Environmental information is missing on fass.se (2021-09-29). It is voluntary for manufacturers to provide information about environmental impact on fass.se. This summary information on bioaccumulation and toxicity comes from the assessment report and previous environmental information on fass.se. The information about persistence comes from the assessment report. The risk comes from Fass.
Persistence. Dapagliflozin slowly degrades in the environment.
Bioaccumulation. Dapagliflozin has low potential for bioaccumulation.
Toxicity. Dapagliflozin has moderate chronic toxicity.
Risk. The use of dapagliflozin (sales data Sweden 2016) has been judged to entail a insignificant risk of environmental impact.
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.
There are several assessment reports with environmental information for dapagliflozin. The latest more complete is for Qtern (saxagliptin/dapagliflozin) 26 May 2016, EMA/428168/2016.
Persistence: OECD 308: "DT50, total system = 136/66 d (h/l)."Remark: Dapagliflozin is persistent in sediments."
Bioaccumulation: Log Kow = 2.34 at pH 7 (OECD 107).
Toxicity: There are data for 3 trophic levels, most sensitive fish, early life stage toxicity test/Pimephales promelas NOEC 1000 microg/L.
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 0.05 microg/L (default), 0.00915 microg/L (refined).
PNEC = Lowest NOEC, 1000 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 100 microg/L.
PEC/PNEC = 0.0005 (default PEC), 0.0000915 (refined PEC) which gives the risk insignificant.
Fass environmental information
Fass environmental information for Forxiga (dapagliflozin) from AstraZeneca (downloaded 2021-01-18).
Persistence: "The half life of dapagliflozin in both aquatic sediment systems is <120 days. Dapagliflozin is slowly degraded in the environment."
Bioaccumulation: "The octanol-water partition coefficient was 2.34, measured at pH 7.4." (OECD 107)
Toxicity: There are data for 3 trophic levels, most sensitive fish, early life stage toxicity test with Pimephales promelas NOEC 1000 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 4.1 x 10-5 which gives the risk insignificant.
Author: Health and Medical Care Administration, Region Stockholm