Tafazoli Shahrzad, Vo Trung D, Petersen Anne, Constable Anne, Coulet Myriam, Phothirath Phoukham, Lang Johanna, Baldwin Nigel
Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga L5N 2X7, ON, Canada.
Nestlé Product Technology Centre Lebensmittelforschung GmbH, Lange Str.21, 78224 Singen, Germany.
Regul Toxicol Pharmacol. 2017 Jul;87:71-87. doi: 10.1016/j.yrtph.2017.05.006. Epub 2017 May 6.
The potential toxicity of two savory food ingredients produced by fermentation of enzymatically hydrolyzed corn starch (Savory Base 100 and Savory Base 200) was evaluated individually in a bacterial reverse mutation assay, an in vitro mammalian cell gene mutation assay, an acute oral study and as a mixture in a 90-day dietary study. In the bacterial reverse mutation and in vitro mammalian cell gene mutation assays, neither ingredient was mutagenic at concentrations up to 5000 μg/plate and 5000 μg/mL, respectively in the presence and absence of metabolic activation. In the acute study, the no-observed-adverse-effect level (NOAEL) for each Savory Base 100 and Savory Base 200 in male and female rats was 2000 mg/kg body weight. In the 90-day study, the hematology and clinical chemistry findings and histopathological changes noted in the liver, heart and kidneys were deemed to be of no toxicological significance, as the mean values were within the historical control range, were not dose-dependent, occurred at a similar frequency in control groups, or only occurred in the control group. Considering these findings, the NOAEL for Savory Base 100 and Savory Base 200 was 2333 and 1167 mg/kg body weight, respectively, the highest dose tested in each case.
对通过酶解玉米淀粉发酵产生的两种咸味食品成分(咸味基料100和咸味基料200)的潜在毒性进行了评估,评估内容包括细菌回复突变试验、体外哺乳动物细胞基因突变试验、急性经口研究,以及作为混合物进行的90天膳食研究。在细菌回复突变试验和体外哺乳动物细胞基因突变试验中,在有和无代谢活化的情况下,两种成分在浓度分别高达5000μg/平板和5000μg/mL时均无致突变性。在急性研究中,雄性和雌性大鼠中每种咸味基料100和咸味基料200的未观察到不良反应水平(NOAEL)为2000mg/kg体重。在90天研究中,肝脏、心脏和肾脏的血液学和临床化学检查结果以及组织病理学变化被认为无毒理学意义,因为平均值在历史对照范围内,不具有剂量依赖性,在对照组中以相似频率出现,或仅在对照组中出现。考虑到这些结果,咸味基料100和咸味基料200的NOAEL分别为2333和1167mg/kg体重,分别为每种情况下测试的最高剂量。