Regulatory Genotoxicity Studies

Gentronix offers GLP OECD regulatory genotoxicity studies for assessing chemical safety across global industries, covering endpoints detection for mutagenic, clastogenic, and aneugenic mechanisms in our GLP genotoxicity lab.

image/svg+xml Chemicals Biocides EU No 528/2012 EC 1907/2006 (REACH) Typically 3 tests: OECD 471 Ames OECD 476/490 HPRT/MLAOECD 487 in vitro MNT Regulations In vitro studies image/svg+xml Regulations In vitro studies In vivo studies Cosmetics Regulation (EC) No 1223/2009;SCCS/1602/18 OECD471 Ames + OECD 487 in vitro micronucleus Animal testing prohibited image/svg+xml Agrichemicals (Active Substances) EC 1107/2009; EU 283/2013 Typically 3 tests: OECD 471 Ames OECD 476/490 HPRT/MLAOECD 487 in vitro MNT Minimum of 1, typically OECD 474 Regulations In vitro studies In vivo studies image/svg+xml Pharmaceuticals ICH S2(R1) OECD471 Ames + OECD 487 in vitro micronucleus OECD471 Ames only Minimum of 1, OECD 474 In vivo study assessing 2 endpoints Regulations In vitro studies In vivo studies

SERVICE INFORMATION

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

OECD 471: Ames Test

A bacterial reverse mutation assay has long been established to predict point mutagens and is 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. Gentronix experts have decades of experience performing Genotoxicity Ames tests and work with you to perform the studies, 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 detects structural and numerical chromosomal damage, utilising either TK6 or primary human lymphocyte cells. When the in vitro genotoxicity micronucleus assay is combined with an Ames test for Genotoxicity or mouse lymphoma assay, all key classes of genotoxic agents can be reliably detected.  The assay can also be modified by adding FISH to enable discrimination between clastogenic and aneugenic mechanisms, which can be critical for refining risk assessments.

OECD 490: Mouse Lymphoma Assay (MLA)

The MLA is a mammalian cell gene mutation assay that can detect clastogenicity and point mutations, making it a favoured Genotoxicity assay for many clients.  The MLA is complementary to the Genotoxicity 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, detecting clastogenic and aneugenic modes of action for substances with systemic exposure. The test is used to identify substances that induce micronuclei formation 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 and providing further investigation of genotoxicity detected within the in vitro assay battery.

Laboratory professional in a white coat handling and organizing test tubes on a bench in a modern laboratory environment.
Scientist handling cryogenically frozen samples with gloved hands, part of the OECD 442C Direct Peptide Reactivity Assay process for testing skin sensitization using peptides.

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