What Is It?
Polypropylene Glycol (PPG) Buteths (PPG-12-Buteth-16, PPG-9-Buteth-12, PPG-26-Buteth-26, PPG-28-Buteth-35) are colorless or pale yellow, transparent liquids. In cosmetics and personal care products, PPG Buteth ingredients are used in the formulation of bubble baths and other bath products, shampoos and other hair products, skin fresheners, skin cleansers, and shaving products.
Why Is It Used?
PPG Buteth ingredients enhance the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment. They also enhance the appearance of dry or damaged skin by reducing flaking and restoring suppleness. PPG Buteths help to form emulsions by reducing the surface tension of the substances to be emulsified. PPG-12-Buteth-16 can also be used to dissolve other substances, usually liquids.
PPG Buteth ingredients are synthetic polymers prepared from small chemical compounds called monomers. PPG Buteths are made from equal amounts ethylene oxide and propylene oxide monomers, and the reaction is initiated by the addition of butyl alcohol. The first number in the name indicates the average number of units of propylene oxide, while the second number indicates the average number of units of ethylene oxide.
The Food and Drug Administration (FDA) includes PPG Buteth ingredients on its list of approved indirect food additives. These ingredients may be used as components of polymers used in food contact surfaces. The safety of the PPG Buteth ingredients has been assessed by the The Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel (CIREP). The CIR Expert Panel evaluated the scientific data and concluded that PPG-9-Buteth-12, PPG-12-Buteth-16, PPG-26-Buteth-26 and PPG-28-Buteth-35 were safe as used in cosmetics and personal care products.
CIR Safety Review: Very little acute toxicity was seen after oral exposure to various PPG Buteth ingredients. Acute, short-term, and subchronic inhalation studies with various PPG Buteths were negative as well. Hepatic and renal lesions were observed in subchronic oral toxicity studies of PPG-24-Buteth-27 and PPG-33-Buteth-45.
In chronic feeding studies, no significantly different incidences of neoplasms or other lesions were seen with PPG-7-Buteth-10 and PPG-33-Buteth-45. While PPG-24-Buteth-27 produced mild ocular toxicity, mixed results were seen with PPG-26-Buteth-26, and no irritation was observed with several other PPG Buteths. PPG Buteth ingredients produced skin irritation in some tests. In two lifetime skin painting studies, PPG-7-Buteth-10 and PPG-33-Buteth-45 did not induce papillomas or carcinomas. Clinical testing of PPG-26-Buteth-26 produced no skin irritation or sensitization. Clinical testing of PPG-12-Buteth-16 likewise produced no skin irritation or sensitization.
Based on its large molecular weight alone, it is unlikely that PPG-28-Buteth-35 would be associated with any skin irritation or sensitization. PPG-9-Buteth-12 has a lower molecular weight than the PPG Buteths for which there has been shown an absence of skin sensitization and irritation, but it is highly soluble in water and has a molecular weight over 1000.
These factors suggest that skin absorption would be very limited and it would be unlikely that PPG-9-Buteth-12 would produce skin irritation or sensitization. Because PPG Buteths are butanol-initiated random linear copolymers, there was concern that a reproductive and developmental toxin, n-butyl Alcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages., could be present. Data were provided showing the absence of n-butyl alcohol in PPG-26-Buteth-26 from which it was inferred that this compound is not found in other PPG Buteths.
Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the PPG Buteth ingredients. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations. Link to more information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane.
Link to FDA Code of Federal Regulations for Poly (oxyethylene/oxypropylene)monobutylether (PPG Buteths)
PPG Buteths may be used in cosmetics and personal care products marketed in Europe according to the Under the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..
Link to the EU Cosmetic Regulation:
More Scientific Information
PPG-12-Buteth-16, PPG-9-Buteth-12, PPG-26-Buteth-26, and PPG-28-Buteth-35 are polyoxypropylene, polyoxyethylene ethers of butyl alcohol. In cosmetics and personal care products, these ingredients function as hair conditioning agents, skin conditioning agents – miscellaneous, and surfactants – emulsifying agents. PPG-12-Buteth-16 is also used as a Substances, usually liquids, that are used to dissolve other substances..
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…
Substances Generally Recognized As Safe (“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/