Genotoxicity
ISO 10993-3 genetic toxicology of device extracts: bacterial reverse mutation (Ames), chromosomal aberration, and mouse lymphoma (TK). These are three methods, not one panel, unless the evaluation says otherwise.
Genotoxicity is a battery, not a testISO 10993-3 expects both a bacterial and a mammalian-cell assay; a negative Ames alone does not close the endpoint. It is also the endpoint most often addressed by chemical characterization and a toxicological risk assessment instead — except in China, where a chemistry-first substitution is not accepted.
Genotoxicity: Bacterial Reverse Mutation Assay (AMES), 2 Extracts (GLP) - Internationally Sourced
Bacterial reverse mutation (Ames) assay per ISO 10993-3:2014, using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.
GRK-4005-01X
Genotoxicity: Chromosomal Aberration Assay, 2 Extracts (GLP) - Internationally Sourced
In vitro chromosomal aberration assay per ISO 10993-3:2014.
GRK-4005-02X
Genotoxicity: Mouse Lymphoma Assay (TK Assay), 2 Extracts (GLP) - Internationally Sourced
Mouse lymphoma (tk) assay per ISO 10993-3:2014.
GRK-4005-03X
Filter by
Filter by attributes
- Turnaround band
- Testing location
- Endpoint
- Standards
- Subcontracted