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Safety assessment on polyethylene glycols (PEGs) and their derivatives as used in cosmetic products.
Toxicology. 2005 Oct 15; 214(1-2):1-38.T

Abstract

This assessment focusses on polyethylene glycols (PEGs) and on anionic or nonionic PEG derivatives, which are currently used in cosmetics in Europe. These compounds are used in a great variety of cosmetic applications because of their solubility and viscosity properties, and because of their low toxicity. The PEGs, their ethers, and their 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 in view of the wide use of preparations containing PEG and PEG derivatives, only few case reports on sensitisation reactions have been published, mainly involving patients with exposure to PEGs in medicines or following exposure to injured or chronically inflamed skin. On healthy skin, the sensitising potential of these compounds appears to be negligible. For some representative substances of this class, information was available on reproductive and developmental toxicity, on genotoxicty and carcinogenic properties. Taking into consideration all available information from related compounds, as well as the mode and mechanism of action, no safety concern with regard to these endpoints could be identified. Based on the available data it is therefore concluded that PEGs of 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. Taking into account all the information available for closely related compounds, it can be assumed that these compounds as presently used in cosmetic preparations will not present a risk for 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 available. As all PEGs and PEG derivatives, they must 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, it is concluded, that the PEGs covered in this review are safe for use in cosmetics under the present conditions of intended use.

Authors+Show Affiliations

CATS Consultants GmbH, Toxicology and Preclinical Affairs, Saarburgstr. 31, D-82166 Gräfelfing, Germany. claudia@catsconsultants.com

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

16011869

Citation

Fruijtier-Pölloth, Claudia. "Safety Assessment On Polyethylene Glycols (PEGs) and Their Derivatives as Used in Cosmetic Products." Toxicology, vol. 214, no. 1-2, 2005, pp. 1-38.
Fruijtier-Pölloth C. Safety assessment on polyethylene glycols (PEGs) and their derivatives as used in cosmetic products. Toxicology. 2005;214(1-2):1-38.
Fruijtier-Pölloth, C. (2005). Safety assessment on polyethylene glycols (PEGs) and their derivatives as used in cosmetic products. Toxicology, 214(1-2), 1-38.
Fruijtier-Pölloth C. Safety Assessment On Polyethylene Glycols (PEGs) and Their Derivatives as Used in Cosmetic Products. Toxicology. 2005 Oct 15;214(1-2):1-38. PubMed PMID: 16011869.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety assessment on polyethylene glycols (PEGs) and their derivatives as used in cosmetic products. A1 - Fruijtier-Pölloth,Claudia, PY - 2005/04/29/received PY - 2005/06/02/revised PY - 2005/06/03/accepted PY - 2005/7/14/pubmed PY - 2005/12/13/medline PY - 2005/7/14/entrez SP - 1 EP - 38 JF - Toxicology JO - Toxicology VL - 214 IS - 1-2 N2 - This assessment focusses on polyethylene glycols (PEGs) and on anionic or nonionic PEG derivatives, which are currently used in cosmetics in Europe. These compounds are used in a great variety of cosmetic applications because of their solubility and viscosity properties, and because of their low toxicity. The PEGs, their ethers, and their 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 in view of the wide use of preparations containing PEG and PEG derivatives, only few case reports on sensitisation reactions have been published, mainly involving patients with exposure to PEGs in medicines or following exposure to injured or chronically inflamed skin. On healthy skin, the sensitising potential of these compounds appears to be negligible. For some representative substances of this class, information was available on reproductive and developmental toxicity, on genotoxicty and carcinogenic properties. Taking into consideration all available information from related compounds, as well as the mode and mechanism of action, no safety concern with regard to these endpoints could be identified. Based on the available data it is therefore concluded that PEGs of 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. Taking into account all the information available for closely related compounds, it can be assumed that these compounds as presently used in cosmetic preparations will not present a risk for 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 available. As all PEGs and PEG derivatives, they must 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, it is concluded, that the PEGs covered in this review are safe for use in cosmetics under the present conditions of intended use. SN - 0300-483X UR - https://www.unboundmedicine.com/medline/citation/16011869/Safety_assessment_on_polyethylene_glycols__PEGs__and_their_derivatives_as_used_in_cosmetic_products_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0300-483X(05)00269-6 DB - PRIME DP - Unbound Medicine ER -