134 JOURNAL OF COSMETIC SCIENCE been traced to the use of drugs (70). Our survey of cosmetic products found that the highest levels of phthalate esters were present in nail and fragrance products. Products such as nail polish harden rapidly after application, and so phthalate ester absorption through the nail is likely to be significantly inhibited. Exposure to phthalate esters from products such as soaps, shampoos, and conditioners that are washed off the skin soon after application will also be very low, due to limited contact time with the skin. For cosmetic products that are left on the skin, exposure is a function of the area of skin exposed to the product and the absorption rate, and it has been shown that phthalate ester absorption rates through human skin are slow compared to those of rodents (71). Since our 2002 survey was conducted, the FDA has observed that some cosmetic prod- ucts are being reformulated to remove phthalate esters. The FDA will continue to monitor and evaluate all available data to assure that phthalate ester levels in cosmetic products are not a health concern. The Federal Food, Drug and Cosmetic Act does not provide for premarket approval of cosmetic products, and the standard for regulatory action requires that the agency prove a product is adulterated or harmful under condi- tions of use. Based on the safety and toxicity data currently available, the agency has concluded that there is no basis upon which to take regulatory action at this time. If the FDA determines that a health hazard exists, the agency will advise the public and will consider its regulatory options. REFERENCES (1) H. Fromme, T. Kuchler, T. Otto, K. Pilz, J. Muller, and A. Wenzel, Occurrence of phthalates and bisphenol A and F in the environment, Water Res., 36, 1429-1438 (2002). (2) J.-D. Berset and R. Etter-Holzer, Determination of phthalates in crude extracts of sewage sludges by high-resolution capillary gas chromatography with mass spectrometric detection,]. AOAC lnternat., 84, 383-391 (2001). (3) A. Penalver, E. Pocurull, F. Borrull, and R. M. Maree, Comparison of different fibers for the solid- phase microextraction of phthalate esters from water,]. Chromatogr. A, 922, 377-384 (2001). (4) A. Penalver, E. Pocurull, F. Borrull, and R. M. Maree, Determination of phthalate esters in water samples by solid-phase microextraction and gas chromatography with mass spectrometric detection,]. Chromatogr. A, 872, 191-201 (2000). (5) J. J. Adibi, F. P. Perera, W. Jedrychowski, D. E. Camano, D. Barr, R. Jacek, and R. M. Whyatt, Prenatal exposures to phthalates among women in New York City and Krakow, Poland, Environ. Health Perspect., 111, 1719-1722 (2003). (6) H. Toda, K. Sako, Y. Yagome, and T. Nakamura, Simultaneous determination of phosphate esters and phthalate esters in clean room air and indoor air by gas chromatography-mass spectrometry, Anal. Chim. Acta, 519, 213-218 (2004). (7) 0. W. Lau and S.-K. Wong, Determination of plasticisers in food by gas chromatography-mass spectrometry with ion-trap mass detection,]. Chromatogr. A, 737, 338-342 (1996). (8) J. H. Petersen, Survey of di-(2-ethylhexyl)phthalate plasticiser contamination of retail Danish milks, Food Add. Contam., 8, 701-706 (1991). (9) I. Tomita, Y. Naramura, and Y. Yagi, Phthalic acid esters in various foodstuffs and biological materials, Ecotoxicol. Environ. Safety, 1, 275-287 (1977). (10) G. Di Bella, M. Saitta, M. Pellegrino, F. Salvo, and G. Dugo, Contamination ofltalian citrus essential oils: Presence of phthalate esters,]. Agric. Food Chem., 47, 1009-1012 (1999). (11) T. Dine, M. Luychx, M. Cazin, J.C. Cazin, and F. Goudaliez, Rapid determination by high perfor- mance liquid chromatography of di-2-ethylhexyl phthalate in plasma stored in plastic bags, Biomed. Chromatogr., 5, 94-97 (1991). (12) J. Vessman and G. Rietz, Determination of di(ethylhexyl)phthalate in human plasma and plasma proteins by electron capture gas chromatography,]. Chromatogr., 100, 153-163 (1974).
