A safety assessment was conducted for microbial collagenase (COL) enzyme expressed in Streptomyces violaceoruber. The acute oral toxicity of COL was examined in Sprague-Dawley rats and the LD50 of COL via single oral administration to rats was higher than 2000 mg/kg body weight. A 13-week oral gavage study of COL showed no adverse effects due to the enzyme up to a dose of 234.9 mg total organic solids (TOS)/kg body weight per day (NOAEL). A bacterial reverse mutation test showed no mutagenic activity at the highest dose (4698 μg TOS per plate). In the mouse lymphoma TK assay, a positive result was observed at the highest dose of 4698 μg TOS/mL although it had low reproducibility. To confirm the chromosome aberration potential, an in vivo micronucleus test was conducted that demonstrated the lack of mutagenic potential on the bone marrow of rats at doses up to 1879 mg TOS/kg body weight per day. The results of the genotoxicity studies and acute and subchronic rat studies support the safe use in food production of collagenase produced from S. violaceoruber.

中文翻译：

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Violaceoruber链霉菌胶原酶的安全性评估。

对紫链霉菌中表达的微生物胶原酶（COL）酶进行了安全性评估。在Sprague-Dawley大鼠中检查了COL的急性口服毒性，单次口服给大鼠的COL LD50高于2000 mg / kg体重。一项为期13周的对COL的管饲法研究显示，每天最多可摄入234.9 mg总有机固体（TOS）/ kg体重（NOAEL）的酶，不会产生任何不良影响。细菌反向突变测试显示最高剂量（每板4698μgTOS）没有诱变活性。在小鼠淋巴瘤TK分析中，尽管重现性较低，但在最高剂量4698μgTOS / mL处观察到阳性结果。为了确认染色体畸变潜能，进行了一项体内微核试验，该试验证明每天最高1879 mg TOS / kg体重的剂量对大鼠的骨髓缺乏致突变性。遗传毒性研究以及急性和亚慢性大鼠研究的结果支持安全生产食品中由紫薇链球菌产生的胶原酶。