Draize eye irritation test

Van Paassen [57,67] reported a synergistic decrease of the skin and eye irritation level of sodium lauryl ether sulfate by combination with lauryl ether carboxylates. The investigations have been carried out using the Draize eye irritation test and human patch test (Tables 13 and 14). Furthermore, measurements by in vitro methods, the Zein test, and the red blood cell test show low to no irritancy [251-253]. 

Draize eye irritations test using pharmaceutical intermediates. Fundam. Appl. Toxicol. 26 20-31. 

Rosenkranz, H.S., Zhang, Y.P., and Klopman, G., The development and characterisation of a structure-activity relationship model of the Draize eye irritation test, Alternatives Lab. Anim. (ATLA), 26,779-809,1998. 

The Draize eye irritancy test, in which unanesthetized rabbits have irritant substances applied to their eyes, yields results that are inherently unreliable in predicting human toxicity. Humans and rabbits differ in the structure of their eyelids and corneas as well as in their abilities to produce tears. When comparing rabbit to human data on the duration of inflammation after exposure to 14 household products, they differed by a factor of 18 to 250. 

Perrot S, DutertreCatella H, Martin C et aL (2003) Rezasurin metabolism assay is a new sensitive alternative test in isolated pig cornea. Toxicol Sci 72 122-129 Prinsen MK, Koeter HB (1993) Justification of the enucleated eye test with eyes of slaughterhouse animals as an alternative to the Draize eye irritation test with rabbits. Food Chem Toxicol 31 69-76... 

Sina JF, Galer DM, Sussman RG et al. (1995) A collaborative evaluation of seven alternatives to the Draize eye irritation test using pharmaceutical intermediates. Fundam Appl Toxicol 26(1) 20—31... 

In order to gain a better understanding of how many test substances would be acceptable, a computer simulation based on the Draize eye irritation test was used to investigate the effects of changing sample size on the precision of future predictions of an in vivo test result from an alternative method test score. For this simulation, it was assumed that the relationship between a hypothetical alternative method response, X, and a corresponding eye irritation response, Y, has the linear form ... 

Spielmann H, Liebsch M, Kalweit S, et al. (2000) Results of a validation study in Germany on two in vitro alternatives to the Draize eye irritation test, the HET-CAM test and the 3T3-NRU cytotoxicity test. Alternatives to Laboratory Animals 24 741-858. 

None of the in vitro alternative eye tests has proven applicable as a valid replacement for the Draize eye irritation test or has been acceptable for regulatory purposes (Table 5), though some are considered either reliable or reproducible. The most frequently used test has been the ex vivo bovine cornea opacity and permeability assay. The newer human corneal equivalents system, an in vitro culture of immortalized human corneal cells that develops into... 

Balls M, Botham PA, Bruner LH, Spielmann H (1995) The EC/HO international validation study on alternatives to the Draize eye irritation test. Toxicol In Vitro 9 871-929... 

ILSI Health and Environmental Sciences Institute (1996) Replacing the Draize eye irritation test scientific background and research needs. J Toxicol Cutaneous Ocular Toxicol 15 211-234... 

Vaiiparys, R L.. Dcknudl, G, H Sysmans, M, Touns. G Coussemem, W and Van Cauteren, M. H. (1993). Evaluation of the bnvine corneal opacity-permeability assay as an in vitro alternative to the Draize eye irritation test. Toxicol in Ynro 7, 471-476. 

Blein, O. Adolphe, M. Lakhdar, B. Cambar, J. Gubanski, G. Castelli, D. Contie, C. Hubert, R Latrille, F. Correlation and validation of alternative methods to the Draize eye irritation test (OPAL project). Toxicol, in Vitro 1991, 5, 555-557. 

Table 1. Maximum tolerated concentrations (MTC) of seven test substances determined from the Draize eye irritation test (EIT), and the [ HI-AA release test (pH]-AART)... 

Figure 3. MTC values of Draize eye irritation test (EIT) plotted versus MTC values of pH]-AART. The linear regression line, the corresponding equation, and the correlation coefficient (r ) are shown in the figure.

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