Miljöpåverkan
Olodaterol
Miljörisk:
Risk för miljöpåverkan av olodaterol kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att olodaterol är persistent, då data saknas.
Bioackumulering:
Olodaterol 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) = 7*10-9 µg/L
Where:
A = 0.00005 kg olodaterol hydrochloride (total sold amount API in Sweden year 2020, data from IQVIA/LIF).
R = 0 % removal rate.
P = number of inhabitants in Sweden = 10 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (I)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (I)
Justification of chosen environmental risk phrase:
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of Olodaterol is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01µg/L. However as there is no ecotoxicity data the conclusion is: risk of environmental impact of Olodaterol cannot be excluded, since no ecotoxicity data are available.
Bioaccumulation
Partitioning coefficient
Log Dow = 1.2 at pH 7.4, and 2.5 at pH 9 (OECD 107). (II)
Justification of chosen bioaccumulation phrase:
Since Log Dow < 4 at pH 7, Olodaterol has low potential for bioaccumulation.
Degradation
No studies regarding degradation of Olodaterol hydrochloride are available. The low PEC and Log Dow values did not warrant such investigations.
Justification of chosen degradation phrase:
Since no data are available, the potential for persistence of Olodaterol cannot be excluded, due to lack of data.
Excretion (metabolism)
Olodaterol is excreted to 42.6% as parent compound after intravenous administration; to 60.3% as parent compound after oral administration and to more than 20% as the metabolite desmethyl-olodaterol. The pharmacological activity of the metabolites is not known. (II)
References
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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
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Boehringer Ingelheim GmbH internal report (U11-2156-02), 2012