The T-value in the score for hazard refers to chronic toxicity.
Assessment report for Resolor (prucalopride) 23 April 2015, EMA/CHMP/772340/2014 - adopted.
Persistence: OECD 308: DT50, water = 2.2 days (river), 1.2 days (pond), DT50, sediment = DT50, whole system = 223 days (river), 240 days (pond) % shifting to sediment = 65-69%
Bioaccumulation: log Kow = -0.43 to 2.09 (pH 5 to 9). Conclusion not B.
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for alge, 440 microg/L.
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 0.01 microg/L
PNEC = Lowest NOEC, 440 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 44 microg/L
PEC/PNEC = 0.000 227, i.e. insignificant
Environmental information is missing on fass.se (2018-06-14). It is voluntary for manufacturers to provide information about environmental impact on fass.se.
Author: The Pharmaceutical unit of Region Stockholm