March

8 No. LD503,420 mg/kg 1 LD50 2,630 mg/kg, ,000 30,000 ppm 15 30,000 ppm Maita et al, , ,000 ppm 15 ppm (Zn) Hagen et al, mg Zn Matthew et al, mg/ / *1, *2 ESOD Zn Yadrick et al, 1989 * mg/ / 4 ESOD Zn 6 Fischer et al, 1984 * mg/ / 23 Zn Bonham, O Connor, McAnena et al, 2003 *3 24 Bonham, O Connor, mg/ / ESOD SOD Alexander et al, 2003 * Zn Davis et al, 2000 * mg/ / Zn Milne et al, mg/ / Botash et al, mg/ / Zn ESOD erythrocyte Cu-, Zn-superoxide dismutase 10 mg/ / 3mg/ / *1 IOM 19, 20 *2 EPA 21 *3 EU 23, 24 25, 26

9 Tolerable Upper Intake Level UL UL UL RDARecommended Dietary Allowance AIAdequate Intake UL UL UL UL UL ( ) Dietary Reference Intakes: A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients, Food and Nutrition Board, Institute of Medicine, National Academy Press Washington, D.C. 1998