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Breath Odor Control with ProFresh VS

"Stabilized Chlorine Dioxide" Mouthwash

The primary source of breath odor is sulfur gases resulting from the putrifaction of sulfur-amino acids in oral epithelial cells, saliva, blood elements and food debris in the mouth by oral bacteria. Hydrogen sulfide and methylmercaptan (H2S and CH3SH, respectively) are the principal odor molecules, and these are detectable in air at the parts per billion level.

These compounds are readily oxidized and destroyed by the oxidant chlorine dioxide (Cl02), which has long been used to disinfect and deodorize municipal water supplies worldwide. Chlorine Dioxide mouth rinse is uniquely effective in oxidizing odoriferous, organic compounds such as those responsible for bad breath.

There have been many attempts to make a mouthwash that contains chlorine dioxide to combat bad breath. The most conspicuous of these have been mouth rinses that contain a chemical called sodium chlorite which is a salt used in the manufacture of chlorine dioxide. Because it is a chemical precursor of chlorine dioxide, sodium chlorite is also called "stabilized chlorine dioxide" despite the fact that it contains no chlorine dioxide.

"Stabilized chlorine dioxide" mouthwash was introduced in the 1970's and claimed the benefits of chlorine dioxide without any substantiating research. Today we still have "stabilized chlorine dioxide" mouth rinses such as Oxyfresh® and Dr. Katz's Therabreath® which are marketed with claims as though they contain chlorine dioxide although they do not.

In 1992, Dr. Jon L. Richter developed a new formula for a chlorine dioxide mouthwash that maintains a constant concentration of 25-35 mg per liter of chlorine dioxide over a period of six months after activation. Each bottle is activated by the user upon opening. The ProFresh formula is U.S.Patented. By law this formula cannot be duplicated, and as a result, no other brand of mouthwash may include any significant amount of chlorine dioxide as an ingredient. ProFresh Mouth Rinse is also registered with the FDA.

Recent studies confirm that the effect of "stabilized chlorine dioxide" mouthwash on bad breath odorants are negligible compared to ProFresh Chlorine Dioxide Oral Rinse!

For more information about chlorine dioxide mouth rinse, please review the Karch Report.

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 Assessment
1701 K Street N.W. o Suite 1000 - Washington D.C. 20006
Telephone (202) 463-0400 - FAX (202) 463-0502
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