Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

There is no toxicokinetic study available for Isosorbide Monooleate (CAS 28454-96-8), but there is one study performed with the structural analogue Isosorbide Diesters (EC 700-073-5). In the study nine Sprague Dawley rats per sex per dose were exposed to the test substance via oral gavage. The animals were exposed to 0, 575, 1150, 2300 mg/kg bw of test substance dissolved in water, corresponding with 0, 500, 1000, 2000 mg/kg bw of the active ingredient (Isosorbide Diesters). Blood samples were taken on D1 (at pre-dose and at 30 min, 1 h, 2 h, 4 h and 8 h post-dose), on D28 at pre-dose and on D91 (pre-dose and at 30 min, 1 h, 2 h, 4 h and 8 h post-dose). The half-life was found between 2.09 to 4.65 hours. Comparison of exposure in males and females suggests that the males were slightly more exposed than the females. Furthermore, AUC last increased with the dose level and are comparable between D1 and D91. There was a good linearity between exposure or Cmax and the dose levels. The test substance is therefore considered to have a low bioaccumulation potential. Based on this information Isosorbide Monooleate is assumed to also have a low bioaccumulation potential.