BeautySecrets DoesACommonChemicalInNailPolish PoseRisksToHumanHealth?

E NVIRONMENTAL TM W ORKING GROUP JaneHoulihan RichardWiles Acknowledgments

This report was written by Jane Houlihan and Richard Wiles of the Environmental Working Group.

This report was made possible by grants from the W. Alton Jones Foundation, the Turner Foundation, Inc., the Mitchell Kapor Foundation and the Jenifer Altman Foundation.

Copyright © November 2000 by Environmental Working Group. All rights reserved. Manufactured in the United States of America. Printed on recycled paper.

Environmental Working Group

The Environmental Working Group (EWG) is a nonprofit environmental research organization based in Wash- ington, D.C. Through analysis of government and private sector databases, environmental monitoring programs, and scientifically grounded research, EWG develops high-profile publications, computer databases and Internet resources that consistently create public awareness and concern about high priority environmental problems and solutions.

Kenneth A. Cook, President Richard Wiles, Vice President for Research Mike Casey, Vice President for Public Affairs

To order a copy Copies of this report may be ordered for $25.00 each (plus 6% sales tax or $1.50 for Washington, DC residents) and $3.00 for postage and handling. Payment must accompany all orders. Please make checks payable to:

Environmental Working Group 1718 Connecticut Avenue, N.W. Suite 600 Washington, D.C. 20009 (202) 667-6982 (phone) (202) 232-2592 (fax)

www.ewg.org

This and many other EWG publications are available on the World Wide Web at www.ewg.org. Beauty Secrets

Contents

Executive Summary ...... 1

Chapter 1: Chemical industry systematically defeats health protections...... 7

Chapter 2: Phthalates ...... 11

Chapter 3: Phthalates in cosmetics and beauty products ...... 19

References ...... 25 Beauty Secrets

Executive Summary

In September 2000, research- estimates for these women were DBP is just one ers at the Centers for Disease above the federal safety standard ingredient in an Control and Prevention (CDC) (Blount et al 2000, Kohn et al alphabet soup of reported that every single one of 2000, EPA 1990). EPA rates their the 289 persons tested for the overall confidence in the safety pollutants that plasticizer dibutyl phthalate standard as “low”, largely be- contaminate every (DBP) had the compound in cause it is based on a study person in the their bodies. The finding passed published in 1953 that did not industrialized world. with little public fanfare, but examine the test animals for the surprised government scientists, birth defects that concern scien- who just one month earlier had tists today (EPA 1990). rated DBP of little health con- cern based on the scientific DBP is just one ingredient in assumption, which later turned an alphabet soup of pollutants out to be wrong, that levels in that contaminate every person in humans were within safe limits. the industrialized world. A DBP causes a number of birth patchwork of studies from the defects in lab animals, primarily federal government indicates that to male offspring, including everyone in the United States testicular atrophy, reduced carries more than 100 chemical sperm count, and defects in the pollutants, pesticides, and toxic structure of the penis (CERHR metals in their bodies. No one 2000). knows exactly where these exposures come from, and no The most critical population, one has studied the effect of women of childbearing age constant exposure to this low- whose fetuses are exposed in level mixture of poisons. Nor is the womb, appear to receive the it possible to do so. To test 100 highest exposures. Estimates chemicals in combinations of No one knows exactly based on data published by the three for just one health effect where these exposures same CDC researchers in Octo- (cancer, for example, as opposed come from, and no ber 2000, indicate that DBP to birth defects) would require one has studied the exposures for 3 million women 162,000 new tests. There are effect of constant of childbearing age may be up currently 75,000 chemicals li- exposure to this low- to 20 times greater than for the censed for use in the United average person in the popula- States. Approximately 15,000 are level mixture of tion. The highest exposure sold in volumes greater than poisons.

