Cupron Pillowcases and Eye Masks SAFETY REPORTS

Transcription

1 Cupron Ltd. Ligad Center 2, 4 Hama`ayan St., Modiin P.O.B , Jerusalem Tel: Fax: Company no.: Cupron Pillowcases and Eye Masks SAFETY REPORTS

2 Safety of Copper Copper is an essential trace element needed for the normal function of many tissues, including the nervous system, immune system, heart, skin and for the formation of capillaries 1 and for wound healing. 2 As a cofactor for at least 13 enzymes, copper drives a crucial array of chemical reactions that underpin human health and development. 3 The daily recommended intake of copper is 1-2 mg. 4 Copper is extremely well metabolized by humans. 5 Copper oxide (2 mg) is used in vitamins supplements as a safe source of copper. 6 Cupric oxide or cuprous oxide powder is used as a copper source for sheep and cattle. 7 Sheep receiving for 65 consecutive days 10 grams of cupric oxide particles did not show any signs of clinical toxicity. 8 Doses of 2.5 grams of cupric oxide powder can be used to prevent short periods of copper deficiency in sheep at pasture without risk of adverse reactions. 9 In cattle receiving a single 40 gram oral dose of copper oxide particles, no biochemical evidence of toxicity was recorded. 10 Over-the-counter wound healing treatments contain copper. 11 The risk of dermal sensitivity to copper is considered extremely minimal. 12 Treatment with the 2 different ointments containing 0.4% cupric oxide or 20% metallic copper did 1 Uauy et al (1998) Essentiality of copper in humans. Am J Clin Nutr 67:952S-9S; Sen et al. (2002) Copperinduced vascular endothelial growth factor expression and wound healing. Am J Physiol Heart Circ Physiol; 282:H ; Philips et al. (2010) Stimulation of Cell Proliferation and Expression of Matrixmetalloproteinase-1 and Interluekin-8 Genes in Dermal Fibroblasts by Copper. Connect Tissue Res. In press. 2 Borkow G, Gabbay J. and Zatcoff R. (2008) Could chronic wounds not heal due to too low local copper levels? Medical Hypotheses 70(3): ; Borkow et al. (2010) Molecular mechanisms of enhanced wound healing by copper oxide impregnated dressings. Wound Repair and Regeneration. In press. 3 Uauy et al (1998) Essentiality of copper in humans. Am J Clin Nutr 67:952S-9S. 4 Trumbo P, Yates AA, Schlicker S, Poos M. (2001) Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 101: Uauy et al (1998) Essentiality of copper in humans. Am J Clin Nutr 67:952S-9S. 6 e.g. 7 Suttle NF. (1987) Safety and effectiveness of cupric oxide particles for increasing liver copper stores in cattle. Res.Vet.Sci. 42:224-7; Cavanagh NA, and Judson JG. (1994) Copper oxide powder as a copper supplement for sheep. J.Trace Elem.Electrolytes Health Dis. 8: Suttle NF. (1987) Safety and effectiveness of cupric oxide particles for increasing liver copper stores in sheep. Res.Vet.Sci. 42: Cavanagh NA, and Judson JG. (1994) Copper oxide powder as a copper supplement for sheep. J.Trace Elem.Electrolytes Health Dis. 8: Suttle NF. (1987) Safety and effectiveness of cupric oxide particles for increasing liver copper stores in cattle. Res.Vet.Sci. 42: Pereira CE, Felcman J. (1998) Correlation between five minerals and the healing effect of Brazilian medicinal plants. Biol Trace Elem Res. 65:251-9;Schlemm et al. (1999) Medicinal yeast extracts. Cell Stress Chaperones.4: Hostynek JJ, and Maibach HI. (2003) Copper hypersensitivity: dermatologic aspects--an overview. Rev Environ Health 18:

3 not cause toxic irritations to the skin. 13 Today several cosmetic creams contain copper as their active ingredient. Copper is considered safe to humans, as demonstrated by the widespread (millions of women) and prolonged (more than 10 years by a single individual) use by women of copper intrauterine devices 14 and over-the-counter wound healing treatments containing copper. 15 In 1994 the US FDA approved a 10-year claim of efficacy and safety for the TCu380A IUD. 16 Cupron Pillowcase and Eye Masks - Safety The following are extracts from 3 reports of double blind placebo controlled clinical trials with the Cupron pillowcases and eye masks, which were conducted by independent laboratories. 13 Gorter, R. W., M. Butorac, and E. P. Cobian Examination of the cutaneous absorption of copper after the use of copper-containing ointments. Am.J.Ther. 11: Hubacher et al (2001) Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 345:561-7; Anon. (2002) Copper IUDs, infection and infertility. Drug Ther Bull. 40:67-9; Bilian X. (2002) Intrauterine devices. Best Pract Res Clin Obstet Gynaecol. 16: Pereira CE, and Felcman J. (1998) Correlation between five minerals and the healing effect of Brazilian medicinal plants. Biol Trace Elem Res. 65: ; Schlemm et al. (1999) Medicinal yeast extracts. Cell Stress Chaperones. 1999;4: Bilian X. (2002) Intrauterine devices. Best Pract Res Clin Obstet Gynaecol. 16(2):155-68; Cheng D. (2000) The intrauterine device: still misunderstood after all these years. South Med J.93(9):859-64; Hubacher D et al., (2001) Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 345(8):561-7.

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