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Sub-Acute/Sub-Chronic Toxicity Test

Sub-Acute/Sub-Chronic Toxicity Test

The Biocompatibility Sub-acute and Sub-chronic Toxicity test is used to discover the effects a material with repeat exposure would have on a patient, including any compound toxicity effects. It determines the systemic effect of repeated doses of materials or their extracts for no less than 24 hours and no greater than 10% of the total life span of the test animal. This Biocompatibility  Sub-acute/Sub-chronic Toxicity testing complies with ISO 10993-11.

Download the biocompatibility test matrix. [Based on ISO 10993-1:2010 (E) and FDA G95-1 Guidelines]

Applicable Standards

  • ISO 10993

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
SCX410 Sub-Acute Toxicity: 14 day and 14 dose (mice) Add
SCX420 Sub-Acute Toxicity: 14 day and 14 dose (rats) Add
SCX410 - Sub-Acute Toxicity: 14 day and 14 dose (mice)
Standard TAT not available for this product
SCX420 - Sub-Acute Toxicity: 14 day and 14 dose (rats)
Standard TAT not available for this product

Sample Specifications

SCX410: Turn Around Time is 91 days from PDS approval. 14 complete devices, each device must be 120 cm2 or 4 grams.
SCX420: Turn Around Time is 91 days from PDS approval. 14 complete devices, each device must be 270 cm2 or 9 grams.

Study Outline

In the Biocompatibility Sub-acute/Sub-chronic Toxicity test, mice or rats will be administered, intravenously or intraperitoneally, a dose of 0.9% normal saline or cotton seed extract of the test article/vehicle control 14 times over a 14-day test period. Animals will be observed once daily for signs of toxicity. Animal weights will be recorded on Day 0, Day 7 and Day 14. On Day 14, blood samples will be collected for hematology and clinical chemistry analysis. A gross necropsy will be performed, and any lesions will be collected. The tissues listed in the appendix will be collected and submitted for histopathology.
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