Varenicline
Summary
Persistence. Varenicline is slowly degrade in the environment.
Bioaccumulation. Varenicline has low potential for bioaccumulation.
Toxicity. Varenicline has very high chronic toxicity.
Risk. The use of varenicline (sales data Sweden 2020) has been considered to result in nsignificant environmental risk.
This summary information comes from Fass.
Scientific discussion
Scientific discussion for Champix (varenicline) 11/10/2006.
Hazard
Persistence: No data. "Varenicline did not meet the criteria for PBT/PvBv substances."
Bioaccumulation: No data. "Varenicline did not meet the criteria for PBT/PvBv substances."
Chronic toxicity: There is NOEC for 1 trophic level, crustacean (Ceriodaphnia dubia) 0.003 mg/L.
Risk
The risk, PEC/PNEC, is from a European perspective:
PEC = 0.01 microg/L.
PEC/PNEC = 0.03 which gives the risk insignificant.
Fass environmental information
Fass environmental information for Champix (varenicline) from Pfizer (downloaded 2023-03-15).
Hazard
Persistence: As the total system DT50 value (water-sediment transformation simulation, OECD 308) was calculated to <120 days, it corresponds to the degradation phrase ”varenicline is slowly degraded in the environment.
Bioaccumulation: Log Dow vid pH 7 = -0,817. Since log Dow < 4 at 7, varenicline has low potential for bioaccumulation.
Chronic toxicity: There are data for 3 trophic levels, most sensitive crustacean (Ceriodaphnia Dubia) "7-day NOEC of 2.7 microg/L"
Risk
PEC/PNEC is based on sales data in Sweden 2020. PEC/PNEC = 0.00077 which gives the risk insignificant.
Author: Health and Medical Care Administration, Region Stockholm