Umeclidinium

Summary

This summary information comes from assessment reports and Fass.

Persistence. It cannot be excluded that umeclidinium is persistent, due to the lack of data.
Bioaccumulation. Umeclidinium has low potential for bioaccumulation.
Toxicity. Umeclidinium has high chronic toxicity.
Risk. The use of umeclidinium (sales data Sweden 2018) has been considered to result in insignificant environmental risk.

Detailed information

Assessment report

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

Hazard

Persistence: No data.

Bioaccumulation: log K_ow = 1.256, conclusion not B.

Chronic 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 PEC_surfacewater 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) from GlaxoSmithKline (downloaded 2022-01-18).

Hazard

Persistence: No data.

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

Chronic 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 2018. PEC/PNEC = 1.68 x 10^-6 which gives the risk insignificant.

References

Author: Health and Medical Care Administration, Region Stockholm