Miljöpåverkan
Rokuronium
Miljörisk:
Risk för miljöpåverkan av rokuronium kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att rokuronium är persistent, då data saknas.
Bioackumulering:
Rokuronium 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 = 0.002 μg/L
Where:
A = 16.91 kg (total sold amount API in Sweden year 2023, data from IQVIA) (Ref. I)
R = 0 % removal rate (worst case assumption)
P = number of inhabitants in Sweden = 10 *10-6
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. II)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. II)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of rocuronium bromide 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.
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
No data available.
Environmental risk classification
Since no data are available the phrase “Risk of environmental impact cannot be excluded for rocuronium bromide since no ecotoxicity data are available” is justified.
Degradation
No data available.
Justification of chosen degradation phrase:
Since no data are available the phrase “The potential for persistence of rocuronium bromide cannot be excluded due to lack of data” is justified.
Bioaccumulation
Partioning coefficient:
Rocuronium Log Dow = -0.4 at pH 7.4 (unknown method) (Ref. III)
Justification of chosen bioaccumulation phrase:
Since the log Dow < 4 at pH 7.4, the the substance has low potential for bioaccumulation.
References
I. Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2024 (data 2023)”.
II. 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
III. Chemspider. https://www.chemspider.com/Chemical-Structure.390053.html.