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Glycopyrronium bromide

Hazard 4 P 3 B 0 T 1 Risk Insignificant

Information

The T-value in the score for hazard refers to acute toxicity. Underlying data for B is from the assessment report for Trydonis and Fass. Underlying data for P, T and risk are from Fass environmental information for Bevespi Aerosphere.

Assessment report Trydonis

Assessment report for glycopyrronium bromide from Trydonis (beclometasone, formoterol, glycopyrronium bromide) 22 February 2018, EMA/155337/2018.

Hazard

Persistence: No data.

Bioaccumulation: Log Kow = -1.35.

Toxicity: No data.

Risk

PEC surfacewater, default = 0.00025 microg/L. Conclusion "> 0.01 threshold (N)".

Fass environmental information for Bevespi Aerosphere

Fass environmental information for glycopyrronium bromide from Bevespi Aerosphere (formoterol, glycopyrronium bromide) form AstraZeneca (downloaded 2019-12-13).

Hazard

Persistence: 28 days 0% (OECD 301A). “Glycopyrronium bromide is potentially persistent.”

Bioaccumulation: Log Dow = -2.1 (OECD107).

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) 33 000 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.0000013 which gives the risk insignificant.

Fass environmental information for Seebri Breezhaler

Fass environmental information from Seebri Breezhaler (glycopyrronium bromide) from Novartis (downloaded 2019-12-13).

Hazard

Persistence: 28 days 0% (OECD 301A). “Glycopyrronium bromide is potentially persistent.”

Bioaccumulation: Log Dow = -2.1 (OECD107).

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) 33 000 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.00000089 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm