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Definition and Structure Hyaluronic Acid (CAS No. 9004-61-9; Figure 1) is a linear glycosaminoglycan composed of repeating disaccharides of β4-glucuronic acid-β3-N-acetylglucosamine.3 The remaining ingredients in this report are derivatives of Hyaluronic Acid (e.g., Sodium Hyaluronate (CAS No. 9067-32-7) is a sodium salt of Hyaluronic Acid). The definitions of the ingredients included in this review are provided in Table 1.  Distributed for Comment Only -- Do Not Cite or Quote Figure 1. Hyaluronates (when R is hydrogen = Hyaluronic Acid; when R is sodium = Sodium Hyaluronate; etc.) Chemical Properties Hyaluronic Acid is a water-soluble substance that is available as a highly purified, freeze-dried powder or aqueous solution.1 Hyaluronic Acid may also be presented as its potassium or sodium salt (i.e., Potassium Hyaluronate or Sodium Hyaluronate). The molecular weight (MW) of Hyaluronic Acid in cosmetics is highly variable and ranges from 5 – 1800 kiloDaltons (kDa), dependent upon manufacturing procedures. Hyaluronic Acid has a high capacity for water retention; 1 g of Hyaluronic Acid can hold up to 6 l of water. These hyaluronates have a wide range of MW. For instance, according to the Food Chemicals Codex (FCC), the formula weight (FW) of Sodium Hyaluronate can vary from 80.2 to 4010 kDa. Other chemical properties of Hyaluronic Acid and Sodium Hyaluronate can be found in Table 2. Method of Manufacture Hyaluronic Acid is an ubiquitous substance that can be derived from several natural sources.1 These sources can be found in the Natural Occurrence section of this report. According to unpublished data, Hyaluronic Acid obtained for cosmetic use is derived via either bacterial fermentation or extraction from rooster combs.1 Hyaluronic Acid … [kırpıldı - bölüm toplam 15707 karakter]

No genotoxicity was observed in an Ames assays evaluating Sodium Hyaluronate (up to 1%; up to 5000 µg/plate) in Staphylococcus aureus, Salmonella typhimurium and Escherichia coli or in an in vitro chromosomal aberration assay evaluating the genotoxic potential of Sodium Hyaluronate (up to 1000 µg/ml) in Chinese hamster lung fibroblasts. Negative results were also observed in an in vivo micronucleus assay using 1% Sodium Hyaluronate (up to 400 mg/kg) in CD-1 (ICR) mice and in a micronucleus assay evaluating ICR (Crj: CD-1) mice treated with 360 mg/kg Sodium Hyaluronate for up to 4 d. Details on the genotoxicity assays summarized below can be found in Table 9. Hydrolyzed Sodium Hyaluronate (FW = 5-10 kDa), Hydrolyzed Sodium Hyaluronate (FW < 1 kDa) and Sodium Hyaluronate were determined to be non-genotoxic in several Ames assays when tested at up to 5 mg/plate, with and without metabolic activation (assays performed in S. typhimurium strains TA97a, TA98, TA100, TA102, TA1535, TA537 and E. coli WP2 uvrA).16,29-31 In addition, Sodium Hyaluronate (up to 5000 mg/kg bw) was non-mutagenic in mouse micronucleus assays.29

Several reproductive and developmental studies on subcutaneously injected Hyaluronic Acid (up to 60 mg/kg/d) and Sodium Hyaluronate (up to 50 mg/kg/d) were performed in rats and rabbits (majority of dosing occurred on days 7 to 17 of pregnancy or day 17 of pregnancy to day 20-21 after delivery in rats, and on days 6-18 of gestation in rabbits).1 In most assays, treatment with the test substance had no effect on mortality, necropsy observations post-delivery, food or water consumption, or fertility in dams. However, in one assay in which rats were given up to 60 mg/kg bw of a 1% Hyaluronic Acid solution in physiological saline via subcutaneous injection, nodular hyperplasia of reticular zone cells was present in the adrenal glands of treated dams (treatment on day 17 of pregnancy to day 20 after parturition). No fetal abnormalities were observed in rats or rabbits. Sodium Hyaluronate A sperm malformation assay was performed in adult male mice (strain not stated; 10/group).29 Sodium Hyaluronate (20 ml/kg bw), cyclophosphamide (40 mg/kg bw (positive control), and distilled water (negative control) was given to animals via gavage, once a day, for 5 d. Mice were killed 30 d after the last administration. No other details were provided. The test substance had no influence on sperm malformation rate. A teratogenicity assay was performed in Wistar rats (15/group) given Sodium Hyaluronate (FW = 270 kDa) via gavage in doses of 0, 170, 330, or 670 mg/kg bw/d (administration during gestation days 7 - 16).16 Dams were euthanized and evaluated on day 20 of gestation. No statistically significant differences (P > 0.05) were observed in the maternal, uterine, and ovary weights or in the number of corpus lutea and nidation between test and control groups. In addition, no statistically significant differences (P > 0.05) were observed between the control and treated groups regarding the weight, length, and … [kırpıldı - bölüm toplam 2869 karakter]

