Miljöpåverkan
Bromokriptin
Miljörisk:
Risk för miljöpåverkan av bromokriptin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att bromokriptin är persistent, då data saknas.
Bioackumulering:
Bromokriptin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Detailed background information
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 = 1,29*10-4 μg/L
Where:
A = 0.9397 kg (total amount API of bromocriptine mesilate in Sweden year 2023, data from IQVIA) (Ref. 1)
R = removal rate = 0% (no data available)
P = number of inhabitants in Sweden = 10*106
V (L/day) = volume of waste water per capita and day = 200 (ECHA default) (Ref. 2)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 2)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of bromocriptine 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.
Ecotoxicological studies
No ecotoxicological data available.
Degradation
No degradation data available.
Bioaccumulation
A computed Log P of 3.8 (XLogP3) (Ref. 3) indicates that bromocriptine has low potential for bioaccumulation.
Log P < 4 which justifies the phrase “Bromocriptine has low potential for bioaccumulation”.
References:
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Data from IQVIA “Consumption assessment in kg for input to environmental classification” – updated 2024 (data 2023)
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ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011.http://echa.europa.eu/documents/10162/13643/information_requirements_r2_en.pdf
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U.S. National Library of Medicine, National Center for Biotechnology Information. PubChem Compound Database; CID=31101, http://pubchem.ncbi.nlm.nih.gov/compound/31101