Mutagenicity / Genotoxicity
Mutagenicity / Genotoxicity

Mutagenicity and Genotoxicity

Mutagenicity and Genotoxicity

For the evaluation of genotoxic and/or mutagenic effects LAUS offers the following test methods:

Test methods
Guideline Description

OECD 471

Bacterial Reverse Mutation Test – Ames Test

 

Ames Treat & Wash: modified procedure for amino acid-containing material

 

Ames MITI: for Japanese Ministry of International Trade and Industry

 

Ames ICH M7: for pharmaceutical impurities

 

Ames MPF: miniaturized assay for extreme small amounts (screening)

OECD 473

In Vitro Mammalian Chromosome Aberration Test

OECD 487

In Vitro Mammalian Cell Micronucleus Test

OECD 490

In Vitro Mammalian Cell Gene Mutation Test: Mouse Lymphoma Test

OECD 476

Hypoxanthine-guanine phosphoribosyl transferase Test: HPRT Test

The selection of a suitable test systems often depends on the test substance as well as the regulatory requirements. For nanomaterials, for example, exposure and proof of uptake into the cells are central components of the study. We will gladly develop a customized protocol with you to address specific properties of the test substance or to meet specific requirements.

Since a single test is not capable to detect all relevant genotoxic/mutagenic agents, the usual approach is to conduct a battery of tests of different focuses. Therefore, the tests are separated in three different categories:

  • Testing of gene mutations on bacteria
  • Testing of numerical and/or structural chromosome aberrations (aneugenic and clastogenic effects) on mammalian cells/human lymphocytes
  • Testing of gene mutations on mammalian cells

In addition to human lymphocytes, the following cell lines are available:

  • TK6 CRL8015 (human lymphoblast cell line isolated from spleen)
  • L5178Y TK+/- clone (3.7.2C) (mouse lymphocytes)
  • V79-4 (hamster lung fibroblasts)

The study you need is not listed? Please contact us. We’ll prepare you an individual offer for your needs.