Bosentan
Summary
Persistence. Bosentan is potentially persistent.
Bioaccumulation. Bosentan has low potential for bioaccumulation.
Toxicity. Bosentan has moderate acute toxicity.
Risk. Risk of environmental impact of bosentan cannot be excluded since there is not sufficient ecotoxicity data available.
This summary information comes from Fass.
Detailed information
Fass environmental information
Fass environmental information for Stayveer (bosentan [anhydrous]) from Janssen (downloaded 2024-08-09).
Hazard
Persistence: Biotic degradation. Ready biodegradation. 0%, 28 days. Manometric Respirometry Test, OECD Test Guideline No. 301 F. Not readily biodegradable. Inherent biodegradation, 0%, 28 days. MITI Test II, OECD Test Guideline No. 302 C. Not inherently biodegradable.
Bioaccumulation: Data according open literature ...: ChemSpider reports: ACD/LogD (pH 7.4): 1.53. Bioconcentration. Data according open literature ...: ChemSpider reports: ACD/BCF (pH 7.4): 2.85.
Acute toxicity: There are data for 2 trophic levels, most sensitive water fleas Daphnia magna (OECD 202) ...: EC50 48 h: 66 mg/L (endpoint: not specified).
Risk
"Because not all data for each of the three trophic levels (fish, invertebrates and algae) are available, the PNEC cannot be calculated."
Risk of environmental impact of bosentan cannot be excluded since there is not sufficient ecotoxicity data available.
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.
The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.
Assessment report
Assessment report for Stayveer, 21 March 2013, EMA/CHMP/294640/2013.
"The data provided related to the environmental risk assessment are considered acceptable."
Author: Health and Medical Care Administration, Region Stockholm