Hazard 3* P 3* B 0 T 0* Risk Cannot be excluded
The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B, T and risk are from assessment report.
Fass environmental information
Fass environmental information for Truberzi (eluxadoline) 21 July 2016, EMA/549473/2016.
Persistence OECD 308: "DT50, water = , DT50, sediment = , DT50, whole system = ,% shifting to sediment = ." Remarks: pending.
Bioaccumulation OECD 107: -0.8 (pH 4), -0.5 (pH 7), -1.4 (pH 9). Conklusion: not B.
Toxicity: There are data for 2 trophic levels, most sensitive crustacean (Daphnia sp.) OECD 211 NOEC 100 000 microg/L.
"PEC surfacewater, default or refined (e.g. prevalence, literature) = 1 microg/L." Conklusion: > 0.01 threshold Y.
"As a result of the above considerations, the available data do not allow to conclude definitively on the potential risk of Eluxadoline to the environment. In the context of the obligation of the MAH to take due account of technical and scientific progress, the CHMP recommends the following points for further investigation: To submit all the relevant Phase II Tier A & Tier B study reports including an updated ERA after completion. Beside a water-sediment study and an adsorption/desorption study, the applicant should provide a new respiration inhibition study according to OECD 209 under consideration of the above mentioned points for improvement. The test substance should be added directly into the test vessels or an analytical estimation of the real test concentration in the test vessels should be performed." No such supplementary environmental information has been found on the EMA's website (2019-02-08). According to contact with the Swedish Medical Products Agency (mail 2019-02-11), the company has submitted an update at the end of January this year and the authority is currently reviewing the material.
Author: Health and Medical Care Administration, Region Stockholm