Comparison of In Vivo (Draize Method) and In Vitro (Corrositex Assay) Dermal Corrosion Values for Selected Industrial Chemicals

Abstract

Skin irritation is a common occupational hazard for employees engaged in the manufacture, transport, and use of industrial chemicals. The most common method used to evaluate dermal irritation and/or corrosion has typically been in vivo tests using rabbits (Draize method). Several in vitro test methods have been developed, with Corrositex being the first to gain approval by a regulatory agency (U.S. Department of Transportation). The purpose of this study was to compare the results of in vitro (Corrositex) assays of dermal irritation/corrosion to in vivo test data for several industrial chemical formulations and to determine the predictability and usefulness of the Corrositex assay for these types of products. Twenty-four (24) formulations were qualified, categorized, and evaluated using the Corrositex method and the results compared to available animal data for each of the formulations. The Corrositex assay accurately predicted a corrosive end point in 8 (57.1%) of the 14 formulations identified as corrosive by the in vivo evaluations. Corrositex accurately predicted a noncorrosive end point for 1 (10%) of 10 formulations determined to be noncorrosive in animal studies. The Corrositex assay overpredicted the packing group for 12 (50%) of the 24 formulations, and underpredicted the packing group for 7 (29.2%) of the 24 formulations. Compared to the in vivo results, Corrositex correctly classified as corrosive or noncorrosive 37.5% of the formulations tested. A concordance of 20.8% for the packing group assignments of the evaluated formulations was calculated. The Corrositex assay did not accurately predict a corrosive end point or packing group assignment for all of the formulations used in this study. Manufacturers should assess the relevance of this method to their products prior to relying on it for compliance with hazardous material and worker safety regulations.

Microemulsion System for Topical Delivery of Thai Mango Seed Kernel Extract: Development, Physicochemical Characterisation and Ex Vivo Skin Permeation Studies

“…To determine the corrosive potential of the MSKE-loaded microemulsion formulation, an ex vivo method was developed that was derived from the Corrositex ® test [37,44]. Corrosive substances can destroy epidermis proteins and result in a colour shift in an underlying chemical detection liquid.…”

Alternative Methods for Eye and Skin Irritation Tests: An Overview

“…The Corrositex assay did not accurately predict a corrosive endpoint or packing group assignment for all of the formulations used in this study. Manufacturers should assess this method's relevance to their products before using it to comply with hazardous material and worker safety regulations 84. Corrositex is a validated and accepted dermal corrosion test method for classifying substances.…”

Screening for potential hazard effects from four nitramines on human eye and skin

“…The Corrositex Skin corrosion test is a non-cellular (no living tissues involved) barrier model (Stobbe et al, 2003). The test method utilizes a synthetic membrane (Biobarrier) designed to respond to corrosive substances in a manner similar to animal skin in situ (Stobbe et al, 2003) and is based on OECD TG 435 (OECD, 2006).…”

“…The test method utilizes a synthetic membrane (Biobarrier) designed to respond to corrosive substances in a manner similar to animal skin in situ (Stobbe et al, 2003) and is based on OECD TG 435 (OECD, 2006).…”