The safety of the palmitates has been assessed by the Expert Panel on Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that ethylhexyl palmitate, cetyl palmitate and isopropyl palmitate were safe as cosmetic ingredients. In 2001, the Expert Panel considered available new data on ethylhexyl, cetyl and isopropyl palmitate and reaffirmed the above conclusion.
The Expert Panel concluded that the palmitates would be expected to be nontoxic in view of their hydrolysis to palmitic acid and to the corresponding alcohols. Dermal acute and subchronic studies with the palmitates did not show evidence of toxicity. Eye irritation tests on the palmitates produced either very slight ocular irritation or none at all. Human skin tests with the palmitates and with products containing the palmitates were reviewed. One of three products containing 40%-50% ethylhexyl palmitate produced mild irritation. Moisturizers containing 2.5%-2.7% cetyl palmitate were minimally irritating and produced no signs of sensitization, phototoxicity or photo-contact allergenicity. Undiluted isopropyl palmitate was minimally irritating and was reported to be a “weak potential sensitizer” of the “lowest grade.” A bath oil product containing 45.6% isopropyl palmitate produced no signs of irritation, sensitization, phototoxicity, or photo contact allergenicity. The Expert Panel noted that ethylhexyl palmitate was not tested at concentrations above 50% for skin irritation and no data on sensitization or phototoxicity were available for this ingredient. Clinical data on cetyl palmitate were limited to concentrations of 2.7%. Based on the available data, the Expert Panel concluded that ethylhexyl palmitate, cetyl palmitate, and isopropyl palmitate were safe as cosmetic ingredients.
Ethylhexyl, cetyl, and isopropyl palmitate 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 provided the fatty acids and fatty alcohols are not of animal origin. Raw materials of animal origin must comply with European Union animal by-products regulations.