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Genotoxicology

The Interaction between Chemical Substances and DNA can have Serious Consequences for the Organism

Genotoxic chemicals are prohibited in many uses. Therefore, the assessment of genotoxicity is a must for any substance to be registered and approved. To obtain information on genotoxicity of a substance, tests are required in different organisms and assessing different genetic endpoints. Based on the results from these different test systems, a final risk assessment for the chemical can then be done.

We can perform for you a complete set of in vitro tests in our GLP-certified laboratories, which as required, can be complemented by further well-established In-Vivo tests.

Genotoxicity testing strategies are designed in a step-wise manner, where the initial tests for gene mutagenicity are performed in bacterial systems. Based on these results, studies follow in e.g. immortalised mammalian cell lines and / or in primary mammalian cell cultures. These test systems cover both gene mutations as well as effects of clastogens and aneugens as important genetic endpoints.

We’re working tirelessly with the establishment and validation of new In-Vitro test systems in order to fulfil the principles of 3R (Refine, Reduce, Replace) and offer new alternatives to animal testing. One such promising alternative for investigating clastogenicity and aneugenicity is the Hen’s Egg Test on induction of micronuclei (HET-MN).

We offer the Bhas 42 cell transformation assay as an adequate test system to identify non-genotoxic carcinogens.

Most of the In-Vitro test systems are also offered as modified screening tests and we‘re happy to customise a test design to meet your special needs.

Our Test Methods:

In-Vitro Genotoxicology

  • In-Vitro gene mutation study in bacteria: Ames Test
    • OECD 471 / ICH S2
  • In-Vitro gene mutation study in mammalian cells: Mouse Lymphoma Assay (MLTK Assay)
    • OECD 490 / ICH S2
  • In-Vitro gene mutation study in mammalian cells: HPRT test
    • OECD 476 / ICH S2
  • Micronucleus Assay In-Vitro (Human Lymphocytes or V79 cells)
    • OECD 487 / ICH S2
    • Fluorescence In Situ Hybridisation (FISH)
  • Chromosomal aberration Assay In-Vitro (Human Lymphocytes or V79 cells)
    • OECD 473 / ICH S2
  • Hen’s Egg Test – Induction of Micronuclei (HET-MN)
  • COMET Assay in different cell types

In-Vitro Detection of non-genotoxic Carcinogens

  • Cell Transformation Assay in Bhas Cells
    • OECD GD 231 (draft)

In-Vivo Genotoxicology

  • Mammalian Erythrocyte Micronucleus Test
    • OECD 474 / ICH S2
  • Combined Mammalian Erythrocyte Micronucleus Test with concurrent Alkaline Comet Assay In-Vivo
    • OECD 474 & 489 / ICH S2
  • In-Vivo Mammalian Alkaline Comet Assay (several organs on request)
    • OECD 489 / ICH S2
  • Mammalian Spermatogonial Chromosomal Aberration test
    • OECD 483 / ICH S2
  • Mammalian Bone Marrow Chromosomal Aberration test
    • OECD 475 / ICH S2
Contact

Contact us!

To learn more about us and what we can do for you please contact us at info@iccr-rossdorf.de

The experienced and highly committed GBA Group team offers a variety of different services the following in Areas:

GBA Group - In vitro ADME

In-Vitro ADME

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GBA Group - In vivo DMPK

In-Vivo DMPK

GBA Group - In vitro & in vivo Toxicology

In-Vitro & In-Vivo Toxicology

GBA Group - G(C)LP & non-GLP Bioanalytics

G(C)LP & non-GLP Bioanalytics

GBA Group - Biomarker Services

Biomarker Services

GBA Group - In vitro & in vivo Pharmacology

In-Vitro & In-Vivo Pharmacology

GBA Group - Preclinical Services

Preclinical Services

Genotoxicology

Genotoxicology

General Toxicology

General Toxicology

Sensitisation

Sensitisation

Toxicology Additional Services

Toxicology: Additional Services

Corrosion and Irritation

Corrosion and Irritation

GBA Group Pharma

GBA Group Pharma

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