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Prucalopride

Hazard 4 P 3 B 0 T 1 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity.

Assessment report

Assessment report for Resolor (prucalopride) 23 April 2015, EMA/CHMP/772340/2014 - adopted.

Hazard

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.

Risk

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

Fass environmental information

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