Llana-Ruiz-Cabello M, Maisanaba S, Puerto M, Pichardo S, Jos A, Moyano R, Cameán A M
Area of Toxicology, Faculty of Pharmacy, University of Seville, Profesor García González n°2, 41012 Seville, Spain.
Area of Toxicology, Faculty of Pharmacy, University of Seville, Profesor García González n°2, 41012 Seville, Spain.
Food Chem Toxicol. 2017 Mar;101:36-47. doi: 10.1016/j.fct.2017.01.001. Epub 2017 Jan 5.
Oregano essential oil (Origanum vulgare L. virens) (OEO) is being used in the food industry due to its useful properties to develop new active packaging systems. In this concern, the safety assessment of this natural extract is of great interest before being commercialized. The European Food Safety Authority requests different in vivo assays to ensure the safety of food contact materials. One of these studies is a 90 days repeated-dose oral assay in rodents. In the present work, 40 male and 40 female Wistar rats were orally exposed to 50, 100 and 200 mg/kg body weight (b.w.) OEO during 90 days following the OECD guideline 408. Data revealed no mortality and no treatment-related adverse effects of the OEO in food/water consumption, body weight, haematology, biochemistry, necropsy, organ weight and histopathology. These findings suggest that the oral no-observed-adverse-effect level (NOAEL) of this OEO is 200 mg/kg b.w. in Wistar rats, the highest dose tested. In conclusion, the use of this OEO in food packaging appears to be safe based on the lack of toxicity during the subchronic study at doses 330-fold higher than those expected to be in contact consumers in the worst scenario of exposure.
牛至精油（牛至L. virens）（OEO）因其具有有益特性，正被用于食品工业以开发新型活性包装系统。在这方面，这种天然提取物在商业化之前的安全性评估备受关注。欧洲食品安全局要求进行不同的体内试验，以确保食品接触材料的安全性。其中一项研究是在啮齿动物中进行的90天重复剂量口服试验。在本研究中，按照经合组织准则408，40只雄性和40只雌性Wistar大鼠在90天内口服暴露于50、100和200毫克/千克体重（b.w.）的OEO。数据显示，OEO在食物/水消耗、体重、血液学、生物化学、尸检、器官重量和组织病理学方面未导致死亡，也未产生与治疗相关的不良反应。这些发现表明，这种OEO在Wistar大鼠中的口服无观察到有害作用水平（NOAEL）为200毫克/千克b.w.，即测试的最高剂量。总之，基于在亚慢性研究中未发现毒性，且该剂量比在最坏暴露情况下预期与消费者接触的剂量高330倍，在食品包装中使用这种OEO似乎是安全的。
