Benzophenone-3 (BZ-3) is a category 1 (over-the-counter) product appro
ved by the US Food and Drug Administration (FDA) for use as a sunscree
n agent in medicine, cosmetics, industry, and agriculture. This is due
to its ability to absorb and dissipate ultraviolet light in a harmles
s manner, thus protecting human skin and products from UV irradiation.
This study investigated the safety of BZ-3 after repeated administrat
ion. BZ-3 in ointment base was applied at a dose of 100 mg/kg body wt.
twice daily, for 4 weeks to the skin of male Sprague-Dawley rats. Bod
y weight, organ to body weight ratios, hematological, and clinical che
mistry parameters were not effected. Pathological examination revealed
no significant changes between control and treated animals. No gross
external abnormalities were observed. Both in vivo and in vitro blood
glutathione (GSH) levels were effected by BZ-3 treatment. However, aft
er 60 min of incubation, a reversal of this effect was observed in the
treatment group as blood GSH levels approached normal levels. Further
more, investigation of GSH-reductase and peroxidase with time indicate
d an increase in GSH-reductase activity at 60 and 90 min with no effec
t on GSH-peroxidase. Pre-treatment with phenobarbital modulated the me
tabolic disposition of BZ-3. There was an increase in the formation of
the hydroxy metabolites but not the O-dealkylated form. This study su
ggests that BZ-3 is not toxic to rats when applied dermally at a dose
of 100 mg/kg body wt. for 4 weeks.