genotoxicity

Genotoxicity testing

A full evaluation of a chemical’s ability to induce the possible types of genetic damage involved in adverse human health outcomes (cancer, non-cancer diseases involving somatic cell mutation, and heritable disease) includes tests that can detect gene mutation, chromosomal damage, and aneuploidy. To adequately cover all the genetic endpoints, a battery of tests is required as no individual test can provide information on all endpoints.

Vivotecnia offers complete testing regulatory packages for chemicals which allow the full assessment of the genotoxic potential of your compound through the detection of gene mutations, structural chromosomal aberrations, and numerical chromosomal abnormalities.

The evaluation of the genotoxicity is an important component of the safety assessment of substances, relevant in the context of EU and international regulations aiming at the protection of human health and the environment.

The results of the genotoxicity tests form the scientific basis for risk assessment and are used for classification and labelling (C&L) of chemical substances in the EU (the Dangerous Substances Directive 67/548/EEC and Regulation (EC) No. 1272/2008 on the classification, labelling and packaging (CLP) of substances and mixtures), and across the world (UN Globally Harmonised System (GHS), which apply in parallel with the REACH regulation (Regulation (EC) No 1907/2006.

According to REACH regulation, genotoxicity testing is tonnage triggered:

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Methodology
  • REACH regulation (Regulation (EC) No 1907/2006.
  •  Directive 67/548/EEC and Regulation (EC) No. 1272/2008 on the classification, labelling and
    packaging (CLP) of substances and mixtures
  • The Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

Test Methods

  • Test No. 471: Bacterial Reverse Mutation Test
  • Test No. 476: In Vitro Mammalian Cell Gene Mutation Test (Mouse Lymphoma Assay, MLA)
  • Test No. 473: In vitro Mammalian Chromosome Aberration Test
  • Test No. 487: In Vitro Mammalian Cell Micronucleus Test
  • Test No. 474: Mammalian Erythrocyte Micronucleus Test
  • Test No. 489: In Vivo Mammalian Alkaline Comet Assay
  • Test No. 486: Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo
Our team and Experience

Vivotecnia provides services and solutions to help pharmaceutical, chemical, cosmetics and other industries
to optimize the development of their compounds by testing genotoxicity through our testing packages
complying regulatory guidelines and GLP standards.
You can rely on the vast experience of our team of scientist, which have conducted hundred of assays, to
conduct an accurate and reliable genetic toxicology assessment of your compound. Vivotecnia can provide
assays and advice on follow-up strategies for mechanism elucidation (involving clastogenicity, aneugenicity
and DNA effects such as frameshift, transverse and transition mutations).

Our team will discuss with you the specific needs of your project providing detailed assay documentation and
data reporting in compliance with our internal Standard Operating Procedure protocols.

The staff is fully trained, which allow us to offer a very efficient and cost-effective service. Moreover, our team of experts is trained to troubleshoot all the issues on genotoxicity testing, and can advise you on assay design and performance to yield the best data for your compound.

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