Final report on the safety assessment of Trihydroxystearin

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Trihydroxystearin is the triester of glycerin and hydroxystearic acid. It is used as a skin conditioning agent, a solvent, and as a viscosity increasing agent in cosmetic formulations at concentrations up to 5%. In acute oral toxicity studies in rats, no deaths were reported at a dose of 5 g/kg. Trihydroxystearin was reported to be a mild ocular irritant, but not a skin irritant in animal tests. Ames test results indicate that the ingredient is not mutagenic. Clinical testing found no skin irritation. Although the data on Trihydroxystearin are limited, the Cosmetic Ingredient Review (CIR) Expert Panel had previously conducted a safety assessment of Glyderyl Stearate and Hydroxystearic Acid. These data indicate no mutagenic, carcinogenic, or teratogenic effects in animals, and no irritation or sensitization in clinical tests. The data on these two ingredients are considered relevant to the assessment of Trihydroxystearin because of the chemical similarity of the ingredients. The data on Glyceryl Stearate and Hydroxystearic Acid are also consistent with the limited data that are available on Trihydroxystearin itself. Therefore, based on the available animal and clinical data in this report, which includes study summaries from earlier safety assessments of Hydroxystearic Acid and Glyceryl Stearate and Glyceryl Stearate/SE, the Expert Panel concludes that Trihydroxystearin is safe as used in cosmetic formulations.

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... [21] Since then, the use of 12-HSA in food has been banned due to its laxative properties, but due to its low skin-irritation properties, it has found use in cosmetic formulations. [22] The formation of microcapsules with such high content of oil can be considered as an important aspect of this method and can be exploited to load and encapsulate oil-soluble functional ingredients (such as antioxidants, sunscreens, etc.) for cosmetic and personal-care products. The encapsulation potential of these microcapsules was demonstrated by loading a high level of oil-soluble antioxidant (a-tocopherol) and measuring the antioxidant activity after encapsulation. ...
A new type of microcapsules with controllable morphology is presented. They are based on a low-molecular-weight gelator and can be switched from temperature-stable to temperature-responsive by simply modifying the preparation method.
Hydroxystearic Acid is a fatty acid used as a surfactant-cleansing agent in cosmetic products. Initial review of available safety test data resulted in a finding that there were insufficient data to support the safety of Hydroxystearic Acid for use in cosmetic products. Data needed included concentration of use, chemical characterization, dermal reproductive and developmental toxicity, genotoxicity (and carcinogenicity data if the genotoxicity data were positive), and skin irritation data. Subsequent to that conclusion, new data were received. Use concentrations were reported as high as 10%. Small amounts of other fatty acids are commonly found in preparations of Hydroxystearic Acid. Genotoxicity was not found in bacterial or mammalian systems and only subcutaneous sarcomas at the site of injection were found in carcinogenicity studies. Dermal reproductive and developmental toxicity studies were negative. Skin irritation was produced by antiperspirant prototype formulations containing Hydroxystearic Acid under occluded or semioccluded patch test conditions. It was considered that such formulations under those exaggerated conditions can be irritating, but are generally not irritating in actual use. Because Hydroxystearic Acid and Stearic Acid are structurally similar, data from a previous safety assessment of Oleic Acid, Lauric Acid, Palmitic Acid, Myristic Acid, and Stearic Acid were summarized. On the basis of the animal and clinical data, it was concluded that Hydroxystearic Acid is safe as a cosmetic ingredient in the present practices of use.
When 0.5–1% of 12-hydroxystearic acid or the corresponding triglyceride is incorporated into unhardened peanut butter, the resulting product has stiff creamy consistency, and no oil separation takes place upon standing. Sensory evaluation of this peanut butter indicated that it was indistinguishable from typical commercial material in flavor and texture.