Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (11) EYTEXTM

An overview of current techniques for ocular toxicity testing

“…One of the original alternative ocular irritation models was the EYTEX TM system which was developed, tested and evaluated in the 1990s (Courtellemont et al, 1999;Gordon et al, 1990;Matsukawa et al, 1999;Roy et al, 1994). Although EYTEX TM was unreliable at predicting ocular irritancy, primarily due to the lack of an appropriate prediction model; it did set the stage for the development of ocular toxicity models.…”

Liposome Assay for Evaluating Ocular Toxicity of Surfactants

“…Both coefficients were computed for comparisons with either in vitro method, as both Pearson's 3,4,6 -8,13,18,20 and Spearman's 3,6,8,19 have been reported for correlations between in vitro methods and Draize data. The prediction equations calculated from Draize data at 10% from Kennah et al, 18 Tachon et al, 19 and Matsukawa et al 4 were compared with 95% confidence intervals used for mean Draize scores as a function of percentage calcein leakage (JMP software; SAS, Cary, NC). The predicted Draize scores from the correlations were used to assign each surfactant to one of three categories based on the following scale: mild/moderate (0 -25), irritant (Ͼ25-50), and severe (Ͼ50 -110).…”

“…Draize scores for 10 of the surfactants tested (SDS, Tween 20, Tween 40, Tween 80, Triton X-100, MTAB, CTAB, OTAB, CPC, and BKC) were obtained from three independently published studies. 4,18,19 Kennah et al 18 published 24-hour average Draize scores for multiple concentrations of surfactants, enabling two correlations from their publication. Their scores for concentrations of 10% and 1% (vol%) were used.…”

“…Tachon et al 19 reported the maximum Draize score after 1 hour or 24 hours at 10% wt/vol surfactant concentrations. Finally, Matsukawa et al 4 reported both the maximum average scores and the 24-hour average scores for 10% solutions; the latter was used for consistency. Table 1 shows the surfactants used for the in vitro/in vivo correlations and their corresponding Draize scores from each publication.…”

“…Vian et al 3 explored three in vitro assays and showed relatively poor correlations with Draize scores. Matsukawa et al 4 reported mixed results for the EYTEX test (Ropak Labs, Irvine, CA), clearly showing several weaknesses of the test. The use of red blood cells to measure ocular toxicity has been touted as quick, inexpensive, and effective.…”