Drospirenone

Detailed information

Assessment report

Assessment report for drospirenone from Drovelis (estetrol, drospirenone) Gedeon Richter, 25 March 2021, EMA/212533/2021. Corresponding data for drospirenone in the assessment report for drospirenone from Lydisilka (estetrol, drospirenone) Estetra SRL, 25 March 2021, EMA/212533/2021.

Hazard

Persistence: DT₅₀ = 19d (20°C) DT₅₀ = 40.6d (12°C). Not readily biodegradable. ... "It is not readily biodegradable, considered very persistent (vP) in a water:sediment simulation study and there is a potential for accumulation in for sediment."

Bioaccumulation: Log K_ow (pH 7) = 3.1.

Toxicity: There are data available for three trophic levels, with the most sensitive fish species showing a LOEC of < 0.00023 mg/L. This gives a rough estimate of the NOEC (LOEC/2), i.e., 0.115 µg/L.

"The substance meets the T-criterion and the vP criterion but does not meet the B-criterion based on a bioconcentration study in fish, hence DRSP is not PBT, nor vPvB."

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

Default PEC_{surface-water} = 0.015 microg/L.

PNEC = Lowest NOEC, 0.115 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.0115 microg/L

PEC/PNEC = 1.304 which corresponds to a medium risk. Given the uncertainty involved in extrapolating NOEC from LOEC, this should be interpreted with caution.

Fass environmental information Drovelis

Fass environmental information for drospirenone from Drovelis from Gedeon Richter (retrieved on 2025-06-17).

Hazard

Persistence: "Drospirenone did not pass the ready degradability test. The phrase " Drospirenone is potentially persistent" is thus chosen." Further details are available at Fass.se.

Bioaccumulation: The log K_ow was reported with 3.1 at pH 7. Guideline OECD 117.

Toxicity: There are data for 3 trophic levels, most sensitive fish "LOEC = 0.23 μg/L. Guideline OECD 240."

Risk

"The PNEC was calculated by division of the lowest effect level (NOEC or LOEC) of the most sensitive taxonomic group considering an appropriate assessment factor (AF). The most sensitive taxonomic group were fish and the lowest effect level was reported as LOEC = 0.23 μg/L. The regulatory default standard AF of 10 was used, which is applicable when there are chronic aquatic toxicity studies representing the three trophic levels (algae, crustaceans, and fish). PNEC = 0.23 μg/L/10 = 0.023 μg/L." PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 0.69, which indicates a low risk. If NOEC is estimated as LOEC/2, then PEC/PNEC = 1.37, which corresponds to a medium risk.

Fass environmental information Yasmin

Fass environmental information for drospirenone from Yasmin (drospirenone, ethinylestradiol) from Bayer (retrieved on 2025-06-17).

Hazard

Persistence: Drospirenone established a DT₅₀ > 120 d for the total system which qualifies for the phrase “Drospirenone is potentially persistent.”.

Bioaccumulation: "The log D_ow was reported with 3.1 at pH 7. Guideline OECD 117. ... The steady state bioconcentration factors for total radioactive residue were 97 and 99 for the 0.1 and 1.0 μg/L treatment level, respectively, based on lipid content of 4.83 %. Normalised to 5% fat tissue, the BCFss for whole fish are 100 and 102 for the 0.1 and 1.0 μg/L treatment levels, respectively. Guideline OECD 305. (Reference XII) Justification of chosen bioaccumulation phrase: As the log D_ow was < 4 and/or BCF < 500 Drospirenone is not considered bioaccumulative which qualifies for the phrase “Drospirenone has low potential for bioaccumulation.”."

Toxicity: There are data for 3 trophic levels, most sensitive fish NOEC 0.23 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0.63 which gives the risk low.

Report Goodpoint 2024

The report from Goodpoint 2024 aims to present an overall, comparative assessment for the treatment options recommended for all indications under the therapeutic area of ​​gynecology and obstetrics in the 2024 Wise list (the formulary for Region Stockholm, Sweden) containing either estrogens or progestogens + estetrol. The risk assessment does not aim to assess absolute or quantitative risk (which, for example, strongly depends on dilution in different recipients) but is primarily of a comparative nature, i.e., a ranking of the risk between different treatment options. For more information see the report.