Short Time Exposure (STE) test in conjunction with Bovine Corneal Opacity and Permeability (BCOP) assay including histopathology to evaluate correspondence with the Globally Harmonized System (GHS) eye irritation classification of textile dyes

Abstract

Eye irritation evaluation is mandatory for predicting health risks in consumers exposed to textile dyes. The two dyes, Reactive Orange 16 (RO16) and Reactive Green 19 (RG19) are classified as Category 2A (irritating to eyes) based on the UN Globally Harmonized System for classification (UN GHS), according to the Draize test. On the other hand, animal welfare considerations and the enforcement of a new regulation in the EU are drawing much attention in reducing or replacing animal experiments with alternative methods. This study evaluated the eye irritation of the two dyes RO16 and RG19 by combining the Short Time Exposure (STE) and the Bovine Corneal Opacity and Permeability (BCOP) assays and then comparing them with in vivo data from the GHS classification. The STE test (first level screening) categorized both dyes as GHS Category 1 (severe irritant). In the BCOP, dye RG19 was also classified as GHS Category 1 while dye RO16 was classified as GHS no prediction can be made. Both dyes caused damage to the corneal tissue as confirmed by histopathological analysis. Our findings demonstrated that the STE test did not contribute to arriving at a better conclusion about the eye irritation potential of the dyes when used in conjunction with the BCOP test. Adding the histopathology to the BCOP test could be an appropriate tool for a more meaningful prediction of the eye irritation potential of dyes.

Fundamental pharmacological expressions on ocular exposure to capsaicin, the principal constituent in pepper sprays

“…Classification of eye irritation by the BCOP is as follows: a test substance that indicates an IVIS ≤ 3 is classified as UN GHS No Category; indication of 3 < IVIS ≤ 55 is classified as UN GHS No prediction can be made; and an indication of IVIS > 55 is classified as UN GHS Category 1 (corrosive or severe irritant) 12 . Our observations on 5, 25 and 50 mg/ml treatments of capsaicin brought us to conclusion that “no prediction could be made” (Table 3 ).…”

“…Oliveira et al . had combined the Short Time Exposure (STE) test with BCOP assay to assess the correspondence of two particular textile dyes with their Globally Harmonized System (GHS) eye irritation classification 12 . The current determination of the irritation potential of capsaicin might be a novel technique as it accomplishes and associates the results of the AEI and BCOP tests as a tiered approach to evaluate the UN GHS categorization of capsaicin.…”

“…The Bovine Corneal Opacity and Permeability assay, (BCOP), was adopted by the OECD in 2009, to identify ocular corrosives and serious irritants as mentioned in the OECD Test Guideline 437 11 . The BCOP test is an organotypic archetype and assures short-term sustenance of the common physiological as well as biochemical environment of the bovine cornea in vitro 12 . Corneal deterioration is determined through quantitative assessment of modifications in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer subsequently 13 .…”

LQFM184: A Novel Wide Ultraviolet Radiation Range Absorber Compound

“…Corneas were kept in 10% phosphate buffered formalin, and histomorphometric evaluation was performed based on protocol described by Oliveira, Ducas, Teixeira, Batista, Oliveira and Valadares (27). The tissue sections were observed by a light microscope and photographed using an AxioCamMRc Carl Zeiss camera and analyzed in AxioVs40 V 4.7.2.0 Carl Zeis software (Axio Scope A1 Carl Zeiss, Jena, TH, Germany).…”

Ophthalmic gels: Past, present and future

“…A histopathological examination of the corneal tissue after exposure to the investigated ophthalmic gel can provide a more comprehensive insight on the degree and depth of the corneal injury at cellular levels [156,157]. The diffusion of the gel comprising materials (polymer, solvent, ions, and drug) through the main layers of the cornea (epithelium, stroma and endothelium) depends on the degree of the corneal injury.…”