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.
Our endocrine disruption services
- Literature and desktop searches
- QSAR modelling to predict endocrine activity
- Preparation of an ECHA-guideline compliant ED assessment reports
Evaluating everyday exposures to Endocrine Disrupting Chemicals
How people are exposed to endocrine disrupting chemicals
- 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
A human health risk assessment of API-related impurities
Case study
Whilst developing an inhalation spray drug product, the client identified two impurities with chemical structures related to the Active Pharmaceutical Ingredient (API). Click through to read more about how we dealt with this interesting project.
Human health risk assessment of unknown contamination
Case study
The client reported that small “brown spots” had been observed on the inside surface of a batch of aluminium tubes that contain a topical drug product. The source and chemical composition of the brown spots was unknown. Click through to read more about how we dealt with this interesting project.
Toxicological risk assessment of a disinfecting agent in a syringe medical device
Case study
The client manufactures a product which is used as part of a syringe line medical device. The connection set-up has the potential to introduce a disinfectant chemical into the line and be injected into patients. Click through to read more about how we dealt with this interesting project.
