OECD Test Guideline 474: What is the Mammalian Erythrocyte Micronucleus Test?
Various toxicological tests are carried out to assess the safety of newly developed pharmaceutical, biocidal or other chemical products for human and environmental health. One of these tests is OECD Testing Guideline 474 – Mammalian Erythrocyte Micronucleus Test.
This test, carried out within the framework of GLP (Good Laboratory Practice), is used in particular to demonstrate the potential of products to damage genetic material, i.e. the risk of genotoxicity.
Purpose of Mammalian Erythrocyte Micronucleus Test
This test examines the formation of micronuclei (small, abnormal nuclear structures) in erythrocytes from bone marrow or peripheral blood to detect chromosomal damage. Micronuclei are formed by the incorrect separation of chromosomes or chromosome fragments during cell division and are considered an indicator of genetic damage.
- This test is particularly preferred in the following cases:
- Development process of pharmaceutical products
- Safety assessments of biocidal and pesticide products
- Toxicological Testing of Industrial Chemicals
- Required cases for cosmetics or personal care products
Application process according to OECD TG 474
The micronucleus test performed in accordance with GLP standards includes the following steps:
- Preparation of the substance to be tested:The product is prepared by specifying suitable solvents and dosage ranges.
- Use of laboratory animals:As a rule, mice or rats are used. Before the work begins, the approval of the ethics committee is obtained.
- Exposure: The test substance is administered to the animals orally, dermally or by inhalation.
- Sampling: After a certain time, red blood cell samples are taken from the bone marrow or peripheral blood.
- Micronucleus analysis: The erythrocytes are examined under the microscope. The frequency of micronucleus formation is determined.
- Evaluation of the results: A comparison with the control group is carried out and a statistical analysis is carried out.
For which products is the erythrocyte micronucleus test in mammals suitable?
- Pharmaceutical Raw materials and finished products
- Biocidal products
- Pesticides and agricultural chemicals
- Industrial Chemicals
- Cosmetics and personal care products
- Food additives (if necessary)
Why choose our laboratory?
- GLP accreditation and OECD TG 474 compliant test infrastructure
- Expert toxicologists and experienced laboratory team
- Working in accordance with ethical principles and the 3R principles
- Fast, reliable and compliant reporting
- Scientific support in approval and R&D processes