Assessment of human epidermal model LabCyte EPI-MODEL for in vitro skin irritation testing according to European Centre for the Validation of Alternative Methods (ECVAM)-validated protocol

Katoh, Masakazu; Hamajima, Fumiyasu; Ogasawara, Takahiro; Hata, Keiko

doi:10.2131/jts.34.327

Cited by 64 publications

(23 citation statements)

References 9 publications

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“…Furthermore, appendages of human skin critically influence water diffusion through the SC, making stable measurement of transepidermal water loss in vitro difficult (14). Reconstructed human epidermis (RHE), which is free of appendages, has been developed as an alternative to animal tests; its use is recommended for in vitro dermatological research because it shares many characteristics with normal human epidermis (15)(16)(17).…”

mentioning

confidence: 99%

Stratum Corneum Drying Drives Vertical Compression and Lipid Organization and Improves Barrier Function In vitro

Iwai¹,

Kunizawa²,

Yagi³

et al. 2013

Acta Derm Venerol

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The stratum corneum dehydrates after exogenous hydration due to skincare or bathing. In this study, sheets of stratum corneum were isolated from reconstructed human epidermis and the barrier function and structure of these sheets were assessed during drying with the aim of improving our understanding of skincare. Water diffusion through the sheets of stratum corneum decreased with drying, accompanied by decreased thickness and increased visible light transmission through the sheets. Electron paramagnetic resonance revealed that the order parameter values of stratum corneum lipids increased with drying. X-ray diffraction analysis revealed increases in the diffraction intensity of lamellar structures, with an 11-12 nm periodicity and spacing of 0.42 nm for lattice structures with drying. These results suggest that the drying process improves the barrier function of the stratum corneum by organizing the intercellular lipids in a vertically compressed arrangement.

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mentioning

confidence: 99%

Stratum Corneum Drying Drives Vertical Compression and Lipid Organization and Improves Barrier Function In vitro

Iwai¹,

Kunizawa²,

Yagi³

et al. 2013

Acta Derm Venerol

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“…LabCyte EPI-MODEL has already been characterized in terms of its tissue structure and lipid composition under light and electron microscopy (data not shown), its barrier function, its immunohistochemistry and the reduction of MTT assays (Katoh et al, 2009). In addition, its application to in-house skin irritation tests such as for screening 1 1,2-Diaminopropane C 1 13.1 ± 1.9 26.3 ± 7.3 C 2 12.6 ± 2.4 13.0 ± 4.1 C 3 9.7 ± 2.7 27.9 ± 3.4 C 2 Acrylic acid C 1 1.9 ± 1.6 0.5 ± 0.6 C 2 4.8 ± 5.0 1.1 ± 0.9 C 3 14.5 ± 5.5 0.9 ± 0.6 C Assessment of the LabCyte EPI-MODEL for skin corrosion tests levels has been examined.…”

Section: Discussionmentioning

confidence: 99%

Assessment of the human epidermal model LabCyte EPI-MODEL for In vitro skin corrosion testing according to the OECD test guideline 431

Katoh¹,

Hamajima²,

Ogasawara³

et al. 2010

J. Toxicol. Sci.

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-A new OECD test guideline 431 (TG431) for in vitro skin corrosion tests using human reconstructed skin models was adopted by OECD in 2004. TG431 defines the criteria for the general function and performance of applicable skin models. In order to confirm that the new reconstructed human epidermal model, LabCyte EPI-MODEL is applicable for the skin corrosion test according to TG431, the predictability and repeatability of the model for the skin corrosion test was evaluated. The test was performed according to the test protocol described in TG431. Based on the knowledge that LabCyte EPI-MODEL is an epidermal model as well as EpiDerm, we decided to adopt the the Epiderm prediction model of skin corrosion for the LabCyte EPI-MODEL, using twenty test chemicals (10 corrosive chemicals and 10 non-corrosive chemicals) in the 1 st stage. The prediction model results showed that the distinction of non-corrosion to corrosion corresponded perfectly. Therefore, it was judged that the prediction model of EpiDerm could be applied to the LabCyte EPI-MODEL. In the 2 nd stage, the repeatability of this test protocol with the LabCyte EPI-MODEL was examined using twelve chemicals (6 corrosive chemicals and 6 non-corrosive chemicals) that are described in TG431, and these results recognized a high repeatability and accurate predictability. It was concluded that LabCyte EPI-MODEL is applicable for the skin corrosive test protocol according to TG431.

