Propofol

Detailed information

Fass environmental information for Diprivan

Fass environmental information for Diprivan (propofol) from Aspen Nordic (downloaded 2024-01-19).

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.

Based on the information that propofol is not readily biodegradable (no other studies are available) the statement ”propofol is potentially persistent” has been assigned."

Bioaccumulation: Log P = 3.9. [...] 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 triggerof 500, therefore the statement “propofol has low potential for bioaccumulation” has been assigned.

Acute toxicity: There are data for 3 trophic levels, most sensitive fish (rainbow trout) 96h LC₅₀ = 0.37 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2009. PEC/PNEC = 0.14 which gives the risk low.

"Chronic studies have been performed at two trophic levels, ie algae and Daphna magna, the latter being the most sensitive of these species. However, the most sensitive acute data are for fish. Therefore, the PNEC is based on the most sensitive fish species as a worst case assumption; rainbow trout 96h LC₅₀ of 0.37 mg/L. Since short term effects data are available for species from three trophic levels, an assessment factor of 1000 is used to calculate the PNEC. This is in accordance with ECHA guidance."

Fass environmental information for Propolipid

Fass environmental information for Propolipid (propofol) from Fresenius Kabi (downloaded 2024-01-19).

Hazard

Persistence:"Biodegradation. Aerobic biodegradation (OECD 301F) ...: Degradation after 28 days = 2,8. Not readily biodegradable. % removal from aqueous phase after 28 days = 91.1%. Anaerobic Biodegradation (UK DoE Method,Modified according to ISO 11734). % anaerobic biodegradation after 40 days = 0%. % carbon removal from aqueous phase after 40 days = 27%. According to the above results, Propofol is not readily biodegradable and is not expected to undergo significant biodegradation under aerobic or anaerobic conditions. Justification of chosen degradation phrase: Based on the data presented above, the phrase,"Propofol is potentially persistent"."

Bioaccumulation: LogP = 3.79.

Acute toxicity: There are data for 3 trophic levels, most sensitive fish (rainbow trout) 96h LC₅₀ = 0.37 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0.146 which gives the risk low.

Report "Läkemedelsrester i Stockholms vattenmiljö"

Propofol is listed as readily biodegradable.