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Budesonide

Hazard 5 P 3 B 0 T 2 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 Pulmicort (budesonide) (downloaded 2018-07-04).

Hazard

Persistence: OECD301E: "Degradation after 7 days <8 %. Not readily biodegradable."

Bioaccumulation: "The Log octanol-water partition coefficient is 3.3, measured at pH 7.4."

Acute toxicity: There are data for 3 trophic levels, lowest for green algae (Pseudokirchinella subcapitata) 8.6 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 0.0013 which gives the risk insignificant.

Assessment report

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 Kow = 3.23. "OECD 305: Pending, expected end 2018."

Toxicitet: 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."

Author: The Pharmaceutical unit of Region Stockholm