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“…LabCyte was cultured from human epidermis cell and stratified on polyethylene terephthalate (PET) membrane (thickness: 13.6±0.9 μm, pore size: 0.4 μm) as a supporting layer. LabCyte morphologically resembles human skin 10) and consists of SC and viable epidermis (Epi) which is made up from granulocyte, stratum spinosum, and basal layer. The SC was differentiated from the viable epidermis (Epi model) and formed after two weeks cultivation; it was named SCEpi model.…”

Section: Three-dimensional Cultured Human Epidermis (Che)mentioning

confidence: 99%

“…Katoh et al reported that LabCyte can be applied to in vitro skin irritation testing according to ECVAM validated protocol. 10) In Vitro Skin Penetration Experiments To fit LabCyte (10 mm in diameter) between side-by-side in vitro diffusion cells (KH cell, volume; 5 mL, Vidrex Ltd., Fukuoka, Japan) of 9 mm in diameter, a silicone elastomer adaptor (external diameter; 22 mm, internal diameter; 8 mm, and thickness; 1 mm) was used. LabCyte sandwiched between the adapters was mounted between the KH cells and then the effective diffusion area for LabCyte was 0.50 cm 2 .…”

Section: Three-dimensional Cultured Human Epidermis (Che)mentioning

confidence: 99%

Prediction of Percutaneous Absorption in Human Using Three-Dimensional Human Cultured Epidermis LabCyte EPI-MODEL

Hikima

Kaneda

Matsuo

et al. 2012

Biological & Pharmaceutical Bulletin

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The objective of this study is to establish a relationship of the skin penetration parameters between the three-dimensional cultured human epidermis LabCyte EPI-MODEL (LabCyte) and hairless mouse (HLM) skin penetration in vitro and to predict the skin penetration and plasma concentration profile in human. The skin penetration experiments through LabCyte and HLM skin were investigated using 19 drugs that have a different molecular weight and lipophilicity. The penetration flux for LabCyte reached 30 times larger at maximum than that for HLM skin. The human data can be estimated from the in silico approach with the diffusion coefficient (D), the partition coefficient (K) and the skin surface concentration (C) of drugs by assuming the bi-layer skin model for both LabCyte and HLM skin. The human skin penetration of β-estradiol, prednisolone, testosterone and ethynylestradiol was well agreed between the simulated profiles and in vitro experimental data. Plasma concentration profiles of β-estradiol in human were also simulated and well agreed with the clinical data. The present alternative method may decrease human or animal skin experiment for in vitro skin penetration.Key words in silico correlation; reconstructed epidermis; LabCyte EPI-MODEL; hairless mouse Human skin permeability of drugs in vivo can be estimated from in vitro experiment using human skin. However, some researchers have ethical and cultural difficulty to get human skins. Thus, animal skins have been widely used for pharmaceutical, toxicological and cosmetic R&D although the skins have a species difference between human. Recently, the 7th Amendment of the EC Cosmetic Directive prohibits the sale of cosmetics and ingredients validated their safety by animal testing with an alternative method. 1) Thus, researchers utilize reconstructed human skin instead of animal skin. The experiments used reconstructed epidermis is approved by the European Centre for the Validation of Alternative Methods (ECVAM) as the scientifically validated methods for skin corrosion and irritation. 2,3) Permeability studies with Episkin ® , EpiDerm TM and SkinEthic ® comparison to human and animal skin were investigated and the authors reported that the penetration flux through the reconstructed skin was higher than that of skin. [4][5][6] The OECD regulations accepted the results from the reconstructed skin 7) but don't approve it as an alternative method for in vitro human skin penetration experiment yet.Skin penetration is widely expressed by the mathematical models on the basis of the process of diffusion and dissolution. Penetration parameters, diffusion coefficient D [cm 2 /s] and partition coefficient K [-], through stratum corneum (SC) and viable skin (VS) of hairless mouse skin are found to well agree with that of human skin. 8) Not only the skin penetration profile but the blood concentration profile in human is well simulated using the penetration parameters determined from hairless mouse skin, the thickness of human SC and VS, the skin enzymatic parameters (first-ord...

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Assessment of human epidermal model LabCyte EPI-MODEL for in vitro skin irritation testing according to European Centre for the Validation of Alternative Methods (ECVAM)-validated protocol

Cited by 64 publications

References 9 publications

Stratum Corneum Drying Drives Vertical Compression and Lipid Organization and Improves Barrier Function In vitro

Stratum Corneum Drying Drives Vertical Compression and Lipid Organization and Improves Barrier Function In vitro

Assessment of the human epidermal model LabCyte EPI-MODEL for In vitro skin corrosion testing according to the OECD test guideline 431

Prediction of Percutaneous Absorption in Human Using Three-Dimensional Human Cultured Epidermis LabCyte EPI-MODEL

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