Beclomethasone dipropionate

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). The environmental aspect is not considered in the benefit/risk assessments of human medicines. If new data become available after approval that requires an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the medicines authority.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.

Assessment reports

Assessment report for B17MP from Trydonis (beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium) an extension of the marketing authorisation, Chiesi Farmaceutici S.p.A., 14 October 2021, EMA/619369/2021. Corresponding information is available for B17MP in the assessment report for Trimbow (beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium) an extension of the marketing authorisation, Chiesi Farmaceutici S.p.A., 28 January 2021, EMA/93446/2021.

"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: Log K_ow 3.49/3.14. Bioaccumaluation in fish. OECD 305. No bioconcentration factor calculated. Conclusion. No accumulation occurred.

Toxicity: There is data for one trophic level. "Flow-through life-cycle toxicity test with the fathead minnow (Pimephales Promelas), OECD on fish life-cycle tests, NOEC 0.13 microg/L. Conclusion: B17MP is unlikely to represent a risk. [...] 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. On the basis of the tailored ERA it was concluded that beclometasone is not readily biodegradable, not toxic to fish and not expected to bioconcentrate in fish." The interpretation is that B17MP was concluded not being toxic to fish."

Risk

"A risk to the environment was not indicated."