Our work

The human endocrine system is a complex and interlinked series of organs and glands producing hormones critical for normal growth and development, metabolic homeostasis and reproduction. Endocrine-active chemicals that have the ability to disrupt this intricate and well-balanced system, or endocrine disruptors (EDs), are of significant toxicological, and current regulatory, concern.

Current focus is on those compounds that disrupt the Estrogenic, Androgenic, Thyroid and/or Steroidogenesis (EATS) axes. Comprehensive guidance on testing frameworks for endocrine disrupting chemicals acting on these axes have been published by the OECD and by ECHA/EFSA, with the joint ECHA/EFSA guidance also providing strategies for gathering evidence on, and evaluation and interpretation of the endocrine disruption hazard.

Our toxicologists are skilled in the use of high-throughput screening tools, such as the US EPA’s ToxCast, and in the evaluation and interpretation of in silico and in vitro New Approach Methodologies (NAMs) as well as extracting relevant data from existing laboratory animal and epidemiological studies.

Every day exposures to Endocrine Disrupting Chemicals

ED graphic

How people are exposed

  • Children's toys (phthalates)
  • Plastic drinking bottles (BPA, BPS, BPF)
  • Cleaning products (phthalates, triclosan)
  • House dust (flame retardants, pesticides)
  • Home furniture (flame retardants, PFAS)
  • Building materials (flame retardants, phthalates, PFAS)
  • Fragrances (phthalates)
  • Food (pesticides such as chlorpyrifos)
  • Food packaging (BPA, PFAS, phthalates)
  • Thermal cash register receipts (BPA, BPS)
  • Drinking water (arsenic, lead, perchlorate)
  • Personal care products (parabens, phthalates, triclosan)

ED Assessment under BPR and PPPR

Bibra toxicologists have extensive experience of evaluating the ED properties of active substances and non-active co-formulants under the Biocidal Products Regulations (BPR) (EU 2017/2100) and active substances under the Plant Protection Products Regulations (PPPR) (EU 2018/605). We work within the ECHA/EFSA guidance, utilising our long-established expertise in conducting comprehensive literature searches, selecting relevant studies, and judging their scientific adequacy and quality. We enter relevant data into the Appendix E1 Excel template and critically assess the resultant “Lines of evidence” for adversity and endocrine activity.

ED Assessment under EU CLP and REACH

On 31 March 2023, the European Commission adopted the Commission delegated regulation (EU) 2023/707 which added new Endocrine Disruption hazard classes to Regulation (EC) No 1272/2008 on the classification, labelling and packaging (CLP) of substances and mixtures. As such, in regard to human health and/or the environment, known or presumed EDCs must be classified as Category 1 and suspected EDCs as Category 2. Our toxicologists can evaluate existing REACH registration dossier study summaries for ED-relevant endpoints and, as part of a Weight-of-Evidence (WoE) assessment, advise on the need for additional testing.

ED Assessment in other areas

Evaluation of Endocrine Disruption potential forms a key part of our human health risk assessments for extractables and leachables. We have also conducted bespoke Endocrine Disrupting Chemical assessments for the food and food contact industries, and for consumer products.

Some of our Endocrine Disruption case studies

Evaluation of the endocrine-disrupting potential of a plant protection product

Case study

The Plant Protection Products Regulation (EC) No 1107/2009 is amended by Regulation (EU) 2018/605, requiring that information on the potential endocrine-disrupting properties of such products must be collated and evaluated. The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have published “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009”, detailing the performance of such hazard identification, together with an Excel spreadsheet to be used as a template for gathering the necessary information on “human and animal health” and “non-target organisms”.

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