259. ASSESSMENT OF OCULAR IRRITATION RANGES OF MARKET-LEADING COSMETIC AND PERSONAL-CARE PRODUCTS USING AN IN VITRO TISSUE EQUIVALENT.

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McCain, N.E., Binetti, R.R., Gettings, S.D., Jones, B.C. Cell Biology & In Vitro Toxicology, Avon Products, Inc., Suffern, NY. The Toxicologist, 66 (1-S), 243, Soc. of Toxicol. (Reston, VA), Abstract #1191, (2002).

Summary:
The cosmetics and personal-care industry has focused considerable effort on the search for replacements for traditional animal-based safety tests. In vitro models have been found to be particularly useful for the assessment of eye irritation potential.

Scientists in the Cell Biology & In Vitro Toxicology Dept., Avon Products, Inc. have used the MatTek EpiOcular™ OCL-200 tissue model (composed of human epidermal keratinocytes that differentiate and form a stratified squamous epithelium similar to corneal tissue) to establish ranges of in vitro ocular irritation scores for several categories of cosmetic and personal-care products.

A significant advantage of the EpiOcular model is that it can be used to discriminate between the irritation potential of extremely mild products (most cosmetic and personal care products are formulated for inherent mildness).

Materials were topically applied to the EpiOcular tissue equivalents (167 L/cm2). Surfactant-based products were tested at a concentration of 10% to simulate "rinse- off" exposures; all other products were tested without dilution. Materials were tested using either the standard (4 hours) or extended (20 hours) exposure protocol based on their expected irritation potential (i.e. consideration of formula composition, product type, etc.).

Cellular viability was used as a marker for irritation potential and measured at various time points by a MTT metabolism colorimetric assay. MTT was quantitated spectrophotometrically at 570nm and an ET50 (time to 50% loss of viability) calculated for each product. A range of in vitro ocular ET50 scores was then determined for each product category.

The results obtained from this study provide a reference database of in vitro ocular irritation scores for a cross-section of currently marketed cosmetic and personal-care products. Comparison of the ET50 for new formulations with the range of ET50 scores established for currently marketed products of similar type is a useful benchmark of anticipated consumer acceptability under conditions of actual use.

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EpiOcular Data Sheet

EpiOcular Specifications

EpiOcular Technical References

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Applications: Cosmetics analysis, Irritation - eye (ocular), Personal care products, Sunscreens

Keywords: Baby, Children, Corneal tissue, Draize, EpiOcular, Market-leading, Mild products, Non-surfactant haircare, Ocular irritancy, Ocular irritation, Sub-Draize, Surfactant formulas, Surfactant-based products, Surfactants, UV absorbers

Endpoints: ET50, MTT

Materials Tested: Adult conditioner, Adult cream, Adult lotion, Adult shampoo, Anti-dandruff shampoo, Baby lotion, Baby shampoo, Baby wash, Children's, Children's conditioner, Children's hair detangler, Children's shampoo, Cosmetic Personal Care Products, Creams, Eye area cosmetics, Eye cream, Facial creams, Liquid eyeliner, Lotions, Mascara, Mild products, Non-surfactant haircare, Pencil eyeliner, Preservatives, Sun screens

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