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Bezafibrate

Information

This summary information on toxicity and persistence is based on previous environmental information on fass.se for Bezalip from Actavis (downloaded 2011-04-14). Bioaccumulation and risk come from the report from Goodpoint.

Persistence. Bezafibrate is slowly degraded in the environment.
Bioaccumulation. All fibrates examined are fat soluble with a log P between 3.9 and 5.2. This is likely low enough for some to be found in soluble form in surface water, but at the same time high enough to bioconcentrate effectively.
Toxicity. Bezafibrate has high acute toxicity.
Risk. The use of bezafibrate, fenofibrate and gemfibrozil is not considered to pose an environmental risk.

Detailed information

Fass environmental information for Bezalip (bezafibrate) from Teva (downloaded 2021-04-14)

Hazard

Persistence: No data.

Bioaccumulation: Log P = 3.97.

Toxicity: No data.

Risk

Risk of environmental impact of bezafibrate cannot be excluded, due to the lack of environmental toxicity data.

Fass environmental information for Bezalip from Actavis (downloaded 2011-04-14)

Hazard

Persistence: "Bezafibrate is not readily biodegradable. However, it was removed both in experimental sewage treatment plant models and in actual sewage works, with elimination efficiencies ranging from negative to 100%, with an estimated overall removal of approximately 50%. Elimination in sewage works is primarily dependent on sludge retention time and temperature, both of which suggest biodegradation as the main mechanism. In surface waters, bezafibrate was shown to attenuate rapidly over a river stretch of 1 km, with unquantified adsorption to undissolved solids being noted. Moreover, it was demonstrated to be eliminated during river bank filtration and in groundwater, also in soil. In addition, photodegradation was shown to play a role in the environmental fate. Bezafibrate is not a persistent substance."

Bioaccumulation: "In spite of a comparatively high log Kow of 4.25, bezafibrate has no significant bioaccumulation potential, with a calculated log D at pH 7 of 0.9."

Acute toxicity: There are data for 3 trophic levels, most sensitive fish 6000 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden. It is unclear in what year. PEC/PNEC = 0.0075 which gives the risk insignificant.

Report Goodpoint 2020

Comparative assessment of environmental risk when using the fibrates bezafibrate, fenofibrate and gemfibrozil from a Swedish perspective.

The three fibrates and the active metabolite fenofibratic acid are likely to occur in concentrations of single ng/L in Swedish aquatic environments exposed to treated municipal wastewater. A comparative assessment of the risk of receptor influence via the fish plasma model shows a very low risk for all substances studied. Ecotoxicological studies are extensive for gemfibrozil and scarce for other fibrates. However, many studies are considered to be of low quality and reliability. Available and reliable efficacy data indicate a very low risk for all investigated fibrates.

Recommendation

The use of bezafibrate, fenofibrate and gemfibrozil is not considered to pose an environmental risk. Therefore, no exchanges from an environmental risk point of view are recommended.

Author: Health and Medical Care Administration, Region Stockholm