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Lurasidone

Hazard 8 P 3 B 3 T 2 Risk Low

Information

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

Assessment report

Assessment report for Latuda (lurasidone), 23 January 2014, EMA/113836/2014.

Hazard

Persistence: "DT50 or ready biodegradability = 191 days"

Bioaccumulation: BCF = 2 798–2 585.

Chronic toxicity: There is NOEC for three trophic levels, lowest NOEC for crustacean (Daphnia magna) 26 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC = 0.8 microg/L

PNEC = Lowest NOEC 26 microg/L/10 (Assessment Factor (AF) for three chronic studies) = 2.6 microg/L

PEC/PNEC = 0.308 which gives the risk low.

"In conclusion, lurasidone is not a PBT substance and is not expected to pose a risk to the environment."

Author: Health and Medical Care Administration, Region Stockholm