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Varenicline

Hazard 9* P 3 B 3 T 3* Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for T comes from scientific discussion for Champix (varenicline), see below. Underlying data for P, B and risk comes from Fass environmental information for Champix, see below.

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, from the scientific discussion from a European perspective:

PEC = 0.01 microg/L.

PEC/PNEC = 0.03.

Fass environmental information

Fass environmental information for Champix (downloaded 2011-05-27).

Hazard

Persistence: The substance breaks down slowly in the environment.

Bioaccumulation: The substance has the potential to be accumulated in aquatic organisms.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Ceriodaphnia Dubia) "7-day NOEC of 2.7 ug/L"

Risk

PEC/PNEC is based on sales data in Sweden, which year is not stated. PEC/PNEC = 0.007 which gives the risk insignificant.

Author: The Pharmaceutical unit of Region Stockholm