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Propranolol

Information

This summary information comes from Fass. The risk is confirmed by the report from Goodpoint and the assessment report.

Persistence. Propranolol l is degraded in the environment.
Bioaccumulation. Propranolol has low potential for bioaccumulation.
Toxicity. Propranolol has very high chronic toxicity.
Risk. The use of propranolol (sales data Sweden 2017) has been considered to result in insignificant environmental risk.

Detailed information

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.

Assessment report

Assessment report for Hemangiol (propranolol), Pierre Fabre Dermatologie, 20 February 2014, EMA/CHMP/8171/2014.

Hazard

Persistence: No data.

Bioaccumulation: "Log Kow between -0.41 and 3.65 (literature)."

Toxicity: No data.

"The values log Kow are variable according the references provided and were not determined experimentally. As propranolol hydrochloride is an ionisable compound, an ion-corrected log Dow and log Kow was calculated to be 0.68 ± 0.01 or 3.45 ± 0.01, respectively, below the action limit of 4.5. As a result testing for persistence, bioaccumulation and toxicity is not required. The values log Kow are variable according the references provided and were not determined experimentally. As propranolol hydrochloride is an ionisable compound, an ion-corrected log Dow and log Kow was calculated to be 0.68 ± 0.01 or 3.45 ± 0.01, respectively, below the action limit of 4.5. As a result testing for persistence, bioaccumulation and toxicity is not required.

Risk

"A risk for the environment is not expected."

Fass environmental information

Fass environmental information for Inderal (propranolol) from AstraZeneca (downloaded 2021-10-27).

Hazard

Persistence: Under conditions of the OECD301B test, propranolol fulfilled the criteria for ready biodegradability at 0.1 mg/L, more than 60% mineralization was achieved. In the highest concentration of propranolol (100 mg/L) with the lowest concentration of sludge (30 mg/L), propranolol could not be classified as readily biodegradable. However, at higher sludge concentration (3000 mg/L), comparable to those of most sewage treatment works, propranolol was found to be readily biodegradable at 100 mg/L. Based on this information, propranolol has been assigned the risk phrase: “Propranolol is degraded in the environment.”."

Bioaccumulation: "Since BCF < 500, and Log P < 4 at pH intervals 4-9, propranolol has low potential to bioaccumulate and the phrase “Propranolol has low potential for bioaccumulation.” is assigned."

Toxicity: There are data for 3 trophic levels, most sensitive Sea urchin (Paracentrotus lividus) NOEC 2 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.070 which gives the risk insignificant.

Report Goodpoint

Propranolol is very well researched in terms of both exposure and effect. Studies reporting effects of low concentrations are not significant. The margin of safety is good.

Author: Health and Medical Care Administration, Region Stockholm