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Empagliflozin

Summary

This summary information comes from Fass and the assessment report.

Persistence. Empagliflozin is considered to be degraded in the environment. However, empaglifozin forms a persistent metabolite (M3).
Bioaccumulation. Empagliflozin has low potential for bioaccumulation.
Toxicity. Empagliflozin has low chronic toxicity.
Risk. The use of empagliflozin (sales data Sweden 2019) has been considered to result in insignificant environmental risk.

Detailed information

Assessment report

Assessment report for Glyxambi (empagliflozin, linagliptin) 15 September 2016, EMA/749639/2016.

Hazard

Persistence parent: DT50, water = 2.3/2.1 d (r/p), DT50, sediment = 4.9/3.6 d (r/p), DT50, whole system = 2.5/2.5 d (r/p), r=river, p=pond, DT50 values corrected to 12°C; Conclusion: not P
Persistence metabolite M3: DT50, sediment = 169/125 (r/p), DT50 values corrected to 12°C. Conclusion: P

Bioaccumulation: Log Kow = 1.73, i.e. not B.

Chronic toxicity:There is NOEC for three trophic levels, lowest NOEC for fish 2400 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 0.125 microg/L.
PNEC = Lowest NOEC, 2400 microg/L/10 (Assessment Factor (AF) for chronic studies with three species) = 240 microg/L.
PEC/PNEC = 0,00052 which gives the risk insignificant.

Fass environmental information

Fass environmental information for Jardiance (empagliflozin) from Boehringer Ingelheim (downloaded 2021-09-29).

Hazard

Persistence : "Since Empagliflozin has a DT50 of ≤ 32d and with < 15% remaining as parent compound at the end of the study in the two systems, Empagliflozin is considered to be degraded in the environment."

Bioaccumulation: "Based on the data from the OECD Guideline 107 study with an n-octanol/water partition coefficient of 1.73 at pH 7.0, Empagliflozin is considered to have low potential for bioaccumulation."

Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (Danio rerio) NOEC 35d (length, wet weight, dry weight)" = 2400 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2019. PEC/PNEC = 1,17 x 10-4 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm