Current Approaches to the Preclinical Assessment of Endocrine Toxicity

Scientific relevance . Endocrine disruptors affect the functioning of endocrine organs, which leads to adverse drug reactions. toxicity requires special attention in preclinical studies candidate medicinal products. Aim. The study aimed review international guidelines and approaches assessing risk associated with Discussion. This covers documents that provide a methodological framework for identifying classifying chemical compound as an disruptor. These include following: Revised Guidance Document 150 on Standardised Test Guidelines Evaluating Chemicals Disruption (Organisation Economic Cooperation Development, 2018), Nonclinical Evaluation Endocrine-Related Drug Toxicity (Food Administration, 2015), Identification Disruptors Context Regulations (EU) No. 528/2012 (EC) 1107/2009. proposed algorithm assessment involves collecting all available data test compound, such literature previously obtained experimental data, including acute subchronic silico predictions. Particular should be paid standard battery chronic studies, can identify most side effects system. main endpoints changes mass histopathology major organs (adrenal glands, testes, epididymides, ovaries, thyroid gland), oestrous cycle effects, reproductive toxicity, transplacental action. A thorough provides determination unfavourable activity further studies. Conclusions. OECD offer set validated vivo vitro tests characterise important mechanisms (oestrogen, androgen, thyroid, steroidogenic pathways) by identified toxic effects. approach allows researchers potential disorders early development process optimise scope required accordingly.