Research Summary
This assessment focuses on polyethylene glycols (PEGs) and on anionic or nonionic PEG derivatives, which are currently used in cosmetics in Europe. These compounds are widely utilized in various cosmetic applications due to their solubility, viscosity properties, and low toxicity. PEGs, their ethers, and fatty acid esters produce little or no ocular or dermal irritation and have extremely low acute and chronic toxicities. They do not readily penetrate intact skin, and despite the extensive use of products containing PEG and PEG derivatives, there are only a few case reports of sensitization reactions, primarily involving patients exposed to PEGs in medicines or through injured or chronically inflamed skin. On healthy skin, the sensitizing potential of these compounds appears to be negligible.
For some representative substances in this class, information on reproductive and developmental toxicity, genotoxicity, and carcinogenic properties was available. Taking into consideration all available information from related compounds, as well as their mode and mechanism of action, no safety concerns were identified with regard to these endpoints. Based on the available data, it is concluded that PEGs across a wide molecular weight range (from 200 to over 10,000), their ethers (laureths, ceteths, ceteareths, steareths, and oleths), and fatty acid esters (laurates, dilaurates, stearates, distearates) are safe for use in cosmetics.
Limited data were available for PEG sorbitan/sorbitol fatty acid esters, PEG sorbitan beeswax, and PEG soy sterols. However, taking into account all available information for closely related compounds, it can be assumed that these compounds, as currently used in cosmetic preparations, will not pose a risk to human health. PEG castor oils and PEG hydrogenated castor oils have caused anaphylactic reactions when used in intravenous medicinal products. Their topical use in cosmetics is, however, considered safe as they are not expected to be systemically absorbed. As with all PEGs and PEG derivatives, they must not be applied to damaged skin. Manufacturers of PEGs and PEG derivatives must continue efforts to remove impurities and by-products such as ethylene oxide and 1,4-dioxane.
Overall, it is concluded that the PEGs covered in this review are safe for use in cosmetics under the present conditions of intended use.
Keywords: Polyethylene glycol; PEG; Cosmetics; Safety assessment; Toxicology.
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