Safflower (Carthamus tinctorius) petals have been used for centuries as a spice, in tea blends and in traditional Asian medicine. Aqueous extracts of Safflower petals have been used as a colouring food over the last 30 years due to their bright colour. Publications in the past raised concerns about fertility impairing, maternal toxicity, fetotoxic and teratogenic properties in rodents. As the tested extracts were poorly characterized and the studies were not performed according to guidelines, a need for further evaluation was seen. In silico predictions for the main pigments provided negative results for bacterial mutagenicity. Further, in vitro genotoxicity and in vivo reproductive toxicity studies of a well-characterized aqueous safflower concentrate generated more relevant data for risk assessment of its use in food. In vitro AMES tests and a mouse lymphoma cell assay were negative. An OECD guideline 421 screening study was performed in rats with oral daily doses of up to 1000 mg/kg bodyweight, applied via gavage to simulate a bolus effect. The highest dose reflected a toxicological limit test. The study did not give indications of general toxicity, did not show any effect on fertility and reproduction nor any effect on prenatal development and, also in contrast to previous results, treatment did not affect estradiol and FSH levels. Furthermore, pups raised until PND 14-16, developed normally with no adverse effects observed. With the established NOAEL of at least 1000 mg/kg/d, a considerable margin of exposure is achieved when compared with human intake estimates.

几个世纪以来，红花 ( Carthamus tinctorius ) 花瓣一直被用作香料、茶混合物和传统亚洲医学。过去 30 年来，红花花瓣的水提取物因其鲜艳的颜色而被用作着色食品。过去的出版物引起了对啮齿动物生育能力受损、母体毒性、胎儿毒性和致畸特性的担忧。由于测试的提取物的特征很差，并且研究没有按照指南进行，因此需要进一步评估。对主要色素的计算机模拟预测为细菌致突变性提供了负面结果。此外，体外遗传毒性和体内对充分表征的红花浓缩液的生殖毒性研究产生了更多相关数据，用于对其在食品中的使用进行风险评估。体外AMES 试验和小鼠淋巴瘤细胞试验均为阴性。经合组织指南 421 筛选研究在大鼠中进行，每日口服剂量高达 1000 毫克/公斤体重，通过管饲法模拟推注效应。最高剂量反映了毒理学限度测试。该研究没有给出一般毒性的迹象，没有显示对生育力和生殖的任何影响，也没有显示对产前发育的任何影响，而且与之前的结果相反，治疗不影响雌二醇和 FSH 水平。此外，幼崽被抚养到 PND 14-16，发育正常，没有观察到任何不利影响。已确定的 NOAEL 至少为 1000 mg/kg/d，与人类摄入量估计值相比，可实现相当大的暴露裕度。