Harlan Laboratories offers a complete range of genetic toxicology studies to support the worldwide registration of pharmaceuticals, industrial chemicals, and agrochemicals, meeting current guideline requirements.
Consulting services
We offer consulting services to review data already held, and to advise on further testing requirements/strategies, if required. These services also include access to in silico analysis to assist in hazard identification and risk assessment.
In vitro studies
- Bacterial reverse mutation assay (Ames test) using Salmonella typhimurium and E.coli bacterial strains
- Chromosome aberration tests (OECD473) using human lymphocytes or rodent cell lines (CHO, CHL and V79)
- In vitro micronucleus tests (OECD 487) using human lymphocytes or V79 cells
- Mammalian cell mutation assays (OECD 476) using L5178Y (MLA), V79 or CHO cells (HPRT)
- Screening assays using the single-cell gel electrophoresis (Comet) assay
In addition to full OECD-compliant versions of the above test methods, screening versions can be offered to reduce costs in the early development stages of new molecules.
Cell transformation assays are also offered using SHE and Balb/c 3T3 cells to clients who may not be allowed to perform in vivo studies to investigate the possible carcinogenic potential of in vitro positive results in genetic toxicology tests
In vivo studies
- Micronucleus studies in bone marrow (OECD 474) in either mice or rats
- Chromosome aberration tests in bone marrow (OECD 475) in either mice or rats
- UDS studies (OECD 486) in liver cells in rats
- Comet assays in mice or rats with multiple tissues