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Ethinylestradiol

Summary

Persistence. Ethinylestradiol is degraded in the environment
Bioaccumulation. Ethinylestradiol has high potential for bioaccumulation.
Toxicity. Ethinylestradiol has a very high chronic toxicity.
Risk. "At the same time, estrogens, especially EE2, are very potent and can interfere with reproduction in fish. The greatest evidence for effects in the environment is for EE2 with measured concentrations that relatively often exceed safe effect levels. How the risk would change when replacing EE2 with E2 or E4 is discussed under the heading "risk assessment when replacing." EE2 = ethinylestradiol, E2 = estradiol och E4 = estetrol. For more information see the report from Goodpoint 2024.

 

This summary information comes from fass.se with the exception of the risk that comes from the report from Goodpoint 2024.

 

Suggestions on how to reduce the emissions of ethinylestradiol

Detailed information

Fass environmental information from Bayer

Fass environmental information for ethinylestradiol from Neovletta 28 (ethinylestradiol, levonorgestrel) from Bayer (downloaded 2025-01-24).

Hazard

Persistence: "In the total water/sediment systems the DT50 of [14C] ethinylestradiol was 24, 36, and 28 days for the 2 systems. The DT50 values differed ranked in two cases below the threshold of 32 days and exceeded this threshold in one case. Since two of three water-sediment systems report DT50 below the criterion and the exceedance of one system is moderate, ethinylestradiol can be classified as being degradable. In conclusion, this study reported a half-life of ethinylestradiol of 4.0–5.9 days in water and 24–36 days in sediment/total system. Guideline OECD 308."

Bioaccumulation: "As the log Dow was > 4 and BCF > 500 ethinylestradiol is considered bioaccumulative which qualifies for the phrase “ethinylestradiol has high potential for bioaccumulation.”."

Chronic toxicity: There are data for 3 trophic levels, most sensitive fish NOEC 0.0003 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 12.3, which gives the risk high.

EU water legislation

Ethinylestradiol has previously been monitored within the framework of EU water legislation. There is now enough data to assess whether ethinylestradiol is to be proposed as a priority substance when the European parliament and the Council next time proposes a revised directive regarding priority substances in the field of water policy.

The Swedish Agency for Marine and Water Management

Ethinylestradiol is among special pollutants in the Swedish Agency for Marine and Water Management regulation HVMFS 2019:25.

Report Goodpoint 2016

Estimated levels in Swedish waters are in some cases sufficiently high to affect reproduction and gender development in fish.

Ethinylestradiol is included in Region Stockholm's table of pharmaceuticals with a negative environmental impact according to the environmental programme 2017–2021 based on lowest effect concentration, LOEC = 0.32 nanog/L, and concentrations found in treated wastewater.

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.

The Wise list

Ethinylestradiol is recommended in the Wise list in Region Stockholm. Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise list. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.

Suggestions on how to reduce the emissions of ethinylestradiol

Concrete proposals on how to work to reduce emissions of environmentally harmful pharmaceuticals on the list have been developed in close cooperation with the Stockholm Drug and Therapeutics Committee's expert groups. The action proposals were developed from an environmental perspective. The patient's best always goes first and several pharmaceuticals on the list are also included in the Wise list. However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.

Concrete proposal for ethinylestradiol

  • Ethinylestradiol (combined contraceptives) is recommended in the Wise list.
  • Individual adjustment of  contraceptives is important  in order to optimize treatment and avoid side effects.
  • Ensure that you, in your own business, discard leftover pharmaceuticals and used rings and patches correctly.
  • Inform the patient about the importance of discarding leftover pharmaceuticals, as well as used P-rings and patches, correctly.
  • Order the folder for patients "Protect the Environment – Throw in the Right Way".

References

  1. Fass för vårdpersonal.
  2. Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm.
  3. Havs- och vattenmyndighetens föreskrift HVMFS 2019:25.
  4. Goodpoint. Prioritering av läkemedel med miljörisk inom SLL. Stockholm: Goodpoint; 2016. Rapport LS 2016–0634.
  5. Region Stockholm. Förteckning över miljöbelastande läkemedel med åtgärdsförslag framtagen inom ramen för Region Stockholms miljöprogram 2017–2021.
  6. Goodpoint. Östrogener och gestagener: jämförande miljöriskbedömning. 2024-12-12.
  7. Region Stockholms läkemedelskommitté. Kloka listan.
  8. Region Stockholm's Drug and Therapeutics Committee. The Wise list 2015.

Author: Health and Medical Care Administration, Region Stockholm