EVALUATING THE OCULAR IRRITATION POTENTIAL OF 54 TEST ARTICLES USING THE EPIOCULAR™ HUMAN TISSUE CONSTRUCT MODEL (OCL-200).

Colgate-Palmolive is sponsoring a research program to validate the use of the EpiOcular™ Model in evaluating the eye irritation potential of surfactants. Previously, in a study that demonstrated the reliability of the EpiOcular Model, four laboratories using a formal and detailed study protocol tested 19 test materials. In the current study, two laboratories (Institute for In Vitro Sciences and MatTek Corp.) tested 54 test articles using the same study protocol. EpiOcular is a commercially available three-dimensional in vitro model of the human corneal epithelium composed of normal human-derived epidermal keratinocytes. Test articles included a shampoo formulation and 30 different surfactants (10-cationic; 11-anionic; 7-nonionic; 1-amphoteric; 1-zwitterionic) which were liquids, powders or creams. Multiple concentrations of 11 of the surfactants were tested to evaluate EpiOcular’s ability to predict dose-related differences in a test article’s potential for ocular irritation. Testing was conducted in compliance with FDA GLPs. The laboratories were blinded to the identities of the test articles. Test results were compared to previously published animal eye irritation studies. In terms of reliability, the results were reproducible within and between the laboratories. In terms of relevance, the EpiOcular model correctly predicted the Draize score for a majority of the samples tested. The model also correctly predicted increasing irritation potential of surfactants with increased concentrations. These data provide additional evidence that the EpiOcular model meets the validation criteria, as defined by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM, NIH Publication No. 97-3981) for assessing the ocular irritation potential of certain classes of surfactant and surfactant-based formulations.

Amphoteric, Animal eye irritation studies, Anionic, Cationic, Dose-related, Draize, EpiOcular, Eye irritation potential, FDA, GLP, Human corneal epithelium, ICCVAM, Interagency Coordinating Committee on the Validation of Alternative Methods, Nonionic, Normal human-derived epidermal keratinocytes, Ocular irritation, Ocular irritation potential, Prediction model, Relevance, Reliability, Surfactant, Surfactants, Validation criteria, Zwitterionic

+Disodium 2-sulfolaurate, +cetearyl alcohol, Alkyldimethyl benzyl ammonium, Ammonium lauryl sulfate (12%), Ammonium lauryl sulfate (28.2%), Ammonium nonoxyl-4 sulfate (10%), Behentrimonium methosulfate, Benzalkonium chloride, Benzalkonium chloride (0.1%), Benzalkonium chloride (0.5%), Benzalkonium chloride (1%), Benzalkonium chloride (1%), Benzalkonium chloride (10%), Benzalkonium chloride (2.5%), Benzalkonium chloride (5%), Branched alkyldimethyl (amine 30%), Branched alkyldimethylamine (1.5%), C10-12 Alcohol ethoxylate (PO), Ceteareth-12, Cetrimonium chloride (2.5%), Cetyl alcohol, Cetylpyridinium bromide (0.1%), Cetylpyridinium bromide (1%), Cetylpyridinium bromide (10%), Chloride (5%), Cocamidopropyl betaine (10%), Cocamidopropyl betaine (30%), Decyl glucoside (10%), Didecyldimonium chloride (50%), Didecyldimonium chloride (1%), Didecyldimonium chloride (3.2%), Didetyldimonium chloride (5%), Lauryl glucoside (10%), Myristalkonium chloride (20%) + 20% Quaternium-14, Myristalkonium chloride /Quaternium -14/Ethanol (3%), Myristalkonium chloride /Quaternium-14/Ethanol (20%), Octoxynol-9 (1%), Octoxynol-9 (10%), Octoxynol-9 (2.5%), Octoxynol-9 (20%), Octoxynol-9 (5%), PPG -5 Ceteth-20, Quaternium-18, Shampoo (regular), Sodium C14-16 olefin sulfonate (10%), Sodium ether sulfate 3EO (30%), Sodium laureth sulfate (12%), Sodium laureth sulfate (25.7%), Sodium lauroyl sarcosinate (10%), Sodium lauroyl sarcosinate (30%), Sodium lauryl sulfate (10%), Sodium lauryl sulfate (15%), Sodium lauryl sulfate (20%), Sodium lauryl sulfate (3%), Sodium lauryl sulfate (30%), Sodium methyl 2-sulfolaurate, TEA- lauryl sulfate (20%)