When this test applies
ISO 10993-1:2025 flags systemic toxicity across contact durations from limited (up to 24 hours) through long-term. Acute systemic injection is the single-exposure arm of that endpoint: it asks what one dose of the extractables does. For most devices it is the first systemic study required, and for many short-contact devices it is the only one.
When to run it
After cytotoxicity, and after chemical characterisation where the schedule allows. An ISO 10993-17 toxicological risk assessment built on good extractables data can sometimes address the systemic endpoint without an animal study, and that is a cheaper question to ask first. The material and its manufacturing process should be locked either way.
What a pass tells you
That the test animals showed no significantly greater biological reactivity than the controls — no mortality, and no significant clinical signs or body-weight effects attributable to the extract — across the observation period, assessed per ISO 10993-11.
What it does not tell you
Nothing about cumulative exposure. A clear single-dose result does not predict what daily dosing over 14 or 28 days would show, which is exactly why the repeated-dose studies exist. It also says nothing about pyrogenicity, which is a distinct endpoint with its own test, nor about local tissue response, genotoxicity or sensitization.
Method
Testing per ISO 10993-11:2017. Two extracts are prepared at 10 mL per extract, one polar and one non-polar, giving at least two discrete dose portions. 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. Dosing is by systemic injection in the mouse (or rat) against concurrent controls, followed by observation for mortality, clinical signs and body weight.
Choosing a source
This method is available both domestically sourced and internationally sourced. Domestic shortens shipping and simplifies chain-of-custody documentation; international is generally the lower-cost route. Both laboratories are ISO/IEC 17025 accredited and GLP certified, and either report is issued under Groenakker cover, in Groenakker’s report template or in your document template on request at no extra cost. Turnaround is 6 to 7 weeks by either route.
Usually ordered alongside
Material-mediated pyrogenicity (GRK-4004-01), which is a separate endpoint rather than a subset of this one. Where contact duration warrants it, the repeated-dose studies follow — 14-day (GRK-4004-03) or 28-day dual route (GRK-4004-04). Chemical characterisation with an ISO 10993-17 assessment can reduce or remove the need for all of them.
