Chemicals, they’re all around us. And many will say “we eat it every day” or “it is naturally occurring in our body, so don’t bother avoiding it.” Oh, and “it is found in breastmilk so you can’t say that breastfeeding is best.” But, natural doesn’t mean best, and chemical additives may have a purpose, but it doesn’t mean they are always necessary.
Polysorbate 80 (generic name darbepoetin alfa) is a nonionic surfactant and emulsifier often used in foods and cosmetics, and is also called Tween 80. Additional sorbates include polysorbates 20, 60, 65, and 80. Tween 80, seems to be the most common, and found often in our food, cosmetics and even tooth paste, so I’m focusing on that chemical today. I mean, you can buy it on ebay and amazon even!
The Amazon version’s description says the following:
Description: Emulsifying agent consisting of sorbitol, ethylene oxide and oleic acid (polyoxyethylene-20 sorbitan monooleate), oleic acid is derived from vegetable oil. Purity > 95%. Amber, viscous liquid, odorless. Soluble in water and alcohols, insoluble in oils. HLB value 15 (gives oil-in-water emulsions). CAS# 9005-65-6. INCI Name: Polysorbate-80. Properties: Non-ionic emulsifier (enables water and oil to mix), dispersing agent, solubilizer, mild antistatic and conditioning properties, solubilizer and stabilizer of essential oils. May promote hair growth. Use: Can be added to formulas as is. Applications: Body washes, hair shampoos, hair loss treatments, lotions, creams, bath oils, solubilizates.
Sorbitan mono-9-octadecanoate poly(oxy-1,2-ethanediyl) derivatives; complex mixtures of polyoxyethylene ethers used as emulsifiers or dispersing agents in pharmaceuticals.
So what does the science say about the safety of Tween80 or Polysorbate 80?
First we need to know that olysorbates, including polysortbate 80, are widely used to protect biological drug products from unfolding, aggregation, and recipitation during shipping and handling.
Polysorbate 80 is found in everything from cosmetics to chemotherapy drugs. But, there have been black box warnings (basically warnings that nurses see on items to prevent issues/contraindications) on items containing polysorbate 80. Why? Basically we know some people are sensitive or allergic to Polysorbate 80, but we aren’t checking to see if someone is sensitive before routinely using it. Read more from Oncology Practice (Peer Reviewed) here.
Polysorbate 80’s MSDS indicates that most of the toxicology on it is “unavailable” but does that mean it is safe? Well MSDS sheet does say, “May cause adverse reproductive effects based on animal test data. No human data found. May cause cancer based on animal test data. No human data found. May affect genetic material (mutagenic).” It also indicates:
From MSDS: Acute Potential Health Effects: Skin: No irritation is expected, but it may cause mild/slight irritation in more sensitive individuals. It will probably not be absorbed through the skin. Eyes: It may cause eye irritation. Inhalation: No expected to be a health hazard. No irritation is expected to be associated with the inhalation of this material. No toxic effects are known to be associated with the inhalation of this material. Ingestion: This material is not likely to cause irritation upon ingestion. It is classified as “relatively harmless” by ingestion and considered to be a low ingestion hazard. Ingestion of very large doses may cause abdominal spasms and diarrhea. Animal studies have shown it to cause cardiac changes, changes in behavior (altered sleep time) and weight loss (upon repeated or prolonged ingestion). However, no similar human data has been reported.
How many people are sensitive to polysorbate 80?
We don’t know. But we know that some people react to polysorbate 80. In an article in Ann Allergy Asthma Immunol. 2005 Dec;95(6):593-9., entitled “Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions.” by Coors EA, et al, they found that
Polysorbate 80 was identified as the causative agent for the anaphylactoid reaction of nonimmunologic origin in the patient. Polysorbate specific IgE antibodies were not identified in enzyme-linked immunosorbent assay and immunoblot examinations, confirming the nonimmunologic nature of the anaphylactoid reaction.
Symptoms of sensitivity or allergy?
For some people it is a simple rash, but to others it can be a major issue. You can test for an allergy to polysorbate 80. Skin prick testing, enzyme-linked immunosorbent assay, IgE immunoblotting, and flow cytometric detection of basophil activation were performed in controls and in a patient with a medical history of anaphylactic shock due to intravenous administration of a multivitamin product during pregnancy.
From Toxnet (NIH): Polysorbates are widely used in cosmetics, food products, and oral, parenteral, and topical pharmaceutical formulations, and are generally regarded as nontoxic and nonirritant materials. There have, however, been occasional reports of hypersensitivity to polysorbates following their topical and intramuscular use. Polysorbates have also been associated with serious adverse effects, including some deaths, in low birthweight infants intravenously administered a vitamin E preparation containing a mixture of polysorbates 20 and 80.
The next thing that comes across is what about emulsifiers in general? Are they okay to have in our diets?
Here’s the thing, science (and technology) are always changing, but are we applying things we know to be true, or even potentially true, to help us make new and better decisions?
But, even if you aren’t allergic or have a sensitivity, should we use polysorbate 80?