Several reproductive and developmental studies on subcutaneously injected Hyaluronic Acid (up to 60 mg/kg/d) and Sodium Hyaluronate (up to 50 mg/kg/d) were performed in rats and rabbits.1 In the majority of assays, treatment with the test substance had no effect on mortality, necropsy observations post-delivery, food or water consumption, or fertility in dams. However, in one assay in which rats were given up to 60 mg/kg bw of a 1% Hyaluronic Acid solution in physiological saline via subcutaneous injection, nodular hyperplasia of reticular zone cells were present in the adrenal glands of treated dams (treatment on day 17 of pregnancy to day 20 after parturition). No severe fetal abnormalities were observed in rats or rabbits. Sodium Hyaluronate A sperm malformation assay was performed in adult male mice (strain not stated; 10/group).30 Sodium Hyaluronate (20 ml/kg bw), cyclophosphamide (40 mg/kg bw (positive control), and distilled water (negative control) was given to animals via gavage, once a day, for 5 d. Mice were killed 30 d after the last administration. No other details were provided. The test substance had no influence on sperm malformation rate. A teratogenicity assay was performed in Wistar rats (15/group) given Sodium Hyaluronate (FW = 270 kDa) via gavage in doses of 0, 170, 330, or 670 mg/kg bw/d (administration during gestation days 7 - 16).16 Dams were euthanized and evaluated on day 20 of gestation. No statistically significant differences (P > 0.05) were observed in the maternal, uterine, and ovary weights or in the number of corpus lutea and nidation between test and control groups. In addition, no statistically significant differences (P > 0.05) were observed between the control and treated groups regarding the weight, length, and number of living embryos. No evidence of maternal or embryo toxicity resulting from the test substance administration was observed. … [kırpıldı - bölüm toplam 2736 karakter]

Definition and Structure Hyaluronic Acid (CAS No. 9004-61-9; Figure 1) is a linear glycosaminoglycan composed of repeating disaccharides of β4-glucuronic acid-β3-N-acetylglucosamine.3 The remaining ingredients in this report are derivatives of Hyaluronic Acid (e.g., Sodium Hyaluronate (CAS No. 9067-32-7) is a sodium salt of Hyaluronic Acid). The definitions of the ingredients included in this review are provided in Table 1.  Distributed for Comment Only -- Do Not Cite or Quote Figure 1. Hyaluronates (when R is hydrogen = Hyaluronic Acid; when R is sodium = Sodium Hyaluronate; etc.) Chemical Properties Hyaluronic Acid is a water-soluble substance that is available as a highly purified, freeze-dried powder or aqueous solution.1 Hyaluronic Acid may also be presented as its potassium or sodium salt (i.e., Potassium Hyaluronate or Sodium Hyaluronate). The molecular weight (MW) of Hyaluronic Acid in cosmetics is highly variable and ranges from 5 – 1800 kiloDaltons (kDa), dependent upon manufacturing procedures. Hyaluronic Acid has a high capacity for water retention; 1 g of Hyaluronic Acid can hold up to 6 l of water. These hyaluronates have a wide range of MW. For instance, according to the Food Chemicals Codex (FCC), the formula weight (FW) of Sodium Hyaluronate can vary from 80.2 to 4010 kDa. Other chemical properties of Hyaluronic Acid and Sodium Hyaluronate can be found in Table 2. Method of Manufacture Hyaluronic Acid is an ubiquitous substance that can be derived from several natural sources.1 These sources can be found in the Natural Occurrence section of this report. According to unpublished data, Hyaluronic Acid obtained for cosmetic use is derived via either bacterial fermentation or extraction from rooster combs.1 Hyaluronic Acid … [kırpıldı - bölüm toplam 15541 karakter]