Genetic Toxicology

NUCRO-TECHNICS is capable of conducting testing of new Active Pharmaceutical Ingredients (APIs), biotechnology products, chemical, and other agents. The following array of test systems satisfies the test requirements of the FDA, OECD, ICH, EPA, EU, EMEA, ISO, USP and Health Canada:

BACTERIAL REVERSE MUTATION TEST

• Bacterial Reverse Mutation (Ames) Tests including the Salmonella and E. Coli strains

IN-VITRO DNA DAMAGE IN MAMMALIAN CELLS

• Chromosome Aberrations in cultured CHO/CHL cells and human peripheral blood lymphocytes
• Mammalian gene mutation assay using mouse lymphoma L51784 (tk +/-) cells
• Micronucleus test in culture CHO cells and human peripheral blood lymphocytes

IN-VIVO TEST FOR GENETIC DAMAGE

• In-vivo Mouse Bone Marrow Chromosome Aberration Test – acute or subchronic treatment
• Micronucleus assay in mouse bone marrow – single treatment and multiple sacrifices or multiple treatments and single sacrifice

CYTOTOXICITY

• Cytotoxicity Determination by Elution & Direct Contact Methods
• Neutral Red Assay (NR) – lysosomes integrity
• Extracellular Lactate Dehydrogenase (LDHe) – plasma membrane damage
• Tetrazolium Salt (XTT) – mitochondrial respiratory chain
• Multiplex assay – any combination of NR, LDHe and XTT in the same plate
• Cleaved caspase-3 detection – apoptosis quantification

PHOTOMUTAGENICITY AND PHOTOTOXICITY

• Chromosomal aberration and Micronucleus
• NRU Photoxicity

We recognize that our clients have particular testing needs; we would be pleased to work with you to customize a protocol that will meet your budget and scientific requirements.

For further information about these services, to receive a quotation, or to schedule a test, please contact NUCRO-TECHNICS.