Oral Irritation

During product development of new oral care formulations, the oral irritation potential is evaluated to identify substances which may result in adverse reactions in the oral cavity. Understanding the irritation potential of oral care products and excipients is an important consideration in reducing potential risks.

The in vitro­ EpiOral (buccal) and EpiGingival (gingival) MTT ET-50 assay is used as a screen to assign expected in vivo irritancy responses based on the time to toxicity (ET-50) results obtained with EpiOral and EpiGingival. This assay is also used to rank order oral formulations according to their irritation potential.

MatTek offers the EpiOral and EpiGingival buccal irritation tests as non-GLP services.

Protocol

Test Model EpiOral or EpiGingival
Replicates N=3 tissues per test condition
Exposure Time 20, 60 and 120 minute topical exposure to 100µl of 1:1 diluted material per tissue
Assay Controls Negative Control – Untreated
Endpoints MTT Tissue Viability Assay
Data Delivery ET-50 Values
Expected in Vivo Irritancy Category (i.e. strong, moderate, mild, non-irritating)

Download the EpiOral & EpiGingival Irritation Protocol

Data

EpiOral-Dose-Response-Curve

 

References

Klausner, et al., (2007). Organotypic Human Oral Tissue Models for Toxicological Studies. Toxicology in Vitro. 2007 August;21(5):938-949. 

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