Acute Systemic Toxicity Test

1. Biological Effect: Acute Systemic Toxicity
2. Turnaround time: 6 weeks
3. Sample Requirements:

ISO

120 cm² (test item < 0.5 mm thick);
60 cm² (test item ≥ 0.5 mm thick);
4 grams;
at least 2 test items;

4. Animal Quantity: 20 mice

ISO 10993-11

The purpose of the study is to determine solutions and medical device extracts for potential toxic effects as a result of a single-dose systemic injection in mice. The test item is exposed to the assay system directly or through test item extracts. Extracts of the medical device are prepared in polar vehicle (saline) and/or non-polar vehicle (cottonseed oil). The test item extract is injected intravenously and/or intraperitoneally in groups of 5 mice. The animals are observed for 24h, 48h and 72 h after administration for signs of biological reactivity. This assay is considered negative if none of the animals injected with the medical device show a significantly greater biological reaction than the animals treated with the control. If 2 or more mice die, or if 3 or more mice lose more than 2 g of body weight, or show signs of toxicity, the medical device does not meet the requirements of the assay.