101. NEW EPIDERMAL MODEL FOR DERMAL IRRITANCY TESTING.

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Cannon, C.L., Neal, P.J., Kubilus, J., Klausner, M. MatTek Corp., 200 Homer Ave., Ashland, MA 01721 USA. Presented at J.F. Morgan Research Foundation symposium, "Current Trends in In Vitro Skin Toxicology and Eye Irritancy Testing," Ottawa, Canada, April (1993).

Summary:
A model of the human epidermis, EpiDerm™, based on neonatal, foreskin-derived normal human epidermal keratinocytes (NHEK) has been developed over the past 18 months at MatTek Corporation.

Cultured in easily handled Millicell® CM (Millipore Corp.) cell culture inserts, the model allows application of liquid and solid test materials (potential dermal irritants) directly to the stratum corneum of this air-lifted, highly differentiated culture.

An interlaboratory comparison, which tested 16 anionic and non-ionic surfactants and surfactant-containing final formulations, utilized the MTT assay with both concentration (EC-50) and time protocols (ET-50). The 16 compounds were tested on different production lots of EpiDerm following 1 and 2 day storage periods (post-shipping) at MatTek and at an independent contract testing laboratory.

The EC-50's and ET-50's from the 2 laboratories were plotted against one another and least squares fit to the Y=X. The resultant correlation coefficient, r, for the EC-50 data was 0.970; for the ET-50 data, r=0.989.

Correlation of these in vitro results to human clinical chamber irritation and repeat handwash testing gave correlations with r values ranging from 0.977 to 0.993.

Thus, the EpiDerm model appears to have utility in predicting clinically observed dermal irritation in vitro.

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EpiDerm Data Sheet

EpiDerm Specifications

EpiDerm Technical References

Skin Irritation (EpiDerm Application)

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Applications: Irritation - skin

Keywords: Cutaneous irritancy, Cutaneous irritation, Cutaneous toxicity, Dermal irritancy, Dermal irritancy testing, Dermal irritation, Endpoints, MTT, EpiDerm, MTT, MTT ET-50 tissue viability assay, MTT assay, Skin irritancy, Skin irritation, Surfactants

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