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Fluticasone propionate

Hazard 6* P 3 B 0 T 3* Risk Cannot be excluded

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T are from Fass. The risk has been assessed based on the information in Fass.

Fass environmental information

Fass environmental information for Flutide Diskus (fluticasone propionate) (downloaded 2019-01-15).

Hazard

Persistence: "Ready degradability: < 1.50% degradation in 28 days (TAD 3.11). Soil Metabolism: 9-50% degradation in 64 days (OECD 307). The phrase "fluticasone propionate is potentially persistent" is thus chosen."

Bioaccumulation: Log Kow = 2.80 at pH 7 (TAD 3.02).

Toxicity: There are data for 2 trophic levels, most sensitive fish (Pimephales promelas) NOEC 0.58 microg/L.

Risk

PPEC/PNEC is based on sales data in Sweden in year 2015. "PNEC (μg/L) = lowest NOEC/10, where 10 is the assessment factor applied for one long-term NOECs but where there is a high degree of confidence that the dataset includes the most sensitive species (fish) and addresses the specific mode of action (endocrine disruption). On this basis the NOEC for fish has been used in the calculation." PEC/PNEC = 0,0333 which gives the risk insignificant. According to ECHA's guidelines for AF 10, long-term data is required from 3 trophic levels, we here specify "Cannot be excluded".

Assessment report

Assessment report for Elebrato Ellipta (fluticasone furoate/umeclidinium/vilanterol) 14 September 2017 EMA/25056/2018

Fluticasone propionate and fluticasone furoate are glucocorticoids and as such could be considered as potential endocrine disruptor.

Author: The Pharmaceutical unit of Region Stockholm