Registration Dossier

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Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Candesartan cilexetil is a pro-drug, it is extensively metabolised in the body to form the active drug

candesartan. Therefore, the active metabolite is expected to enter the environment following

patient use and candesartan is the focus of the environmental testing and risk assessment. Based on

the physical-chemical properties of candesartan, it is predicted to remain in the aqueous phase

during wastewater treatment and is unlikely to be removed via adsorption to sewage sludge solids.

Candesartan is not readily biodegradable. Once in the aquatic environment candesartan is

hydrolytically stable and the water-sediment transformation study showed little evidence of

degradation. The octanol-water partition coefficients, measured across the environmentally relevant

pH range, are low and candesartan is not predicted to bioaccumulate in aquatic organisms.

The substance did not show significant adsorption to sewage sludge (a Kd value was not determined).

Additional information