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Updated: Jun 10, 2026
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An In Vitro Skin Irritation Test (SIT) using the EpiDerm Reconstructed Human Epidermal (RHE) Model
Published on: July 13, 2009
In vitro oral mucosa irritation testing with human cell cultures.
J N Norton1, L A Rylander, J L Richards
1The Procter & Gamble Company, Miami Valley Laboratories, PO Box 398707, Cincinnati, OH 45239-8707, USA.
Summary
Oral mucosa organ equivalent cultures (OMOEC) and skin equivalent cultures (SEC) effectively predict oral irritation. These in vitro models show dose- and time-dependent responses to dentifrices, supporting tiered safety assessments.
Area of Science:
- Toxicology and In Vitro Testing
- Dermatology and Oral Health
Background:
- Predicting in vivo oral mucosa irritation is crucial for oral care product safety.
- Current methods may lack direct correlation with human oral tissue responses.
Purpose of the Study:
- To evaluate the responsiveness of oral mucosa organ equivalent cultures (OMOEC) and skin equivalent cultures (SEC) to dentifrice-induced irritation.
- To establish the utility of these in vitro models for predicting oral irritation potential.
Main Methods:
- OMOEC and SEC derived from human tissue were exposed to test dentifrices with varying irritation potentials.
- Responses were assessed using histopathology, cell viability (MTT assay), and cytotoxicity (AST release).
Main Results:
- Both OMOEC and SEC demonstrated reduced cell viability in a dose- and time-dependent manner.
- Increased aspartate aminotransferase (AST) release, indicating cytotoxicity, was observed proportionally to dentifrice concentration and exposure time.
- The in vitro models exhibited linear responses correlating with the graded irritation potential of the dentifrices.
Conclusions:
- OMOEC and SEC serve as reliable in vitro models for assessing oral mucosa irritation.
- These models provide a basis for comparing in vitro and in vivo irritation data.
- The findings support a tiered approach for evaluating the safety of oral care products.
