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 = 0.0098 μg/L

Where:

A = 71.3 kg (total amount API of ephedrine hydrochloride and ephedrine sulfate 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)

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 2021 (data 2020)”.

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, 2018-07-18, FASS.se.