Miljöpåverkan
Dexrazoxan
Miljörisk:
Risk för miljöpåverkan av dexrazoxan kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att dexrazoxan är persistent, då data saknas.
Bioackumulering:
Dexrazoxan 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 = 0.0000103 μg/L
Where:
A = 0.0750 kg. (Total amount of dexrazoxane hydrochloride sold in Sweden year 2021, data from IQVIA).
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) (Ref. I)
D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Ref. I)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of dexrazoxane 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 ecotoxicological data are available.
Environmental risk classification (PEC/PNEC ratio)
As no ecotoxicological data are available, the PEC/PNEC ratio cannot be calculated. This justifies the phrase "Risk of environmental impact of dexrazoxane cannot be excluded, since no ecotoxicity data are available".
Degradation
No degradation data are available.
Bioaccumulation
Partitioning coefficient:
Log Kow = 0.025. (Ref. II)
Since log Kow < 4 at pH 7, dexrazoxane has low potential for bioaccumulation.
References
I. ECHA 2008, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
II. PDR 2005, Physicians’ Desk Reference. 58th ed. Thomson PDR. Montvale, NJ p. 2771 (2005). As cited on https://pubchemdocs.ncbi.nlm.nih.gov