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COSMETICS EUROPE MULTI-LABORATORY PRE-VALIDATION OF THE EPIOCULAR™ RECONSTITUTED HUMAN TISSUE TEST METHOD FOR THE PREDICTION OF EYE IRRITATION.

Pfannenbecker1, U., Bessou-Touya2, S., Faller3, C., Harbell4, J., Jacob5, T., Raabe6, H., Tailhardat7, M., Alépée8, N., De Smedt9, A., De Wever10, B., Jones11, P., Kaluzhny12, Y., Le Varlet13, B., McNamee14, P., Marrec-Fairley15, M., Van Goethem9, F.  1Beiersdorf AG, Hamburg, Germany.  2Laboratoire Pierre Fabre, Castres, France.  3Procter & Gamble/Cosmital, Marly, Switzerland.  4Mary Kay Inc., Dallas, TX, USA.  5Avon Products, Inc., Suffern, NY, USA.  6Institute for In Vitro Sciences, Inc., Gaithersburg, MD, USA.  7LVMH Recherche, St. Jean De Braye Cedex, France.  8L’Oréal Research & Innovation, Aulnay Sous Bois, France.  9Janssen Research & Development, Beerse, Belgium.  10Henkel AG & Co. KGaA, Düsseldorf, Germany.  11Safety and Environmental Assurance Centre, Unilever, Sharnbrook, UK.  12MatTek Corporation, Ashland, MA, USA.  13Consultant, Links Ingénierie, Paris, France. 14The Procter & Gamble Company, Egham, Surrey, UK.  15Colipa, Brussels, Belgium.
Abstract

Cosmetics Europe, The Personal Care Association (known as Colipa before 2012), conducted a program of  technology transfer andwithin/between laboratory reproducibility of MatTek Corporation’s EpiOcular™  Eye Irritation Test (EIT) as one of the two human reconstructed tissue test methods. This EIT EpiOcular™ used a single exposure period for each chemical and a prediction model based on a cut-off in relative survival [≤660% = irritant (I) (GHS categories 2 and 1); >60% = no classification (NC)]. Test substance single exposure time was 30 min with a 2-h post-exposure incubation for liquids and 90 min with an 18-h post-exposure incubation for solids. Tissue viability was determined by tetrazolium dye (MTT) reduction.  Combinations of 20 coded chemicals were tested in 7 laboratories. Standardized laboratory documentation was used by all laboratories. Twenty liquids (11 NC/9 I) plus 5 solids (3 NC/2 I) were selected so that both exposure regimens could be assessed. Concurrent positive (methyl acetate) and negative (water) controls were tested in each trial. In all, 298 independent trials were performed and demonstrated 99.7% agreement in prediction (NC/I) across the laboratories. Coefficients of variation for the% survival for tissues from each treatment group across laboratories were generally low. This protocol has entered in 2010 the experimental phase of a formal ECVAM validation program.  

Keywords

Cosmetics Europe, Eye irritation test (EIT), Interlaboratory transferability, OCL-200, Reproducibility, Validation, Validation study

Materials Tested

1-Octanol, 2-Ethyl-1-hexanol, 2-Methyl-1-pentanol, 3,3-Dimethylpentane, 3-Methoxy-1,2-propanediol, Acetone, Aluminum hydroxide, Benzalkonium chloride, Cetylpyridinium bromide, Cyclohexanol, Ethanol, Glycerol 56-81-5, Iminodibenzyl, Methyl acetate , Methyl amyl ketone, Methyl cyclopentane, Methyl isobutyl ketone, n-Hexanol, Phenothiazine, Polyethylene glycol, Quinacrine, Sodium hydroxide (1%), Tetraoctylammonium bromide, Toluene, Triton X-100 (5%), Tween 20

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