Miljöpåverkan
Avakopan
Miljörisk:
Risk för miljöpåverkan av avakopan kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att avakopan är persistent, då data saknas.
Bioackumulering:
Avakopan har hög potential att bioackumuleras.
Läs mer
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 = 0.0006 μg/L
Where:
A = 4.38 kg (forecasted sales five years after launch).
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) (Ref I)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref I)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of Avakopan is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) at the time of registration was below the action limit 0.01 μg/L.
Bioaccumulation
ACD/LogD (pH 7.4) = 6.45 (Ref II). Predicted data, method unknown.
Since log Dow > 4 at pH 7, the substance has high potential for bioaccumulation.
References
-
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
-
Royal Society of Chemistry, Chemspider.com.
https://www.chemspider.com/Chemical-Structure.52083514.html