PHTHALATE ESTERS IN COSMETIC PRODUCTS 135 (13) H. G. Wahl, A. Hoffmann, H.-U. Haring, and H. M. Liebich, Identification of plasticizers in medical products by a combined direct thermodesorption-cooled injection system and gas chromatography- mass spectrometry,]. Chromatogr., 847, 1-7 (1999). (14) M. Fujii, N. Shinohara, A. Lim, T. Otake, K. Kumagai, and Y. Yanagisawa, A study on emission of phthalate esters from plastic materials using a passive flux sampler, Atmospheric Environ., 37, 5495- 5504 (2003). (15) J. Houlihan, C. Brody, and B. Schwan, "Not Too Pretty: Phthalates, Beauty Products, & the FDA," a report published by the Environmental Working Group, Coming Clean, and Health Care Without Harm, July 8, 2002 (http:!lwww.ewg.org/reports_content/nottoopretty!NotTooPrettyJinal.pd/). (16) B. C. Blount, M. J. Silva, S. P. Caudil, L. L. Needham, J. L. Pirkle, E. J. Sampson, G. W. Lucier, R. J. Jackson, and J. W. Brock, Levels of seven urinary phthalate metabolites in a human reference popu- lation, Environ. Health Perspect., 108, 979-982 (2000). (17) J. A. Hoppin, J. W. Brock, B. J. Davis, and D. D. Baird, Reproducibility of urinary phthalate me- tabolites in first morning urine samples, Environ. Health Perspect., 110, 515-518 (2002). (18) J. W. Koo, F. Parham, M. C., Kohn, S. A. Masten, J. W. Brock, L. L. Needham, and C. J. Pottier, The association between biomarker-based exposure estimates for phthalates and demographic factors in a human reference population, Environ. Health Perspect., 110, 405--410 (2002). (19) H. Koch, M. Holger, B. Rossbach, H. Drexler, and J. Angerer, Internal exposure of the general population to DEHP and other phthalates-Determination of secondary and primary phthalate mono- ester metabolites in urine, Environ. Res., 93, 177-185 (2003). (20) A. M. Calafat, A. Slakman, S. Ryan, J. Manori, A. R. Herbert, and L. L. Needham, Automated solid phase extraction and quantitative analysis of human milk for 13 phthalate metabolites,]. Chromatogr. B, 805, 49-56 (2004). (21) M. C. Kohn, F. Parham, S. A. Masten, C. J. Portier, M. D. Shelby, J. W. Brock, and L. L. Needham, Human exposure to phthalate esters, Environ. Health Perspect., 108, A440-A442 (2000). (22) M. Ema, E. Miyawaki, and K. Kawashima, Further evaluation of developmental toxicity of di-n-butyl phthalate following administration during late pregnancy in rats, Toxicol. Lett., 98, 87-93 (1998). (23) F. A. Arcadi, C. Costa, C. Imperatore, A. Marchese, A. Rapisarda, M. Salemi, G. R. Trimarchi, and G. Costa, Oral toxicity of bis(2-ethylhexyl) phthalate during pregnancy and suckling in the Long-Evans rat, Food Chem. Toxicol., 36, 963-970 (1998). (24) M. Ema, E. Miyawaki, and K. Kawashima, Effects of dibutyl phthalate on reproductive function in pregnant and pseudopregnant rats, Reprod. Toxicol., 14, 13-19 (2000). (25) M. Ema, E. Miyawaki, and K. Kawashima, Critical period for adverse effects on development of reproductive system in male offspring of rats given di-n-butyl phthalate during late pregnancy, Toxicol. Lett., 111, 271-278 (2000). (26) M. Ema and E. Miyawaki, Effects of monobutyl phthalate on reproductive function in pregnant and pseudopregnant rats, Reprod. Toxicol., 15, 261-267 (2001). (27) M. Ema and E. Miyawaki, Adverse effects on development of the reproductive system in male offspring of rats given monobutyl phthalate, a metabolite of dibutyl phthalate, during late pregnancy, Reprod. Toxicol., 15, 189-194 (2001). (28) E. Mylchreest, R. C. Cattley, and P. M. D. Foster, Male reproductive tract malformations in rats following gestational and lactational exposure to di(n-butyl) phthalate: An antiandrogenic mecha- nism?, Toxicol. Sci., 43, 47-60 (1998). (29) M. Ema and E. Miyawaki, Effects on development of the reproductive system in male offspring of rats given butyl benzyl phthalate during late pregnancy, Reprod. Toxic-of., 16, 71-76 (2002). (30) M. Ema, E. Miyawaki, A. Hirose, and E. Kamara, Decreased anogenital distance and increased incidence of undescended testes in fetuses of rats given monobenzyl phthalate, a major metabolite of butyl benzyl phthalate, Reprod. Toxicol., 17, 407-412 (2003). (31) S. D. Gangolli, Testicular effects of phthalate esters, Environ. Health Perspect., 45, 77-84 (1982). (32) T. Ichimura, M. Kawamura, and A. Mitani, Co-localized expression of FasL, Fas, Caspase-3 and apoptotic DNA fragmentation in mouse testis after oral exposure to di(2-ethylhexyl)phthalate, Toxi- cology, 194, 35-42 (2003). (33) R. Kavlock, K. Boekelheide, R. Chapin, M. Cunningham, E. Faustman, P. Foster, M. Golub, R. Henderson, I. Hinberg, and R. Little, NTP Center for the Evaluation of Risks to Human Reproduc- tion: Phthalates expert panel report on the reproductive and developmental toxicity of di-n-butyl phthalate, Reprod. Toxicol., 16, 489-527 (2002). (34) R. Kavlock, K. Boekelheide, R. Chapin, M. Cunningham, E. Faustman, P. Foster, M. Golub, R.
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PHTHALATE ESTERS IN COSMETIC PRODUCTS Table II Phthalate Esters in Thirteen Commercial Cosmetic Products (PPM) No. of Product products DMP 1 DEP2 BBP3 DBP4 Body lotion 1 ND6 142 ND ND Hairspray 8 ND 81, 118, 178, 204 43 16, 38, 54 Deodorant 9 ND 38, 56, 57, 111, ND 104 681, 805, 2933 Fragrance 5 ND 5486, 8851, 9081, ND ND 11121, 38663 Skin lotion 3 ND 84 ND ND Hair gel 5 ND 53, 67 ND ND Hair mousse 5 ND 31, 56, 75, 128 ND 31, 43 Body wash 3 ND 200, 325 ND ND Shampoo ND ND ND ND Hand cream 2 ND 27 ND ND Nail enamel 6 58, 143, 15395 1136 107 25, 742, 46463, 59815 1 Dimethyl phthalate. 2 Diethyl phthalate. 5 Benzylburyl phthalate. 1 Dibutyl phthalate. 5 Diethylhexyl phthalate. 6 None detected (10 ppm). 7 Number of products containing the phthalate. 133 DEHP5 ND ND ND ND ND ND ND ND ND ND ND The source of phthalate esters in most cosmetic products is most likely the fragrance ingredient. Phthalate esters were only included on the ingredient statements of some of the nail products included in this survey. Individual fragrance ingredients are not required to be included in cosmetic product labeling (64). The Cosmetic Ingredient Review (CIR) Expert Panel, an independent panel of scientists that has been reviewing the safety of cosmetic raw materials since 197 6, has reviewed the safety of several phthalate esters used in cosmetic products. In the first review, conducted in 1985, the CIR concluded that DMP, DBP, and DEP were safe in cosmetic products at levels up to 5%, 25%, and 50%, respectively (65). In a separate review of the safety of BBP, the CIR concluded that BBP is safe at concentrations less than 1 % (66). In 2003, the CIR rereviewed the safety of phthalate esters in cosmetic products in light of reports of phthalate metabolites in human urine, and affirmed their original conclusions that the levels used in cosmetic products were safe. From 1998 to 2000, an expert panel convened by the NTP concluded that reproductive risks from exposure to phthalate esters were minimal to negligible in most cases (67). The NTP has concluded that food is the primary source of human exposure to DBP (33). In the European Union, the Scientific Committee on Cosmetics and Non-Food Products reviewed the safety of DEP and concluded it was safe in cosmetic products (68) however, the committee concluded that DBP should not be intentionally added to cosmetics (69). The significance of phthalate ester exposure from cosmetics compared to exposure from food, water, air, and plastic materials is difficult to assess. Exposure from pharmaceu- ticals must also be factored in, since high urinary levels of the metabolite of DBP have
