1 Final Report on the Safety Assessment of Polysorbates 20, 21, 40, 60, 61, 65, 80, 81, and 85

Abstract

The Polysorbates are a series of polyoxyethylenated sorbitan esters that are used as hydrophilic, nonionic surfactants in a variety of cosmetic products. Polysorbates are hydrolyzed by pancreatic and blood lipases; the fatty acid moiety is released to be absorbed and metabolized, whereas the polyoxyethylene sorbitan moiety is very poorly absorbed and is excreted unchanged. Acute and long-term oral toxicity in animals indicates a low order of toxicity with oral ingestion of the Polysorbates. Polysorbate 80 was shown to be nonmutagenic in the Ames and micronucleus tests. The Polysorbates were noncarcinogenic in laboratory animals. Multiple studies have shown that the Polysorbates enhance the activity of known chemical carcinogens while not actually being carcinogenic themselves. Extensive clinical skin testing showed Polysorbates to have little potential for human skin irritation or evidence of skin sensitization or phototoxicity. The available data indicate that these ingredients are used in numerous preparations without clinical reports of significant adverse effects. It is concluded that they are safe for use in cosmetics at present concentrations of use.

Effect of cationic surfactant on the physicochemical and antibacterial properties of colloidal systems (emulsions and microemulsions)

“…Optically transparent microemulsions are usually formed using relatively high surfactant concentrations and, therefore, the choice of chemically stable and less toxic surfactants is needed. As there is a consensus that nonionic surfactants tend to be less toxic than ionic surfactants, they have been widely used not only in mouthwashes but also in a number of pharmaceutical formulations and as food additive (American College of Toxicology, 1984;Kerwin, 2008). The two main types of nonionic surfactants currently used in the production of TTO containing mouthwashes are the polyoxyethylene derivatives of castor oil and polyoxyethylene sorbitan fatty acid esters (also known as polysorbates or tweens).…”

Pediatric Safety of Polysorbates in Drug Formulations

“…The fatty acids are expected to further metabolize via beta-oxidation leading to formation of carbon dioxide which is exhaled. The polyoxyethylene sorbitan is expelled via urine and to a lesser degree in feces [4]. Despite the breadth of safety data on PS as an excipient in adult pharmaceutical formulations [2], little has been reported in the pediatric population, compared with the frequent exposure of children to this excipient.…”