Centre of Toxicology and Health Safety

NRL for Experimental Immunotoxicology

Head: Markéta Dvořáková, M.Sc., Ph.D.
Email: marketa.dvorakova@szu.gov.cz
Phone: +420 267 082 430, +420 720 797 388

 

The National Reference Laboratory for Experimental Immunotoxicology was established by the Ministry of Health of the Czech Republic. It carries out scientific research and reference activities and provides expert and consulting services in the field of in vitro toxicology. The laboratory systematically monitors current developments and collects and maintains standards, methodologies, and databases to support its activities, including data interpretation, evaluation, and cooperation with partner institutions abroad.

Its research focuses on the development, validation, standardization, and implementation of New Approach Methodologies (NAMs) in toxicology and their application to identify unknown properties of substances of interest. All activities are conducted in accordance with quality assurance and quality management principles, including Good Laboratory Practice (GLP), ISO standards, OECD Test Guidelines (OECD TG), and Good In Vitro Methods Practice (GIVIMP). Within its capacity, the NRL prepares methodological guidelines and standard procedures, conducts research tasks, applies scientific results in practice, and, in cooperation with the Department of Alternative Toxicological Methods, provides preclinical in vitro testing of chemical substances and environmental factors for public health institutes, manufacturers, and other organizations.

The NRL provides information based on its own findings and continuously monitors experience from other institutions, including international partners. It ensures long-term international collaboration in the field of in vitro toxicology, actively participates in training on new methodologies, implements innovative approaches in practice, and contributes to scientific conferences and expert discussions. It also offers consultations on the verification and refinement of results obtained in other laboratories and delivers specialized reference services. An important part of its mission is the preparation of expert materials for intervention programs addressing potential public health impacts, as well as support in managing epidemiologically and hygienically significant situations, including advisory, coordination, and methodological activities in public health.

Currently, the NRL focuses on the development, implementation, and validation of in vitro toxicological methods based on cell and tissue cultures, with the aim of replacing conventional animal testing. It is a leading laboratory in the Czech Republic in this field and is notified within the EU-NETVAL network, which brings together approximately 35 European laboratories collaborating with the European Commission on the development and validation of NAMs. This cooperation is coordinated by the EU Reference Laboratory for Alternatives to Animal Testing (EURL-ECVAM), part of the Joint Research Centre (JRC) of the European Commission.

Experts affiliated with the NRL participate in OECD working and expert groups. The Head of the laboratory serves as the National Coordinator for the OECD Test Guidelines Programme and is actively involved in leading European scientific societies focused on in vitro toxicology and alternatives to animal testing, including ESTIV and EUSAAT. Through the NRL, the Czech Republic is involved in the ERA policy action aimed at accelerating the uptake of NAMs for biomedical research and the testing of medicinal products and medical devices within the European Union’s ERA Policy Agenda 2025–2027.

Within the Centre for Toxicology and Health Safety, the NRL is accredited by the Czech Accreditation Institute as a testing laboratory according to EN ISO/IEC 17025:2018 and operates in compliance with Good Laboratory Practice (GLP) principles for in vitro toxicological methods. The Head of the laboratory is also appointed as the Head of the Quality Assurance Unit within the GLP system. The NRL utilizes the personnel capacities of the Centre, particularly the Department of Alternative Toxicological Methods, whose validated methods expand the laboratory’s expertise and strengthen the competitiveness of the National Institute of Public Health.

 

Methodologies, equipment, instrumentation techniques, test systems:

The laboratory applies a wide range of methodologies and technologies, including cell culture techniques, light and fluorescence microscopy, flow cytometry, spectrophotometry, fluorimetry, luminometry, immunochemical methods, and reporter gene assays. It works with diverse sample types such as chemical substances and mixtures, nanomaterials, cosmetic products, medical devices, and non-pathogenic sterilized biological materials. Testing systems include cell lines, reconstructed human tissue models, organ models, and organoids.

 

OECD Test Guidelines Programme

As part of its role in the OECD Test Guidelines Programme, the NRL contributes to the development and validation of new testing methods and supports the transition from animal testing to NAM-based approaches for safety and risk assessment of chemicals, medical devices, and candidate medicinal products. It also represents the Czech Republic in this programme and participates in the nomination of experts to OECD working and expert groups across areas such as developmental and reproductive toxicity, ecotoxicity, environmental fate and behaviour, genotoxicity and carcinogenicity, immunotoxicity, nanomaterial safety, respiratory and skin sensitisation, toxicokinetics, and residues chemistry.

More information about the OECD Test Guidelines Programme is available at:

https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/test-guidelines.html