title: Safety evaluation of a xylanase expressed in Bacillus subtilis.
abstract: A programme of studies was conducted to establish the safety of a xylanase expressed in a self-cloned strain of Bacillus subtilis to be used as a processing aid in the baking industry. To assess acute and subchronic oral toxicity, rat feeding studies were conducted. In addition, the potential of the enzyme to cause mutagenicity and chromosomal aberrations was assessed in microbial and tissue culture in vitro studies. Acute and subchronic oral toxicity was not detected at the highest dose recommended by OECD guidelines. There was no evidence of mutagenic potential or chromosomal aberrations. Furthermore, the organism used for production of the xylanase is already accepted as safe by several major national regulatory agencies.
authors.affiliation: Danisco Cultor, Edwin Rahrs Vej 38, DK-8220, Brabrand, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Harbak
authors.forename: H V
authors.initials: HV
authors.lastname: Thygesen
mesh_terms: D000818:Animals; D001412:Bacillus subtilis / Q000201:enzymology*; D002869:Chromosome Aberrations; D005260:Female; D005433:Flour; D019649:Food Industry; D015870:Gene Expression; D008297:Male; D008940:Mitotic Index; D009152:Mutagenicity Tests; D051381:Rats; D017208:Rats, Wistar; D011994:Recombinant Proteins / Q000633:toxicity; D012449:Safety; D043325:Xylan Endo-1,3-beta-Xylosidase; D014995:Xylosidases / Q000235:genetics / Q000633:toxicity*
chemical_list: D011994:Recombinant Proteins; D014995:Xylosidases; D043325:Xylan Endo-1,3-beta-Xylosidase