Genetic Toxicology

Assessing the potential of the test article to induce gene mutations or chromosome damage.

Genetic Toxicology Testing Services.

Genotoxicity tests are used to assess the potential of the test article (or test article extract) to induce gene mutations or chromosome damage using a battery of tests in bacterial, mammalian cells in vitro, and in vivo test systems. This information is of critical importance and constitutes an essential part of preclinical studies because genetic damage can cause an increase in the incidence of heritable diseases and cancer in human populations. Physical or chemical agents that induce such effects by interacting with genetic material and alter their structure are considered “genotoxic.”

Testing Capabilities

Test NameRegulatory ComplianceGuidance / Guideline
Bacterial Reverse Mutation Assay (Ames Test)GLP
Non-GLP
ISO, OECD, MHLW, ICH
Ames Screening Assay
• 2 Strain Ames Assay
• 6 Well Plate Ames Assay
Non-GLP
In-Vitro Mammalian Chromosomal Aberration Test
• In Human Peripheral Blood Lymphocytes (HPBL)
• In Chinese Hamster Ovary Cells (CHO)
GLP
Non-GLP
ISO, OECD, MHLW, ICH
In-Vitro Mammalian Micronucleus Test
• In Human B Lymphoblastoid Cell Line (TK6)
GLP
Non-GLP
ISO, OECD, MHLW, ICH
Mouse Lymphoma Gene Mutation Test
• In Mouse Lymphoma (L5178Y) Cells
GLP
Non-GLP
ISO, OECD, MHLW, ICH
In-Vivo Mammalian Erythrocyte Micronucleus Test
• Mouse Peripheral Blood
• Rat Peripheral Blood
GLP
Non-GLP
ISO, OECD, MHLW, ICH S2 (R1)
In-Vivo Chromosome Aberration Test
• Mouse Bone Marrow Cells
• Rat Bone Marrow Cells
GLP
Non-GLP
ISO, OECD, MHLW, ICH
Mouse Embryo AssayGLP
Non-GLP
CFR 21

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
Ames Assay1 Extract: 40 cm² <0.5 mm thick, 20 cm² ≥ 0.5 mm thick, or 1.5 g
2 Extracts with Confirmation: 80 cm² <0.5 mm thick, 40 cm² ≥ 0.5 mm thick, or 3 g, and at least 2 units
4-5 weeks
In-Vitro Chromosomal Aberration Assay 1 Extract: 350 cm² <0.5 mm thick,180 cm² ≥ 0.5 mm thick, or 12 g
2 Extracts: 380 cm² <0.5 mm thick, 190 cm² ≥ 0.5 mm thick, or 13 g, and at least 2 units.
9-10 weeks
Mouse Lymphoma Gene Mutation Assay1 Extract: 700 cm² <0.5 mm thick, 350 cm² ≥ 0.5 mm thick, or 24 g
2 Extracts: 900 cm² <0.5 mm thick, 450 cm² ≥ 0.5 mm thick, or 30 g
7-8 weeks
In-Vitro Micronucleus Assay1 Extract: 350 cm² <0.5 mm thick,180 cm² ≥ 0.5 mm thick, or 12 g
2 Extracts: 380 cm² <0.5 mm thick, 190 cm² ≥ 0.5 mm thick, or 13 g, and at least 2 units.
4-5 weeks
In-Vivo Rodent Blood Micronucleus Assay 1 Extract: 45 cm² <0.5 mm thick, 25 cm² ≥ 0.5 mm thick, or 1.5 g
2 Extracts: 80 cm² <0.5 mm thick, 40 cm² ≥ 0.5 mm thick, or 3 g, and at least 2 units
7-8 weeks
In-Vivo Chromosomal Aberration Assay 1 Extract: 45 cm² <0.5 mm thick, 25 cm² ≥ 0.5 mm thick, or 1.5 g
2 Extracts: 80 cm² <0.5 mm thick, 40 cm² ≥ 0.5 mm thick, or 3 g, and at least 2 units
10 -12 weeks