beta-D-fructofuranosyl alpha-D-glucopyranoside octa(acetate and palmitate and stearate)

Boiling point

Administrative data

Endpoint:

boiling point

Data waiving:

study technically not feasible

Justification for data waiving:

the study does not need to be conducted because the substance is a solid which decomposes before boiling

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING: Testing is Not Technically PossiblePer Column 2 to Annex VII, Section 7.3 a boiling point study need not be conducted for "substances which decompose before boiling."The registered substance is expected to decompose before boiling for a number of reasons. First, we can be compared to a traditional vegetable oil. Soybean oil, for example, has approximately similar fatty acyl groups (C16-18 and C18 unsaturated) as those of the registered substance (C16-18). Soybean oil, like other fats and oils, does not boil. Instead, it undergoes decomposition at a temperature known as the “smoke point.” The smoke point can very significantly, depending on impurities, free fatty acid content, and other factors. The smoke points for soybean oil range from 160-232 ºC, according to http://jonbarron.org/diet-and-nutrition/healthiest-cooking-oil-chart-smoke-points#.VLVKuHvCeM4. Of course, a triglyceride molecule will have only three such fatty acyl groups, whereas the registered substance contains between two and eight (the others being acetate groups). Only 4.5% of the substance has three fatty acyls or fewer, so the vast majority of the substance is much heavier than the triglyceride oils (and would therefore require more energy to volatilize, were it stable enough to reach such temperatures). In all likelihood, the registered substance will undergo decomposition at temperatures similar to that of conventional triglycerides (if not earlier, as discussed below).Second, we can compare the substance to normal sucrose. Sucrose is a solid at room temperature, and its melting point is commonly reported to be approximately 186 ºC. However, recent work suggests that sucrose actually undergoes significant decomposition concurrent with melting. It’s not clear whether the fatty acyl groups of the registered substance would make the sucrose moiety any more or less likely to decompose. However, given that both sucrose and simply fatty triglycerides are known to undergo decomposition before boiling (or even melting), it’s reasonable to conclude that the registered substance is similarly prone to decomposition before boiling.We note that Column 2 to Annex VII, Section 7.3 states that for solids that decompose before boiling the boiling point at reduced pressures may be estimated or measured. To that end the registrant contaced several testing laboratories including Intertek, NETZSCH Instruments North America, LLC, and DAT Laboratories; none of these indicated they could perform such a test on the registered substance.