Propofol

Detaljerad information

Fass miljöinformation för Diprivan

Fass miljöinformation för Diprivan (propofol) från Aspen Nordic (hämtad 2024-01-19).

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Persistens 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."

Bioackumulation: "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."

Akut toxicitet: Finns data för 3 trofinivåer, lägst för fisk (rainbow trout) 96h LC₅₀ = 0,37 mg/L.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2021. PEC/PNEC = 0,14 vilket ger risken låg.

"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 miljöinformation för Propolipid

Fass miljöinformation för Propolipid (propofol) från Fresenius Kabi (hämtad 2024-01-19).

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Persistens: "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"."

Bioackumulation: LogP = 3,79.

Akut toxicitet: Finns data för 3 trofinivåer, lägst för fisk (rainbow trout) 96h LC₅₀ = 0,37 mg/L.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2021. PEC/PNEC = 0,146 vilket ger risken låg.

Rappporten Läkemedelsrester i Stockholms vattenmiljö

Propofol anges som lättnedbrytbart.