What Is the In Vitro Mammalian Cell Gene Mutation (HPRT/MLA) Test?

The In Vitro Mammalian Cell Gene Mutation Test is one of the fundamental genotoxicity tests conducted to evaluate a substance’s potential to cause gene mutations in mammalian cells. Conducted in accordance with OECD TG 476 and OECD TG 490 guidelines, these studies are used to determine whether the tested substances cause permanent genetic changes at the DNA level.

Widely used in safety assessments of pharmaceuticals, biocidal products, medical devices, cosmetic raw materials, industrial chemicals, and newly developed substances, this test is a key component of genetic toxicology studies.

At NanoTox, within our Genetic Toxicology Unit, we offer In Vitro Mammalian Cell Gene Mutation test services that comply with GLP (Good Laboratory Practice) principles and meet international standards.

Purpose of the In Vitro Mammalian Cell Gene Mutation Test

This test aims to determine a substance’s potential to induce mutations at the gene level in mammalian cells.

Bu çalışmalar sayesinde:

• Mutagenic potential is assessed,
• Gene changes associated with DNA damage are investigated,
• Genetic safety data are obtained,
• Düzenleme gereksinimleri karşılanır,
• Human health risk assessments are supported.

The results obtained contribute to the establishment of products’ genotoxic risk profiles.

What Are the HPRT and MLA Tests?

Two different methods are commonly used in in vitro mammalian cell gene mutation assessments:

HPRT Test (OECD TG 476)

The HPRT (Hypoxanthine-Guanine Phosphoribosyl Transferase) test aims to detect mutations occurring in a specific gene region in mammalian cells. This method is a reliable testing approach that has been used for many years, particularly in the evaluation of gene mutations.

MLA Test (OECD TG 490)

The MLA (Mouse Lymphoma Assay) is an advanced method performed on mouse lymphoma cells that enables the detection of not only gene mutations but also minor chromosomal changes.

Both methods are among the key genotoxicity tests accepted by international regulatory authorities.

Studies Conducted in Compliance with OECD TG 476 and OECD TG 490 Guidelines

Studies conducted at NanoTox are carried out in accordance with the following OECD guidelines:

• OECD TG 476 – In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt Genes
• OECD TG 490 – In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene

Under these guidelines:

• Appropriate cell lines are used,
• Positive and negative controls are evaluated,
• Metabolically activated and non-activated systems are applied,
• Dose-response relationships are analyzed,
• Cytotoxicity and mutation frequency are evaluated together.

Test Prensibi

During the test, mammalian cells are exposed to the test substance at different concentrations. Following exposure, gene mutations are assessed in selective culture media, and the mutation frequency is calculated.

Cell lines frequently used in studies include:

• CHO cells,
• V79 cells,
• L5178Y mouse lymphoma cells,
• TK6 cells

Diğerleri arasında.

Additionally, the S9 metabolic activation system may be used to mimic mammalian metabolism.

Parametreler Test Kapsam içinde Evaluated

Within the scope of the In Vitro Mammalian Cell Gene Mutation Test:

• Mutation frequency,
• Dose-response relationship,
• Cytotoxicity assessments,
• Hücre kullanılabilirliği,
• Effects of metabolic activation,
• Statistical analyses

incelenmiştir.

These evaluations scientifically demonstrate the tested substance’s potential to induce gene mutations.

Reliable Genetic Toxicology Studies with NanoTox

NanoTox conducts In Vitro Mammalian Cell Gene Mutation tests in accordance with OECD TG 476 and OECD TG 490, adhering to international quality standards, thanks to its expert genetic toxicology team and advanced laboratory infrastructure. We ensure the acquisition of reliable genotoxicity data required in the development processes of pharmaceuticals, medical devices, biocidal products, and chemical substances.

For detailed information about the In Vitro Mammalian Cell Gene Mutation (HPRT / MLA) Test and our other genetic toxicology services, please contact NanoTox.