ProFresh solution contains about 0.0040%... of ClO2, a deceptively low level for what it can accomplish.
Robert D. Kross
Director Kross-Link Laboratories
Lab Report on Safety
KROSS-LINK LABORATORIES
SAFETY OF PROFRESH ORAL RINSE
Chlorine dioxide (ClO2) is a water-soluble gas that is a highly effective yet non-toxic malodor counteractant and germicide. It is listed as an ingredient in many mouthrinses, although only one product [ProFresh] actually contains it, at a safe level of acidity. This uniqueness is confirmed by ProFresh's patent on the use of ClO2 for neutralizing oral malodor (U.S. Patent No.5,738,840).
ProFresh solution contains about 0.0040% [which is 40 parts per million ("ppm")] of ClO2, a deceptively low level for what it can accomplish. For example, many municipal water supplies use ClO2 as a disinfectant, at levels less than 1 ppm, in place of higher levels of chlorine, a well-known mutagen. The ClO2 in ProFresh is prepared by the user, who adds to the unactivated solution a small amount of oxidizer and pH adjuster from separate pouches. The unactivated solution contains an excess of chlorite (as sodium chlorite). The oxidizer is fully destroyed in the process, and is replaced by ClO2. The activated solution still contains additional chlorite reservoir, from which further ClO2 is produced to replace the small amounts that may be lost from daily usage.
When ClO2 is used in drinking water disinfection, it slowly degrades to chlorite, chloride, and chlorate. The EPA, in establishing the safety of drinking water with ClO2 and these degradation products, assumes that an average person will drink up to 2 liters (more than 2 quarts) of this water daily. To determine the safety of continuous daily drinking of ClO2-treated water, the EPA makes use of so-called proposed Reference doses (RfDs) based on a series of toxicology studies, in which the animal received much higher levels of the various chloro-species mentioned above. RfDs are conservative figures which can be used to determine how much of different chemicals may be safely ingested on a daily basis. The RfDs are expressed in amount (mgs) of material per unit of body weight (kgs) per day. This allows them to account for the different sizes of the various test animals used in the studies. And, as more studies are completed, these RfDs are updated.
We have compared the estimated intake of ClO2 and chlorite that ProFresh users may ingest, based on their swallowing as much as 10% of the half-ounce (15 ml) rinse dose, twice a day. These estimated daily doses are 0.0024 and 0.1 mg/kg/day, for ClO2 and chlorite respectively. In contrast, the most current RfD's for ClO2 and chlorite, respectively, are 0.01 mg/kg/day and 0.1 mg/kg/day. It can therefore be concluded that, when the product is used as directed:
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 during rinsing and swallowing, the manufacturer's recommended use of the product ProFresh by adults, including incidental ingestion, does not represent a risk to human health.
