When this test applies
ISO 10993-1:2025 flags genotoxicity for devices with prolonged or long-term contact. The chromosomal aberration assay is the clastogenicity arm of the ISO 10993-3 battery — it detects structural chromosome damage, which the Ames assay cannot — and is the usual second test where a full in vitro battery is required.
When to run it
After cytotoxicity, with the material and process locked, and normally in the same campaign as the Ames assay so that extract preparation is shared. It is the longest of the three in vitro genotoxicity assays, so plan it early in the schedule. Where a toxicologist can address genotoxicity from chemical characterisation data, confirm that first.
What a pass tells you
That neither extract produced a statistically significant, concentration-related increase in structural chromosomal aberrations relative to the concurrent negative control, with and without S9 activation, and with the positive controls responding as expected — a non-clastogenic result under ISO 10993-3 and OECD 473.
What it does not tell you
A negative result addresses structural chromosome damage only. It does not cover gene mutation (the Ames assay) or mammalian cell mutation at the tk locus (the mouse lymphoma assay), and it says nothing about cytotoxicity, sensitization, irritation or systemic toxicity.
Method
Testing per ISO 10993-3:2014 and OECD 473. Two extracts are prepared — 0.9% sodium chloride (polar) and dimethyl sulfoxide (non-polar) — and applied to a cultured mammalian cell line with and without S9 metabolic activation, against concurrent negative and positive controls. Cells are arrested in metaphase and scored for structural chromosomal aberrations. 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 Ames assay (GRK-4005-01) for gene mutation and the mouse lymphoma assay (GRK-4005-03) for mammalian cell mutation complete the in vitro battery. 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.
