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Ticagrelor

Hazard 1 P 0 B 0 T 1 Risk Insignificant

Information

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

Assessment report

Assessment report for Brilique (ticagrelor) 17 December 2015, EMA/CHMP/18297/2016.

Hazard

Persistence: "DegT50: DT50, water = 4.7/6.2 d, DT50, sediment = 49/66 d, DT50, system = 23/42 d. Conclusion: DT50 values corrected to 12°C. Conclusion: not P.
OECD 308: DT50, water = 2.2/2.9 d, DT50, sediment = 23/31 d, DT50, whole system = 11/20 d. shifting to sediment > 10%. DT50values at 20°C; Significant shifting to sediment observed." According to expert ticagrlor is not persistent (Researcher at the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University 2019-10-21).

Bioaccumulation: log Dow > 4.0, BCF < 6.4 L/kg. Conclusion: not B.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia sp.) NOEC 530 microg/L.

Risk

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

PECsurfacewater, default Fpen = 0.9 microg/L.

PNEC = Lowest NOEC, 530 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 53 microg/L

PEC/PNEC = 0.017 which gives the risk insignificant.

Fass environmental information

Fass environmental information for Brilique from AstraZeneca (downloaded 2019-10-21).

Hazard

Persistence: "Overall, evidence from the OECD 308 study suggests that ticagrelor will not be persistent in the aquatic environment. [---] Therefore, the phrase “Ticagrelor is degraded in the environment” has been assigned." For details see Fass.

Bioaccumulation: BCF = 6.36.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) NOEC 530 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.0025 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm