Miljöpåverkan
Tibolon
Miljörisk:
Risk för miljöpåverkan av tibolon kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att tibolon är persistent, då data saknas.
Bioackumulering:
Tibolon 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 = 0.00067 μg/L
Where:
A = 4.9405 kg (total sold amount API in Sweden year 2021, data from IQVIA) (Ref. I)
R = 0 % removal rate (worst case assumption)
P = number of inhabitants in Sweden = 10 *106
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)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
No data available
Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC could not be calculated due to lack of ecotoxicity data which justifies the phrase "Risk of environmental impact of tibolone cannot be excluded, since no ecotoxicity data are available."
Degradation
Degradability:
No degradability data are available.
Justification of chosen degradation phrase:
No degradability data are available. The phrase “The potential for persistence of tibolone cannot be excluded, due to lack of data” is thus chosen.
Bioaccumulation
Partitioning coefficient:
Log Kow = 3.93 (KOWWIN v1.67 estimate) (Ref. III)
Justification of chosen bioaccumulation phrase:
Since log Kow < 4, tibolone has low potential for bioaccumulation.
References
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2022 (data 2021)”.
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Environmental classification of pharmaceuticals at www.fass.se
Guidance for pharmaceutical companies 2012 v 3.0
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Tibolone | C21H28O2 | ChemSpider Accessed 25 October 2022