Nattokinase, as NSK-SD from Japan Bio Science Laboratory, was found to have a no-observed-adverse-effect-level (NOAEL) of approximately 250 mg/kg-day in humans, according to findings published in Food and Chemical Toxicology.
Bradley Lampe and Caroline English from NSF International analyzed several GLP-compliant genotoxicity, acute toxicity, repeated dose studies in rodents, performed a four-week clinical study in human volunteers, and studied the pathogenicity of Bacillus subtilis var. natto, the bacterial strain used to produce NSK-SD.
“We take great pride in this assessment, as it demonstrates further validated, clinical evidence for the safety of NSK-SD nattokinase under the conditions evaluated in the assessment,” said Vincent Hackel, President of JBSL-USA, Incorporated. “This safety assessment, in combination with our ever-growing wealth of additional studies, supports JBSL as a valued leader for NSK-SD nattokinase across the globe.”
Specifically, the results of the studies demonstrate that JBSL's nattokinase, 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 1000 mg/kg-day, respectively. Mice inoculated with 755 million CFU of the enzyme-producing bacterial strain showed no signs of toxicity or residual tissue concentrations of viable bacteria.
“Publishing robust safety assessments in a reputable, peer-reviewed journal like Food Chemical and Toxicology provides tremendous value to public health,” said Robert Donofrio, PhD, Director of the Applied Research Center at NSF International.
“It ushers important safety information into the public domain and provides scientific assurance to regulatory agencies as well as companies interested in bringing the latest food and dietary ingredients like NSK-SD into their products safely.”
Source: Food and Chemical Toxicology
Volume 88, February 2016, Pages 87-99
“Toxicological assessment of nattokinase derived from Bacillus subtilis var. natto”
Authors: B.J. Lampe, J.C. English