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Fluticasone furoate

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 assessment report. For the risk, see discussion below under Fass.

Assessment report

Assessment report for Elebrato Ellipta och Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) EMEA/H/C/WS1369, 20 September 2018, EMA/630775/2018.

Hazard

Persistence: "OECD 304 A = DT50 > 137 d (12°C). Inherent biodegradability in Soil OECD 304 A = DT50 > 64d 3% mineralization in 64d. Remarks: Reliable Report provided FF (flutikasonfuroat, anm. redaktionen) considered as P."

Bioaccumulation: log Kow = 2.61.

Toxicity: There are data for 2 trophic levels, most sensitive fish (Pimephales promelas) NOEC 0.29 microg/L.

"Fluticasone furoate 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."

Risk

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

PEC = 0,0011 microg/L

PNEC = Lowest NOEC, 0.29 microg/L/100 (bAssessment Factor (AF) for 1 chronic study) = 0.0029 microg/L

PEC/PNEC = 0.379 which gives the risk low.

Fass environmental information

Fass environmental information for Avamys (fluticasone furoate) (downloaded 2019-01-16)

Hazard

Persistence: "Inherent degradability: 0% degradation in 28 days (OECD 302C). Soil Metabolism: 3% degradation in 64 days (OECD 304). Fluticasone furoate is not readily degradable or inherently degradable but it is slowly degraded in soil. The phrase “fluticasone furoate is potentially persistent” is thus chosen."

Bioaccumulation: Log Kow = 2.61 at pH 7 (OECD 117).

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

Risk

PEC/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 = 0,000686 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".

Author: Health and Medical Care Administration, Region Stockholm