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: T M Coenen, A M Bertens, S C de Hoog, C M Verspeek-Rip
• Journal: Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association (Food Chem Toxicol) Vol. 38 Issue 8 Pg. 671-7 (Aug 2000) ISSN: 0278-6915 [Print] England
• PMID: 10908814 (Publication Type: Journal Article)

Chemical References

• Mutagens
• Lactase
• beta-Galactosidase

Topics

• Animals
• Chromosome Aberrations
• Clinical Chemistry Tests
• Female
• Hematologic Tests
• Humans
• Kluyveromyces (enzymology)
• Lactase
• Lymphocytes (drug effects)
• Male
• Microsomes, Liver (drug effects, metabolism)
• Mutagenicity Tests
• Mutagens (toxicity)
• No-Observed-Adverse-Effect Level
• Rats
• Rats, Wistar
• Salmonella typhimurium (drug effects, genetics)
• beta-Galactosidase (metabolism, toxicity)