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Ilomedin®

Miljöinformation
Receptstatus
Förmånsstatus
Bayer

Koncentrat till infusionsvätska, lösning 20 mikrog/ml
(Lösningen är klar och fri från partiklar.)

Antikoagulantia

Aktiv substans:
ATC-kod: B01AC11
Utbytbarhet: Utbytbara läkemedel
Läkemedel från Bayer omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Iloprost

Miljörisk: Risk för miljöpåverkan av iloprost kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Det kan inte uteslutas att iloprost är persistent, då data saknas.
Bioackumulering: Iloprost 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) = 1.37*10-6*A*(100-R)

PEC = 0.0000000548 μg/L


Where:

A = 0.0004 kg (total sold amount API in Sweden year 2021, data from IQVIA/LIF)

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 10 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference I)

D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Reference I)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies*

Crustacean (Daphnia magna)

Acute toxicity

EC50 48 h (immobilization) ≥ 100,000 μg/L (guideline OECD 202) (Reference II)


Justification of chosen environmental risk phrase:

Due to very limited ecotoxicological data a PNEC may not be determined, and a risk quotient may not be derived. This qualifies for the phrase “Risk of environmental impact of iloprost trometamol cannot be excluded, since there is not sufficient ecotoxicity data available.”


Degradation

Biotic degradation

Ready degradability:

The study was conducted with iloprost ß-cyclodextrin clathrate. The biodegradation rate reached 85% at day 28, 60% degradation was reached at day 7. However, the test procedure does not allow a distinction between the degradation of the ß-cyclodextrin clathrate fraction of the molecule and the iloprost fraction. Therefore, the study cannot be clearly interpreted with regard to the degradability of iloprost (guideline OECD 301E). (Reference III)


Justification of chosen degradation phrase:

Biotic degradation of Iloprost trometamol may not be evaluated due to lack of appropriate data, which qualifies for the phrase “The potential for persistence of iloprost trometamol cannot be excluded, due to lack of data”.


Bioaccumulation

Partitioning coefficient:

The log Dow was reported with 1.6 (guideline OECD 107). (Reference IV)


Justification of chosen bioaccumulation phrase: 

Due to the log Dow < 4 iloprost trometamol is considered bioaccumulative which qualifies for the phrase “Iloprost trometamol has a low potential for bioaccumulation”.


References

  1. 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

  2. Acute immobilization test of iloprost clathrate with Daphnia magna. Schering AG, Experimental Toxicology, Report no. A491, Study no. TX92246, 1992

  3. ZK96944 – Ready biodegradability (modified OECD screening test). Schering AG, Experimental Toxicology, Report no. A937, Study no. TX92281, 1992

  4. Determination of the n-octanol/water partition coefficient of (iloprost ZK39374). Schering AG, General Physicochemistry, Report no. LD10, study no. 0804, 1992


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