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EC number: 616-105-5 | CAS number: 74504-65-7
No data was available on the acute toxicity by oral route for Dermosoft DGMC. Data on this endpount was therefore obtained for the main constituents in the substance as a weight of evidemce documentation of the toxicity. Thus, LD50(oral, rat) of 3320 mg/kg bw has been found for decanoic acid while a LD50(oral, rat) > 10g/kg bw was found of other polyglycerol esters of fatty acids. Based on this assessment it is concluded that the reaction mass containing decanoic acid, 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl ester and decanoic acid, 1-(2,3-dihydroxypropoxy)-3-hydroxypropyl ester (Dermosoft DGMC) is of low acute oral toxicity and that no animal test is necessary. No impurities or by-products of high toxicity, its acute oral toxicity were identified in the Certificate of Analysis. Therefore, the acute oral toxicity in rats can be predicted by weight-of-evidence assessment to be higher than 2000 mg/kg body weight.
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