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Umeclidinium

Hazard 5* P 3* B 0 T 2 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. The same risk in Fass.

Assessment report

Assessment report for Anoro (umeclidinium, vilanterol) 28 March 2014 EMA/CHMP/163509/2014 and Laventair (umeclidinium, vilanterol) 28 March 2014 EMA/CHM/163506/2014.

Hazard

Persistence: No data.

Bioaccumulation: log Kow = 1.256, conclusion not B.

Toxicity: There are data for 3 trophic levels, most sensitive alge NOEC 62.5 microg/L.

Risk

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

PEC surfacewater = 0.00063 microg/L. "The PECsurfacewater is below 0.01 μg/L, and thus a phase II assessment is not necessary."

PNEC = Lowest NOEC, 62.5 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 6.25 microg/L

PEC/PNEC = 0,00010 which gives the risk insignificant.

Fass environmental information

Fass environmental information for Anoro Ellipta (umeclidinium, vilanterol) (downloaded 2019-01-24).

Hazard

Persistence: No data.

Bioaccumulation: Log Dow at pH 5 = 0.092, Log Dow at pH 7 = 1.35, Log Dow at pH 9 = 1.39.

Toxicity: here are data for 3 trophic levels, most sensitive green alge NOEC 95.4 microg/L.

Risk

PEC/PNEC is based on expected sales in Sweden during 2020. PEC/PNEC = 0.0000157 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm