Endocrine disruption

Do you want to assess the endocrine disrupting effect of a product?
Do you want to screen a portfolio of substances as part of an R&D approach?

The laboratory Eurofins Ecotoxicologie France offers new biological models for measuring the endocrine disrupting effect.

Definition

"An endocrine disruptor (ED) refers to an exogenous substance or mixture which alters the functions of the endocrine system and consequently induces harmful effects on the health of an intact organism (or) of its descendants…" – WHO (2002). This definition was adopted by the EU to establish the regulatory criteria for the identification of endocrine disruptors.

In essence, the endocrine system of a human or animal is dynamic. Indeed, it adapts the production of hormones according to many variables: emotional state, stress, outside temperature, physical activity, etc. When we talk about "endocrine disruptors" we are talking about a substance that fulfils 3 regulatory criteria:

• A harmful effect on the whole organism;
• A mode of action (via a receptor, an enzyme, a transporter, etc.);
• A plausible link of cause and effect between the two.

The sources of endocrine disruption are very diverse: agri-food, biocides, phytosanitary substances, food contact, cosmetics, chemistry, etc. In addition, there is the complexity of their modes of action on an organism, the complexity of the traceability of their future (mixing, metabolisation) and the capacity of certain pollutants to act at very low concentrations. This also makes the study of these phenomena particularly complex.

Regulation

To date, in Europe, only biocidal and phytosanitary products are regulated.
• Biocides: EU regulation 2018/605 of 19/04/2018 (application on 07/06/2018)
• Phytosanitary substances: EU regulation 2018/605 of 19/04/2018 (application on 20/10/2018)

These regulations concern new substances placed on the market as well as those which are coming up for renewal. The ECHA (European CHemical Agency) and EFSA (European Food Safety Authority) act as regulators, so that each country has the same vision and applies the regulations. Finally, we are expecting regulations to arrive for the other families of products: chemistry, cosmetics, food contact, water, etc.

Test strategy and applications

The OECD 150 guideline lists all the endocrine disruption tests, focusing on the following 4 axes: Estrogenic, Androgenic, Thyroid and Steroid. Certain endocrine mechanisms are common to several areas: Steroidogenesis is a set of mechanisms common to the estrogenic and androgenic axes.

The OECD 150 considers 5 levels of analysis, in ascending order of regulatory evidence.

• Level 1: data collection to sort and prioritise (also includes QSAR)
• Level 2: in vitro testing on cells
• Level 3: tests on whole organisms, reproducing the specific mechanisms of the disruption criteria
• Level 4: tests on whole organisms, reproducing the specific harmful effect of the disruption criteria
• Level 5: Test on whole organisms, throughout the entire life-cycle

Whether it is for environmental applications or for industrial applications, these in vivo detection tests have wide-reaching applications and methodological potential.

• Environment
  • Evaluating the impact of the discharges from an urban or industrial wastewater treatment plant ("STEP") into the natural environment
  • Optimising or choosing a type of treatment
  • Monitoring the quality of a discharge, a water course or a water table over time
• Industries
  • Primary characterisation of substances in R&D
  • Screening substances before formulation (decision-making aid)
  • Carrying out a preliminary test before the regulatory study in accordance with GLP (Good Laboratory Practices)
  • Building the weight of regulatory evidence with mechanistic data to check the plausibility link (GLP or non-GLP data)

Our analytical offer

We offer our customers a battery of level 3 tests because this level is the only one that validates the points below:

• Weight of regulatory proof: evaluating an endocrine activity; highlighting a specific physiological response to a disruption criterion; checking the plausibility link between mode of action and physiological effect.
• Tests on the 3 axes: yes (estrogenic, androgenic, thyroid) taking into account the steroidogenesis.
• Authorization for the cosmetic industry: yes*
• Cost of the test: much cheaper than testing a whole organism

*The organisms used for these bioassays are amphibian or fish embryos. At this stage of development, they cannot feed themselves (nutritional reserves of the egg). These early stages can be exposed in vitro and constitute an alternative for replacing (ethical replacement principle – 3Rs rule) laboratory animals.

Related analysis

YES/YAS (Yeast Estrogen Screen/Yeast Androgen Screen) test on Saccharomyces Cerevisiae yeast: Confirmation of a specific endocrine mechanism for the estrogen or androgen receptor alpha.

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Need additional analyses?

Consult the other sections of our catalogue:

• Ecotoxicology
• Biodegradability
• HP criteria