Understanding Systemic Toxicity Testing
Acute systemic toxicity assaying is the most commonly performed, and includes a single exposure with a 72-hour observation period. Repeat or continuous exposure periods are classified as subacute, chronic, and subchronic. The route of exposure should be chosen based on clinical relevance. Possible dose routes include implantation, intraperitoneal, intravenous, oral, and subcutaneous. Exposure to the test article may be in the form of an extract or direct exposure of the test article, as appropriate. Unlike acute systemic toxicity, the sub-acute, sub-chronic, and chronic toxicity studies, include full clinical pathology (clinical chemistry, hematology, and coagulation), necropsy and organ weights, as well as histopathology.
Subacute and subchronic toxicity testing can either be performed with full histopathology or a limited, abridged tissue evaluation.
Testing Capabilities
- Acute, subacute, subchronic and chronic toxicity
- Dose routes: IV, IP, IM, subcutaneous, dermal, and oral
- Customized studies
Testing Categories and Specifications – Acute Systemic Toxicity
Test Name | Sample Needed | Turn-around Time |
---|---|---|
Acute Systemic Injection Assay | 1 Extract: 120 cm² < 0.5mm thick, 60 cm² ≥ 0.5 mm thick, or 4 g 2 Extracts: 240 cm² < 0.5mm thick, 120 cm² ≥ 0.5 mm thick, or 8 g 3 Extracts: 360 cm² < 0.5mm thick, 180 cm² ≥ 0.5 mm thick, or 12 g 4 Extracts: 480 cm² < 0.5mm thick, 240 cm² ≥ 0.5 mm thick, or 16 g Direct Exposure: minimum of 10 mL | 4 weeks |
Testing Categories and Specifications – Subacute Systemic Toxicity
Test Name | Sample Needed | Turn-around Time |
---|---|---|
14-Day IV and /or IP Subacute Toxicity Study | 5,040 cm² (IV), 450 (IP) <0.5 mm thick, 2,520 (IV), 225 (IP) cm² ≥0.5 mm thick, or 168 grams (IV), 30 grams (IP) | 10 weeks |
28-Day Implant Subacute Toxicity Study | To be determined | 14 weeks |
Testing Categories and Specifications – Subchronic Systemic Toxicity
Test Name | Sample Needed | Turn-around Time |
---|---|---|
28-Day IV and /or IP Subchronic Toxicity Study | 10,080 cm² (IV), 900 (IP) <0.5 mm thick, 5,090 cm² (IV), 450 (IP) cm² ≥0.5 mm thick, or 336 grams (IV), 60 grams (IP) | 16 weeks |
90-Day Implant Subchronic Toxicity Study | To be determined | 21 weeks |
Testing Categories and Specifications – Chronic Systemic Toxicity
Test Name | Sample Needed | Turn-around Time |
---|---|---|
26-Week Implant Chronic Toxicity Study | To be determined | 34 weeks |