Miljöpåverkan
ixazomib
Miljörisk:
Risk för miljöpåverkan av ixazomib kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att ixazomib är persistent, då data saknas.
Bioackumulering:
ixazomib 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) = 1,5*10-6*A(100-R)
PEC = 6,69 x 10–7 (μg/L)
Where:
A = 0,0045 kg (total sold amount API in Sweden year 2018, data from IQVIA).
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 = 9 *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)
Predicted No Effect Concentration (PNEC)
Data not available
Environmental risk classification (PEC/PNEC ratio)
Risk of environmental impact of ixazomib cannot be excluded, since there is
not sufficient ecotoxicity data available.
Degradation
Data not available
Bioaccumulation
Partitioning coefficient:
The shake flask method at pH 6.0 was applied for the determination of the partition coefficient (Pow).
The Pow value of the test substance at 20°C was 2.0 x 102.
Log Pow = 2,3 (Ref. 5)
Since log Pow < 4, the substance has low potential for bioaccumulation.
References
1. Committee for Medicinal Products for Human Use (CHMP) Guideline on the
Environmental Risk Assessment of Medicinal Products for Human Use
(EMA/CHMP/SWP/4447/00, June 2006).
2. Committee for Medicinal Products for Human Use (CHMP), 2011. Questions and
answers on ‘Guideline on the environmental risk assessment of medicinal products for human use’ (EMA/CHMP/SWP/44609/2010, 17 March 2011).
3. Ninlaro EPAR
4. Millennium Pharmaceuticals, Inc. Ixazomib Environmental Risk Assessment (ERA).
Information for Phase I ERA, November 2013 (company data).
5. Lammers I., 2014. Determination of the partition coefficient of Ixazomib. WIL
Research Project 503538. Report MLN NCDS-02018. 11 April 2014 (company data).
6. Orphanet version 4.10.2
7. Millennium memorandum 15 Jan 2014 (company data).