Comprehensive genotoxicity and mutagenicity testing for safe product development
Genotoxicity refers to the capacity for a substance to damage genetic material within cells through interactions with the DNA sequence and structure. Mutagenicity refers to the capacity for a substance to cause permanent, transmissible changes to genetic structure or amount of genetic material.
Intox offers a broad array of genotoxicity/mutagenicity studies, both in vivo and in vitro. Robust historical control data developed in our laboratories for various vehicles and positive controls convincingly supports the outcome of the experiments. We will provide you with reliable, efficient data as you screen libraries of multiple compounds for de-risking your portfolio and candidate selection. Further, we will also support you with GLP safety studies as you move towards regulatory filings.
The genotoxicity testing protocols at Intox are developed and validated by our experts in regulatory toxicology. The study reports have been accepted by regulatory agencies across the globe. While experimental designs for various test items will vary with their type, the intended application and the regulatory requirements, a consultation with our toxicology and regulatory experts will create the most appropriately tailored testing strategy for your product.
- Bacterial reverse mutation test / Ames test (OECD 471) Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 , Conventional AMES. Enhanced AMES, mini-AMES Salmonella typhimurium TA98, TA100, TA1535, TA1537 and E. coli WP2 uvrA, E. coli WP2 [pKM101]
- Chromosome aberration test: (OECD 473) Human Peripheral Blood Lymphocytes
- Cell gene mutation test / HPRT assay and TK Gene (OECD 490) L5178Y/Tk+/--3.7.2C mouse lymphoma cell line (OECD 476) CHO-K1 Cell Line
- Micronucleus test OECD 487 Human Peripheral Blood Lymphocytes, TK6 Human Lymphoblastoid Cell line
For in vivo and in vitro micronucleus tests, we are using state of art flow cytometer instead of manual slide counting
- Micronucleus test in mice/ (with/without TK) OECD 474 Mice (Swiss albino)
- Chromosome aberration test in mice/(with/without TK) OECD 475 Mice (Swiss albino)
- In vitro skin corrosion OECD 475 Mice (Swiss albino)
- In vitro skin irritation OECD 439 Reconstructed Human Epidermis
- In vitro eye irritation OECD 491 Statens Seruminstitut Rabbit Cornea Cell Line (SIRC)
- Phototoxicity OECD 432 BALB/c 3T3, clone A31, (ATCC) CCL163 Mouse Fibroblast cell line Cytotoxicity ISO 10993-5,12 L929 Mouse Fibroblast Cell line
