Corneal permeability in a redesigned corneal holder for the bovine cornea opacity and permeability assay

Data on eye irritation are generally needed for the hazard identification of chemicals. As the Bovine Corneal Opacity and Permeability (BCOP) test has been accepted by many regulatory agencies for the identification of corrosive and severe ocular irritants since September 2009 (OECD Test Guideline 437, TG 437), we evaluated this alternative method for routine testing at BASF. We demonstrated our technical proficiency by testing the reference standards recommended in TG 437, and 21 additional materials with published BCOP and in vivo data. Our results matched the published in vitro data very well, but with some intentionally selected false negatives (FNs) and false positives (FPs), the concordance was 77% (24/31), with FN and FP rates of 20% (2/10) and 24% (5/21), respectively. In addition, we tested 21 in-house materials, demonstrating the utility of the BCOP assay for our own test material panel. Histopathological assessment of the corneas by light microscopy was also conducted, as this was suggested as a means of improving the identification of FNs. The histopathology corrected the classification of some FNs, but also increased the number of FPs. Parallel to the test method evaluation, we compared three new opacitometer models with the current standard device. We recommend the use of an opacitometer developed in our BASF laboratory, which has certified components and electronic data storage, resulting in what we consider to be excellent sensitivity, stability and reproducibility.

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“…In line with our results with 30% TCA (No. 5), others also did not detect permeability after a 10minute treatment (13). Concerning No.…”

Section: Technical Proficiency and Reliabilitymentioning

confidence: 94%

“…a nearby slaughterhouse, can be easily found. Possibly due to these various reasons, the BCOP test has been more often used for assessing eye irritation within the last decade (10)(11)(12)(13)(14)(15)(16) than the ICE test (17).…”

Section: Introductionmentioning

confidence: 99%

The Bovine Corneal Opacity and Permeability Test in Routine Ocular Irritation Testing and its Improvement within the Limits of OECD Test Guideline 437

et al. 2011

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“…The holder used consisted of a Plexiglas structure, with a donor and a receiving compartment, respectively, on the epithelial and on the endothelial side of the cornea, which must be placed in the orifice, which divides the two compartments as reported by Gallarate et al [ 30 ]. To minimize the irritation caused to the cornea by the holder itself, according to the literature [ 42 ], the Plexiglas structure O-ring clamped the scleral ring all around the corneal circumference; moreover, the holder structure allowed maintaining the natural cornea curvature. The area available for diffusion was 0.63 cm 2 .…”

Section: Methodsmentioning

confidence: 99%

Assessment of In-Situ Gelling Microemulsion Systems upon Temperature and Dilution Condition for Corneal Delivery of Bevacizumab

et al. 2021

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Bevacizumab (BVZ), a recombinant humanized monoclonal antibody, has recently been proposed as a topical application in the treatment of anterior segment neovascularization; however, as there are some disadvantages in the administration of common eye-drops, ophthalmic topical drug delivery systems are under study to improve the precorneal residence time, reducing the frequency of administration. In this work, oil-in-water and water-in-oil BVZ-loaded microemulsions are developed, able to increase their viscosity, either by the formation of a liquid-crystalline structure upon aqueous dilution, thanks to the presence of Epikuron® 200 and polysorbate 80, or by body-temperature-induced jellification for the presence of Pluronic® F127 aqueous solution as an external phase. In oil-in-water microemulsion, hydrophobic ion pairs of BVZ were also prepared, and their incorporation was determined by release studies. Microemulsions were characterized for rheological behavior, corneal opacity, in vitro corneal permeation, and adhesion properties. The studied microemulsions were able to incorporate BVZ (from 1.25 to 1.6 mg/mL), which maintained dose-dependent activity on retinal pigment epithelial ARPE-19 cell lines. BVZ loaded in microemulsions permeated the excised cornea easier (0.76–1.56% BVZ diffused, 4–20% BVZ accumulated) than BVZ commercial solution (0.4% BVZ diffused, 5% accumulated) and only a mild irritation effect on the excised cornea was observed. The good adhesion properties as well the increased viscosity after application, under conditions that mimic the corneal environment (from 1 × 103 to more than 100·× 103 mPa·s), might prolong precorneal residence time, proving these systems could be excellent topical BVZ release systems.

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“…Considering eye damage and the testing of potential eye irritation can be assessed by different in vitro studies, three different categories are considered. The first category comprises organotypic test methods such as the bovine cornea opacity permeability (BCOP) test and the isolated chicken eye (ICE) test [70]. The second one englobes cytotoxicity/cell function methods as the fluorescein leakage (FL) test that studies the increase in permeability of sodium fluorescein and evaluates the toxic response in specific kidney cells and the short time exposure (STE) test that resorts to a corneal cell line from rabbit to evaluate the cytotoxic response [71].…”

Section: General Requirements For the Assessment Of Toxicological Datamentioning

confidence: 99%

Safety Assessment of Nanomaterials in Cosmetics: Focus on Dermal and Hair Dyes Products

Coimbra

Sousa-Oliveira²,

Ferreira-Faria³

et al. 2022

Cosmetics

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Nanomaterials use in cosmetics is markedly enhancing, so their exposure and toxicity are important parameters to consider for their risk assessment. This review article provides an overview of the active cosmetic ingredients used for cosmetic application, including dermal cosmetics and also hair dye cosmetics, as well as their safety assessment, enriched with a compilation of the safety assessment tests available to evaluate the different types of toxicity. In fact, despite the increase in research and the number of papers published in the field of nanotechnology, the related safety assessment is still insufficient. To elucidate the possible effects that nanosized particles can have on living systems, more studies reproducing similar conditions to what happens in vivo should be conducted, particularly considering the complex interactions of the biological systems and active cosmetic ingredients to achieve newer, safer, and more efficient nanomaterials. Toward this end, ecological issues and the toxicological pattern should also be a study target.

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Corneal permeability in a redesigned corneal holder for the bovine cornea opacity and permeability assay

Cited by 10 publications

References 13 publications

The Bovine Corneal Opacity and Permeability Test in Routine Ocular Irritation Testing and its Improvement within the Limits of OECD Test Guideline 437

The Bovine Corneal Opacity and Permeability Test in Routine Ocular Irritation Testing and its Improvement within the Limits of OECD Test Guideline 437

Assessment of In-Situ Gelling Microemulsion Systems upon Temperature and Dilution Condition for Corneal Delivery of Bevacizumab

Safety Assessment of Nanomaterials in Cosmetics: Focus on Dermal and Hair Dyes Products

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