Polysorbate 80 (emulsifier) and Gut Health
What has been found is that polysorbate 80 causes diseases similar to ulcerative colitis and Chron’s disease in laboratory mice. In the study, including Andrew Gewitz of the Center for Inflammation, Immunity and Infection, Institute for Biomedical Sciences at Georgia State University (http://biomedical.gsu.edu/profile/andrew-gewirtz/), mice were fed emulsifiers diluted in drinking water or added into food, which were found to trigger low-grade intestinal inflammation and features of metabolic syndrome (read more about Metabolic Syndrom here) such as blood glucose level abnormalities, increased body weight and abdominal fat weight. What? I hate to link to Reuters, but here it is, their article reviewed some recent (2015) research, and succinctly put it this way:
inflammatory bowel diseases and metabolic syndrome is a change in the gut microbiota – the roughly 100 trillion bacteria that inhabit the intestinal tract – in ways that promote inflammation. In mice given emulsifiers, the bacteria were more apt to digest and infiltrate the dense mucus layer that lines and protects the intestines. (read more here)
Read the study http://www.nature.com/nature/journal/v519/n7541/full/nature14232.html or see the abstract at NIH here because that’s what people prefer to see, right “NIH”
Moreover, they suggest that the broad use of emulsifying agents might be contributing to an increased societal incidence of obesity/metabolic syndrome and other chronic inflammatory diseases.
Wow, it is a good thing we’re not mice!
So we know gut bacteria is important. We know that there are issues between immulsifiers, including polysorbate 80 and the intestines. We know that there is research supporting a healthy gut and immunity… So we really need to consider the role of polysorbate 80 and other emulsifiers in our lives.
There are more issues surrounding Tween 80 (Polysorbate 80) According to Annals of Allergy, Asthma and Immunology, Volume 95, Number 6, December 2005, pp. 593-599(7), “it is of current relevance as a ‘hidden’ inductor of anaphylactoid reactions”, and “Polysorbate 80 was identified as the causative agent for the anaphylactoid reaction of nonimmunologic origin in the patient. Conclusions: Polysorbate 80 is a ubiquitously used solubilizing agent that can cause severe nonimmunologic anaphylactoid reactions.”
Other studies show more shocking side effects of this easy to find, easy to use, easy to injest, inject and apply product:
- Baby female rats were injected with polysorbate 80 at days 4-7 after birth. It massively accelerated the maturing of the rats and caused changes to the vagina and womb lining, hormonal changes, ovary deformities and degenerative follicles. (Source: Gajdova M, Jakubovsky J, Valky J.Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats. Food Chem Toxicol. 1993 Mar;31(3):183-90. PMID: 8473002.)
But wait, when you buy it on Amazon it is for making shampoos and stuff right? Well yes, but you see above where it says it has pharmaceutical formulations.
According to the same polysorbate 80 study, it may be a carcinogenic, (cause cancer), as well as a mutagenic (cause birth defects).”
Where do you find Polysorbate 80?
Well, read the food labels. I was looking at some “indian simmer sauce” that was on sale at Target, it was Target’s Archer Hill brand. Guess what, it had polysorbate 80 listed! So, nope, didn’t buy it.
Next, read your shampoo and soap bottles. Of course, this is being applied and NOT injected or taken orally (or rectally). So some people will find a topical application with polysorbate 80 okay. Again, this is for everyone to decide individually for their family.
Finally, read your vaccine inserts. Oh, wait, we’re not given those! From the Pink Book from the CDC.
- DTAP (brand: Infanrix)
DTaP-IPV (brand: Kinrix)
DTaP-IPV/Hib (brand: Pentacel)
Human Papillomavirus (HPV) (brand: Gardasil)
Influenza (brand: Agriflu)
- Influenza (brand: Fluarix)
- Influenza (brand: Flucelvax)
Pneumococcal PCV13 (brand: Prevnar 13)
- Rotavirus (brand: RotaTeq)
- Tdap (brand: Boostrix)
So they say toxicity for ingestion is pretty hard to get to: Practically nontoxic: probable oral lethal dose (human) above 15 g/kg, more than 1 quart (2.2 lb) for 70 kg person (150 lb), but what about infants? What about injection? Where is the study on that?
Source: Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-181]
But, do we know how our bodies rids itself of polysorbate 80 and other toxins? Do we all do it the same way? For example, latest research is showing that those with MTHFR mutations (full scientific name: methylenetetrahydrofolate reductase (NAD(P)H)) may be less able to rid its body of toxins or metabolizes entrants to the system (which is the point of this whole post, right?) and thus are more likely to suffer reactions to toxins.
But do we know how we will react individually to Polysorbate 80 and other items that we introduce to our system in a variety of ways?
What questions should we be asking when we decide to use a product (whether it is a prepared food, a cosmetic or a medication)? When polysorbate 80 is used in anti-cancer drugs to help pass to the brain (link here: http://www.ncbi.nlm.nih.gov/pubmed/17150277), does it pass into the brain when we use it in a vaccine? Is that okay to have happen? Do we know for sure it is safe to have in our bodies? What about just on us or something we eat? What studies will come out later? Is it worth it?
If you are making your own shampoos or tooth pastes and want to ship it on to friends and decide to use polysorbate 80, at minimum, please consider the use the food grade version and not cosmetic grade.
When you have an alternative to emulsifiers like polysorbate 80, wouldn’t it be worth while to avoid it? I feel we have more questions than answers here, so the science on this one, definitely is not closed.
Are we better off avoiding potential toxins when possible, and then just use them when they are for a clear and present benefit?
I mean, we can at least not EAT it, right?