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During product development of new personal care or cosmetic formulations, the eye irritation potential is evaluated to identify which may cause adverse corneal reaction. Understanding and evaluating the irritation potential of chemicals or formulations is an important consideration to avoid exposing human volunteers to potentially irritating materials during clinical testing.
的 在体外 Epi眼 MTT ET-50 assay is used as a screen to assign expected 在活的有机体内 irritancy responses based on the time to toxicity (ET-50) results obtained with Epi眼. This test is also used to rank order test formulations according to their eye irritation potential.
Epi眼 “Sub-Draize” Ultra-mildness Test
的 Epi眼 Ultra-mildness Test is an 在体外 risk assessment assay routinely utilized for mild materials for which the Draize test is insensitive. This highly reproducible assay allows for quantifiable discrimination among mild, milder and mildest product formulations.
Epi眼 MTT ET-50 (Neat)
This 在体外 risk assessment assay is based on the effective time at which a material (applied neat) causes a 50% reduction in tissue viability (ET-50). Based on the ET-50, the test article is categorized into one of 4 classifications ranging from non-irritating to severe/extreme which correspond to groupings of Rabbit Draize Eye Scores (MMAS).
Epi眼 MTT ET-50 (Dilution)
Similar to the MTT ET-50 Neat method, this 在体外 risk assessment assay is based on the effective time at which a material (diluted to 20% in water) causes a 50% reduction in tissue viability (ET-50). Based on the ET-50, the test article is categorized into one of 4 classifications ranging from non-irritating to severe/extreme which correspond to groupings of Rabbit Draize Eye Scores (MMAS). This method is recommended for surfactant-based solutions and is applicable to water-soluble materials with a specific gravity of > 0.95.
Kandarova H. 等., (2018). CON4EI: Epi眼 Eye Irritation Test (Epi眼 EIT) for hazard identification and labeling of eye irritating chemicals. Toxicol. in Vitro 49, 21-23.
Kandarova H.Klausner,米.、Kubilus J.Ayehunie,年代.海登,P.Kaluzhny Y., Letasiova, S., and Sheasgreen, J. Update on Validation Status and Industry Utilization of Normal Human 3D NHu-3D Animal Alternative Models. Presented at 8th World Congress on Alternative and Animal Use, Montreal, Canada, 2011.
Klausner, M.奥斯本,米., Bellavance, K., Breyfogle B.、Kubilus J.Cerven D.R., and DeGeorge, G. 的 Epi眼 Prediction Model: 在活的有机体内 Versus 在体外 Draize Scores for Consumer 产品. Presented at the 2000 Society of 毒理学 Meeting.
Kubilis J.、Sennott H.眉目传情,P., and Klausner, M. Reproducibility and Correlation of Epi眼, a Three-Dimensional Tissue Culture Model of the Human Corneal Epithelium. Presented at the 1996 Society of 毒理学 Meeting.
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