Registration Dossier
Registration Dossier
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EC number: 604-045-2 | CAS number: 137862-53-4
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- 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.
Reference
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
