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Clinical Studies - Tooth Whitening

NITE WHITE with ACP Excel2 "Z"

Acute Oral Toxicity Study (Modified FHSA Method) In The Rat Activator Lot #990202 and 20% Excel 2 Lot #990201



SUMMARY

The test article, Activator Lot #990202 and 20% Excel 2 Lot #990201, was screened for oral toxicity. The test was conducted in accordance with the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500, but was modified by NAMSA to reduce the number of animals from ten to five and the number of observation days from 14 to 7. A single dose of 5g/kg of body weight was gavaged to five rats. The animals were then observed for up to 7 days for any signs 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 5g/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.


 



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