Estetrol

Detailed information

Assessment report

Assessment report for Drovelis (drospirenone, estetrol) about estetrol, 25 March 2021, EMA/212533/2021.

Hazard

Persistence: "Whole system DT₅₀ (20°C) = 3.99d–7.3d, water DT₅₀ (12°C) = 8.1d–25.7d, sediment DT₅₀ (12°C) = 8.7d–14.3d." According to expert estetrol is degraded in the environment (C. Coll, Department of Environmental Chemistry, Eawag, 2023-10-04).

Bioaccumulation: Log D_OW = 1.65.

Toxicity: There are data for 3 trophic levels, most sensitive fish NOEC 0.69 microg/L.

"Although the FFLC concentration hatching response relation is not fully monotonic, considering that there are statistically significant differences in hatching in the middle concentrations (and partly supported by statistically significant changes in anal papillae at the highest concentration), and that E4 is an endocrine active substance which is expected to be effective on reproductive endpoints at very low concentrations, the lowest concentration (0.69 ug/L) is chosen as the basis for the risk assessment."

Risk

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

Default PEC_sw = 0.071 mikrog/L.

PNEC = Lowest NOEC, 0.69 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.069 microg/L

PEC/PNEC = 1.0289 which gives the risk moderate.

"The proposed E4 PEC_sw is 0.0312 ug/L based on a refined Fpen of 0.0044. The Applicant is committed to submit an updated ERA with this PEC_sw as a basis. For the surface water compartment, this is stated to give a risk quotient of < 1, but the final conclusion can only be made with the submission of the updated ERA." No such information has been found on the EMA website. A question has been sent to EMA 2023-09-21. No response has yet been received (2023-12-15).

Fass environmental information

Environmental information is missing for estetrol on fass.se (2023-12-15). It is voluntary for manufacturers to provide information about environmental impact on fass.se.