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.

365体育网投 offers the EpiOral and EpiGingival buccal irritation tests as non-GLP services.


Test ModelEpiOral or EpiGingival
ReplicatesN=3 tissues per test condition
Exposure Time20, 60 and 120 minute topical exposure to 100µl of 1:1 diluted material per tissue
Assay ControlsNegative Control – Untreated
EndpointsMTT Tissue Viability Assay
Data DeliveryET-50 Values
Expected in Vivo Irritancy Category (i.e. strong, moderate, mild, non-irritating)

Download the EpiOral & EpiGingival Irritation Protocol





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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