Dronedaron

Fass miljöinformation

Fass miljöinformation för Multaq (dronedaron) (hämtad 2018-07-12).

Fara

Persistens: "Ready biodegradation: Test showed < 25% degradation in 28 days (OECD 301B). Inherent degradability: Test showed 22.8% degradation in 29 days (OECD 302B). Hydrolysis: Test showed 1.6% degradation in 5 days (OECD 111)."

Bioackumulation: Log Pow = 4,63 vid pH 7 (OECD 107). "Whole fish steady state total radioactive residue (TRR) BCF of 466 and a steady state dronedarone BCF of 134 at the highest test concentration of 11 μg/L. Normalized to 6% body fat, this results in a whole fish TRR BCF of 730 and a Dronedarone BCF of 210. (OECD 305)."

Kronisk toxicitet: Finns NOEC för 3 trofinivåer, lägst NOEC för alg (Pseudokirchneriella subcapitata) 4 mikrog/L.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2015. PEC/PNEC = 0,4 vilket ger risken låg.

Assessment report

Assessment report för Multaq, Procedure No. EMEA/H/C/001043 (2009-12-16)
"With respect to the environmental risk assessment, the following conclusions have been drawn: DRO is neither PBT nor vPvB, risk to the microorganisms in a sewage treatment plants, risk to the aquatic compartment, the groundwater compartment and the terrestrial is considered to be negligible. In order to complete the environmental risk assessment, it has been agreed that further studies, i.e. OECD 307 and OECD 308 will be performed as well as recalculation of the kinetic BCF OECD 305 fish BCF study. It has been agreed that these data will provided as a follow-up measures (FUM1 – 3)." Ingen senare information har återfunnits vid sökning på EMAs webbplats 2018-07-12.