Empagliflozin

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 K_ow = 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.