Budesonide

Detailed information

Fass environmental information

Environmental information is missing on fass.se for budesonide (2021-06-10). It is voluntary for manufacturers to provide information on environmental impact on fass.se.

Assessment report for Jorveza (budesonide) 09 November 2017 EMA/774645/2017

Hazard

Persistence: "OECD 301: not readily biodegradable. OECD 308: Pending, expected end 2018."

Bioaccumulation: log K_ow = 3.23. "OECD 305: Pending, expected end 2018."

Toxicity: No data.

Risk

PEC_surfacewater 0.00008 microg/L. Conclusion: "> 0.01 threshold: N"

"The environmental risk assessment for budesonide can however not be finished until the ongoing test on transformation in aquatic sediment systems (OECD 308), bioaccumulation study (OECD 305) and fish full life-cycle Test (OPPTS 850.1500) are completed by end of 2018."

Other information

"Budesonid is a glucocorticoid and, as such, is considered a potential endocrine disruptor and therefore the potential endocrine activity of this compound was investigated in an appropriate chronic test system with relevant endpoints."

Assessment report for Jorveza 26 March 2020, EMA/199925/2020

Hazard

Persistence according to OECD 308: DT_{50, 12 °C water} = 14.7 d.
DT_{50, 12 °C sediment} = 62.6 d.
DT_{50, 12 °C whole system} = 38.6 d. 

Bioaccumulation: Log K_ow 3.23. BCF = 9.

Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (Danio rerio) NOEC 0.032 microg/L.

Risk

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

PEC_{surfacewater, refined} = 0.00017 microg/L.

PNEC = Lowest NOEC, 0.032 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.0032 microg/L

PEC/PNEC = 0.053125 which gives the risk insignificant.

Assessment report for Trixeo Aerosphere (formoterol, glycopyrronium bromide, budesonide) 15 October 2020, EMA/582495/2020

Hazard

Persistence according to OECD 308: DT_{50, whole system} = 12.5 days (River); 18.1 (Pond).
DT_{50, aqueous phase} = 6.45 days (River); 6.9 (Pond).
DT_{50, sediment system} = 22.7 days (River); not calculable (Pond).

Bioaccumulation: Log K_ow = 3.45.

Chronic toxicity: There are data for 2 trophic levels, most sensitive crustacean (Daphnia sp.) NOEC 3400 microg/L.

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

PEC_surfacewater = 0.0032 microg/L.

PNEC = Lowest NOEC 3400 microg/L/50 (ssessment Factor (AF) for 2 chronic studies) = 68 microg/L

PEC/PNEC = 0.000047 which gives the risk insignificant.

Comment on persistence

Based on the assessment reports from 2020, budesonide is likely non-persistent according to an expert (C. Coll, Department of Environmental Chemistry, Eawag, 2021-05-03).

Report Goodpoint 2020

Comparative assessment of environmental risk when using the corticosteroids betamethasone, budesonide, hydrocortisone and prednisolone from a Swedish perspective.

The use of both betamethasone and budesonide poses an environmental risk, and exchange with synthetic glucocorticoids with a lower environmental risk is to be advocated in cases where it is possible from a clinical perspective. Hydrocortisone and prednisolone have a lower environmental risk but are rarely medically interchangeable alternatives to betamethasone and budesonide. Note that corresponding environmental risk assessments have not been made for other synthetic glucocorticoids that are available on the Swedish market, and which could possibly constitute exchange alternatives. No actions are recommended with regard to replacement of hydrocortisone and prednisolone as their use poses a low environmental risk given the current state of knowledge.