The Performance of the Tissue Equivalent Assay using the Skin(2)(TM) ZK1200 Model in the COLIPA International Validation Study on Alternatives to the Draize Eye Irritation Test

Toxicology in Vitro : an International Journal Published in Association with BIBRA
J A SoutheeE S Rasmussen

Abstract

The tissue equivalent assay (TEA) (Osborne et al., 1995) was used to evaluate 55 mixed ingredients and formulations in the COLIPA International Validation Study on Alternatives to the Draize Rabbit Eye Irritation Test (Brantom et al., 1997). The TEA can be used to test all types of materials since it uses a topical application approach and is not limited to only testing liquid or soluble materials. A prediction model (PM) for the test was developed using historical eye irritation data from a total of 132 materials on which in vivo and in vitro data were available. A regression model was derived from these data and used to relate the in vitro endpoint (t(50)) obtained in the study to a Draize MMAS (modified maximum average score). This provided a measure of the predicted in vivo eye irritation scores. In the current study, two separate laboratories used the same protocol to test the same set of coded materials and the results of both laboratories were compared to the initial PM. The TEA met the reliability criteria of the validation study in reproducing the predefined PM in both laboratories, and a good relationship between predicted and observed Draize MMAS values was obtained (r=0.906 and r=0.850). Good correlations were maint...Continue Reading

References

Nov 1, 1995·Fundamental and Applied Toxicology : Official Journal of the Society of Toxicology·R OsborneD A Roberts
Jan 1, 1997·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·R D CurrenJ F Régnier
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Feb 1, 1997·Toxicology in Vitro : an International Journal Published in Association with BIBRA·R J EspersenE S Rasmussen
Feb 1, 1997·Toxicology in Vitro : an International Journal Published in Association with BIBRA·P G BrantomM Stern

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Citations

Jun 29, 2013·International Journal of Pharmaceutics·César Burgos-DíazAna M Marqués
Nov 20, 2012·Toxicology in Vitro : an International Journal Published in Association with BIBRA·U PfannenbeckerF Van Goethem
Oct 24, 2001·Environmental Health Perspectives·A R Cunningham, H S Rosenkranz
Dec 15, 2004·Alternatives to Laboratory Animals : ATLA·Ludwig A Hothorn
Nov 16, 2001·Alternatives to Laboratory Animals : ATLA·P A JonesJ H Fentem
Jan 7, 2003·Alternatives to Laboratory Animals : ATLA·Rodger D Curren, John W Harbell
Oct 1, 2005·Alternatives to Laboratory Animals : ATLA·Chantra EskesValérie Zuang

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