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.