Detaljerad miljöinformation

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 = 0.000005393 µg/L

Where:

A = total actual API sales in Sweden for the most recent year 0.03936 kg (total sold amount API in the most recent sales data for Sweden (2022) was distributed by IQVIA in 2023)

R = 0

P = number of inhabitants in Sweden = 10 *10⁶

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference I)

D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Reference I)

According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of Decitabine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.

Background information:

For decitabine no environmental fate and effect studies are available.

The reason for this is that in Phase I of the ERA, according to EMA guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (CHMP/SWP/4447/00), the calculated PEC was far below 0.01 µg/L and therefore no further Phase II testing was triggered.

Decitabine is a low volume API, with very limited environmental exposure.

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae:

Not available

Crustacean:

Acute toxicity

Not available

Chronic toxicity

Not available

Fish:

Acute toxicity

No data available

Chronic toxicity

No data available

Other ecotoxicity data:

Not available

Environmental risk classification (PEC/PNEC ratio)

Not available

Degradation

Biotic degradation

Not available

Conclusion for degradation:

The potential for persistence of Decitabine cannot be excluded, due to lack of data.

Abiotic degradation

Hydrolysis: -

Photolysis: -

Bioaccumulation

Partition coefficient octanol/water:

The partition coefficient octanol/water was found by using ChemSpider. [Reference II]

Log D = -2

pH: 7.4

Method: predicted data generated using ACD/Labs

Bioconcentration factor (BCF):

The bioconcentration factor was found by using ChemSpider. [Reference II]

BCF = 1

pH: 7.4

Method: predicted data generated using ACD/Labs

Conclusion for bioaccumulation: Decitabine has low potential for bioaccumulation.

Excretion (metabolism)

-

PBT/vPvB assessment

-

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. ChemSpider, LN01254469, data is provided by WuXi LabNetwork (http://www.chemspider.com/Chemical-Structure.397844.html?rid=02568784-dbf7-43ad-a463-3c9a31763b94)