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 = 0.00021 μg/L

Where:

A = 1.55 kg (total sold amount API in Sweden year 2020, 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: 
Log P_ow = 2.73 (pH unknown, estimated data)
(Ref. II)

Justification of chosen bioaccumulation phrase:
Since Log P_ow < 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. III)

A very small amount of ciclopirox is absorbed systemically (< 2 % of applied dose).
(Ref. IV)

References

1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment; find here

2. ChemIDPlus database, assessed as of March 2022; find here

3. Drug Bank for ciclopirox, assessed as of March 2022; find here

4. SmPC text for Onytec medicated nail lacquer from MPA, assessed as of March 2022; find here