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 = 0.18 μg/L

Where:

A = 1316.36 kg (total sold amount API in Sweden year 2021, data from IQVIA) Based on data total amount of hydrocortison for: hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, hydrocortisone sodium succinate and hydrocortisone sodium phosphate.

R = X % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available. R=0

P = number of inhabitants in Sweden = 10 *10⁶

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

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

Metabolism and excretion

Less than 50% of hydrocortisone is absorbed following rectal administration. In the circulation hydrocortisone occurs extensively bound to plasma proteins, mainly globulin and less to albumin. Only unbound hydrocortisone has pharmacological effects or is metabolized. Hydrocortisone is mainly metabolized by the liver and excreted in the urine (Ref. 2).

Ecotoxicity data 

There is not sufficient ecotoxicity data to calculate PNEC.

Since ecotoxicity data of relevance for the PNEC calculation is not available, the statement “Risk of environmental impact of hydrocortisone cannot be excluded, since no ecotoxicity data are available” is used.

In Swedish: “Risk för miljöpåverkan av hydrokortison kan inte uteslutas då ekotoxikologiska data saknas” under the heading “Miljörisk”.

Environmental risk classification (PEC/PNEC ratio)

Cannot be calculated due to unavailable PNEC.

Biotic degradation

No information is available concerning the biodegradability of hydrocortisone, thus the phrase “The potential for persistence of hydrokortison cannot be excluded, due to lack of data” is assigned.

In Swedish: “Det kan inte uteslutas att hydrokortison är persistent, då data saknas” under the heading “Nedbrytning”.

Bioaccumulation

Hydrocortisone

Log K_ow = 1.61 (Ref. 3)

Since the experimental Log K< 4 (Ref. 3) for hydrocortisone, the phrase “Hydrocortisone has low potential for bioaccumulation” is assigned.

In Swedish: ”Hydrokortison har låg potential att bioackumuleras” under the heading ”Bioackumulering”.

Physical Chemistry Data

Hydrocortisone acetate

Endpoint	Method	Test Conditions	Result	Ref
Solubility Water	n/a	n/a	14.1 mg/L	4

References

1. [ECHA] European Chemicals Agency. 2022. Guidance on Information Requirements and Chemical Safety Assessment.
   

2. Xyloproct CDS, Doc-ID-000857589. January 2008.

3. Hansch, C., Leo, A., D. Hoekman. Exploring QSAR - Hydrophobic, Electronic, and Steric Constants. Washington, DC: American Chemical Society., 1995., p. 174

4. PhysProp Database, now part of Syracuse Research Corporation. Fate Pointer Module (accessed October 2015)