Final Report on the Safety Assessment of Glycol Stearate, Glycol Stearate SE, and Glycol Distearate

Abstract

consist primarily of the mono-and diesters of triple-pressed stearic acid. They are used in numerous categories of cosmetic products at concentrations ranging from less than 0.1 to 10%.Animal data for acute oral toxicity, skin and eye irritation, and sensitization show that these ingredients have low acute toxicity. A repeated insult patch test with 50% Glycol Distearate on 125 subjects presented no evidence of skin irritation or hypersensitivity. Human studies using formulations containing Glycol Stearate at levels of 2-5% reported no skin irritation or sensitization.Subchronic testing has not been adequately investigated in laboratory animals. Human test data for formulations containing > 4% Glycol Stearate or Glycol Distearate should be considered. Based on the available information presented herein, it is concluded that Glycol Stearate, Glycol Stearate SE, and Glycol Distearate are safe as cosmetic ingredients in the present practices of use and concentration. CHEMICAL AND PHYSICAL PROPERTIES hese ingredients are mixed esters of ethylene glycol and triple-pressed stearic T acid. The latter consists of 42.5% stearic acid and about an equal amount of palmitic acid, along with lesser amounts of several other fatty acids. The general structural formula for these ingredients Glycol Stearate: which R, i s the acyl The ingredient is comprised of 40-70% of the monoester in portion of triple-pressed stearic acid and R1 is H. Glycol 1 at MOUNT ALLISON UNIV on July 11, 2015 ijt.sagepub.com Downloaded from 2 COSMETIC INGREDIENT REVIEWStearate also contains a significant portion, 30-58%, of the diester in which both R, and R2 are the acyl moiety of triple-pressed stearic acid.(2) Glycol Stearate SE: This ingredient is a self-emulsifying grade of Glycol Stearate containing free stearic acid and some sodium and/or potassium stearate. ( ') Glycol Distearate: This ingredient is the diester of ethylene glycol in which both R, and R2 are the acyl moiety of triple-pressed stearic acid. (2) Glycol Stearate, Glycol Stearate SE, and Glycol Distearate have similar physical properties. They are white to cream colored waxy solids. Their physical properties vary within specified limits according to their proportions of monoand diesters and other components. Depending on the intended use, a purchasing specification is used to set specific limits on the physical characteristics of these ingredients.(2) Analytical MethodsGlycol Stearate and Glycol Distearate can be analyzed by gas chromatogr a p h~. '~) Mass spectrometric analysis of long-chain esters of ethanediol (ethylene glycol) has been described(*); this allows for the identification of individual esters of the diol as well as of classes of diol monoesters. A method of gel-permeation chromatography for Glycol Distearate on Sephadex LH-20 has also been r e p~r t e d . '~) Standard methods have been suggested for determining the chemical properties of these ingredients.(2) Impurities Impurities such as free stearic acid (triple-pressed), the mono-or diesters, ethylene glycol, and c...