Miljöpåverkan (Läs mer om 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) = 1.5*10-6*A(100-R)
Where:
A = 0.0005 kg (total sold amount API in Sweden year 2018, data from IQVIA 2018).
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 waste water per capita and day = 200 (ECHA default)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default)
PEC = 0,00000001 μg/L
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Crustacean (waterflea Daphnia magna):
Acute toxicity
EC50 /48 h (immobilization) = >100 mg/L (guideline OECD 202) as iloprost clathrate (1)
Because there is only one study on acute toxicity with Daphnia magna available, it is justified to use the phrase: Risk of environmental impact of iloprost cannot be excluded, since there is not sufficient data available.
Biodegradation
Iloprost clathrate is readily biodegradable; OECD 301E (2). 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.
The potential for persistence of iloprost can therefore not be excluded due to the lack of data.
Bioaccumulation
Octanol/water partition coefficient (logPow): 1.6 determined according to OECD 107 (3).
This justifies the term iloprost has a low potential for bioaccumulation.
Excretion (metabolism)
Iloprost is excreted in a metabolized form, the main metabolite is tetranoriloprost, which is not pharmacologically active.
References
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Acute immobilization test of iloprost clathrate with Daphnia magna. Schering AG, Experimental Toxicology, Report no. A491, Study no. TX92246, 1992
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ZK96944 – Ready biodegradability (modified OECD screening test). Schering AG, Experimental Toxicology, Report no. A937, Study no. TX92281, 1992
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Determination of the n-octanol/water partition coefficient of (iloprost ZK39374). Schering AG, General Physicochemistry, Report no. LD10, study no. 0804, 1992