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Linagliptin

Hazard 3 P 3 B 0 T 0 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B, T and risk are from assessment report.

Assessment report

Assessment report for assessment report for linagliptin from Glyxambi (empagliflozin, linagliptin) 15 september 2016, EMA/749639/2016.

Hazard

Persistence OECD 308 : "DT50, water = 0.8/1.1d (r/p), DT50, sediment = 110/42.2d (r/p), DT50, whole system = 5.2/1.6d (r/p), Shifting to sediment = 50.9% (r), 72.4% (p) at day 100. r = river, p = pond, DT50 values at 20°C; Significant shifting to sediment observed"." According to expert linagliptin is slowly degraded in the environment (Researcher at the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University 2019-01-21).

Bioaccumulation: Log Kow = 1.7.

Toxicity: There are data for 3 trophic levels, lowest for crustacean (Daphnia sp.) NOEC = 3 200 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC surfacewater, default Fpen = 0,025 microg/L.

PNEC = Lowest NOEC, 3 200 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 320 microg/L

PEC/PNEC = 0.000078 which gives the risk insignificant.

Fass environmental information

Fass environmental information for Trajenta (linagliptin) (downloaded 2019-10-15).

Hazard

Persistence: For details see Fass environmental information. "Linagliptin was not readily biodegradable (OECD 301A, GLP). Further, in an OECD Guideline 308 simulation study, Linagliptin was slowly degraded in the environment. In abiotic degradation studies, Linagliptin did not undergo significant degradation by hydrolysis or photolysis. Based on these combined data, Linagliptin is considered to be slowly degraded in the environment."

Bioaccumulation: "The n-octanol/water partition coefficient was in an OECD Guideline 122 (GLP) study determined to -1.6 at pH 5.0, 0.1 at pH 7.0 and 1.5 at pH 9.0, respectively."

Toxicity: There are data for 3 trophic levels, lowest for crustacean (Daphnia magna) NOEC = 3 200 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 0.0000025 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm