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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 "Use of international standard ISO 10993-1"]

Applicable Standards

  • ISO 10993

Test Options

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Code Test 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)
SCX420 - Sub-Acute Toxicity: 14 day and 14 dose (rats)

Sample Specifications

SCX410: 14 complete devices, each device must be 120 cm2 or 4 grams. CSS Approval is needed to meet TAT.
SCX420: 14 complete devices, each device must be 270 cm2 or 9 grams. CSS Approval is needed to meet TAT.

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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