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EC number: 616-105-5 | CAS number: 74504-65-7
No studies are available for Polyglycerol-2-caprate. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues.
In the rat studies the animals were exposed to polyglycerol esters of fatty acids for 90 days and 22 weeks, respectively (EFSA, 2017b). No toxicity was seen in any of the studies.
In humans, 19-24 years of aged, exposed for 3 weeks to polyglycerol esters of fatty acids though the diet, no signs of toxicity were seen (EFSA, 2017b).
Three studies on mixtures of triglycerides were performed in rats. This was two 90-day studies and one 2 generation study. No adverse effects caused by decanoic acid and octanoic acid in form of medium-chain triglycerides was found. The NOAEL based on these studies was ≥ 7000 mg/kg bw/day (CLH report octanoic acid, 2012). For medium and long chain triglycerides, the NOAEL is reported to be ≥ 8000 mg/kg bw/day (Zhouet al., 2017).
For the fatty acids, a NOAEL for decanoic acid is reported to be > 1000 mg/kg bw/day (CAR Capric acid, 2013). One study was performed on tetra decanoic acid (Lauric acid) in rats reporting a NOEL of > 6000 mg/kg/day (Burdocket al., 2007).
Studies on repeated dose toxicity on synthetic and natural glycerine fed orally to rats is reported with a NOAEL of 10 000 mg/kg bw/d (ECHA, 2018) indicating that the glycerols are non-toxic.
Based on the available studies on the group of polyglyceryl fatty acid esters and the relevant hydrolysis products described above, it can based on an overall weight of evidence approach be concluded that the compound Polyglycerol-2-caprate is of very low concern for repeated dose toxicity. Thus, no STOT RE classification should apply for the substance.
No studies are available forPolyglycerol-2-caprate. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues.
In the rat studies the animals were exposed to polyclycerol esters of fatty acids for 90 days and 22 weeks, respectively (EFSA, 2017b). No toxicity was seen in any of the studies.
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