Miljöpåverkan
Isavukonazonium
Miljörisk:
Risk för miljöpåverkan av isavukonazonium kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Isavukonazonium är potentiellt persistent.
Bioackumulering:
Isavukonazonium har låg potential att bioackumuleras.
Läs mer
Detaljerad miljöinformation
Predicted Eniviromental 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)
PEC=0.00048976407 μg/l
A= 3,2650938 (total amount API of isavukonazoniumsulfat in Sweden year 2019, data from IQVIA) (Ref.1)
R=removal rate=0% (no data available)
P=number of inhabitants in Sweden
V (L/day)=volume of wastewater per capita and day=200 (ECHA default) (Ref.2)
D= factor for dilution of wastewater by surface water flow=10 (ECHA default) (Ref.2)
PNEC (Predicted No Effect Concentration)
Data from long-term toxicity tests is shown below:
Algae (Pseudokirchneriella subcapitata)
EC10=0,02 mg/l
NOEC could statistically not be determined. (Ref.3)
Crustacean (Daphnina magna)
NOEC=0,1 mg/ml (Ref.3)
Fish (Pimephales promelas)
NOEC=0,1 mg/ml (Ref.3)
Since there are not sufficient data for the calculation of PEC/PNEC ratio, the phrase “Risk of environmental impact of isavukonazonium cannot be excluded, since there is not sufficient ecotoxicity data available” is used.
Degradation
Isavukonazonium was not readily biodegradable (Ref.3)
The DT50 for aerobic degradation in a water-sediment system was 204 days. This justifies the phrase “The substance is potentially persistent”. (Ref.3)
Bioaccumulation
The logKow was determined to be 3.9 which is below the trigger value of 4. The substance has low potential for bioaccumulation. (Ref.3)
References
1. Sales data in kg from IQVIA 2019
2. Committee for Medicinal Product for Human Use (CHMP) Guideline on the Enviromental Risk Assessment of Medicinal Product for Human Use (EMEA/CHMP/SWP/4447/00, June 2006).
3. Cardinaals JM, Oudhoff KA, Desmares-Koopmans MJE, Migchielsen
MHJ, Artola-Garicano E, Brands C, Urwyler H: BAL8557: Environmental Risk Assessment of BAL4815 (Protocol BAP01368), 2009