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) = 1,5*10^-6*A(100-R)

PEC = 0.0060 μg/L

Where:

A = 40.08 kg (total sold amount API of morphine hydrochloride (trihydrate) and morphine sulfate (pentahydrate) in Sweden year 2020, data from IQVIA) (Ref. 1)

R = removal rate = 0% (no data available)

P = number of inhabitants in Sweden = 10*10⁶

V (L/day) = volume of waste water per capita and day = 200 (ECHA default) (Ref. 2)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 2)

Ecotoxicology

No ecotoxicological data available.

Degradation

No degradation data available

Bioaccumulation

An experimentally derived Log P_ow of 0.89 (unknown method) (Ref. 3) indicates that morphine has a low potential for bioaccumulation.

Log P_ow < 4 which justifies use of the phrase “Morphine has low potential for bioaccumulation”.

Excretion (metabolism)

Elimination of morphine occurs mainly through glucuronidation, and excretion of unchanged morphine in urine constitutes <0.1%. Morphine-6-glucoronide is excreted via urine, which means that morphine-6-glucoronide may accumulate in case of impaired renal function. Impaired hepatic and renal function affects elimination of the substance. (Ref. 4)

References:

1. Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2021 (data 2020)”.

2. ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011

3. Avdeef A., et al. (1996), ChemID+, US National Library of Medicine, National Institutes of Health

4. SPC (Summary of Product Characteristics) Morfin Meda, 2018-11-02, FASS.se.