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Propofol

Summary

The data on hazard and risk are based on previous environmental information on fass.se (2011-05-24). Environmental information is missing on fass.se (2021-12-08). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Persistence. Propofol is potentially persistent.
Bioaccumulation. No significant bioaccumulation potential.
Toxicity. Propofol has moderate chronic toxicity.
Risk. The use of propofol (sales data Sweden 2009) has been considered to result in low environmental risk.

Detailed information

Assessment report

Assessment report for Diprivan (propofol) from AstraZeneca (downloaded 2011-05-24).

Hazard

Persistence OECD guideline 301F: "The results showed that propofol is not biodegradable, with <5% biodegradation after 28 days. However, >91% removal of propofol from the aqueous phase was observed, which was noted at the time as being possibly due to adsorption to the solid phase.

ISO Guideline 11734: The results showed that propofol was not biodegradable under the anaerobic conditions of the test, although a degree of elimination was observed.

The medicine is potentially persistent."

Bioaccumulation: Log P = 3.9 (at pH 8). BCF 28 D = 27 (at 2 μg/L) and 28 D = 26 (at 0.2 μg/L). [...] Bioconcentration factor (BCF) 28 D = 27 (at 2 µg/L). Bioconcentration factor (BCF) 28 D = 26 (at 0.2 µg/L) These values are well below the trigger value for PBT testing of 2000. Therefore the statement ‘No significant bioaccumulation potential’ is used.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) NOEC chronic toxicity 230 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2009. PEC/PNEC = 0,16 which gives the risk low.

"Chronic studies have been performed at two trophic levels, ie algae and Daphnia magna, the latter being the most sensitive of these species. This would give an assessment factor of 50. However, there is no acute data for the Daphnia magna or algae trophic levels, so no comparison to the fish acute data can be made to determine which is actually the most sensitive species Therefore, the PNECsurface water will be based on the most sensitive fish species as a worst-case assumption; rainbow trout 96h LC50 of 0.37 mg/L."

Report "Läkemedelsrester i Stockholms vattenmiljö"

Propofol is listed as readily biodegradable.

Author: Health and Medical Care Administration, Region Stockholm