KARCH & ASSOCIATES, INC.
REVIEW OF THE TOXICOLOGICAL LITERATURE AND RISK ASSESSMENT OF CHLORINE DIOXIDE AND SODIUM CHLORITE IN PROFRESH
I. EXECUTIVE SUMMARY Karch & Associates,
Inc. prepared the following summary of the toxicological literature
on chlorine dioxide and sodium chlorite, the active ingredients of a
breath rinse product, ProFresh. Reference doses (RfDs) available in
the literature were identified or derived for these compounds using
USEPA methods. These RfDs are the basis for our risk assessment of
chlorine dioxide and sodium chlorite. Based on the recommended use
of ProFresh provided to us as label directions by Roy Goldberg,
Esquire, daily dose estimates were calculated.
Chlorine dioxide and sodium chlorite both are strong oxidizers. The
primary toxic effect associated with compounds at high doses is
methemoglobinemia, the oxidation of hemoglobin in red blood
cells. Other effects have been reported, but these generally are
associated with high doses or the evidence for the association is
conflicting. In an experimental study of humans ingesting chlorine
dioxide and chlorite in drinking water, no adverse effects were
observed at doses as high as 24 mg/L and 5 mg/L, respectively (Lubbers
et al. 1982). In addition, two epidemiological studies of populations
exposed to water disinfected with chlorine dioxide did not demonstrate
any hematological or teratogenic effects.
There is no currently available RfD for either chlorine dioxide or
sodium chlorite. The Final Draft for the Drinking Water Criteria
Document on Chlorine Dioxide, Chlorite, and Chlorate (USEPA 1994),
is currently under review by a USEPA work group. The draft includes
proposed RfDs for chlorine dioxide, 0.01 mg/kg/day, and chlorite,
0.003 mg/kg/day, which is equivalent to a dose of 0.004 mg/kg/day for
sodium chlorite on a mass basis. The proposed RfD for chlorine dioxide was used in this
assessment. However, for sodium chlorite a thorough subchronic study
by Harrington et al. (I 995) was recently published and led to the
derivation of an RfD of 0. I mg/kg/day.
Non-carcinogenic risk is assessed by USEPA based on the ratio of
the daily dose of the compound to the RfD. We have estimated daily
doses of chlorine dioxide and sodium chlorite to be 0. 00 12 and 0. I
mg/kg/day, respectively, from the manufacturer's recommended use of
ProFresh. We have included incidental ingestion while rinsing with
ProFresh.
The daily doses for both compounds, chlorine dioxide and sodium
chlorite, are at or below the RfD. Given the conservative nature of
the risk assessment approach, the lack of effects reported in exposed
humans, and the reduction of these compounds in the mouth during
rinsing and swallowing the manufacturers recommended use of the
product ProFresh by adults, including incidental ingestion, does not represent a risk to human health.
Consultants in Toxicology, Epidemiology and Risk
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