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Miljöinformation
MSD

Depottablett 50 mg/200 mg
Avregistreringsdatum: 2017-12-15 (Tillhandahålls ej) (Lilaspräcklig, oval tablett, en sida slät, en sida märkt ”521”.)

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Aktiva substanser (i bokstavsordning):
ATC-kod: N04BA02
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan

Levodopa

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

  1. Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2020 (data 2019)”.

  2. 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

  3. 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)

  4. ICI Brixham, 1988. "LEVODOPA: Determination of the Acute Toxicity to Daphnia Magna." Study No. BL/B/3276, Brixham, UK, 27 May 1988.

  5. Sangster, J., 1993. “Log Kow Databank”, Sangster Res. Lab. Montreal, Quebec, Canada.

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