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Dapagliflozin

Information

This summary information on bioaccumulation and toxicity comes from the assessment report and Fass. The information about persistence comes from the assessment report. The risk comes from Fass.

Persistence. Dapagliflozin is persistent.
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.

Detailed information

Assessment report

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.

Hazard

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.

Risk

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).

Hazard

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.

Risk

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