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Dutasterid

Fara 5* P 3 B 0 T 2* Risk Försumbar

Information

T-värdet i faropäng avser kronisk toxicitet. Underliggande data för P, B, T och risk kommer från Fass.

Fass miljöinformation

Fass miljöinformation för Avodart (dutasterid) (hämtad 2019-02-15).

Fara

Persistens: "Biotic degradation. Ready degradability: <1% degradation in 28 days (OECD 301B). Inherent degradability: <2.3% degradation in 64 days (OECD 304). Dutasteride is not readily biodegradable nor inherently biodegradable. The phrase “Dutasteride is potentially persistent” is thus chosen."

Bioackumulation: Log Kow = 3,87 (OECD 117). "Since log Pow < 4, the substance has low potential for bioaccumulation."

Toxicitet: Det finns data för 2 trofinivåer, känsligaste fisk (Juvenile Pimephales promelas) NOEC 21 mikrog/L.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2015. PEC/PNEC = 0,0000238 vilket ger risken försumbar.

"PNEC (μg/L) = lowest NOEC/50, where 50 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). On this basis the NOEC for fish has been used in the calculation. An extended Fish ELS study was conducted to investigate the potential of dutasteride, as a 5-alpha-reductase inhibitor, to indirectly act as an endocrine disruptor. This modified extended fish early life stage toxicity test (OECD 210) examined the dose-effect relationship between aquatic dutasteride concentration and the development of secondary sexual characteristics and effects on gonad development in fish. Appropriate LOEC and NOEC values have been generated. Due to the mode of action of dutasteride and the potential receptor-mediated effects there is a high degree of confidence that the fish is the most sensitive species from the species base set and on that basis there is a strong justification for applying an AF of 50."

Författad vid avdelningen Strategiska vårdgivarfrågor, Region Stockholm

Reviderat datum

2019-02-22

[Helena Ramström 2019-02-15] Finns Fass-info från GSK. Ingen assessment report. Inget i några mätrapporter. Ändrat riskbedömt 2014 till 2015. Ändrat risk "kan inte uteslutas" till "försumbar risk". Ändrat B = 3 till B = 0.