title: Safety evaluation of a lactase enzyme preparation derived from Kluyveromyces lactis.
abstract: Neutralact(R), the DSM brand name of a lactase enzyme preparation, obtained from a homologous rDNA strain of Kluyveromyces lactis, was subjected to a series of toxicological tests to document the safety for use as a processing aid in the dairy industry. The enzyme preparation was examined for subacute oral toxicity and mutagenic potential. As a result of these tests, no evidence of oral toxicity, mutagenicity or clastogenicity was found. Administration of the lactase enzyme preparation at doses of 500, 3000 and 10,000 mg/kg body weight/day for 28 days did not induce noticeable signs of toxicity. The no-observed-adverse-effect level (NOAEL) of the enzyme preparation in the acute toxicity study was 10,000 mg/kg body weight/day (equivalent to 114,000 NL units/kg body weight/day). It can be concluded that no safety concerns were identified in the studies conducted with this lactase enzyme preparation derived from Kluyveromyces lactis under controlled fermentation conditions.
authors.affiliation: DSM Gist, PO Box 1, 2600 MA, Delft, s-Hertogenbosch, The Netherlands. dorine.coenen@dsm-group.com
authors.forename: T M
authors.initials: TM
authors.lastname: Coenen
authors.forename: A M
authors.initials: AM
authors.lastname: Bertens
authors.forename: S C
authors.initials: SC
authors.lastname: de Hoog
authors.forename: C M
authors.initials: CM
authors.lastname: Verspeek-Rip
mesh_terms: D000818:Animals; D002869:Chromosome Aberrations; D019963:Clinical Chemistry Tests; D005260:Female; D006403:Hematologic Tests; D006801:Humans; D007716:Kluyveromyces / Q000201:enzymology*; D043322:Lactase; D008214:Lymphocytes / Q000187:drug effects; D008297:Male; D008862:Microsomes, Liver / Q000187:drug effects / Q000378:metabolism; D009152:Mutagenicity Tests; D009153:Mutagens / Q000633:toxicity*; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D017208:Rats, Wistar; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D001616:beta-Galactosidase / Q000378:metabolism / Q000633:toxicity*
chemical_list: D009153:Mutagens; D043322:Lactase; D001616:beta-Galactosidase