PEG-40 Hydrogenated Castor Oil

The Food and Drug Administration (FDA) includes castor oil on its list of flavoring agents and related substances permitted for direct addition to food. PEG Castor Oil ingredients (molecular weight 400-3,000) may also be used as indirect food additives in textiles and textile fabrics in components of articles intended for repeated use. The safety of PEG Castor Oils and PEG Hydrogenated Castor Oils has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that PEG-30, -33, -35, -36 and -40 Castor Oil were safe for use in cosmetics and personal care products at concentrations up to 50% and that PEG-30 and -40 Hydrogenated Castor Oil were safe for use at concentrations up to 100%.

CIR Safety Review: The CIR Expert Panel considered it acceptable to extrapolate the results of the PEG Castor Oils and PEG Hydrogenated Castor Oils that have been studied to all the ingredients in the family. No dermal or ocular irritation was observed following exposure to the PEG Castor Oil and PEG Hydrogenated Castor Oil ingredients. In studies using up to 50% PEG-35 Castor Oil, irritation was seen when this ingredient was placed on the skin, but no sensitization was found on challenge. This ingredient was found to increase the sensitization potential of other ingredients. No evidence of developmental toxicity was seen in feeding studies. These ingredients, tested as vehicle controls, produced no mutagenic or carcinogenic effect. Clinical data were generally negative for irritation and sensitization, although some serious allergic reactions have been seen in studies of intravenous drugs in which PEG-35 Castor Oil was used as the vehicle. The maximum concentration used in sensitization studies was 50% for PEG Castor Oils and 100% for PEG Hydrogenated Castor Oils. Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the PEG Castor Oil and PEG Hydrogenated Castor Oil ingredients. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations.

More information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane. 

FDA: Link to Code of Federal Regulations for castor oil and PEG castor oil

• Natural Flavoring Substances 
• Textiles and Textile Fibers 

Please search this website for Castor Oil for more information about its safety. PEG Castor Oils and PEG Hydrogenated Castor Oils may be used in Europe according to the general provisions of the Cosmetics Regulation of the European Union.