title: Genotoxicity, acute and subchronic toxicity studies in rats of a rooster comb extract rich in sodium hyaluronate.
abstract: The toxicity of a rooster comb extract (IB0004) that contains mainly sodium hyaluronate was assessed in acute and subchronic studies and in a bacterial reverse mutation assay. In a single dose acute study, male and female rats were administered 2000 mg/kg body weight (bw) of the product and observed for 14 days. No mortality was recorded, thus it was considered that the minimum lethal dose for rats by oral route was greater than 2000 mg/kg bw. A 90-day subchronic study (5, 55 and 600 mg/kg bw/day, oral gavage) with 50 male and 50 female Wistar-Hannover rats produced no significant adverse effects on food consumption, body weight, mortality, clinical biochemistry, hematology, gross pathology, and histopathology. Although some differences were observed between the treated and control animals in body weight gain (%) and some hematological parameters, these changes were generally minor in nature and, are considered to be of no toxicological significance. The no-observable-adverse-effects level was established at 600 mg/kg bw/day. There was no evidence of mutagenic activity in Salmonella typhimurium TA98, TA100, TA1535 and TA1537 or in Escherichia coli WP2 uvra pkM101. In conclusion, the results from these safety studies support the safety of rooster comb extract IB0004 in food.
authors.affiliation: Harlan Laboratories S.A., Centro Industrial Santiga, C/Argenters 6, 08130 Santa Perpètua de Mogoda, Barcelona, Spain.
authors.forename: Lourdes
authors.initials: L
authors.lastname: Canut
authors.forename: Jorge
authors.initials: J
authors.lastname: Zapatero
authors.forename: Sílvia
authors.initials: S
authors.lastname: López
authors.forename: Anna
authors.initials: A
authors.lastname: Torrent
authors.forename: Ramon
authors.initials: R
authors.lastname: Ruhí
authors.forename: Laura
authors.initials: L
authors.lastname: Vicente
mesh_terms: D000818:Animals; D001835:Body Weight / Q000187:drug effects / Q000502:physiology; D003129:Comb and Wattles / Q000737:chemistry*; D004435:Eating / Q000187:drug effects / Q000502:physiology; D005260:Female; D006820:Hyaluronic Acid / Q000302:isolation & purification* / Q000633:toxicity*; D008297:Male; D009152:Mutagenicity Tests / Q000379:methods; D011897:Random Allocation; D051381:Rats; D017208:Rats, Wistar; D023382:Toxicity Tests, Acute / Q000379:methods*; D059550:Toxicity Tests, Subchronic / Q000379:methods*
chemical_list: D006820:Hyaluronic Acid