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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