The test article, 35% Carbamide Peroxide, Lot: 25% Whitening Gel Lot# 980401 15% Peppermint DAY WHITE with ACP Lot# 7JF, was evaluated for oral toxicity in accordance wit the guidelines of Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500.

A single dose of 5 g/kg of body weight was gavaged to 10 rats. The animals were then observed for 14 days of toxicity. Under the conditions of this study, there was no mortality or significant evidence of toxicity observed in the rats. The test article would not be considered toxic at a dose of 5 g/kg by the oral route in the rat.


CONCLUSION

Under the conditions of this study, the test article would not be considered toxic at a dose of 5 g/kg by the oral route in the rat.