Abstract

Glutaminase (glutamine aminohydrolase EC 3.5.1.2) is used in the production of food ingredients rich in l‐glutamic acid that are added to finished foods for the purpose of enhancing or improving the savory flavor profile of food. The glutaminase enzyme preparation evaluated in these studies, designated as Sumizyme GT hereafter, is obtained by fermentation of Aspergillus niger strain GT147. The safety of Sumizyme GT was evaluated in a series of standard toxicological studies, including a 90‐day oral toxicity study in rats, an in vitro bacterial reverse mutation assay, an in vitro mammalian chromosome aberration test, and an in vivo alkaline Comet assay. Sumizyme GT was not mutagenic or genotoxic, and administration of the enzyme by gavage at doses up to 2,570 mg total organic solids (TOS)/kg body weight (bw) per day for 90 days was without any systemic toxicity. The no‐observed‐adverse‐effect level was concluded to be 2,570 mg TOS/kg bw per day, the highest dose tested. Considering that A. niger has an established history of safe use in the food industry and its safety in the production of food ingredients and food enzymes is well documented, the results of these studies provide further support of the safety of glutaminase from A. niger when used in food production.

Highlights

  • Glutaminase is an enzyme used by the food industry to produce glutamic acid-rich food ingredients that are subsequently added to finished foods to improve the savory or “umami” flavor of foods

  • Ohshita et al (2000) conducted a safety assessment of glutaminase derived from different strains of Cryptococcus albidus, a filamentous fungus, and reported a no-observed-adverse-effect level (NOAEL) of 7.5 and 7.9 g/kg body weight/day for male and female ddY-F mice, respectively, 8.8 and 9.9 g/kg bw per day for male and female F244/ DuCrj rats, respectively, and 1.1 and 1.2 g/kg bw per day for male and female Std:Wistar rats, respectively, the highest dose tested in all cases, based on the results of 13-week oral toxicity studies

  • The stability of the dose formulations was validated by measurements of enzyme activity, and the results demonstrated the test doses were stable after storage under refrigeration temperatures for 7 days followed by 24-hr storage at room temperature at concentrations up to 128.5 mg total organic solids (TOS)/ml

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Summary

| INTRODUCTION

Glutaminase (glutamine aminohydrolase; EC3.5.1.2) is an enzyme used by the food industry to produce glutamic acid-rich food ingredients that are subsequently added to finished foods to improve the savory or “umami” flavor of foods. Ohshita et al (2000) conducted a safety assessment of glutaminase derived from different strains of Cryptococcus albidus, a filamentous fungus, and reported a no-observed-adverse-effect level (NOAEL) of 7.5 and 7.9 g/kg body weight (bw)/day for male and female ddY-F mice, respectively, 8.8 and 9.9 g/kg bw per day for male and female F244/ DuCrj rats, respectively, and 1.1 and 1.2 g/kg bw per day for male and female Std:Wistar rats, respectively, the highest dose tested in all cases, based on the results of 13-week oral toxicity studies. The objective of this study was to evaluate the safety of a glutaminase enzyme preparation derived from A. niger, namely Sumizyme GT, for use in food processing. The subchronic toxicity of Sumizyme GT was evaluated in a 90-day repeated-dose oral toxicity study in Sprague Dawley rats The details of these toxicological studies are outlined in detail below

| MATERIALS AND METHODS
Findings
| DISCUSSION

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