Miljöpåverkan
Miljöinformationen för ciklopirox är framtagen av företaget Almirall för Onytec
Miljörisk:
Risk för miljöpåverkan av ciklopirox kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Det kan inte uteslutas att ciklopirox är persistent, då data saknas.
Bioackumulering:
Ciklopirox 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 = 0.000597 μg/L
Where:
A = 4,3549 kg (total sold amount API in Sweden year 2023, data from IQVIA).
R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.
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 waste water by surface water flow = 10 (ECHA default) (Ref. I)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
No data is available.
Environmental risk classification (PEC/PNEC ratio)
It is not possible to calculate the environmental risk classification (PEC/PNEC ratio) due to lack of data.
Summary phrases for the environmental risk:
Risk of environmental impact of ciclopirox cannot be excluded, since no ecotoxicity data are available.
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of ciclopirox is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit of 0.01 μg/L.
Degradation
No degradation data is available.
Summary phrases for degradation:
The potential for persistence of ciclopirox cannot be excluded, due to lack of data.
Bioaccumulation
Partitioning coefficient:
LogP = 2.3 (experimental data, pH unknown, method unknown)
LogP = 2.15 (predicted data, pH unknown (source ALOGPS)),
LogP = 2.22 (predicted data, pH unknown (source Chemaxon))
(Ref. II)
Justification of chosen bioaccumulation phrase:
Since LogP < 4, ciclopirox has low potential for bioaccumulation.
Excretion (metabolism)
Glucuronidation is the main metabolic pathway of ciclopirox.
Most of the compound is excreted either unchanged or as glucuronide. After oral administration of 10 mg of radiolabeled drug (14C-ciclopirox) to healthy volunteers, approximately 96 % of the radioactivity was excreted renally within 12 hours of administration. Ninety-four percent of the renally excreted radioactivity was in the form of glucuronides.
(Ref. II)
A very small amount of ciclopirox is absorbed systemically (< 2 % of applied dose).
(Ref. III)
References