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Beclomethasone dipropionate

Summary

Beclomethasone dipropionate is a prodrug where the major metabolite is beclomethasone-17-monopropionate (B17MP).

This summary information comes from the assessment report on Trydonis (beclomethasone dipropionate, formoterol fumarate dihydrate and glycopyrronium) and is based on B17MP.

Persistence. B17MP is potentially persistent.
Bioaccumulation. B17MP has low potential for bioaccumulation.
Toxicity. It cannot be excluded that B17MP is toxic, due to the lack of data.
Risk. Risk of environmental impact of B17MP cannot be excluded, due to the lack of environmental toxicity data. However, the assessment report states the following:"It can be expected that the present extension will not pose a risk to the environment when used in accordance with the SmPC."

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

Assessment report

Assessment report for Trydonis (beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium), Chiesi Farmaceutici S.p.A., 14 October 2021, EMA/619369/2021.

"However, due to the potential endocrine disrupting properties of glucocorticoids, a tailored ERA for the active metabolite of beclometasone dipropionate (pro-drug), i.e. beclometasone-17-monopropionate (B17MP), had been performed."

Hazard

Persistence: OECD 301B: Not readily biodegradable. Conclusion. Additional evaluation required. OECD 308: Emperor Lake. Water: DT50 3.0 days. Overall system: DT50 3.9 days. Conclusion. Lower dissipation. Calwich Abbey Lake. Aerobic: DT50 <1 day. Anaerobic: DT50 <1 day. Conclusion. Rapidly dissipated. According to expert B17MP is potentially persistent (C. Coll, Department of Environmental Chemistry, Eawag, 2022-01-28).

Bioaccumulation: Bioaccumaluation in fish. OECD 305. No bioconcentration factor calculated. Conclusion. No accumulation occurred.

Toxicity: No data.

Risk

"It can be expected that the present extension will not pose a risk to the environment when used in accordance with the SmPC."

Author: Health and Medical Care Administration, Region Stockholm