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 employed in a variety of cosmetic applications due to their solubility, viscosity properties, and low toxicity. PEGs, their ethers, and their fatty acid esters cause little to no ocular or dermal irritation and exhibit extremely low acute and chronic toxicities. They do not readily penetrate intact skin, and considering the widespread use of preparations containing PEG and PEG derivatives, there have been few reported cases of sensitization reactions. These cases primarily involve patients exposed to PEGs in medicines or following exposure to injured or chronically inflamed skin. On healthy skin, the sensitizing potential of these compounds appears to be negligible.
For some representative substances of this class, information was available on reproductive and developmental toxicity, as well as genotoxicity and carcinogenic properties. Based on all available information from related compounds, as well as the mode and mechanism of action, no safety concerns regarding these endpoints were identified. Therefore, it is concluded that PEGs with a wide molecular weight range (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 the available information for closely related compounds, it can be assumed that these compounds, as currently used in cosmetic preparations, do 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 considered safe, as they are not expected to be systemically absorbed. As with all PEGs and PEG derivatives, they should not be applied to damaged skin.
Manufacturers of PEGs and PEG derivatives must continue their efforts to remove impurities and by-products such as ethylene oxide and 1,4-dioxane. Overall, the review concludes that the PEGs covered are safe for use in cosmetics under current conditions of intended use.
Keywords: Polyethylene glycol; PEG; Cosmetics; Safety assessment; Toxicology.
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