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Corrositex (OECD 435)

The Corrositex® assay is a standardized and quantitative in vitro test developed as a replacement for the dermal corrosivity rabbit test. The Corrositex kit, manufactured by In Vitro International (IVI), uses a proprietary biobarrier membrane to model the skin for evaluating the potential dermal corrosivity of a test material.

A test material is evaluated based on its penetration through the biobarrier membrane into a Chemical Detection System (CDS). The time required for the test material to break through the biobarrier and into the CDS is determined. A U.S. Department of Transportation (USDOT) packing group is assigned based on the break through time.

The Corrositex® assay is presently the only in vitro assay approved by the U.S. Department of Transportation for testing potential corrosive materials and assigning packing group categories.

For more information about testing your materials using this assay, please see Applications. Please contact IIVS for assistance in developing specialized protocols for your test materials.

Corrositex Assay: Components of the Corrositex Assay Kit as provided by In Vitro International.
Corrositex Assay: Components of the Corrositex Assay Kit as provided by In Vitro International.
Quick Facts

Assay Model: proprietary biobarrier membrane

Detection Agent: CDS (chemical detection system)

Endpoint: the time required for a corrosive material to break through the membrane

Applications

Test Material Compatibility

The assay is compatible with both water soluble and insoluble formulations. Both solid and liquid test materials can be tested.

In order to be tested in the Corrositex® assay, test materials must cause an observable color change in the CDS. Additionally, the use of the Corrositex® assay to assign packing goups is limited to specific chemical classes, including acids, acid derivatives, acyl halides, (poly)alkylamines, bases, chlorosylanes, metal halides, and oxyhalides.

Validation/Regulatory Acceptance

  • The U.S. Department of Transportation (USDOT) accepts Corrositex® as a test to assign subcategories of corrosivity packing groups for labeling purposes according to the United Nations transport guidelines.
  • ECVAM has recommended its use as a stand-alone alternative to in vivo corrosivity tests when used in specific testing circumstances (i.e., as required by USDOT).
  • It is endorsed by NIEHS, NTP, and 13 federal agencies that support ICCVAM.
  • In 2006, OECD Test Guideline (TG 435) was adopted for the Corrositex®Assay.
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