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 µg/L

Where:

A = 0 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 of dilution of waste water 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 gemeprost is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

No ecotoxicological test results are available.

Environmental risk classification (PEC/PNEC ratio)

The PEC/PNEC ratio could not be determined since no ecotoxicological test results are available.

Justification of chosen summary phrases for the environmental risk:

Risk of environmental impact of gemeprost cannot be excluded, since no ecotoxicity data are available.

Degradation

No data available.

Justification of chosen degradation phrase:
The potential for persistence of gemeprost cannot be excluded, due to lack of data.

Bioaccumulation
Partitioning coefficient:

log P = 4.02; 4.71 (predicted (ALOGPS; ChemAxon, respectively)
(Ref. II)

Justification of chosen bioaccumulation phrase:
Since log P > 4, gemeprost has high potential for bioaccumulation.

Excretion (metabolism)
The main metabolite of gemeprost is de-esterified gemeprost. Between 12 % and 28 % of the vaginal dose is eventually absorbed into the circulation, and 50 % of this is excreted in the urine. The unabsorbed dose is largely recovered from the genital area, either washed out in the urine or from pads used to absorb postoperative blood loss.
(Ref. III)

References

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

2. Gemeprost at Drug Bank, retrieved 2021-12-10 from Drug Bank.com; find here.

3. SmPC of Cervagem 1 mg Pessary, retrieved 2021-12-10 from medicines.org.uk; find here.