Endocrine Disruptors (ED) are substances which interfere with processes in the body that are controlled by hormones. Even very low concentrations may cause adverse effects to the health of human and wildlife.
ECHA and EFSA have provided guidance for the Assessment of Endocrine Properties: The ”Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009” is based on the “OECD Conceptual Framework for Testing and Assessment of Endocrine Disrupting Chemicals, revised 2018 (OECD, 2018b)” and “OECD GD 150”.
Data may be used in three different legal frameworks:
- Chemicals: Under REACH Endocrine Disruptors may be identified as Substances of Very High Concern (SVHC).
- Biocidal Products: Under the Biocidal Products Regulation all active substances have to undergo a formal ED Assessment. Co-formulants may be classified as Substance of Concern (SoC).
- Plant Protection Products (Agrochemicals): The Plant Protection Product Regulation also requires ED Assessment.
The ED test strategy describes a leveled approach:
Level 1: Sorting & prioritization based on existing information
Level 2: In vitro assays providing data about single endocrine mechanisms and pathways
Level 3: In vivo assays providing data about single endocrine mechanisms and pathways
Level 4: In vivo assays providing data on adverse effects on endocrine relevant endpoints
Level 5: In vivo assays providing more comprehensive data over more extensive parts of the life cycle of the organisms
LAUS can support you with the following studies for the assessment of your substance:
- Estrogen or Androgen Receptor Binding Affinity (YES/YAS Assay)
- Fish Early Life Stage (ELS) Toxicity Test (OECD 210)
- Daphnia magna Reproduction Test (OECD 211)
- Sediment Water Lumbriculus Toxicity Test using Spiked Sediment (OECD 225)
The study you need is not listed? Please contact us.