Systemic Acute, Subacute, Subchronic, and Chronic Toxicity

Systemic toxicity tests are in-vivo assays used to assess the impairment or activation of a system – rather than the impairment of individual cells or organs. Systemic toxicity assays evaluate a test article’s potential to induce a systemic response after exposure. Categories are based on duration of exposure and dose route.

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 NameSample NeededTurn-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 NameSample NeededTurn-around Time
14-Day IV and /or IP Subacute Toxicity Study5,040 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 StudyTo be determined14 weeks

Testing Categories and Specifications – Subchronic Systemic Toxicity

Test NameSample NeededTurn-around Time
28-Day IV and /or IP Subchronic Toxicity Study10,080 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 StudyTo be determined21 weeks

Testing Categories and Specifications – Chronic Systemic Toxicity

Test NameSample NeededTurn-around Time
26-Week Implant Chronic Toxicity StudyTo be determined34 weeks