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Corrositex®

What is Corrositex®?


Corrositex® is an in vitro test that determines chemical corrosivity and permits assignment of GHS Category and U.N. Packing Group classification for Class 8 corrosives. This test fully replaces the rabbit test of dermal corrosivity by providing a reliable means of mimicking this test. The proprietary core technology of the Corrositex® test is based upon a biomembrane and chemical detection system, which becomes colored when exposed to potentially corrosive substances.

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How the Test Works

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The Corrositex® testing system consists of a glass vial filled with a chemical detection fluid capped by a proprietary bio-barrier membrane, which is designed to mimic the effect of corrosives on living skin.

The Corrositex® test is performed in three steps. First, a qualification test is done to insure that the test sample and the CDS reagent are compatible. If a physical change or color change is observed, the sample is judged to be compatible with the detection solution and the remainder of the test is performed. The second step of the Corrositex® test utilizes appropriate indicator solutions to permit categorization of the test sample as either a Corrositex® Category 1 or Corrositex® Category 2 material. Corrositex® Category 1 materials are typically strong acids/bases, while Corrositex® Category 2 materials are typically weak acids/bases. The third step in the test is performed by applying the test sample to the biobarrier. When the chemical permeates through or destroys the full thickness of this biobarrier, it comes into contact with the CDS which then undergoes a simple color change. This color change is visually observed and the time required for the color change to occur is recorded. Users simply record the time it takes for the sample to break through the membrane. Then, depending on their needs, they can assign the proper GHS Category and/or U.N. Packing Group classification for U.S. DOT or EPA compliance, or use the data as a ranking tool or to substantiate marketing claims.

Why Use Corrositex®?

Because it’s regulatory approval will save you time and money.                                     

  • The test method was granted regulatory approval (1995) as a full replacement for the in vivo rabbit skin corrosivity test for specific classes of chemicals, such as acids, bases and their derivatives which meet the technical requirements of the assay, and to rank them with respect to their degree of corrosive effect as permitted in the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) (OECD Test Guideline 435, OECD, 2006).
  • Time Savings: Unlike animal testing that can take 2 to 4 weeks, Corrositex® testing can provide a Packing Group determination in as little as 3 minutes and no longer than 4 hours.
  • Cost Savings: In a recent evaluation, one customer saved up to $50,000 annually, in shipping costs, for a single compound when using the Corrositex® test to define the Packing Group instead of relying on pH. In addition to the reduction in shipping charges, additional cost savings are found in the areas of workplace safety and MSDS development.

Regulatory Acceptance.
Following is a list of agencies that accept Corrositex. This list continues to grow as regulatory bodies look for more accurate, cost-effective and humane testing methods. Copies provided upon request.

United Nations (UN) GHS

Acceptance, Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Fifth revised edition, UN New York and Geneva, 2013. P. 126 (d).

EU/OECD
Approval July 19, 2006

European Centre for the Validation of Alternative Methods (ECVAM)
12/2002


Department of Transportation – DOT-E 10904 

Original exemption granted April 28, 1993

US DOT (PHMSA) Communication eliminating need for SP-10904

Transport Canada – Permit For Equivalent Level of Safety SU 4483
Original approval 8/14/96
Additional renewal 9/18/98
Additional renewal 1/15/01
Full Draize Replacement Acceptance 3/5/02

Occupational Safety and Health Administration (OSHA)
Letter of Interpretation dated March 3, 1994
Formal Acceptance, NIEHS press release dated 3/21/00

International Air Transportation Association (IATA)
Letter of acceptance dated December 17, 1993

EPA Federal Register / Vol. 60, No. 142 Dermal Corrosion Method 1120 June 13, 1997
Formal Acceptance, NIEHS press release dated 3/21/00

Consumer Product Safety Commission (CPSC)
Formal Acceptance, NIEHS press release dated 3/21/00