Hazard 4 P 3 B 0 T 1 Risk See below
The T-value in the score for hazard refers to acute toxicity. Underlying data for P, B anda T are from Fass (Lipitor downloaded 2011-04-14).
Fass environmental information for Lipitor (atorvastatin) from Pfizer (downloaded 2011-04-14).
Persistence: The substance degrades slowly in the environment
Bioaccumulation: OECD 107: pH 4.0 = 3.18 and pH 7.4 = 1.42.
Toxicity: There are data for 3 trophic levels, most sensitive algae 24 mg/L.
PEC/PNEC is based on sales data in Sweden in year 2004. PEC/PNEC = 0.0036 which gives the risk insignificant.
Fass environmental information for Atorvastatin Actavis from Teva (downloaded 2019-10-30).
Persistence: No data.
Bioaccumulation: No data.
Toxicity: No data.
Risk of environmental impact of atorvastatin cannot be excluded, since no ecotoxicity data are available.
Sales in Region Stockholm have increased in recent years, but measurements during the same period have shown that there is a good margin between environmental levels and the concentration that gives environmental impact.
Comparative assessment of environmental risk when using simvastatin, atorvastatin, rosuvastatin, pravastatin and ezetimibe from a Swedish perspective.
Although there are knowledge gaps in particular regarding relevant toxicity studies, there is no obvious environmental risk with any of the investigated substances in Swedish water given the current state of knowledge. No exchanges are therefore recommended from an environmental point of view. The risk seems entirely insignificant for the highly water-soluble substance rosuvastatin. More fat-soluble statins (simvastatin, atorvastatin) may be quite potent and (together with ezetimibe) represent a slightly higher risk than the others, but the levels in the environment are probably well below the concentrations that give rise to effects. However, more impact studies are needed. For ezetimibe and pravastatin, efficacy data are even more deficient. For pravastatin, however, the risk was assessed based on its relatively low fat solubility (and thus the ability to accumulate in biota) in relation to its potency in humans. Ezetimibe is more fat-soluble, but at least partially separated in the wastewater treatment plants, how much is unclear due to high detection limits. Based on measured bioconcentration potential, there is some, but low risk for this substance.
Author: Health and Medical Care Administration, Region Stockholm