Evaluation of Local Tolerance of Structurally Different Olaflur Compounds.

Fluorides are widely used in oral care products to prevent dental caries. However, toxicological data on Olaflur, a relatively new fluoride compound in China, is limited. Three types of Olaflur were selected as test substances: cetylamine Olaflur, stearylamine Olaflur and oleylamine Olaflur. Skin irritation and sensitization tests were performed using reconstructed human epidermis models and the '2 out of 3' approach, respectively. For oral mucosal irritation testing, animal models were employed. The results showed that, at concentrations of 0.515% and 1.97%, none of the three compounds exhibited skin irritation. None of the three compounds showed sensitization potential. In oral mucosal irritation tests, at concentrations of 0.515% and 1.97%, all three compounds showed minimal or no irritation. Overall, under reasonable conditions of use, all three types of Olaflur are considered safe for use in oral care products.