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 = 0.0237 μg/L

Where:

A = 173.6 kg (total amount API of ephedrine hydrochloride and ephedrine sulfate in Sweden year 2023, 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)

Ecotoxicological studies

No ecotoxicological data available.

Degradation

No degradation data available.

Bioaccumulation

An experimentally derived log K_ow of 1.13 (unknown method) (Ref. 3) indicates that ephedrine has low potential for bioaccumulation.

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

Excretion (metabolism)

During 24 hours, 55-75% is excreted as the unchanged substance through urine. The metabolism takes place mainly in the liver through N-demethylation to the main metabolite norephedrine -phenylpropanolamine, which is pharmacologically active with central stimulant properties. (Ref. 4)

References:

1. Data from IQVIA ”Consumption assessment in kg for input to environmental classification v1 - updated 2024 (data 2023)”.

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

3. Avdeef, A (1997), ChemID+, US National Library of Medicin.

4. SPC (Summary of Product Characteristics) Lepheton, 2024-02-19, FASS.se.

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 = 0.032 μg/L

Where:

A = 231.54 kg (total amount API of ethylmorphine hydrochloride in Sweden year 2023, 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)

Ecotoxicological studies

No ecotoxicological data available.

Degradation

No degradation data available.

Bioaccumulation

An estimated Log P of 1.77 (Ref. 3) indicates that ethylmorphine has low potential for bioaccumulation.

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

Excretion (metabolism)

Ethylmorphine is metabolised through N-demethylation to norethylmorphine and through O-deethylation to morphine, reactions catalysed by different forms of cytochrome P450 (CYP 2D6 and CYP 3A4).

Ethylmorphine and its metabolites are mainly excreted via the kidneys as conjugates with glucoronic acid. After 48 hours, about 70% of a given dose was found in the urine. (Ref. 4)

References:

1. Data from IQVIA ”Consumption assessment in kg for input to environmental classification v1 - updated 2024 (data 2023)”.

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

3. Meylan WM and Howard PH (1995), ChemID+, US National Library of Medicin, National Institutes of Health.

4. SPC (Summary of Product Characteristics) Cocillana-Etyfin, 2023-12-08, FASS.se