Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
Following oral and intraveinous investigations, sodium saccharin is rapidly absorbed and also eliminated rapidly through the urine. It is concluded therefore that there is little possibility of saturation of the renal clearance route of excretion at ‘normal’ esposure levels since the doses given in the present study were at least 20 times those estimated as the average daily intake.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The toxicokinetics of sodium saccharin have been investigated in a number of investigative studies and a guideline-compliant human study. Following oral and intravenous administration, sodium saccharin is rapidly absorbed and is excreted rapidly and predominantly in the urine.

It is concluded therefore that there is little possibility of saturation of the renal clearance route of excretion at ‘normal’ exposure levels since the doses given in the present study were at least 20 times those estimated as the average daily intake.