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Titre du document / Document title

Comparison of in vivo (draize method) and in vitro (corrositex assay) dermal corrosion values for selected industrial chemicals

Auteur(s) / Author(s)

STOBBE Jody L. (1) ; DRAKE Kevin D. (2) ; MAIER Kurt J. (3) ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

(1) Buckman Laboratories International, Inc., Memphis, Tennessee, ETATS-UNIS
(2) Microban Products Co., Huntersville, North Carolina, ETATS-UNIS
(3) Department of Environmental Health, East Tennessee State University, Johnson City, Tennessee, ETATS-UNIS

Résumé / 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 under-predicted 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.

Revue / Journal Title

International journal of toxicology    ISSN  1091-5818   CODEN IJTOFN 

Source / Source

2003, vol. 22, no2, pp. 99-107 [9 page(s) (article)] (16 ref.)

Langue / Language

Anglais

Editeur / Publisher

Sage, Thousand Oaks, CA, ETATS-UNIS  (1997) (Revue)

Mots-clés anglais / English Keywords

Alternative method

;

Irritation

;

Skin disease

;

Toxicity

;

Chemical compound

;

Investigation method

;

In vitro

;

Mots-clés français / French Keywords

Méthode alternative

;

Irritation

;

Peau pathologie

;

Toxicité

;

Composé chimique

;

Méthode étude

;

In vitro

;

Mots-clés espagnols / Spanish Keywords

Método alternativo

;

Irritación

;

Piel patología

;

Toxicidad

;

Compuesto químico

;

Método estudio

;

In vitro

;

Localisation / Location

INIST-CNRS, Cote INIST : 20351, 35400011106011.0050

Nº notice refdoc (ud4) : 14763182



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