Peg-40 Hydrogenated Castor Oil
Also known as Polyoxyl 40 Hydrogenated Castor Oil, Cremophor RH 40, Ethoxylated hydrogenated castor oil (40 EO), Hydrogenated castor oil ethoxylate
“CIR Expert Panel says: safe as used in cosmetics.”
PEG-40 Hydrogenated Castor Oil is a nonionic surfactant/emulsifier produced by ethoxylating hydrogenated castor oil with approximately 40 moles of ethylene oxide. The CIR Expert Panel assessed this ingredient twice (IJT 16(S3):269-306, 1997 and IJT 33(S4):13-39, 2014) and concluded it is safe qualified (SQ): safe for use in cosmetics when formulated to be non-irritating, with no upper concentration limit specified. A 2017 in vitro/in vivo safety study (PMID 28362322) confirmed acceptable safety of high-concentration PEG-40 hydrogenated castor oil in oral nanoemulsion formulations. The principal manufacturing impurity concern is trace 1,4-dioxane from the ethoxylation process, which the CIR Panel addressed in the 2013 Amended Safety Assessment of PEGylated Oils, emphasizing continued industry use of purification procedures.
Highly effective nonionic emulsifier and solubilizer for oils, fragrances, and lipophilic actives in aqueous systems
Among the most-used PEGylated castor oils in cosmetics (2,107 reported uses as of the 2013 CIR re-review), demonstrating broad industry acceptance
Non-ionic character provides excellent compatibility across a wide range of formulation pH and co-ingredient types
Safe at concentrations used in cosmetics without an upper limit restriction; the original 1997 CIR assessment established safety up to 100% for PEG-40 Hydrogenated Castor Oil
- · CIR qualified approval (SQ): must be formulated to be non-irritating; some irritation potential noted for the PEGylated castor oil class at undiluted concentrations.
1,4-Dioxane is an unavoidable trace byproduct of the ethoxylation manufacturing process; not listed on the ingredient label. The CIR Expert Panel (2013 Amended Safety Assessment of PEGylated Oils) stressed that the cosmetic industry should continue using necessary purification procedures to remove it before blending into cosmetic formulations.
As a penetration enhancer class, PEGylated castor oils may increase dermal absorption of co-formulated ingredients; the CIR Panel noted care should be taken when combining with ingredients whose safety depends on lack of dermal absorption.
CIR Quick Reference Table (12/2017, revised 07/2018) — PEG-40 Hydrogenated Castor Oil row: Finding=SQ, Citation=IJT 16(S3):269-306, 1997;…
“PEG-40 Hydrogenated Castor Oil | SQ | safe for use in cosmetics when formulated to be none-irritating | IJT 16(S3):269-306, 1997; IJT 33(S4):13-39, 2014”— QRT-122017revised072018.pdf, p. 87