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Vilanterol

Hazard 5* P 3* B 0 T 2 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity.

Assessment report

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

Hazard

Persistence: No data.

Bioaccumulation: log Kow 0.092 (to pH 5), 1.354 (to pH 7), 1.390 (to pH 9). Conclusion: not B.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae 95.4 microg/L.

Risk

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

PEC = 0.000 13 microg/L

PNEC = Lowest NOEC, 95.4 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 9.54 microg/L

PEC/PNEC = 0.000 0136, i.e. insignificant.

Fass environmental information

Fass environmental information for Relvar Ellipta (fluticasone furoate, vilanterol) and vilanterol (downloaded 2018-06-14).

Hazard

Persistence: It can not be excluded that vilanterol is persistent, as data is missing.

Bioaccumulation: Log Pow = 1.26

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae 62.50 microg/L

Risk

PEC/PNEC is based on estimated sales in Sweden in 2020. PEC/PNEC = 2.40 x 10-5, i.e. insignificant.

Author: The Pharmaceutical unit of Region Stockholm