Is Therabreath Safe?
March 10, 2010 12:04 AM   Subscribe

Is Therabreath safe?

Google is totally spammed out on every therabreath-related search I can think of. Apparently the active ingredient (according to the website) is chlorine dioxide, about which I can find very little of use regarding its safety/toxicity in solution in humans. Wikipedia states that it is used to disinfect water but that the EPA limits the concentration of the chlorite ions that result from it to under 1 ppm, which makes me wonder why it would be safe to use a mouthwash or toothpaste whose primary active ingredient is chlorite.
posted by holympus to Health & Fitness (10 answers total)
According to this MSDS, it sounds like something you wouldn't want in your mouth, or to breath either, in any kind of concentration.

It reports an LClo for rats as 15 minutes of exposure to 500 ppm. LClo means "the lowest concentration of a material in air reported to have caused the death of animals or humans."

The other side of the coin is that they're not permitted to sell something like that without FDA approval, and the FDA is extremely conservative about dangers.
posted by Chocolate Pickle at 12:45 AM on March 10, 2010

You could ask your ENT (ear-nose-throat) doctor, who would either confirm or deny its safety, or even suggest other treatments that work better and/or are safer.
posted by Blazecock Pileon at 12:55 AM on March 10, 2010

Just Googling for it within the ingredients of mouthwash and toothpaste, it appears that chlorine dioxide has been a common ingredient for several decades in many brands.

From Disinfection, Sterilization, and Preservation by Seymour Stanton Block p. 221:
Studies with human subjects have not detected any serious toxicities associated with the acute or chronic ingestion of of chlorine dioxide and chlorite... The study affirmed the relative safety and tolerance of normal, healthy, adult males and normal, healthy, adult male G-6-PD individuals to daily 12-week ingestion of 500mL of chlorine dioxide at a concentration of 5 mg/L.
Of course, you aren't supposed to ingest toothpaste or mouthwash anyways, though; toothpastes normally do contain substances that are poisonous if swallowed in large quantities. Here in the U.S. tubes of toothpaste often have printed on them instructions for calling the poison control center.
posted by XMLicious at 1:11 AM on March 10, 2010

Chocolate Pickle: "This product and information has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent disease."

Plenty of alternative medicine is sold without FDA approval.
posted by equalpants at 1:13 AM on March 10, 2010

Actually, the MSDS linked above doesn't really provide any information that suggests that this compound is unsafe to you. The inhalation study that chocolate pickle is referencing was talking about the gas version of chlorine dioxide, not a small quantity of dissolved chlorine dioxide. Those are entirely different things.

Also, that MSDS is referring to a pure solution of chlorine dioxide dissolved in water, at a concentration of 0.054%. I'm sure that toothpaste does not have such a high concentration of the compound. So even at that high concentration, it seems like - according to the MSDS - the main threat is skin irritation.
posted by sickinthehead at 6:18 AM on March 10, 2010

And I just want to second that the FDA has nothing to do with "alternative" or "homeopathic" medicine. Those substances are unregulated and there is no burden of proof with their manufacturers that they even need to contain what they say they contain.

Furthermore, don't be so naive that the FDA wouldn't approve things that are dangerous to humans. That happens all the time, and recalls happen all the time, too.
posted by sickinthehead at 6:20 AM on March 10, 2010 [1 favorite]

I believe the package insert on the oral rinse says it's OK to swallow. For whatever that's worth.
posted by cairnish at 7:52 AM on March 10, 2010

Chlorine dioxide is a very widely used biocide (water treatment, biological decontamination, etc...). That is, it kills everything, bacteria, viruses, fungi, yeasts, you, in high enough concentrations. It's also a pretty good bleach. It's a really good disinfectant because it doesn't leave behind breakdown products that cause more problems (as chlorine gas can), just salts and water. Chlorine dioxide is, in fact, one of the safest things to use as a topical sterilizer.

So, in low concentrations, it can be safe. As mentioned above, the FDA won't let them sell concentrations that are too high to safely use. The question should be not, is it safe, but in concentrations low enough to be safe, is it effective. That question, I don't know the answer for.
posted by bonehead at 9:13 AM on March 10, 2010

bonehead, from what people are mentioning above, it doesn't sound like the Therabreath products have FDA approval. I'm not interested in data about whether or not it works because it seems that a simple test of that would be to try it. I'm interested in any data that would support your claim that "chlorine dioxide is one of the safest things to use as a topical sterilizer." Are there studies in humans of chlorine dioxide used as a topical sterilizer? All the data cited above appear to be about chlorine dioxide in solution when it's used to disinfect water at very, very low concentrations, except the MSDS, which I have difficulty interpreting.
posted by holympus at 11:47 AM on March 10, 2010

I'll work from some of the summary data sources, as referring back to the original literature would take a long time and the papers may not be available to you online anyway. If you wish, you can follow the references in the articles I link to below back to their original papers. This may mean that you have to visit a university library though.

The best place to start is the NIH IRIS listing for Chlorine Dioxide. This is a compilation of all of the literature of studies on the toxicology of this chemical, focusing on human toxicity.

Under the Chronic Health Hazard Assessment for Noncarcinogenic Effects section, look at the the No Observable Adverse Effects Level (NOAEL). This is 3 mg/kg (of bodyweight) per day, well below the Lowest Observable Adverse Effects Level (LOAEL) of 6 mg/kg/day. Note that these are typically quite conservative numbers, erring on the side of safety always.

You can read the following text to understand what those adverse effects are, but the effects are low level injuries and the uncertainties cause of the injuries by the chemical are high. In other words, it's not clear that the chemical really did the damage reported.

You can skip over the Inhalation section. That's important for people who work with the gas form, but not nearly as much for a dissolved product.

The other important section is the Carcinogenicity Assessment for Lifetime Exposure, i.e., will this stuff cause cancer if you use it. If you read the assessment, you'll find that no links to cancer have ever been conclusively demonstrated. Your level of comfort may be lower than mine, but I don't see anything here that would cause significant concern.

Now, we need a small bit of math to figure out the risk of using these drops.

From the MSDS linked to above, the nasal drops are 540 mg/L ClO2. The recommended dose is 2 drops. That's about 2/10,000 of 1L. That's a total dose of about 0.1 mg (0.0002 * 540).

Let's assume you weight about 100 lbs --- 45 kg. Your maximum allowable dose for no adverse effects is: 150 mg/day (45 * 3)

So, you could take more than 1000 doses (150 / 0.1) of those nasal drops in a single day (approximately the whole 15 mL bottle) and still be confident that you would suffer no adverse effects.

Remember the lowest observable effect level, 6 mg/kg/day? That would be about two bottles per day.

A safety factor of 1000 is very good, much better than asprin or tyleonol, for example.

Again, my questions about this product would be about its effectiveness, not its safety.
posted by bonehead at 12:37 PM on March 10, 2010

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