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Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
biodegradation in water: simulation testing on ultimate degradation in surface water
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of sediment is unlikely
Justification for type of information:
The substance is 91% converted into the active pharmaceutical ingredient. Release of Valsartan in wastewater discharged from ETP is routinely monitored. Valsartan was not detected in past 12 months (to Feb 2019).
Sludge and solvent recovery residues are sent for Off site incineration. The solid waste stream is recycled off site.

Description of key information

The substance is solely used in pharmaceutical industry as intermediate to synthesize a drug substance. The study does not need to be conducted because no exposure of the environment is expected.

Key value for chemical safety assessment

Additional information