Hjortkjaer R K, Stavnsbjerg M, Pedersen P B, Heath J, Wilson J A, Marshall R R, Clements J
Danish Toxicology Centre, Hørsholm.
Food Chem Toxicol. 1993 Dec;31(12):999-1011. doi: 10.1016/0278-6915(93)90010-v.
Esperase is a proteolytic enzyme preparation that can be used as a processing aid in the food industry. The following studies were performed to establish safety for the consumer: oral toxicity study (13 wk) in the rat; teratogenicity study in the rat; gene mutation assays in Salmonella typhimurium and mammalian cells in vitro, and chromosome aberration assay in vitro. General toxicity was low; the effects seen were attributed to proteolytic activity and the loading with sodium chloride. Neither of these factors will be relevant to consumers of the processed food. There was no evidence of effects on pregnancy outcome or mutagenic potential. When these results are considered together with existing knowledge of the production organism and the chemical and microbiological characterization of the enzyme preparation, they indicate that Esperase will be safe for its intended application in food processing.
埃斯帕酶是一种蛋白水解酶制剂，可作为食品工业中的加工助剂。进行了以下研究以确定其对消费者的安全性：大鼠口服毒性研究（13周）；大鼠致畸性研究；鼠伤寒沙门氏菌和哺乳动物细胞体外基因突变试验，以及体外染色体畸变试验。总体毒性较低；所观察到的影响归因于蛋白水解活性和氯化钠负载量。这两个因素对于加工食品的消费者均不相关。没有证据表明对妊娠结局或致突变潜力有影响。当将这些结果与生产菌株的现有知识以及酶制剂的化学和微生物特性综合考虑时，表明埃斯帕酶在食品加工中的预期应用将是安全的。
