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Titolo:
Safety evaluation of phosphodiesterase produced from Penicillium citrinum:Summary of toxicological data
Autore:
Kondo, M; Nishimura, S; Tanaka, N; Flood, M;
Indirizzi:
Keller & Heckman LLP, Washington, DC 20001 USA Keller & Heckman LLP Washington DC USA 20001 LP, Washington, DC 20001 USA Amano Pharmaceut Co Ltd, Dept Safety Assessment, Nishiharu, Aichi 4818543,Japan Amano Pharmaceut Co Ltd Nishiharu Aichi Japan 4818543 Aichi 4818543,Japan Bozo Res Ctr Inc, Gotemba Lab, Gotemba, Shizuoka 4120039, Japan Bozo Res Ctr Inc Gotemba Shizuoka Japan 4120039 , Shizuoka 4120039, Japan Hatano Res Inst, Food & Drug Safety Ctr, Kanagawa 2578523, Japan Hatano Res Inst Kanagawa Japan 2578523 fety Ctr, Kanagawa 2578523, Japan
Titolo Testata:
REGULATORY TOXICOLOGY AND PHARMACOLOGY
fascicolo: 1, volume: 33, anno: 2001,
pagine: 2 - 11
SICI:
0273-2300(200102)33:1<2:SEOPPF>2.0.ZU;2-S
Fonte:
ISI
Lingua:
ENG
Soggetto:
MUTAGENICITY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
28
Recensione:
Indirizzi per estratti:
Indirizzo: Flood, M Keller & Heckman LLP, 1001 G St NW, Washington, DC 20001 USA Keller & Heckman LLP 1001 G St NW Washington DC USA 20001 001 USA
Citazione:
M. Kondo et al., "Safety evaluation of phosphodiesterase produced from Penicillium citrinum:Summary of toxicological data", REGUL TOX P, 33(1), 2001, pp. 2-11

Abstract

The toxicity of Enzyme RP-1, an enzyme preparation used to hydrolyze yeastRNA to produce flavor enhancers for use in the food industry, was evaluated in a series of studies. A 5-week dietary toxicity study in Wister rats was conducted in which animals received Enzyme RP-1 in feed at concentrationsof 0, 500, 2000, or 8000 mg/kg body wt/day. A 13-week dietary toxicity study in Sprague-Dawley rats was conducted in which animals received RP-1 concentrate at 0, 0.125, 0.5, or 2% in their diets. At the highest dose levels in both studies, submandibular glands in the oral cavity were enlarged, an effect attributed to protease activity of the enzyme preparation. The no-observed-effect level in rats in the 13-week study was 0.5%, equivalent to 317 mg/kg body wt/day for males and 346 mg/kg body wt/day for females. Based on estimated dietary exposure to the enzyme preparation, the margin of exposure is estimated to be greater than 38,000, Lack of genotoxic potential was demonstrated by an in vitro reverse mutation assay in Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 and in Escherichia coil strain WP2uvr and by an in vitro chromosome aberration test in CHL/IU cells derived from fibroblasts from the lungs of Chinese hamsters, Finally, the particular strain of Penicillium citrinum, the fungal strain used to prepare Enzyme RP-1, was shown to have low pathogenicity upon a single injection into the tail vein of rats of viable spores at doses up to 2.8 x 10(5) colony-forming units per animal. The results of these studies demonstrate that the enzyme preparation may be considered safe to workers and consumers when employed in the production of flavor enhancers from yeast. (C) 2001 Academic Press.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/11/20 alle ore 10:52:22