At BioScience Laboratories, Inc., we currently use EpiOcular and EpiDerm tissue models in ocular and dermal irritation studies, respectively, performed according to the MTT Effective Time-50 viable cell assay.  The EpiOcular viable cell assay is designed to provide both a Draize and a potential ocular irritation score.  The EpiDerm viable cell assay is designed to provide a potential dermal irritation score only.  These testing methods are becoming increasingly popular as a move is made toward replacing animal testing with an in-vitro means of evaluation.  We have successfully used these models to test a wide range of products: cosmetics (liquids, powders, gels, mascaras or creams at multiple concentrations), personal care products, household products (cleaners, inks, shaver heads, etc.), pharmaceutical products, and surfactant-based products tested at a concentration of 10% to simulate “rinse-off” exposures (general use hand soaps and detergents) utilizing both of these methods.

 

Additionally, other testing methods have also been developed using the EpiDerm tissue model.  These other testing methods are conducted in ways very similar to the dermal irritation method and are also performed at BioScience Laboratories:

 

Dermal corrosion testing measures the production of scarring usually as a result of corrosive tissue destruction (necrosis) following the application of a substance (irreversible).  The potential for chemically-induced dermal corrosion is an important consideration in establishing procedures for the safe handling, packing, and transport of chemicals.

 

Dermal phototoxicity testing identifies the existence or absence of possible hazards likely to arise from a test substance in association with exposure to UV and visible light.  A typical application is testing the phototoxicity of new sunscreen product formulations while in development to identify chemicals that might induce adverse skin reactions.

 

Percutaneous absorption testing uses various EpiDerm kits to calculate the permeability coefficient of a test article.  Also, this is the underlying technology used in transdermal drug delivery studies.

 

Looking towards the future, BioScience Laboratories is developing test methods to make use of the other tissue models available from the manufacturer of the EpiOcular and EpiDerm models. 

 

MelanoDerm is the model of choice in tissue testing procedures useful as an in-vitro means to evaluate cosmetic and pharmaceutical agents designed to modulate skin pigmentation and usually involves topical application of skin lighteners or self-tanning agents.

 

EpiAirway is the model of choice in tissue testing procedures for gas phase exposure of volatile articles for airway inflammation and irritancy studies.  These methods also allow the measurement of transepithelial permeability for inhaled drug delivery studies.

 

EpiOral is the model of choice in tissue testing procedures which enable the in-vitro study of irritation, oral pathologies, and basic oral cavity phenomena.  Some companies have also used this model to grow commensal and pathogenic bacteria in order to study their effects on the oral tissues.

 

Dendritic/Langerhans cells can be used to develop in-vitro assays for contact sensitization and other immunological reactions of the body.

 

As you look to develop new products and differentiate them within the marketplace, which of these tissue models are most attractive to your company to use in product testing?  How important is it to your customers that products are tested without harming animals?

 

Jessica McDonnell-Philipp, In-Vitro Laboratory Study Director

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