Inter-laboratory study of short time exposure (STE) test for predicting eye irritation potential of chemicals and correspondence to globally harmonized system (GHS) classification

Abstract

-Short time exposure (STE) test using rabbit corneal cell line (SIRC) cells was developed as an alternative eye irritation test. STE test uses relative viability as the endpoint after cells are exposed to the test material at constant concentrations for 5 min. In this inter-laboratory study with 3 laboratories, 44 chemicals with a wide range of classes were evaluated for the transferability, between-lab reproducibility and predictive capacity of the STE test as an alternative eye irritation test. Globally harmonized sysin vivo data. Transferability was assessed using standard chemicals (sodium lauryl sulfate, calcium thioglycolate, andThe irritation category (Irritant or Non irritant) at each test concentration (5% and 0.05%) in STE test was --el (PM) based on the relative viability at two concentrations (5% and 0.05%) were highly correlated with the GHS ranks of non-irritant, category 1, and category 2, respectively (accuracy was 75.0% at all laboratories). These results suggest that the STE test possessed easy transferability, reproducibility, good predictive performance.

A tiered approach combining the short time exposure (STE) test and the bovine corneal opacity and permeability (BCOP) assay for predicting eye irritation potential of chemicals

“…STE assay is able to not only discriminate the eye irritation categories between irritant (I) and non irritant (NI) but also classify the eye irritation in three rankings (i.e., Rank 1, minimally irritant; Rank 2, moderate irritant; Rank 3, severe irritant) over a range of irritation potentials (Takahashi et al, 2008). Furthermore, good correlations (accuracy 73% or 75%) were confirmed between STE and GHS rank classifications even when using a wide variety of chemicals (Takahashi et al, 2009(Takahashi et al, , 2011.…”

“…The false positive for Tween 20 was observed in the classification of the STE results. As suggested by Takahashi et al (2009), the modified maximum average score value of Tween 20 (undiluted sample) in the Draize test was 4 (ECETOC, 1998). The high molecular weight of Tween 20 (within 1128) may be the major factor for the discrepancy observed between the Draize test score and the STE test results.…”

Determination of eye irritation potential of low-irritant products: comparison of in vitro results with the in vivo draize rabbit test

“…Despite some progress in the areas of reduction and refinement, no single test has emerged as being acceptable as a complete replacement for the conventional Draize test, so that development of a battery of nonanimal eye irritation alternative tests is actively being proposed (McNamme et al 2009;Barile 2010). On the development of in vitro eye irritation tests, a variety of methods such as cell-based cytotoxicity, reconstituted tissue models, chorioallantoic membrane (CAM) methods, isolated organ assays and other systems have been developed since the 1980s (North-Rooth et al 1985;Luepke and Kemper 1986;Pape et al 1987;Roguet et al 1992;Balls et al 1995;Harbell et al 1997;Spielmann et al 1997;Jones et al 1999;Pape et al 1999;Steiling et al 1999;Cooper et al 2001;Hutak et al 2003;Eskes et al 2005;Doucet et al 2006;Vinardell and Mitjans 2006;Alves et al 2008;Cater and Harbell 2008;Schutte et al 2009;Takahashi et al 2009). On the other hand, the relevance of some currently used in vitro tests for a reliable prediction of human eye irritation, particularly concerning mild and moderate irritants, is still uncertain.…”

A Reassessment of the in vitro total protein content determination (TPC) with SIRC and 3T3 cells for the evaluation of the ocular irritation potential of shampoos: comparison with the in vivo Draize rabbit test

“…It should be noted that the choice of SIRC cells was mainly due to the fact that it has been one of cell lineage widely used by many researchers in the studies of physiology of the cornea, as well as in the immunological and toxicological studies. Moreover, it is extensively used to predict the eye irritation, showing an excellent correlation between the effects in vivo and in vitro caused by the surfactants and cosmetics (North-Rooth et al, 1985;Tani et al, 1999;Hutak et al, 2003;Takahashi et al, 2009). In addition to its ophthalmic origin, the advantages of this cell line include their commercial availability and ease of cultivation.…”