Miljöpåverkan
Miljöinformationen för levodopa är framtagen av företaget MSD för Sinemet®, Sinemet® Depot, Sinemet® Depot Mite
Miljörisk:
Risk för miljöpåverkan av levodopa kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Levodopa bryts ned i miljön.
Bioackumulering:
Levodopa har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Levodopa
Environmental risk: Risk of environmental impact of Levodopa cannot be excluded, since there is not sufficient ecotoxicity data available.
Degradation: Levodopa is degraded in the environment.
Bioaccumulation: Levodopa has low potential for bioaccumulation
Detailed background information
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) = 1.5*10-6*A(100-R)
PEC = 0.69 μg/L
Where:
A = 4602 (total sold amount API in Sweden year 2019, data from IQVIA) (Ref I.)
R = 0 % removal rate (worst case assumption)
P = number of inhabitants in Sweden = 9 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. II)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. II)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Crustacean, water flea (Daphnia magna) (OECD 202) (Ref. IV):
Acute toxicity
EC50 48 h (immobility) = 16 mg/L
Fish, rainbow trout (Oncorhynchus mykiss) (OECD 203) (Ref. III):
Acute toxicity
LC50 72 h (mortality) > 100 mg/L
Environmental risk classification (PEC/PNEC ratio)
Risk of environmental impact of Levodopa cannot be excluded, since there is not sufficient ecotoxicity data available.
Degradation
Biotic degradation (OECD 301F) (Ref. III)
Biodegradation: 72 %
Exposure time: 28 d
Readily biodegradable
Justification of chosen degradation phrase:
Based on the data presented above, the phrase, “Levodopa is degraded in the environment” is chosen.
Bioaccumulation
Partitioning coefficient (Method unknown) (Ref. V):
Log Kow = -2.39
Justification of chosen bioaccumulation phrase:
Since log Kow < 4 the substance has low potential for bioaccumulation.
References
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2020 (data 2019)”.
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
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Roche, 2020. “Safety Data Sheet for MADOPAR Tablets 50/12.5 mg”, accessed on 2 Dec 2020 via EHS_L_TEXT(CED-U00 (roche.com)
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ICI Brixham, 1988. "LEVODOPA: Determination of the Acute Toxicity to Daphnia Magna." Study No. BL/B/3276, Brixham, UK, 27 May 1988.
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Sangster, J., 1993. “Log Kow Databank”, Sangster Res. Lab. Montreal, Quebec, Canada.