Ocular Toxicity

Eskes, Chantra; Vliet, Erwin van; Schäffer, Michael; Zuang, Valérie

doi:10.1007/978-1-4939-0521-8_8

Cited by 2 publications

(2 citation statements)

References 53 publications

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“…The Ocular Irritection ® assay, a upgraded version of Eytex ® method, evaluates the ocular irritancy of test chemicals by assessing the denaturation of corneal proteins ( 40 ). The Ocular Irritection ® assay can identify chemicals inducing serious eye damage (Category 1) and non-irritants (No category).…”

Section: Alternatives To Draize Rabbit Eye Irritation Testmentioning

confidence: 99%

“…Irritants induce the denaturation and disaggregation of the protein reagent that can be quantified by measuring OD405. The ocular irritancy potential of a test substance is expressed as an Irritection Draize Equivalent (IDE) score ( 40 ). The scores are obtained through establishing a standard curve with a set of calibration substances with well-documented irritancy potential.…”

Section: Alternatives To Draize Rabbit Eye Irritation Testmentioning

confidence: 99%

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Alternatives toIn VivoDraize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

2017

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Human eyes and skin are frequently exposed to chemicals accidentally or on purpose due to their external location. Therefore, chemicals are required to undergo the evaluation of the ocular and dermal irritancy for their safe handling and use before release into the market. Draize rabbit eye and skin irritation test developed in 1944, has been a gold standard test which was enlisted as OECD TG 404 and OECD TG 405 but it has been criticized with respect to animal welfare due to invasive and cruel procedure. To replace it, diverse alternatives have been developed: (i) For Draize eye irritation test, organotypic assay, in vitro cytotoxicity-based method, in chemico tests, in silico prediction model, and 3D reconstructed human cornea-like epithelium (RhCE); (ii) For Draize skin irritation test, in vitro cytotoxicity-based cell model, and 3D reconstructed human epidermis models (RhE). Of these, RhCE and RhE models are getting spotlight as a promising alternative with a wide applicability domain covering cosmetics and personal care products. In this review, we overviewed the current alternatives to Draize test with a focus on 3D human epithelium models to provide an insight into advancing and widening their utility.

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Section: Alternatives To Draize Rabbit Eye Irritation Testmentioning

confidence: 99%

Section: Alternatives To Draize Rabbit Eye Irritation Testmentioning

confidence: 99%

Alternatives toIn VivoDraize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

2017

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Determination and application of the permitted daily exposure (PDE) for topical ocular drugs in multipurpose manufacturing facilities

Barle

Bizec

Glogovac

et al. 2017

Pharmaceutical Development and Technology

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Limits for the carry-over of product residues should be based on toxicological evaluation such as described in the "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities". The toxicological evaluation should be performed also for locally administered drugs to ensure patient safety. Currently, there is no guidance on setting PDE for ocular drug substances in particular. The purpose of this investigation was to identify and describe a method for calculating a PDE value for topical ocular drugs (PDE). As an alternative method, extrapolation of a PDE for systemically administered drugs to a PDE is presented. These methods may be applied in cross-contamination risk assessments for manufacturing of topical ocular drugs. Similarly, the methods apply to systemically administered drugs, if their production precedes manufacturing of a topical ocular drug. We have examined pharmacokinetic (PK) properties of topical ocular drugs and compared them to the PK parameters of systemically administered drugs. Furthermore, we examined possible adverse effects of the carry-over in topical ocular drugs at therapeutic doses.

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Ocular Toxicity

Cited by 2 publications

References 53 publications

Alternatives toIn VivoDraize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

Alternatives toIn VivoDraize Rabbit Eye and Skin Irritation Tests with a Focus on 3D Reconstructed Human Cornea-Like Epithelium and Epidermis Models

Determination and application of the permitted daily exposure (PDE) for topical ocular drugs in multipurpose manufacturing facilities

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