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Miljöinformation

Miljöpåverkan

Miljöinformationen för sevofluran är framtagen av företaget AbbVie för Sevorane®

Miljörisk: Användning av sevofluran har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Sevofluran är potentiellt persistent.
Bioackumulering: Sevofluran har låg potential att bioackumuleras.


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Detaljerad miljöinformation


Environmental Risk Classification


Predicted Environmental Concentration (PEC)


PEC is calculated according to the following formula:

PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100)

PEC (μg/L) = (8853.96 *109*(100-0))/(365*9*106*200*10*100)

PEC = 1.35 μg/L

Where:

A = 8853.96 kg (total sold amount API in Sweden year 2018, data from IQVIA) (Ref. 1)

R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9*106 

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. 2)

D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Ref. 2)

(Note: the factor 109 converts the quantity used from kg to μg).


Ecotoxicological studies with Sevoflurane


Algae (Pseudokirchneriella subcapitata), (OECD 201) (Ref. 3)

EC50 (72h) for cell density > 100 mg/L

EC50 (72h) for biomass > 100 mg/L

EC50 (72h) for growth rate > 100 mg/L


NOAEC (72h) for cell density = 25mg/L

NOAEC (72h) for biomass = 50 mg/L

NOAEC (72h) for growth rate = 25 mg/L


Crustacean (Daphnia magna): Acute toxicity (OECD 202) (Ref. 4)

EC50 (48h) for immobility = 48 mg/L

NOEC for immobility = 13 mg/L


Fish (Pimephales promelas): Acute toxicity (OECD 203) (Ref. 5)

LC50 (96h) for mortality = 43 mg/L

NOEC (96h) for mortality = 13 mg/L


Predicted No Effect Concentration (PNEC)


PNEC (μg/L) = lowest EC50/AF

AF = Assessment Factor= 1,000


The EC50 for the fathead minnow (Pimephales promelas) has been used for this calculation since it is the most sensitive of the three tested species (algae, crustacean, fish).


EC50 = 43 mg/L = 43,000 μg/L

PNEC (μg/L) = 43,000 / 1000

PNEC = 43 μg/L


Environmental Risk classification (PEC/PNEC ratio)


PEC = 1.35 μg/L

PNEC = 43 μg/L


PEC/PNEC = 1.35/43


PEC/PNEC = 0.03


PEC/PNEC ≤ 0.1 which justifies the phrase “Use of Sevoflurane has been considered to result in insignificant environmental risk.”


Degradation


Ready degradability (OECD 301D) (Ref. 6)

4.4% degradation in 28 days


Sevoflurane is potentially persistent.


Bioaccumulation


Partitioning coefficient: (Ref. 7)

Log Kow = 1.75 (KOWWIN v1.67 estimate)

Log D (pH 7.4) = 2.22 (estimated)


Bioaccumulation Estimates from Log Kow (BCFWIN v2.17): (Ref. 7)

BCF = 4.424 (based on Log Kow 1.75, estimated)


Since the Log Kow and Log D values are <4 and the BCF value is <500, it can be concluded that the phrase “Sevoflurane has low potential for bioaccumulation” is justified.


References


  • IQVIA. 2018. IQVIA / LIF - kg consumption/2018.


  • Committee for Medicinal Products for Human Use (European Medicines Agency). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00), 01 June 2006.


  • Claude MB & Krueger HO, 2008a. Sevoflurane: A 72-hour toxicity screening test with the freshwater alga (Pseudokirchneriella subcapitata). Wildlife International, Ltd, Easton, Maryland, project number 161A-108.


  • Claude MB & Krueger HO, 2008b. Ultane Sevoflurance: A 48-hour static acute toxicity screening test with the Cladoceran (Daphnia magna). Wildlife International, Ltd, Easton, Maryland, project number 161A-109.


  • Claude MB & Krueger HO, 2008c. Ultane Sevoflurance: A 96-hour static acute toxicity screening test with the fathead minnow (Pimephales promelas). Wildlife International, Ltd, Easton, Maryland, project number 161A-110.


  • Matthews ME & Schaefer EC, 2008. Sevoflurane: Closed Bottle Test, Wildlife International, Ltd, Easton, Maryland, project number 161E-104.


  • ChemSpider. 2020. Sevoflurane. Available URL: http://www.chemspider.com/Chemical-Structure.5017.html?rid=feac3c6e-bfa9-4f76-9345-dbc0d751432b. Accessed 9 March 2020.