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Tadalafil

Hazard 4 P 3 B 0 T 1 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T are from assessment report.

Assessment report

Assessment report for Tadalafil Lilly 26 January 2017 EMA/CHMP/23344/2017.

Hazard

Persistence according to OECD 302A: "Not readily Biodegradable. < 10% evolution of radiolabeled carbon over 28 days when 14C-tadalafil was incubated with a concentrated inoculum of sewage sludge microorganisms."

Bioaccumulation: Log Kow = 2.32.

Chronic toxicity: There are data for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) 300 microg/L.

Risk

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

PEC = 0.325 microg/L.

PNEC= Lowest NOEC, 300 microg/L/10 (Assessment Factor (AF) for 3 chronic studies)= 30 microg/L.

PEC/PNEC = 0.0108 which gives the risk insignificant.

Fass environmental information

Fass environmental information for Adcirca (tadalafil) (downloaded 2018-10-11).

Hazard

Persistence: "Tadalafil disappeared from water sediment systems with half-lives of 70 and 117 days and there was evidence of biotransformation and mineralization. Therefore, the degradation phrase “Tadalafil is slowly degraded in the environment” is based on the fate in water-sediment systems."

Bioaccumulation: Log Kow = 2.32.

Chronic toxicity: There are data for 3 trophic levels, lowest NOEC for crustacean (Daphnia magna) 480 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.00006 which gives the risk insignificant.

Author: The Pharmaceutical unit of Region Stockholm