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) = 0.0000000406 μg/L

Where:

A = 0.000297 kg (total sold amount API in Sweden year 2023, data from IQVIA / LIF)

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 = 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 (waterflea, Daphnia magna):

Acute toxicity

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

The available ecotoxicological data is insuffient to derive the PNEC.

Environmental risk classification (PEC/PNEC ratio)

The risk quotient may not be calculated as a PNEC could not be derived.

Justification of chosen environmental risk phrase:

The lack of data to calculate the PEC/PNEC ratio qualifies for the phrase “Risk of environmental impact of Iloprost trometamol cannot be excluded, since no ecotoxicity data are 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:

The lack of data 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:

As the log D_ow was < 4 Iloprost trometamol is not considered bioaccumulative, which qualifies for the phrase “Iloprost trometamol has 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