Nováková Jana, Vértesi Adél, Béres Erzsébet, Petkov Spas, Niederberger Katherine E, Van Gaver Davy, Hirka Gábor, Balázs Zoltán
MediTox s.r.o., Pod Zamkem 279, 281 25, Konarovice, Czech Republic.
Toxi-COOP Toxicological Research Center ZRT., Balatonfüred, Arácsi út 97, 8230, Hungary.
Toxicol Rep. 2020 Dec 31;8:139-147. doi: 10.1016/j.toxrep.2020.12.015. eCollection 2021.
A novel 6-phytase (Phytase TSP, trade name OptiPhos® PLUS) with improved thermostability has been developed for use in animal feed. The safety of the new phytase was evaluated by testing for genotoxicity and subchronic toxicity. In and genotoxicity assays Phytase TSP concentrate was not mutagenic and did not induce biologically or statistically significant increases in the frequency of micronucleated polychromatic erythrocytes. In a subchronic toxicity study, male and female rats administered 100, 500 or 1000 mg/kg body weight/day of Phytase TSP concentrate oral gavage for 90 days had no mortalities, and no treatment-related effects on body weight, food consumption, clinical observations or ophthalmology. Furthermore, there were no changes in haematology, clinical chemistry, urinalysis, gross pathology, organ weights or histopathology that could be attributed to the test article. Several endpoints exhibited statistically significant effects, but none was dose-related or considered to be of toxicological relevance. Based on these results, Phytase TSP concentrate (OptiPhos® PLUS) was not genotoxic and the No Observed Adverse Effect Level (NOAEL) for male and female rats was 1000 mg/kg body weight/day.
一种具有更高热稳定性的新型6-植酸酶（植酸酶TSP，商品名OptiPhos® PLUS）已被开发用于动物饲料。通过遗传毒性和亚慢性毒性测试对这种新型植酸酶的安全性进行了评估。在遗传毒性试验中，植酸酶TSP浓缩物没有致突变性，也没有引起微核多染红细胞频率在生物学或统计学上的显著增加。在一项亚慢性毒性研究中，雄性和雌性大鼠经口灌胃给予100、500或1000 mg/kg体重/天的植酸酶TSP浓缩物，持续90天，没有死亡情况，对体重、食物摄入量、临床观察或眼科检查也没有与治疗相关的影响。此外，血液学、临床化学、尿液分析、大体病理学、器官重量或组织病理学方面均未出现可归因于受试物的变化。几个终点指标显示出统计学上的显著影响，但均与剂量无关，也不被认为具有毒理学相关性。基于这些结果，植酸酶TSP浓缩物（OptiPhos® PLUS）没有遗传毒性，雄性和雌性大鼠的未观察到有害作用水平（NOAEL）为1000 mg/kg体重/天。
