Genotoxicity Tests: Toxic Effects on DNA

What are Genotoxicity Tests? On Which Products Are They Performed?

What are Genotoxicity Tests?

Genotoxicity tests consist of various tests that examine possible effects on DNA through different mechanisms. These tests are performed by in vitro (with cells in a laboratory environment) and in vivo (on living organisms) methods.

1. Ames Test (Bacterial Mutagenicity Test)

• Assesses the potential of a chemical to cause gene mutations. The mutagenic effects of the chemical are measured usingSalmonella typhimurium or Escherichia coli bacteria.
• Area of Use: Drugs, cosmetics, pesticides and food additives.

2. Micronucleus Test

• Detects chromosomal damage and abnormalities. Examines micronucleus (small nucleus) structures formed during cell division.
• Area of Use: Medical devices, pharmaceuticals and environmental chemicals.

3. Comet Test (Alkaline Single Cell Gel Electrophoresis)

• Examines breaks and damage to the DNA chain. Damaged DNA is observed to elongate into a tail during electrophoresis.
• Area of Use: Industrial chemicals, food products and cosmetics.

4. Sister Chromatid Exchange (SCE) Test

• Assesses the frequency with which chromosomes exchange fragments as DNA replicates. Changes in chromosomes are visualized using fluorescent dyes.
• Area of Use: Drug development and chemical safety assessment.

5. In Vivo Genotoxicity Tests

• Assesses DNA damage and genotoxic effects in living organisms. Tissues and organs exposed to the substance are examined using subject animals (such as mice or rats).
• Area of Use: Pharmaceutical products, medical devices and industrial chemicals.

Products for which Genotoxicity Tests are Applied

Genotoxicity tests are performed on a wide range of products that may affect human health:

Pharmaceutical Products: It is performed to understand whether the active ingredients of medicines can cause DNA damage. Genotoxicity testing is a mandatory step in the drug development process.

Cosmetic Products: Evaluates the safety of chemicals used in cosmetics such as make-up, skin care products, hair dyes, etc.

Food and Feed Additives: Analyzes the effects of food additives, flavorings and preservatives on genetic material.

Chemicals and Pesticides: Evaluate whether substances such as pesticides, industrial chemicals and cleaning products are genotoxic.

Medical Devices: Examines the biocompatibility and genotoxic effects of devices that come into direct contact with human tissue or are implanted into the body.

Environmental Chemicals: The risk of genetic damage from chemicals that can cause air, water and soil pollution is assessed.

International Standards and Guidelines

Genotoxicity tests are performed in accordance with various international standards and guidelines:

• OECD Test Guidelines: Provides specific protocols for genotoxicity testing.
• ICH Guidelines: Covers genotoxicity testing for drug safety assessment.
• ISO 10993: Includes genotoxicity assessment in biocompatibility testing of medical devices.

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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