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 = 0.0044 µg/L

Where:

A = 28,8875 kg (total sold amount API in Sweden year 2019, data from IQVIA/LIF)

(28,87359 kg (adrenaline tartrate) + 0,01392 kg (adrenalin)). (Ref. 1)

R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation).

P = number of inhabitants in Sweden = 9 * 10⁶

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

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

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Fish (fathead minnow) (method unknown). (Ref. 3)

NOEC 7 days (development) = 50 mg/L

Fish (fathead minnow) (method unknown). (Ref. 3)

LOEC 7 days (development) = 100 mg/L

Other ecotoxicity data:

PNEC = 0,5 mg/L = 500 µg/L where 100 is the assessment factor used. (Ref. 4)

Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC ratio = 0.0044 µg/L / 500 µg/L < 0,01

Summary phrase:

Use of adrenaline tartrate has been considered to result in insignificant environmental risk.

Degradation

Abiotic degradation

Hydrolysis

Test in aquatic solutions at pH 9,2 provided a rate constant which corresponds to an aquatic half-life of 36,5 days (method unknown). (Ref. 5)

Summary phrase:

As no other data is available, the following summary phrase is chosen.

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

Bioaccumulation

Partitioning coefficient:

Log P = -2,59 (method unknown). (Ref. 5)

Summary phrase:

Since Log P < 4 the substance has low potential for bioaccumulation

References:

1 Data from IQVIA/LIF – kg consumption – 2019 (försäljningsdata)

2 ECHA, European Chemicals Agency. 2016 Guidance on information requirements and chemical safety assessment. Chapter R.16.

3 United States Environmental Protection Agency (EPA), ecotox knowledge database. Search on CAS: 51-43-4 https://cfpub.epa.gov/ecotox/search.cfm

4 ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. Chapter R.10. https://echa.europa.eu/documents/10162/17224/information_requirements_r10_en.pdf/bb902be7-a503-4ab7-9036-d866b8ddce69

5 Hazardous Substances Data Bank (HSDB). Hazardous Substance Data Bank number: 4289. https://pubchem.ncbi.nlm.nih.gov/source/hsdb/4289