Miljöpåverkan
Trientin
Miljörisk:
Risk för miljöpåverkan av trientin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att trientin är persistent, då data saknas.
Bioackumulering:
Det kan inte uteslutas att trientin kan bioackumuleras, då data saknas.
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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 = 6,3*10-4 μg/L
A 4.61 kg (total sold amount of trientine dihydrochloride and trientine tetrahydrochloride in Sweden year 2020, 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.I)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref.I)
Predicted No Effect Concentration (PNEC)
The risk of environmental impact of trientine tetrahydrochloride cannot be excluded, since no ecotoxicity data are available.
Degradation
The potential for persistence of trientine tetrahydrochloride cannot be excluded, due to lack of data.
Bioaccumulation
During the Phase I of the Environmental Risk Assessment (ERA), PBT screening regarding potential log Kow for trientine tetrahydrochloride was calculated to -1.4 and -2.65, but no experimentally value has ever been reported. Trientine tetrahydrochloride has 4 ionisable groups and is reported as completely miscible in water. With this in mind, the substance should not be expected to have a log Kow > 4. However, since there is no experimentally value for trientine tetrahydrochloride this justifies the assigned phrase “The potential for bioaccumulation of trientine tetrahydrochloride cannot be excluded, due to lack of data.” (Ref. II)
References
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ECHA, European Chemicals Agency.
October 2012 Version: 2.1 Guidance on information requirements and chemical safety assessment.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
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EMA, European Medicines Agency. CHMP assessment report for Cuprior, 21 April 2017.