J. Cosmet. Sci., 61, 457–465 (November/December 2010) 457 A survey of phthalate esters in consumer cosmetic products JEAN C. HUBINGER, U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. Accepted for publication August 31, 2010. Synopsis Certain phthalate esters have been shown to cause reproductive toxicity in animal models. For this reason, the FDA has been monitoring the use of phthalate esters in cosmetics. In this study, the U.S. Food and Drug Administration (FDA) conducted a limited survey of 84 adult-use and baby-care cosmetic products for the presence of fi ve phthalate esters: dimethyl phthalate (DMP), diethyl phthalate (DEP), benzylbutyl phthalate (BBP), dibutyl phthalate (DBP), and diethylhexyl phthalate (DEHP) (Figure 1). The analytes were extracted from a cosmetic product/Celite mixture with hexane, and the extract was then analyzed using reversed-phase high-performance chromatography (HPLC) on an instrument equipped with an ultraviolet radiation (UV) detector set at 230 nm. The analytes were separated on a Partisil octadecylsilane (ODS)-3 column (250 mm × 4.6 mm I.D., 5μm). The mobile phase consisted of a mixture of 50% water, 34% acetonitrile, 13% 2-propanol, and 3% methanol that was changed linearly (35 minutes) to 15% water, 55% acetonitrile, 25% 2-propanol, and 5% methanol and held for an additional ten minutes. Spiked recoveries in antiperspirant and nail color ranged from 88% to 104%. Thirty-one of the 60 adult-use cosmetic products were found to con- tain at least one phthalate ester. Twenty products contained DEP and 11 nail products contained DBP. Con- centrations of DBP ranged from 123 μg/g to 62,607 μg/g. Concentrations of DEP ranged from 80 μg/g to 36,006 μg/g. Five of the 24 baby-care products contained DEP at concentrations ranging from 10 μg/g to 274 μg/g. INTRODUCTION Phthalate esters are widely used by industry to impart fl exibility to otherwise rigid poly- mers such as polyvinyl chloride (PVC), to fi x or hold color or fragrance, making the color or fragrance last longer, and to provide a fi lm or gloss, to name just a few applications (1). Because they are not bonded in their matrix, phthalate esters elute to the environment and are among the most abundant of man-made environmental pollutants (1,2). Everyday con- sumer products containing phthalate esters include pharmaceutical tablets and capsules, vitamins, adhesives and glues, detergents and surfactants, fi shing lures, children’s toys, paints and printing inks, food product containers, textiles, and household items such as shower curtains, vinyl upholsteries, and fl oor tiles. In cosmetic products, phthalate esters are used as skin moisturizers, as skin softeners, and as skin penetration enhancers (3,4). They are also used as anti-brittleness and anti-cracking agents in nail polishes and sealants, as anti-foaming agents in aerosols, and as solvents (3,4). Applications for specifi c phthalate esters depend primarily on the physical properties of the individual phthalate ester, determined by the length and branching of the dialkyl or alkyl/aryl side chains (1).

JOURNAL OF COSMETIC SCIENCE 458 Exposure to phthalate esters occurs through food, the indoor and outdoor air we breathe, and our daily contact with consumer products, including cosmetics (3,5–6). In the general population, consumption of food products is generally considered to be the most signifi - cant exposure pathway (3,5,7–9). Sources include environmental uptake during crop cul- tivation and leaching from phthalate-containing processing equipment and packaging materials (7). Dermal contact and absorption of phthalates via the skin is also possible. Little or no exposure occurs from products such as soaps, shampoos, and conditioners that are used frequently but then washed off the skin. Exposure can occur from cosmetics that are left on the skin for extended periods of time, with actual exposure being a function of the area of skin exposed to the product, the frequency of application and length of time left on the skin, and the absorption rate through the skin. A survey of the U.S. population has found elevated levels of the mono-esters of certain phthalates in their urine (10). Although topical exposure to phthalate esters in cosmetic products may contribute to the observed urinary levels of mono-esters (metabolites of phthalate esters) in humans, it should be noted that studies with rodents and experiments with human skin have shown that absorption through the skin of humans is most likely minimal (7). While cosmetics contribute to total expo- sure, no one knows what part of the total human exposure results from the use of cos- metics. Finally, medical devices containing phthalate esters may be important sources in susceptible subpopulations, including neonatal infants undergoing surgical interventions and other hospital patients receiving long-term blood, medicine, or nutritional supple- ments intravenously (1,5,9). Phthalate esters have not been shown to be acutely toxic in animal models or in humans, but chronic studies in animal models, primarily the rodent, have shown developmental and reproductive toxicity (1,9,11–13). In particular, toxicological studies indicate an associa- tion between certain phthalate esters, notably dibutyl phthalate (DBP), benzylbutyl phthalate (BBP), and diethylhexyl phthalate (DEHP), and disruption of reproductive tract develop- ment in human male infants (14). Figure 1. Phthalate esters: dimethyl phthalate (DMP), diethyl phthalate (DEP), dibutyl phthalate (DBP), benzylbutyl phthalate (BBP), and diethylhexyl phthalate (DEHP).