Final Report on the Safety Assessment of Peg-30,-33,-35,-36, ANd-40 Castor Oil and Peg-30 and-40 Hydrogenated Castor Oil

Abstract

PEG Castor Oils and PEG Hydrogenated Castor Oils are a family of polyethylene glycol derivatives of castor oil and hydrogenated castor oil that are used in over 500 formulations representing a wide variety of cosmetic products. They are used as skin conditioning agents and as surfactants (emulsifying and or solubilizing agents). The PEG Castor Oils and PEG Hydrogenated Castor Oils include various chain lengths, depending on the quantity of ethylene oxide used in synthesis. Although not all polymer lengths have been studied, it is considered acceptable to extrapolate the results of the few that have been studied to allingredients in the family. Because a principal noncosmetic use of PEG Castor Oils is as solvents for intravenous drugs, clinical data are available that indicate intravenous exposure can result in cardiovascular changes. Results from animal studies indicate very high LD50 values, with some evidence of acute nephrotoxicity in rats but not in rabbits. Short-term studies with intravenous exposure produced some evidence of toxicity in dogs but not in rabbits. Intramusuclar injection produced no toxicity in several species, including dogs. Subchronic oral studies also were negative. No dermal or ocular irritation was observed in studies in rabbits. Irritation was seen during induction, but no sen-sitization was found on challenge in guinea-pig studies using up to 50% PEG-35 Castor Oil; however, thisingredient was found to be a potent adjuvant in guinea pigs and mice. No evidence of developmental toxicity was seen in mice and rat feeding studies. Theseingredients, tested as vehicle controls, produced no mutagenic or carcinogenic effect. Clinical data are generally negative for irritation and sensitization, although some anaphylactoid reactions have been seen in studies of intravenous drugs in which PEG-35 Castor Oil was used as the vehicle. Because the maximum concentration used in animal sensitization studies was 50% for PEG Castor Oils and 100% for PEG Hydrogenated Castor Oils, it was concluded that PEG Castor Oils are safe for use in cosmetic formulations up to a concentration of 50% and that PEG Hydrogenated Castor Oils are safe as used in cosmetic formulations.