α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate

Basic toxicokinetics

Administrative data

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Justification for type of information:

High reliability as from EU scientific Committee (EFSA and RAC)

Applicant's summary and conclusion

Conclusions:

It is estimated that gastrointestinal absorption of non-hydrolysed or partly hydrolysed sucrose benzoate will not take place. However, some absorption of the mono-esters generated by hydrolysis in the gastrointestinal tract cannot be excluded, whereas 100% absorption of liberated benzoic acid/benzoate and sucrose can be anticipated.

Executive summary:

Oral absorption and metabolism

No data on sucrose benzoate is available.

For sucrose esters of fatty acids* EFSA (2004) found that in humans after oral exposure 20-30% of single doses were retrieved as intact esters from the faeces after 48 hours, whereas the total human faecal excretion of intact sucrose esters after 5 daily treatments was 17%. A high rate of hydrolysis occurred in the gastrointestinal tract, in accordance with the finding that more than 50% of sucrose esters were hydrolysed within 5 hours in cultures of the human intestinal microflora. However, degradation of various sucrose esters of fatty acids in gastric juice was found to be limited. Metabolic studies in vitro and studies in rats, dogs and humans show that these esters* are extensively hydrolysed in the gastrointestinal tract into well-known food constituents prior to absorption. Only small amounts of intact monoesters are absorbed, and incompletely hydrolysed sucrose esters appear to be excreted in the faeces. Studies using radiolabelled sucrose esters indicate that it is unlikely that di- and higher esters are absorbed intact. There is no evidence of tissue accumulation of the absorbed monoesters as the absorbed monoesters were completely metabolised to carbon dioxide or integrated into other endogenous constituents.

(*Sucrose esters of fatty acids consist of a mixture of mono- di- and triesters of sucrose with food fatty acids (mainly C14:0, C16:0, C18:0 and/or C18:1 fatty acids)).

This is in concordance with CIR (2016) that concluded “Generally in rats, dogs, and monkeys, sucrose esters were not found in whole blood or plasma following oral administration”.

In relation to benzoic acid/benzoate (formed by hydrolysis iof sucrose benzoate) the gastrointestinal absorption is rapid and virtually complete in humans, rats, dogs, and hamsters (ECHA/RAC 2012).

From these data it is estimated that gastrointestinal absorption of non-hydrolysed or partly hydrolysed sucrose benzoate will not take place. However, some absorption of the mono-esters generated by hydrolysis in the gastrointestinal tract cannot be excluded, whereas 100% absorption of liberated benzoic acid/benzoate and sucrose can be anticipated.