We can also prepare and submit the safety dossiers for your products. We have successfully prepared many REACH and biocidal products dossiers and have a good working relationship with the European authorities. In addition, we can recommend efficient testing strategies for safety valuation that optimally combine non-testing approaches, in vitro and in vivo testing.
Our Regulatory Services
All of our studies can be carried out under Good Laboratory Practice (GLP).
- OECD 431 In vitro skin corrosion in 3D skin models
- OECD 439 In vitro skin irritation in 3D skin models
- OECD 471 Bacterial reverse mutation test (Ames test)
- OECD 473 In vitro mammalian chromosome aberration test
- 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 486 Unscheduled DNA synthesis (UDS) test in mammalian liver cells in vivo
- OECD 487 In vitro mammalian cell micronucleus test
- OECD 488 In vivo transgenic rodent
Our advanced assays
- Adapted standard regulatory assays for testing of (nano)particles and gases
- Comet assay in vivo in various target organs or in cell lines
- Incorporation of genotoxicity endpoints in 28-d or 90-d repeated dose toxicity studies
- Mutagenicity in vivo (transgenic rodent, OECD 488)
- BlueScreen HC genotoxicity screening assay
Follow-up of positive in vitro results
In the case of positive results from in vitro genotoxicity testing, it may be necessary to conduct in vivo testing to assess whether the genotoxic potential observed in vitro is expressed in vivo. In vivo tests should study the appropriate genotoxic endpoint(s) identified as positive in vitro.
Suitable in vivo tests are:
- A mammalian erythrocyte micronucleus test (OECD 474)
- A transgenic rodent somatic and germ cell gene mutation assays (OECD 488)
- An in vivo Comet assay (internationally agreed protocols available)
The in vivo micronucleus test covers the endpoints of structural and numerical chromosomal aberrations and is an appropriate follow-up for in vitro clastogens and aneugens. Transgenic rodent assays can detect point mutations and small deletions and is therefore an important tool in studying in vivo mutagenicity. The in vivo Comet assay is considered a useful indicator test in terms of its sensitivity to substances which cause gene mutations and/or structural chromosomal aberrations. The advantage of both assays is that they can be used with many target tissues. Triskelion can offer all of the assays described above and is one of the few providers of the transgenic rodent assay (OECD 488). In addition to our toxicology services we offer analytical services to demonstrate exposure in both in vitro and in vivo studies.