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Formoterol

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 P, B, T and risk comes from Fass.se.

Fass environmental information

Fass environmental information for formoterol and Duaklir Genuair (aclidinium, formoterol) (downloaded 2018-07-04).

Hazard

Persistence: "Formoterol fumarate dihydrate is not readily biodegradable (loss of Dissolved Organic Carbon (DOC) < 70% after 28 days) (method: ISO 7827-1984 (E)). Based on the data above (considering that no other data is available), the statement “Formoterol fumarate dihydrate is potentially persistent” has been assigned."

Bioaccumulation: Log D = 0.41 at pH 7.4.

Acute toxicity: There are data for 3 trophic levels, lowest for algae 94 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 0,0000019 which gives the risk insignificant.

Assessment report

Assessment report for formoterol and Riarify (beclometasone/formoterol/glycopyrronium bromide) 22 February 2018, EMA/155339/2018.

Fara

Persistence: No data.

Bioaccumulation: log Kow -0.02.

Toxicitet: No data.

Risk

"PEC surfacewater, default = 0.00012 microg/L. Conclusion: > 0.01 threshold (N)."

Author: Health and Medical Care Administration, Region Stockholm