Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Absorption is not predicted for the intact substance, however limted gastrointestianl hydrolysis in the rat may occur and hydroylsis prodcuts are likely to be absorbed.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The water solubility of the registered substance is very low, therefore dissolution is regarded to be the rate limiting step for gastrointestinal absorption. Data from the rat and dog indicate that the intact substance is not likely to be absorbed, but will be hydrolysed by gastro-intestinal esterases. Hydrolysis in the rat is readily saturated and is insignificant at high levels of exposure, whereas a higher level of hydrolysis (~50%) is seen in the dog at high dose levels. This assessment is based on data from studies with mixed (mono-, di- and tri-) citrate esters of stearic alcohol (C18; stearyl citrate), whereas the registered substance consists of tri-citrate esters of C18, C20 and C22. The limited absorption seen with the test material used in this study is likely to be due largely to the mono-citrate ester, the results therefore indicate that the absorption of the registered substance (which consists of tri-esters only) will be even more limited in the rat

The gastrointestinal absorption of the hydrolysis products (citric acid, C18, C20, C22 fatty alcohols) is predicted; data from the dog indicate the saturation of fatty alcohol absorption at high levels of exposure.

Dermal absorption of the substance is not predicted based on its physicochemical properties. Inhalation exposure to the substance is not predicted based on its physicochemical properties.

Systemic distribution of the intact substance is not predicted. Following gastrointestinal hydrolysis, absorption and subsequent distribution of the hydrolysis product citric acid is predicted. Citric acid is a normal metabolic intermediate; citric acid resulting from hydrolysis of the registered substance and will distributed systemically but will be indistinguishable from the large amounts of citric acid normally present in the body. Data indicate that fatty alcohols are oxidised to the corresponding fatty acid in the enterocytes on absorption from the gastrointestinal tract. Fatty acids will be distributed to the liver and incorporated into normal metabolic pathways.