Consumers worry that crop protection products may potentially cause cancer through direct ingestion of residues on food and from indirect exposure. Across the world, regulators demand data for specific genetic toxicology endpoints for crop protection products, although testing strategies and reporting requirements differ. At Labcorp we understand the importance of characterizing your substance’s genetic toxicology to satisfy regulators, ensure consumer confidence and support market growth. From full strategic support across your genetic toxicology testing to simply helping you with substance.
How to get the genetic toxicology data regulators need
The potential genotoxicity of a crop protection product is driven by the basic physicochemistry of your substance so that is the starting point for planning your testing approach. However, there are a lot of additional considerations. What do different regulators want to see in terms of endpoints and specific studies? How can data for those genetic toxicology endpoints be gathered in a time and cost-efficient manner? Have you got data from one region that could be leveraged in another region?
Designing study programs that are right for you, your chemical and regulators
Labcorp can design a genotoxicology solution to suit you need – big or small. From full program design to simply performing a single assay – we can help. Our dedicated team of scientists have a track record of designing and executing genetic toxicology studies yielding high quality data. By taking a joined-up approach that combines scientific and regulatory insight, you can be confident that data is built to satisfy regulatory requirements.
High quality genetic toxicology testing matched to your needs
Labcorp run a comprehensive suite of in vitro and in vivo genetic toxicology assays:
In vitro assays:
- OECD Test No 471: Bacterial Reverse Mutation (Ames)
- OECD Test No 473: In vitro Mammalian Chromosome Aberration Test (Human lymphocytes and CHL cell)
- OECD Test No 487: In vitro Micronucleus Test (Human lymphocytes, L5178Y cells, TK6 cells)
- OECD Test No 490: In vitro Mammalian Cell Gene Mutation Test MLA (L5178Y cells)
- OECD Test No 476: In vitro Mammalian Cell Gene Mutation Test – HPRT (CHO cells and V79 cells)
In vivo assays:
- OECD Test No 474: Rodent Bone Marrow Micronucleus Test
- OECD Test No 489: Rodent Comet Assay