A New Type of Colored Alumina/Glass Composite Biological Safety Assessment - Oral Mucous Membrane Irritation and Skin Sensitivity Tests

Objective: to describe and demonstrate an oral mucosa irritation and a skin sensitivity test for evaluation of the biological safety of a colored alumina/glass composite (AGC). Methods: colored alumina/glass composite and control materials were sutured to mucine bilateral cheek pouch mucosa, in a position for gross observation and for histological and cytological examination; skin irritation activity of the composite was tested by intradermal injection of a guinea pig test solution, by inducing, enhancing, and stimulating the allergic response observed after local tissue exposure. Results: colored AGC in mouse cheek pouch mucosa stimulated the same reaction as the control, with no significant inflammatory reaction or infiltration of inflammatory cells. Guinea pigs showed no obvious erythema or edema from the irritation test, such that the assessment of colored AGC skin allergy response in mice was 0%. Conclusion: colored AGC was benign towards mouse oral mucosa and elicited no allergic skin inflammation response, indicating that in these aspects this material had good biological safety.