134 JOURNAL OF COSMETIC SCIENCE been traced to the use of drugs (70). Our survey of cosmetic products found that the highest levels of phthalate esters were present in nail and fragrance products. Products such as nail polish harden rapidly after application, and so phthalate ester absorption through the nail is likely to be significantly inhibited. Exposure to phthalate esters from products such as soaps, shampoos, and conditioners that are washed off the skin soon after application will also be very low, due to limited contact time with the skin. For cosmetic products that are left on the skin, exposure is a function of the area of skin exposed to the product and the absorption rate, and it has been shown that phthalate ester absorption rates through human skin are slow compared to those of rodents (71). Since our 2002 survey was conducted, the FDA has observed that some cosmetic prod- ucts are being reformulated to remove phthalate esters. The FDA will continue to monitor and evaluate all available data to assure that phthalate ester levels in cosmetic products are not a health concern. The Federal Food, Drug and Cosmetic Act does not provide for premarket approval of cosmetic products, and the standard for regulatory action requires that the agency prove a product is adulterated or harmful under condi- tions of use. Based on the safety and toxicity data currently available, the agency has concluded that there is no basis upon which to take regulatory action at this time. If the FDA determines that a health hazard exists, the agency will advise the public and will consider its regulatory options. REFERENCES (1) H. Fromme, T. Kuchler, T. Otto, K. Pilz, J. Muller, and A. Wenzel, Occurrence of phthalates and bisphenol A and F in the environment, Water Res., 36, 1429-1438 (2002). (2) J.-D. Berset and R. Etter-Holzer, Determination of phthalates in crude extracts of sewage sludges by high-resolution capillary gas chromatography with mass spectrometric detection,]. AOAC lnternat., 84, 383-391 (2001). (3) A. Penalver, E. Pocurull, F. Borrull, and R. M. Maree, Comparison of different fibers for the solid- phase microextraction of phthalate esters from water,]. Chromatogr. A, 922, 377-384 (2001). (4) A. Penalver, E. Pocurull, F. Borrull, and R. M. Maree, Determination of phthalate esters in water samples by solid-phase microextraction and gas chromatography with mass spectrometric detection,]. Chromatogr. A, 872, 191-201 (2000). (5) J. J. Adibi, F. P. Perera, W. Jedrychowski, D. E. Camano, D. Barr, R. Jacek, and R. M. Whyatt, Prenatal exposures to phthalates among women in New York City and Krakow, Poland, Environ. Health Perspect., 111, 1719-1722 (2003). (6) H. Toda, K. Sako, Y. Yagome, and T. Nakamura, Simultaneous determination of phosphate esters and phthalate esters in clean room air and indoor air by gas chromatography-mass spectrometry, Anal. Chim. Acta, 519, 213-218 (2004). (7) 0. W. Lau and S.-K. Wong, Determination of plasticisers in food by gas chromatography-mass spectrometry with ion-trap mass detection,]. Chromatogr. A, 737, 338-342 (1996). (8) J. H. Petersen, Survey of di-(2-ethylhexyl)phthalate plasticiser contamination of retail Danish milks, Food Add. Contam., 8, 701-706 (1991). (9) I. Tomita, Y. Naramura, and Y. Yagi, Phthalic acid esters in various foodstuffs and biological materials, Ecotoxicol. Environ. Safety, 1, 275-287 (1977). (10) G. Di Bella, M. Saitta, M. Pellegrino, F. Salvo, and G. Dugo, Contamination ofltalian citrus essential oils: Presence of phthalate esters,]. Agric. Food Chem., 47, 1009-1012 (1999). (11) T. Dine, M. Luychx, M. Cazin, J.C. Cazin, and F. Goudaliez, Rapid determination by high perfor- mance liquid chromatography of di-2-ethylhexyl phthalate in plasma stored in plastic bags, Biomed. Chromatogr., 5, 94-97 (1991). (12) J. Vessman and G. Rietz, Determination of di(ethylhexyl)phthalate in human plasma and plasma proteins by electron capture gas chromatography,]. Chromatogr., 100, 153-163 (1974).

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