The dietary fibre product examined is a pectic polysaccharide extract from carrot (Daucus carota), enriched for pectin fragments comprising mainly rhamnogalacturonan-I (RG-I) (abbreviated product name cRG-I). To assess the safety of cRG-I for use as food ingredient, repeated-dose oral toxicity and in vitro genotoxicity studies were conducted. In the subchronic toxicity study (OECD test guideline 408), Wistar Hannover rats received cRG-I at dietary levels (w/w) of 0%, 2.5%, 5% and 10% for 13 weeks. cRG-I induced no adverse effects in this study. The NOAEL was 10% in the diet (equivalent to 6.9 and 7.8 g cRG-I/kg body weight/day in male and female rats, respectively). A package of three in vitro genotoxicity tests (Ames, mouse lymphoma and micronucleus assay in human peripheral blood lymphocytes) was negative for induction of point mutation and chromosome damage. An initial Ames test showed a weak positive response in Salmonella typhimurium strain (TA1537). This response was non-reproducible and attributed to microbial contamination as subsequent tests with an irradiated batch of cRG-I including a repeat Ames test were negative. cRG-I was therefore considered to be non-mutagenic.

中文翻译：

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鼠李糖半乳糖醛酸丰富的胡萝卜果胶级分的安全性评估：大鼠90天口服毒性研究和体外遗传毒性研究。

所检查的膳食纤维产品是胡萝卜（Daucus carota）的果胶多糖提取物，富含果糖片段，主要包含鼠李糖半乳糖醛酸聚糖-I（RG-1）（简称产品名称cRG-1）。为了评估cRG-1用作食品成分的安全性，进行了重复剂量的口服毒性和体外遗传毒性研究。在亚慢性毒性研究（OECD测试指南408）中，Wistar Hannover大鼠在13周内接受饮食水平（w / w）为0％，2.5％，5％和10％的cRG-1。cRG-1在这项研究中未引起任何不良反应。日粮中的NOAEL为10％（分别在雄性和雌性大鼠中分别为6.9和7.8 g cRG-I / kg体重/天）。一揽子三项体外遗传毒性测试（Ames，小鼠淋巴瘤和人外周血淋巴细胞中的微核试验）对点突变和染色体损伤的诱导呈阴性。最初的Ames试验显示鼠伤寒沙门氏菌菌株（TA1537）的阳性反应较弱。这种反应是不可重现的，并且归因于微生物污染，因为随后用辐照的cRG-1批次进行的测试（包括重复的Ames测试）为阴性。因此，认为cRG-1是非诱变的。