title: Safety and toxicological evaluation of a novel, fermented, peptide-enriched, hydrolyzed swine placenta extract powder.
abstract: Placenta is an important organ that connects the developing fetus to allow nutrient uptake, antibody provisions and gas exchange via the blood supply of the mother. We developed a novel, standardized, stable, water-soluble, peptide-enriched hydrolyzed, Horus fermented placenta powder (HFPEP) from healthy, pathogen-free, swine placenta. Earlier studies demonstrated that HFPEP significantly improves physical fatigue, hepatic functions and repair of muscle fibers. We examined the broad safety of HFPEP in various toxicology models in Good Laboratory Practices-approved laboratories. The acute oral toxicity study was conducted in female Sprague-Dawley rats, and the acute oral LD50 was found to be greater than 5000 mg/kg body weight. Ames' bacterial reverse mutation assay was conducted to determine the ability of HFPEP to induce reverse mutation at selected histidine loci in five tester strains of Salmonella typhimurium viz. TA1535, TA1537, TA98, TA100 and TA102 in the presence and absence of a metabolic activation system (S9) at the doses of 50, 15, 4.5, 1.35 and 0.41 mg/ml. No mutagenic potential was observed. Mutagenic potential was also evaluated using in vivo micronucleus test, and no mutagenic potential of HFPEP was observed. Repeated dose 28-d oral toxicity study was performed in male and female rats with 14-d recovery period at the dose levels of 250, 500 or 1000 mg/kg. No abnormal clinical signs or toxicity were detected. No observed adverse effect level of HFPEP was found to be greater than 1000 mg/kg body weight. These studies affirm that HFPEP has broad spectrum safety for human consumption.
authors.affiliation: Horus Co., Ltd. , Tokyo , Japan .
authors.forename: Yukio
authors.initials: Y
authors.lastname: Mitsui
authors.forename: Manashi
authors.initials: M
authors.lastname: Bagchi
authors.forename: Palma Ann
authors.initials: PA
authors.lastname: Marone
authors.forename: Hiroyoshi
authors.initials: H
authors.lastname: Moriyama
authors.forename: Debasis
authors.initials: D
authors.lastname: Bagchi
mesh_terms: D000284:Administration, Oral; D000818:Animals; D005260:Female; D005285:Fermentation; D007928:Lethal Dose 50; D008297:Male; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D015162:Micronucleus Tests; D009154:Mutation; D019055:No-Observed-Adverse-Effect Level; D010455:Peptides / Q000008:administration & dosage / Q000633:toxicity*; D010924:Placental Extracts / Q000008:administration & dosage / Q000633:toxicity*; D011208:Powders; D017207:Rats, Sprague-Dawley; D018570:Risk Assessment; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D013552:Swine; D013997:Time Factors
chemical_list: D010455:Peptides; D010924:Placental Extracts; D011208:Powders
keywords: 28-d sub-chronic toxicity; Acute oral toxicity; Ames’ bacterial reverse mutation assay; Horus fermented placenta extract (HFPEP); in vivo micronucleus assay