OECD Test Guideline 474: What is the Mammalian Erythrocyte Micronucleus Test?
Various toxicological tests are conducted to assess the safety of newly developed pharmaceutical, biocidal, or other chemical products for human health and the environment. One of these tests is the OECD Test Guideline 474 – Mammalian Erythrocyte Micronucleus Test.
This test, conducted under GLP (Good Laboratory Practice), is specifically utilized to identify the potential of products to damage genetic material, i.e., the genotoxicity risk.
Purpose of the Mammalian Erythrocyte Micronucleus Test
This test investigates the formation of micronuclei (small, abnormal nuclear structures) in erythrocytes from bone marrow or peripheral blood to detect chromosomal damage. Micronuclei result from the erroneous segregation 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 investigations of industrial chemicals
- Required cases for cosmetics or personal care products
Application process according to OECD TG 474
The micronucleus test, conducted according to GLP standards, includes the following steps:
- Preparation of the Test Substance: The product is prepared by defining appropriate solvents and dosage ranges.
- Use of Test Animals: Typically, mice or rats are used. Prior to commencing work, ethical committee approval is obtained.
- Exposure: The test substance is administered to the animals orally, dermally, or via inhalation.
- Sampling: After a specified period, erythrocyte samples are collected from bone marrow or peripheral blood.
- Micronucleus Analysis: The erythrocytes are examined under a microscope. The frequency of micronucleus formation is determined.
- Evaluation of Results: A comparison with the control group is performed, and statistical analysis is conducted.
For which products is the Mammalian Erythrocyte Micronucleus Test suitable?
- Pharmaceutical raw materials and finished products
- Biocidal Products
- Pesticides and agrochemicals
- Industrial chemicals
- Cosmetics and personal care products
- Food additives (if required)
Why choose our laboratory?
- GLP accreditation and OECD TG 474-compliant testing infrastructure
- Expert toxicologists and experienced laboratory team
- Operating in accordance with ethical principles and the 3R principles
- Prompt, reliable, and compliant reporting
- Scientific support for regulatory approval and R&D processes