Toxicological Assessment of Nattokinase Study Data Published

Japan Bio Science Laboratory (JBSL), a leading manufacturer and supplier of nattokinase, announced “Toxicological Assessment of Nattokinase Derived from Bacillus subtilis var. natto" was published in Food and Chemical Toxicology.

Prepared by the Applied Research Center (ARC) at global public health organization NSF International, the article represents a comprehensive safety assessment of nattokinase, as NSK-SD, from JBSL. Nattokinase is an enzyme present in the traditional Japanese soybean-derived food "natto." The article describes the analysis of several GLP-compliant genotoxicity, acute toxicity, repeated dose studies in rodents, a 4-week clinical study in human volunteers and a study of the pathogenicity of Bacillus subtilis var. natto, the bacterial strain used to produce NSK-SD.

The results of the studies demonstrated JBSL's NSK-SD was non-mutagenic in bacterial cells and non-clastogenic in mammalian cells, and no adverse effects were observed in 28-day and 90-day subchronic toxicity studies conducted in Sprague-Dawley rats at doses up to 167 mg/kg-day and 1,000 mg/kg-day, respectively. Mice inoculated with 7.55 x 108 CFU of the enzyme-producing bacterial strain showed no signs of toxicity or residual tissue concentrations of viable bacteria.

Information from the following studies contracted by JBSL is presented in the report:

• Bacterial reverse mutation test (in-vitro) conducted at Kobuchisawa Laboratories, Fuji Biomedix Co. Ltd., Japan (Study No. FBM 02-8766; April 25, 2003)

• Chromosome aberration test (in-vitro) conducted at Kobuchisawa Laboratories, Fuji Biomedix Co. Ltd., Japan (Study No. FBM 02-8767; April 25, 2003)

• Single dose oral toxicity study in Sprague-Dawley rats conducted at Bozo Research Center Inc., Japan (Study No. C-B269; May 10, 2006)

• Oral repeated-dose 28-day toxicity study in Sprague-Dawley rats conducted at Kobuchisawa Laboratories, Fuji Biomedix Co. Ltd., Japan (Study No. FBM 02-2704; August 8, 2002)

• 13-week oral toxicity study in Sprague-Dawley rats conducted at Bozo Research Center Inc., Japan (Study No. B-5170; June 16, 2004)

• Pathogenicity study in ICR-strain SPF mice conducted at Gifu Research Laboratories, JBS Inc., Japan (Study No. JBS-03-MOPG-549; June 9, 2003)

• Open clinical trial in human volunteers conducted by TTC Co. Ltd., Japan (Study No. 27008).

• An Oral Safety Study of Nattokinase Containing Food, Natural Stuper Kinase II: A Randomized, Placebo Controlled, Double-Blind Study; Progress in Medicine Vol.26 No.5 2006.5