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Lurasidone

CATEGORIES


ALIASES

Latuda, Lurasidone


SUBSTANCES

lurasidone, lurasidone hydrochloride


ENVIRONMENTAL CONCERN: MODERATE
Lurasidone is an atypical antipsychotic developed by Dainippon Sumitomo Pharma. It was approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia on October 29, 2010 and is currently pending approval for the treatment of bipolar disorder in the United States. (Wikipedia)

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

Below is Hazard and Risk according to data from the assessment report for Latuda (lurasidon), 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."

REFERENCES

  1. European Medicines Agency. European public assessment reports (EPAR).