Vivotecnia offers comprehensive regulatory testing packages for chemicals which allow the full assessment of the genotoxic potential of your compound by detecting gene mutations, structural chromosomal aberrations, and numerical chromosomal abnormalities.
Evaluation of genotoxicity is an indispensable component in assessing substance safety, relevant in the context of EU and international regulations aimed at protecting human health and the environment.
Genotoxicity tests results form the scientific basis for risk assessment and are used for classifying and labeling (C&L) chemical substances in the EU (see Directive 67/548/EEC and Regulation (EC) No. 1272/2008), and worldwide (see GHS), which apply in parallel with the REACH regulation (Regulation (EC) No 1907/2006).
According to REACH regulation, genotoxicity testing is tonnage triggered:
- Registration, evaluation, authorisation and restriction of chemicals (REACH), Regulation (EC) No 1907/2006
- Council directive on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, Directive 67/548/EEC
- European Parliament and Council regulation on the classification, labeling and packaging (CLP) of substances and mixtures, Regulation (EC) No. 1272/2008
- Globally Harmonized System of Classification and Labeling of Chemicals (GHS)
- In vitro bacterial reverse mutation test (OECD 471, Ames test)
- In vitro mammalian chromosome aberration test, OECD 473
- Mammalian erythrocyte micronucleus test, OECD 474
- In vitro mammalian cell gene mutation test (mouse lymphoma assay, MLA), OECD 476
- Unscheduled DNA Synthesis (UDS) test with mammalian liver cells in vivo, OECD 486
- In vitro mammalian cell micronucleus test, OECD 487
- In vivo mammalian alkaline comet assay, OECD 489
Our team and Experience
Our scientific team’s vast experience, having performed hundreds of these assays, means you can rely on us to accurately and reliably assess the genetic toxicology of your compound. Vivotecnia can deliver assays and advice on follow-up strategies for mechanism elucidation (involving clastogenicity, aneugenicity and DNA effects such as frameshift or transverse and transition mutations).
Our team will discuss the specific needs of your project with you and provide detailed assay documentation and data reporting in compliance with our internal standard operating procedures.
Our staff is fully trained, making the service we offer highly efficient and cost-effective. Moreover, our team of experts is trained to troubleshoot all issues involved in genotoxicity testing and can advise you on optimum assay design and performance to yield the best data for your compound.
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Inhalation toxicity studies are required to assess the exposure hazards of consumer products or to manufacturing workers.
Our team of experienced, highly-educated scientists, experts in toxicology, molecular biology, chemistry and immunology, fully understands that the drug development process is distinct for each approach.