Miljöpåverkan
Decitabin
Miljörisk:
Användning av decitabin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning:
Det kan inte uteslutas att decitabin är persistent, då data saknas.
Bioackumulering:
Decitabin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
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 = 0.000005393 µg/L
Where:
A = total actual API sales in Sweden for the most recent year 0.03936 kg (total sold amount API in the most recent sales data for Sweden (2022) was distributed by IQVIA in 2023)
R = 0
P = number of inhabitants in Sweden = 10 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference I)
D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Reference I)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of Decitabine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.
Background information:
For decitabine no environmental fate and effect studies are available.
The reason for this is that in Phase I of the ERA, according to EMA guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (CHMP/SWP/4447/00), the calculated PEC was far below 0.01 µg/L and therefore no further Phase II testing was triggered.
Decitabine is a low volume API, with very limited environmental exposure.
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Algae:
Not available
Crustacean:
Acute toxicity
Not available
Chronic toxicity
Not available
Fish:
Acute toxicity
No data available
Chronic toxicity
No data available
Other ecotoxicity data:
Not available
Environmental risk classification (PEC/PNEC ratio)
Not available
Degradation
Biotic degradation
Not available
Conclusion for degradation:
The potential for persistence of Decitabine cannot be excluded, due to lack of data.
Abiotic degradation
Hydrolysis: -
Photolysis: -
Bioaccumulation
Partition coefficient octanol/water:
The partition coefficient octanol/water was found by using ChemSpider. [Reference II]
Log D = -2
pH: 7.4
Method: predicted data generated using ACD/Labs
Bioconcentration factor (BCF):
The bioconcentration factor was found by using ChemSpider. [Reference II]
BCF = 1
pH: 7.4
Method: predicted data generated using ACD/Labs
Conclusion for bioaccumulation: Decitabine has low potential for bioaccumulation.
Excretion (metabolism)
-
PBT/vPvB assessment
-
References
-
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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ChemSpider, LN01254469, data is provided by WuXi LabNetwork (http://www.chemspider.com/Chemical-Structure.397844.html?rid=02568784-dbf7-43ad-a463-3c9a31763b94)