Mometasone furoate

Summary

This summary information comes from assessment report and Fass.

Persistence. Mometasone furoate is slowly degraded in the environment.
Bioaccumulation. Mometasone furoate has low potential for bioaccumulation.
Toxicity. Mometasone furoate has very high chronic toxicity.
Risk. The use of mometasone furoate (sales data Sweden 2018) has been considered to result in low environmental risk.

Detailed information

Assessment report

Assessment report for Enerzair Breezhaler (indacaterol, glycopyrronium bromide, mometasone furoate), Novartis, 30 April 2020, EMA/271332/2020.

Hazard

Persistence: OECD 308:
Taunton River system
DT_{50 (water)} = 3.7 days.
DT_{50 (sediment)} = >1000 days.
DT_{50(20 °C) (whole system)} = > 1000days.
DT_{50(12°C) (whole system)} = >1000 days.
Weweantic River system
DT_{50 (water)} = 4.2 days.
DT_{50 (sediment)} => 1000 days.
DT_{50(20 °C) (whole system)} = 512 days.
DT_{50(12°C) (whole system)} = >1000 days. Conclusion: Very Persistent.

Bioaccumulation: pH 5 log K_ow 4.66, pH 7 log K_ow 4.68, pH 9 log K_ow 4.81. Bioaccumulation BCF_kg 116.62–136.87 L/kg. Conclusion: Not bioaccumulative.

Toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 0,14 microg/L.

Risk

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

PEC_surfacewater = 0.004 microg/L.

PNEC = Lowest NOEC, 0.14 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.014 microg/L

PEC/PNEC = 0.2857 which gives the risk low.

Fass environmental information

Fass environmental information for Asmanex Twisthaler (mometasone furoate) from MSD (downloaded 2021-06-29).

Hazard

Persistence: "DT_{50 (total system)} = 81 to 105 days (OECD 308)." Mometasone is slowly degraded in the environment.

Bioaccumulation: Log K_ow: pH 5 = 4.66, pH 7 = 4.68, pH 9 = 4.81. "BCF_{whole body, total residues} = 104.9 to 107.1. Since BCF < 500, mometasone furoate has low potential for bioaccumulation."

Chronic toxicity: There is NOEC for 3 trophic levels, lowest fish (Pimephales promelas) (OECD 210) NOEC 32d (total length and dry weight) = 0.14 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.45 which gives the risk low.

Pharmaceutial residues in the aquatic environment

Results from environmental measurements are available for mometasone furoate. Report Pharmaceutial residues in the Stockholm aquatic environment.

References

Author: Health and Medical Care Administration, Region Stockholm