Predictive performance and inter-laboratory reproducibility in assessing eye irritation potential of water- and oil-soluble mixtures using the Short Time Exposure test method

Abo, Takayuki; Hilberer, Allison; Behle-Wagner, Christine; Watanabe, Mika; Cameron, David; Kirst, Annette; Nukada, Yuko; Yuki, Takuo; Araki, Daisuke; Sakaguchi, Hitoshi; Itagaki, Hiroshi

doi:10.1016/j.tiv.2017.12.018

Cited by 4 publications

(2 citation statements)

References 15 publications

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“…This suggests that some commercial products may be irritating to humans when applied to the skin on a daily basis. Studies of alternative test methods to assess the safety of cosmetic products have been reported, including skin irritation evaluations by means of RhE models (Kose et al, 2018) and SENS-IS assays (Cottrez et al, 2020) and eye irritation evaluations by the STE test method (Abo et al, 2018). However, further studies are needed to compare the safety of different formulations and to define safety criteria.…”

Section: Discussionmentioning

confidence: 99%

“…An in vitro short-term exposure (STE) test method (OECD TG491) is an eye irritation test. This test method can be applied to mixtures, and one study has shown that it can be used to evaluate the eye irritation potential of cosmetic products (Abo et al, 2018). The STE test method uses a monolayer cell culture, and it is assumed to be a more sensitive predictor of skin irritation than the RhE model, which has a multilayer structure.…”

Section: Introductionmentioning

confidence: 99%

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A trial to predict skin irritancy of cosmetic products using cytotoxicity tests

Mezaki,

Manabe,

Nagumo

et al. 2023

Fundam. Toxicol. Sci.

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Alternatives to animal testing are being used to assess the safety of raw ingredients during the process of developing cosmetics. However, since cosmetic products are composed of a variety of raw ingredients, the safety of the product itself should also be tested. In this study, we attempted to evaluate the skin irritation potential of skin lotions by modifying existing alternative test methods. To evaluate the skin irritation potential of commercial skin lotions in the form of an objective indicator, we calculated their Irritation Score (IS) based on the results of searches using keywords related to skin irritation in review statements posted on Japanese cosmetics and beauty websites. We then modified the reconstructed human epidermis (RhE) test method to evaluate irritation by commercial skin lotions. The results showed that exposure to skin lotions with higher ISs tended to result in lower cell viability, and that exposure to many of the lotions with lower ISs resulted in higher cell viability. Next, we tried using an in vitro shortterm exposure (STE) test method to assess the skin irritation potential of skin lotions. By changing the test-substance exposure concentrations and exposure times in the STE test method, we were able to obtain results that correlated with those obtained by the modified RhE test method. In conclusion, both alternative methods were helpful for assessing the possibility of developing skin irritation of skin lotions. They may also be useful for screening formulations being developed and as means of evaluation before proceeding to human patch tests.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A trial to predict skin irritancy of cosmetic products using cytotoxicity tests

Mezaki,

Manabe,

Nagumo

et al. 2023

Fundam. Toxicol. Sci.

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In vitro reconstructed 3D corneal tissue models for ocular toxicology and ophthalmic drug development

Kaluzhny

Klausner

2021

In Vitro Cell.Dev.Biol.-Animal

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Testing of all manufactured products and their ingredients for eye irritation is a regulatory requirement. In the last two decades, the development of alternatives to the in vivo Draize eye irritation test method has substantially advanced due to the improvements in primary cell isolation, cell culture techniques, and media, which have led to improved in vitro corneal tissue models and test methods. Most in vitro models for ocular toxicology attempt to reproduce the corneal epithelial tissue which consists of 4-5 layers of non-keratinized corneal epithelial cells that form tight junctions, thereby limiting the penetration of chemicals, xenobiotics, and pharmaceuticals. Also, significant efforts have been directed toward the development of more complex threedimensional (3D) equivalents to study wound healing, drug permeation, and bioavailability. This review focuses on in vitro reconstructed 3D corneal tissue models and their utilization in ocular toxicology as well as their application to pharmacology and ophthalmic research. Current human 3D corneal epithelial cell culture models have replaced in vivo animal eye irritation tests for many applications, and substantial validation efforts are in progress to verify and approve alternative eye irritation tests for widespread use. The validation of drug absorption models and further development of models and test methods for many ophthalmic and ocular disease applications is required.

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