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Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
LAB 3822 contains then about 29 % of Isosorbide.
After administration, the LAB 3822 is hydrolysed by the pancreatic lipase. This hydrolysis split LAB 3822 into ISOSORBIDE and free fatty acids.
LAB 3822 is totally and rapidly transformed into isosorbide. Under these conditions, some of the toxicological studies were performed on LAB 3822 and data were extrapolated to isosorbide. No bioaccumulation potential for isosorbide was reported following the oral route of exposure investigated.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

In the study of Wils at all. it appears from the excretion percentages found that 100% of the dose of isosorbide administered orally is excreted unchanged in the 48 hours urines. We can conclude that isosorbide is absorbed across the intestine; it is not metabolized by the organs and it does not accumulate in the tissues. There was no faecal excretion and isosorbide did not increase the faeces dry matter.