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Mouse Micronucleus Test

Mouse Micronucleus Test

The Mouse Micronucleus assay is used to evaluate the potential of a medical device to induce micronuclei formation in immature polychromatic erythrocytes present in the bone marrow of adult mice. Nelson Laboratories performs this test in compliance with ISO 10993-3.

Applicable Standards

  • ISO 10993-3

Test Options

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SCX510 Genotoxicity: In Vivo Mouse Micronucleus, 2 extracts Add
SCX510 - Genotoxicity: In Vivo Mouse Micronucleus, 2 extracts

Sample Specifications

SCX510: 2 complete devices each device must be 120 cm2 or 4 grams per extract. CSS Approval is needed to meet TAT.

Study Outline

In the Mouse Micronucleus test, a medical device is extracted in a polar and non-polar media. The test article extract positive controls and negative controls are administered at 20 mL/kg in both male and female mice. Bone marrow is then harvested at 24 and 48 hours after dosing and examined for the presence of micronucleated polychromatic erythrocytes (PCEs). The presence of PCEs is an indication of mutagenic substance leached off of the device.
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