Regulatory Genotoxicity Studies2018-11-01T16:42:41+00:00

Project Description

REGULATORY GENOTOXICITY STUDIES

Gentronix offers GLP OECD regulatory assays for the assessment of chemical safety across global industries, covering endpoints detection mutagenic, clastogenic and aneugenic mechanisms.

SERVICE INFORMATION

Comprising a scientific team of experts from pharmaceutical, agrochemical and CRO backgrounds, Gentronix has a wealth of experience in delivering regulatory genotoxicity studies. Our laboratory facilities at Alderley Park are GLP compliant and purpose designed for genotoxicity testing. We are committed to provide high quality genotoxicity services, facilitating safety assessment for gene mutation, structural and numerical chromosomal damage.

OECD 471: Ames Test

A bacterial reverse mutation assay, long established as a predictor of point mutagens, and a key element of regulatory safety assessment across global industries. The assay can discriminate some modes of action for direct acting mutagens and is quick to conduct. Our experts have decades of experience in performing Ames tests and work with you to not only perform the studies, but to interpret the results and advise on any appropriate follow-up.

OECD 487: In vitro MNT

The in vitro micronucleus test is a mammalian cell assay that enables the detection of both structural and numerical chromosomal damage, utilising either TK6 or primary human lymphocyte cells. When the in vitro micronucleus assay is used in combination with an Ames or mouse lymphoma assay, all key classes of genotoxic agents can be reliably detected.  The assay can also be modified by the addition of FISH, to enable discrimination between clastogenic and aneugenic mechanisms, which can be a critical factor for refining risk assessments.

OECD 490: Mouse Lymphoma Assay (MLA)

The MLA is a mammalian cell gene mutation assay that can detect both clastogenicity as well as point mutations, which has made it a favoured assay for many clients.  The MLA is complementary to the Ames test, with utility in detecting effects particular to the mammalian DNA regulatory apparatus, providing evidence that a mutagenic substance may or may not carry a mammalian cell risk.

OECD 474: In vivo Micronucleus Assay

The mammalian rodent erythrocyte micronucleus assay is the most used in vivo genotoxicity study, able to detect both clastogenic and aneugenic modes of action, for substance with systemic exposure. The test is used to identify substances induce formation of micronuclei in erythrocytes and can be assessed either in bone marrow via microscopy or peripheral blood using flow cytometry. The ability of the test to take account of factors such as in vivo metabolism, pharmacokinetics and DNA repair processes, assessing both the impact on response these may have, but also providing further investigation of genotoxicity detected within the in vitro assay battery.

Predictive Toxicology, Expertly Delivered

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