The stearate esters (Butyl Stearate, Cetyl Stearate, Isocetyl Stearate, Isopropyl Stearate, Myristyl Stearate, Ethylhexyl Stearate, Isobutyl Stearate) are oily liquids or waxy solids. Ethylhexyl Stearate may also be called Octyl Stearate. In cosmetics and personal care products, stearate esters are used most frequently in the formulation of eye makeup, skin makeup, lipstick and skin care products.
The safety of the stearate ester ingredients has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that Butyl, Cetyl, Isobutyl, Isocetyl, Isopropyl, Myristyl and Ethylhexyl Stearate were safe as cosmetic ingredients. In 2003, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on the stearate esters and reaffirmed the above conclusion.CIR Safety Review: The CIR Expert Panel noted that the safety of the stearate esters has been assessed in a number of studies. They had low acute oral toxicity and were essentially nonirritating to the eyes when tested at and above use concentrations. At cosmetic use concentrations, the stearate esters were, at most, minimally irritating to skin.
In clinical studies, the stearate esters and cosmetics and personal care products containing them, were at most minimally to mildly irritating, essentially nonsensitizing, nonphototoxic and nonphotosensitizing. The CIR Expert Panel indicated that comedogenicity should be considered when using the stearate ester ingredients in cosmetic formulations.
Link to FDA Code of Federal Regulations for Butyl Stearate
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
If they are derived from plants, the stearate esters may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union. Ingredients of animal origin must comply with European Union animal by-products regulations.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The Joint FAO/WHO Expert Committee on Food Additives has not allocated an Acceptable Daily Intake for Butyl Stearate. The Committee believes no safety concern is present at current levels of intake when Butyl Stearate is used as a flavoring agent.
http://www.inchem.org/documents/jecfa/jeceval/jec_288.htm