SafePharm Laboratories - Alternative Toxicology - Skin Irritancy Test

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Alternative Toxicology

Endpoint: Skin Corrosivity

Endpoints: Skin and Eye Irritation

Skin Irritancy Tests using Human Skin Models

Ocular Irritancy Ex Vivo

Endpoint: Mucosal Irritancy

Endpoint: Phototoxicity Testing

Endpoint: In Vitro Dermal Penetration

Endpoint: Skin (Contact) Sensitisation

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Alternative Toxicology - Skin Irritancy Tests using Human Skin Models
A major advantage of these truly in vitro models is that the test substance can be applied directly (topically) to the culture surface (stratum corneum) at the air interface, thereby closely mimicking dermal exposure in humans. The models are therefore particularly appropriate for irritancy testing of products intended for topical exposure in humans such as treatments for skin conditions, cosmetics, wound dressings, transdermal delivery systems and medical devices, but can also be used for irritancy testing of chemicals and agrochemical formulations.
The SkinEthic Human Reconstituted Epidermal Models


SPL are the world’s primary contract testing facility for studies conducted using tissues supplied by SkinEthic Laboratories. The tissues are transported by air from SkinEthic ’s facility in Nice, France to SPL, a journey of little more than two hours. The treated tissues are assessed using a Multiple Endpoint Analysis (MEA) approach for cell viability (MTT reduction test), histopathology, and inflammatory mediator release. The use of MEA increases the interpretative and predictive power of the test system and is therefore appropriate for testing of mild irritants when tissue viability and histology are relatively unaffected. The SkinEthic models are particularly well suited for ‘benchmarking’ the irritancy of new products by comparison with existing products, and for ranking of irritancy potential of candidate formulations.

SkinEthic Human Reconstituted Epidermal (HRE) Model


The SkinEthic HRE is used to assess the skin irritation potential of a test substance following topical application and timed exposure. Tissues are assessed using a Multiple Endpoint Analysis (MEA) approach for cell viability (MTT reduction test), histopathology, and inflammatory mediator release (IL-1 alpha, and IL-8).

SkinEthic Human Corneal Epithelial Model (HCE)


The HCE model from SkinEthic Laboratories consists of transformed human keratinocytes of the cell line HCE (LSU EYE Center, New Orleans, USA) that forms a corneal epithelial tissue (mucosa), devoid of stratum corneum, histologically resembling the corneal epithelium of the human eye. This model is used to assess the ocular irritation potential of test substances following topical application (undiluted and/or end use dilutions can be tested directly). Following a timed exposure to the test substance, tissues are assessed using a Multiple Endpoint Analysis (MEA) approach for cell viability (MTT reduction test), histopathology, and inflammatory mediator release (IL-1 alpha, IL-6 and IL-8).

SkinEthic Human Conjunctival Epithelium Model


In addition to the human corneal model, SafePharm can offer eye irritancy testing using the SkinEthic human reconstituted conjunctival models in order to assess sensitivity of the conjunctivae to the product.
MatTek EpiDerm Human Tissue Models


EPI-200 Epidermal Tissue Model The EPI-200 epidermal tissue model (MatTek Corporation, Irvine, USA) is used to assess the skin irritation potential of test substances following a timed exposure of the test substance to the tissues. Irritant substances are identified by their ability to produce a decrease in cell viability (as determined by using the MTT reduction assay). The endpoint of the assay is the ET50, the time of exposure which reduces MTT reduction in the treated tissues to 50% relative to untreated controls.

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