Corrositex Testing Classifying for Skin Corrosion

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November 9, 2018

Using Corrositex® (OECD 435) to test and classify a product for skin corrosion

By: Joe McCarthy, Lab Service Manager/Senior Regulatory Affairs Specialist

Manufacturers, Importers and Transporters of Workplace and Consumer chemical products are required to evaluate the hazards of the products they produce 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 transporation of hazardous materials require that the hazard classification be determined and that records supporting the hazrad classification be maintained.1,2,3,4

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

Which test methods do the regulations cite for testing skin corrosion?

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”

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;

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).

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®):

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.”

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

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