Miljöpåverkan
Dinoproston
Miljörisk:
Risk för miljöpåverkan av dinoproston kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att dinoproston är persistent, då data saknas.
Bioackumulering:
Dinoproston har låg potential att bioackumuleras.
Läs mer
Detaljerad miljöinformation
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of dinoproston is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.
PEC = 0,0000025893 μg/L
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)
Where:
A = 0,0189 kg (total sold amount API in Sweden year 2023, data from IQVIA).
R = X % 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) (Ref. 1)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 1)
Degradation
No degradation data available.
Bioaccumulation
In a study by Avdeef et. al, the pH dependent octanol water partition behavior of prostaglandings (Pg) E1 and E2 was studied by an automated potentiometric titration method (Ref. 2).
The log P value for dinoprostone (also known as prostaglandin E2) was determined to be 2.90 (Ref. 2).
Since Log P is below 4, dinoprostone 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. Avdeef A, Box KJ, Takács-Novák K. pH-metric log P. 6. Effects of sodium, potassium, and N-CH3-D-glucamine on the octanol-water partitioning of prostaglandins E1 and E2. J Pharm Sci. 1995 May;84(5):523-9. doi: 10.1002/jps.2600840502. PMID: 7658338.jj