Miljöpåverkan
Ganirelix
Miljörisk:
Risk för miljöpåverkan av ganirelix kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att ganirelix är persistent, då data saknas.
Bioackumulering:
Ganirelix 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 = 0.000004 μg/L
Where:
A = 0.0292 kg (Total sold amount of 0.0227 ganirelixacetat and 0.0065 ganirelix in Sweden year 2023, data from IQVIA).
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 ganirelix 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.
Degradation
The potential for persistence of ganirelix cannot be excluded, due to lack of data.
Bioaccumulation
ACD/LogD (pH 7.4) = 0.33 (Ref II). Predicted data, method unknown.
Since log Dow < 4 at pH 7, the substance has low potential for bioaccumulation.
References
I. 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
II. Royal Society of Chemistry. Chemspider.