Detaljerad miljöinformation

Miljörisk

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 * 13.2 * (100-0)

Where:

A = 13.2 kg (total sold amount API in Sweden year 2022, data from IQVIA).

R = % 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 1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref 1)

PEC = 1.8*10^-3 μg/L

According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of folinic acid 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)

No data available so cannot be calculated.

Environmental risk classification (PEC/PNEC ratio)

Cannot be calculated due to unavailable PNEC.

Nedbrytning

No data is available.

Bioackumulering

LogP = -0.46 (Ref 2)

If Log P < 4 at pH 7 the substance has low potential for bioaccumulation.

References

1. 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.

2. Drugbank, 2020-08-03 https://www.drugbank.ca/drugs/DB00650

   (Estimated, ALOGPS)