Skin Irritation & Corrosion Evaluation by Reconstructed Human Epidermis (RhE) Model

Creative Biolabs has accumulated specialized protocols in epidermal-based 3D reconstruction, and is able to provide services for skin irritation and corrosion evaluation based on 3D RhE models, improving the efficiency and accuracy of the detection of candidate compounds and mixtures.

Introduction to RhE Model

Modeling

Select normal human keratinocyte cell lines as standard material.

Selected cell lines are expanded in vitro on special culture inserts to fully differentiate them into multilayered 3D epidemmal structures with a functional stratum coreum.

Commonly used methods include air-liguid interface culture and 3D printing techniques.

Apply to Skin Response Evaluation.

Specific markers

Differentiation markers

Ectodermal proteins
Glutamine transaminase
Keratin 10
Keratin 5
Epidermal ceramides
etc.

Demmal markers

Collagen Type IV
Laminin V
Integrin a6β4
Bullous pemphigoid antigen
etc.

Proliferative markers

Ki67

Features and applications

Excellent stratification and complete structure, remarkably close to the human epidermis.
Test materials do not require pre-dilution and support testing of skin reactivity at full fommulation strength.
Alternatives to traditional animal models in skin testing are more acceptable and economical.
Predicting the potential demmal hazards of chemicals and developing sound regulatory strategies.
Screeningcosmetic fomulation candidates at an eary stage improves development efficiency and reduces clinical trial risk.

Standardized Procedure for Skin Irritation Testing

1	Establish culture equilibrium at 37 °C.
2	Move the model to the test environment.
3	Set up various stimulation conditions (n=3) Liquids and viscous materials Solid materials Waxy and paste materials
4	Stimulation period: model exposure to the substance to be evaluated.
5	Remove stimulating conditions and incubate.
6	Detection of model tissue viability (MTT assay for cell viability).
7	Analyze data on the percentage of reduced MTT in the stimulated model relative to the negative control.
8	Classify compounds with mean tissue survival as a predictive indicator.

Survival rate	Classification
≤50%	Irritating (potentially corrosive), substances Class 2
>50%	Non-irritating substances, Unclassified

Standardized Procedures for Skin Corrosion Testing

When a test material is classified as moderately or more irritating based on skin irritation test results, it can be further tested for potential skin corrosiveness upon request.

Establish the balance of the RhE Model.

Set up the test environment.

Apply the material to be tested locally and uniformly on the model and treat for the specified exposure time.

Remove stimulating conditions and incubate.

Measurement of survival based on the principle that corrosive substances are toxic to the underlying cell layer by diffusion or erosion of the skin stratum corneum (MTT method).

Survival rate	Classification
<50% after 3 minutes of exposure	Corrosives subclassification 1A
≥50% after 3 minutes of exposure and <15% after 60 minutes of exposure	Corrosives subclassification 1B/1C
≥50% after 3 minutes of exposure and ≥15% after 60 minutes of exposure	Non-corrosives

More Skin Toxicity Evaluation Services

Creative Biolabs utilizes the RhE model to provide accurate skin reactivity assessment services to help differentiate between substances to be tested that have the potential to irritate and corrode the skin. If you have any requirements for the evaluation service, please contact us to discuss.

Reference

Catarino, C.M.; et al. Skin corrosion test: a comparison between reconstructed human epidermis and full thickness skin models. Eur J Pharm Biopharm. 2018, 125:51-57.

Research Model

3D Biology Based Biomarker Discovery

3D Biology Based Drug Discovery and Development

3D Biology Based Toxicity Evaluation

Supporting Assays

Related Sections:

Research Model

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