Corrositex® : Testing & Classifying for Skin Corrosion
Using Corrositex® (OECD 435) to test and classify a product for skin corrosion.
Corrositex® is the lowest cost, fastest, and most accurate non-animal OECD/GHS approved corrosion test available.
Dell Tech is the exclusive Canadian supplier of InVitro Corrositex® Kits and the leading accredited Corrositex® testing lab in the country.
Manufacturers, Importers, and Transporters of Workplace and Consumer chemical products are required to evaluate the hazards of their products and prepare labels that communicate the hazard information to customers, users, first responders, and inspectors.
What is a corrosive substance?
A corrosive substance is defined under various regulations including the DOT Hazardous Materials Regulations, OSHA HCS 2012, Federal Hazardous Substances Act, TDG Regulations, Hazardous Products Regulations for compliance with WHMIS (HPR), Consumer Chemicals & Containers Regulations (CCCR), and GHS as material that causes irreversible damage to the skin, namely, visible necrosis through the epidermis and into the dermis.
What do the regulations require of manufacturers?
The regulations applicable to consumer products, workplace products, and transportation of hazardous materials require that the hazard classification be determined and that records supporting the hazard classification be maintained.1,2,3,4
Which test methods do the regulations cite for testing skin corrosion?
1. Hazardous Materials Regulations 49CFR173.137
The regulations advise that “for a Class 8 material, the packing group must be determined using data obtained from tests conducted in accordance with the OECD Guideline for the Testing of Chemicals, Number 435, “In Vitro Membrane Barrier Test Method for Skin Corrosion”
2. Transportation of Dangerous Goods Regulations Section 2.40
The regulations cite testing is required “as determined in accordance with OECD Guidelines 404 or OECD Guidelines 435;
3. OSHA HCS 2012 Appendix A.2.3
OSHA advises that “In vitro alternatives that have been scientifically validated shall be used to make classification decisions” and “Examples of scientifically validated test methods for skin corrosion include OECD TG…..), and 435 (Membrane Barrier Test Method).
4. Hazards Products Regulations (WHMIS 2015)
Section 8.2.4 includes the use of “…data, in vitro or ex vivo, acquired from a scientifically validated method for the evaluation of skin corrosion” and the Technical guidance on the requirements of the Hazardous Products Act and the Hazardous Products Regulations: WHMIS 2015 supplier requirements. Section 8.2.4 cites “Examples of scientifically validated test methods for Skin Corrosion – Category 1 include…OECD TG 435 – in vitro Membrane Barrier Test Method (e.g., Corrositex®):
5. CPSC Regulations 16CFR1500.41
Includes that the use of “validated in vitro test method is recommended” and the Recommended Procedures Regarding the CPSC’s Policy on Animal Testing offers “Data generated using OECD Guidelines can be considered by CPSC in making a hazard determination as a result of the Mutual Acceptance of Data (MAD) agreement.”
6. Consumer Chemicals and Containers Regulations, 2001
CCCR Section 6(1)(e) Precedence of Data Sources accepts “results of tests conducted by the responsible person in accordance with a test methodology that conforms with good scientific practices.” and defines Good Scientific practices as including “test data, conditions and procedures similar to those set out in the OECD Test Guidelines;
Is Corrositex® a validated OECD in vitro method?
Yes. Corrositex® was validated and published in 2015 as OECD 435 In Vitro membrane Barrier test for Skin Corrosion.
Corrositex® (OECD 435) is specifically cited and accepted by the following:
- US DOT Hazardous Materials Regulations
- Canada Transportation of Dangerous Goods Regulations
- OSHA HCS 2012
- WHMIS Technical Guidance
- US EPA Method 1120
Validated in vitro OECD methods cited and accepted by the:
- Consumer Product Safety Commission Hazardous Substances Regulations
- Canada Consumer Chemicals and Containers Regulation
How does Corrositex® (OECD 435) work?
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 respond to corrosive chemicals in a manner similar to animal skin in situ.
The Corrositex® test is performed in three steps.
First, a qualification test is done to ensure 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 UN Packing Group classification for U.S. DOT, EPA compliance, or use the data as a ranking tool to substantiate marketing claims.
Does Corrositex® (OECD 435) require expensive or complicated equipment?
No, Corrositex® (OECD 435) does not require expensive or complicated equipment. The test uses standard laboratory equipment;
Equipment & materials that are required but not included with the Corrositex® (OECD 435) test kits:
- Stirrer Hot plate
- Analytical balance
- Thermometer
- Digital Timers (2)
- Eppendorf repeat pipettor
- Eppendorf combitips 2.5 mL
- Suitable container for water bath
- Refrigerator
- Plastic wrap
Does Corrositex® (OECD 435) require specialized training to perform?
No, Corrositex® (OECD 435) does not require specialized training. Corrositex® (OECD 435) can be performed by people with common laboratory bench skills such as weighing and pipetting.
You can watch a demonstration video here
How fast can the Corrositex® (OECD 435) test be performed?
The Corrositex® (OECD 435) testing can easily be completed from start to finish within one workday (8 hours).
Is Corrositex® (OECD 435) animal testing?
No, Corrositex® (OECD 435) does not use animals. It is an in vitro (test tube) method.
What are the advantages of using Corrositex® (OECD 435)?
- Accurate hazard classifications and defensible data.
- A practical alternative to animal testing.
- For the regulations that apply to your business.
- Corrositex® (OECD 435) is a fraction of the cost of animal testing
- Corrositex® (OECD 435) can reduce shipping costs with properly classified materials.
- Quick results when the timing is critical.
- The test can be performed by your staff at your facility
Where can I get the buy the Corrositex® testing system kits?
Companies residing in the United States of America
In Vitro International
800-2-INVITRO (800-246-8487)
invitro@invitrointl.com
website
Companies residing in Canada
Dell Tech
Joe McCarthy, Lab Services Manager
519-858-5024
jmccarthy@delltech.com
website
Where can I get samples tested using Corrositex® (OECD 435) if I can’t do it myself?
Have Dell Tech contact you
Many of Dell Tech’s Clients have been delighted to see their GHS classification go from 1A to 1B, 1C or non-corrosive.
| Corrosion testing with Dell Tech and Corrositex® can: | ||||||
| Save time and money with transportation (TDG) by going from | Accurately represent your product hazard (GHS) by changing from | |||||
| Corrosive | TO | Limited Quantity | Corrosive | TO | Irritant | |
| Corrosive | TO | Limited Quantity | OR | Corrosive to Skin | TO | Irritant |
1OSHA CPL 02-02-079 Inspection Procedures for the Hazard Communication Standard (HCS 2012) Section X(D)(2)(a)
2Hazardous Materials Regulations 49CFR173.22
3Transportation of Dangerous Goods Regulations 2.2.1 Proof of Classification
4CCCR 2001 Section 5 Record Keeping Requirements
Contact:
Dell Tech
Joe McCarthy, Senior Regulatory Affairs Specialist
jmccarthy@delltech.com
519-858-5024
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.
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