Hazard 6 P 3 B 0 T 3 Risk Low
The T-value in the score for hazard refers to acute/chronic toxicity. Underlying data for P, B, T and risk are from Fass.se.
Fass environmental information
Fass environmental information for Multaq (dronedarone) (downloaded 2018-07-12).
Persistence: "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)."
Bioaccumulation: 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)."
Chronic toxicity: There are data for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) 4 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.4 which gives the risk low.
Assessment report for 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)." No later information has been found when searching the EMA website 2018-07-12.
Author: Health and Medical Care Administration, Region Stockholm