When this test applies
ISO 10993-1:2025 flags genotoxicity for devices with prolonged or long-term contact, and for any device where chemical characterisation or the material itself gives reason for concern. The Ames assay is the gene-mutation arm of the ISO 10993-3 battery and the first test run; the chromosomal aberration and mouse lymphoma assays cover the remaining endpoints.
When to run it
After cytotoxicity, and once the material and process are locked. Run it alongside the other genotoxicity assays you need, because all three use extracts prepared the same way and sample preparation is shared. Where good chemical characterisation exists, an ISO 10993-17 assessment that screens each constituent for genotoxic structural alerts may address the endpoint without testing — check that route with a toxicologist before commissioning.
What a pass tells you
That neither extract produced a concentration-related, reproducible increase in revertant colonies relative to the vehicle control across the five tester strains, with and without S9 metabolic activation — a non-mutagenic result under ISO 10993-3 and OECD 471.
What it does not tell you
A negative Ames result addresses gene mutation in bacteria only. It says nothing about chromosomal damage (clastogenicity) or mammalian cell mutation, which is why ISO 10993-3 asks for a battery rather than one test. It also says nothing about cytotoxicity, sensitization, irritation or systemic effects.
Method
Testing per ISO 10993-3:2014 and OECD 471. Two extracts are prepared at 25 mL per extract — 0.9% sodium chloride (polar) and dimethyl sulfoxide (non-polar) — and tested in a five-concentration design against Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102, with and without S9 activation, against concurrent negative and positive controls. Extraction ratio follows ISO 10993-12: 6 cm²/mL for material under 0.5 mm thick, 3 cm²/mL at 0.5 mm or thicker, or 0.1 to 0.2 g/mL where surface area is indeterminate.
Where it runs
This method is internationally sourced (OUS). The laboratory is ISO/IEC 17025 accredited and GLP certified, and the report is issued under Groenakker’s ISO 13485:2016 certified quality system, in Groenakker’s report template or in your document template on request at no extra cost.
Usually ordered alongside
The rest of the ISO 10993-3 battery where it is required: chromosomal aberration (GRK-4005-02) for clastogenicity and the mouse lymphoma assay (GRK-4005-03) for mammalian cell mutation. Cytotoxicity should already be clear. If you do not yet have a biological evaluation plan, that is the place to start — a BEP typically removes tests from a list rather than adding them.
