Home Pharma Reproductive and (neuro)developmental toxicology Innovative & regulatory genotoxicity & photosafety testing
Innovative & regulatory genotoxicity & photosafety testing
The assessment of genotoxicity & photosafety is required for registration and can be crucial for the further development of your product. In addition to the standard regulatory assays, we offer a range of advanced and innovative methods for a better safety evaluation of your product.We can offer you extensive experience and expertise in both regulatory driven and non-standard assays. Our state-of-the-art study designs are in full compliance with GLP and international guidelines Our alliance with TNO enables us to offer you the latest technologies. Our advanced assays include:
- Comet assay in vivo in various different target organs/ in vitro
- Incorporation of genotoxicity endpoint in 28-d or 90-d repeated dose toxicity studies
- Mutagenicity in vivo (transgenic mouse)
- BlueScreen HC genotoxicity screening assay
- In vivo oral photosafety or dermal photosensitisation testing
- In vitro photosafety or genotoxicity in human skin models and ex vivo human skin tissue
Our regulatory services:
- OECD 432: 3T3 Neutral Red Uptake Phototoxicity Test
- OECD 471 Bacterial reverse mutation test (Ames test)
- OECD 473 In vitro mammalian chromosome aberration test (CHO, HL)
- OECD 474 Mammalian erythrocyte micronucleus test
- OECD 475 Mammalian bone marrow chromosome aberration test
- OECD 476 In vitro mammalian cell gene mutation test (MLA) with mouse lymphoma cells (TK-locus)
- OECD 482 Unscheduled DNA synthesis (UDS) with isolated rat hepatocyes
- OECD 486 Unscheduled DNA synthesis (UDS) test in mammalian liver cells in vivo
- OECD 487 In vitro mammalian cell micronucleus test