ENVIRONMENTAL WORKING GROUP 1 10,000 pounds per year. Under Government researchers the Toxic Substances Control Act speculate that the elevated levels the EPA has regulated just five of DBP among women of child- chemicals (Roe et al 1997). bearing age come from cosmetics and beauty products, but no one Table 1. EWG shoppers turned up 37 DBP-containing has done the studies to test this products from 22 companies. hypothesis. As a first step in discovering some major sources, Name brand Nail care product containing DBP the Environmental Working Black Radiance U.S.A. Black Radiance Nail Color Group (EWG) shopped at a local Bon Bons Bon Bons (nail polish) Rite-Aid, surfed the on-line store Chanel Nail Colour Drugstore.com, and searched the Christian Dior Nail Enamel U.S. patent office records for products that contain DBP in the Club Monaco Nail Color patent application. We found: Cosmar Cosmar Press&Go Nails Kit Cover Girl Cover Girl Nail Slicks § DBP in 37 popular nail pol- Hard Candy Nail Enamel ishes, top coats, and harden- Loud Music Nail Enamel ers, including products by M M Professional Nail Polish L’Oréal, Maybelline, Oil of Olay, and CoverGirl (Table 1). Max Factor Diamond Hard Nail Enamel Maybelline Express Finish Fast-Dry Nail Enamel § Ultimate Wear (nail enamel) Patents proposing to use DBP Salon Finish Nail Enamel) in a broad range of beauty Nailene Professional Solutions Acrylic Tough Polish Shield and personal care products, PROfessional Solutions Acrylic Polish Shield including shampoos and PROfessional Solutions Calcium Growth Builder conditioners, lotions, hair Nail Paints Art Kit growth formulations, antiper- NARS Nail Polish spirants, and sunscreen. Even Naturistics 90 Second Dry Super Fast Nail Color patents relating to gum, Nutra Nail Nutra Nail Maximum Strengthener candy, and pharmaceuticals Nutra Nail Calcium Nail thickener taken orally propose DBP as Nutra Nail Iron Shield Nail Hardener an ingredient. Oil of Olay Nail Lacquer Orly Orly Salon Nails Nail Color § Many major manufacturers Tony & Tina Tony & Tina (nail enamel) who propose to use DBP in Sally Hansen Color Fast! One Coat Fast-Dry Enamel cosmetics and related prod- Maximum Support Strengthen & Grow ucts. Of more than 100 No More Breaks Restructurizing Strengthener patents analyzed by EWG, Hard as Nails with Nylon Procter & Gamble holds the Triple Strong Advanced Gel Nail Fortifier Thicken Up! Strengthening Nail Thickener most (37) that propose to use Ultimate Shield Fortifyng Base & Top Coat DBP in personal care prod- Hard as Nails ucts. Other major companies Instant Strength Calcium Gel Nail Fortifier with multiple patents are Urban Decay Nail Enamel L’Oréal (10), Lever Brothers Wet 'n' Wild Wet 'n' Wild Nail Color (4), and Maybelline (3) (Table Source: Environmental Working Group. 2).

2BEAUTY SECRETS Table 2. Major corporations hold patents that propose to use the toxic plasticizer DBP in a broad range of consumer products, from nail polish to hair growth formulations.

Products for which DBP is proposed as Company holding patent essential or possible additive The Procter & Gamble (Cincinnati, OH) lotion, hairspray, mousse, gel, lotion, cream, pomade, hair spray, conditioner, spritz, hair tonic, facial moisturizers, foundations, lipsticks, mascaras, nail polishes, oral pharmaceuticals, hair loss treatments L'Oreal (Bureau D. A. Casalonga-Josse) hair and nail products Lever Brothers Company (New York, NY) deodorant, skin and hair cleansers Maybelline Cosmetics Corporation (Wilmington, DE) nail enamel Anheuser-Busch, Incorporated (St. Louis, MO) gelled antiperspirant Chesebrough-Pond's USA Co., Division of Conopco, product to treat or prevent baldness Inc. (Greenwich, CT) Colgate Palmolive Company (New York, NY) antiperspirant and deodorant gels Eastman Chemical Company (Kingsport, TN) nail products Elizabeth Arden Co., Division of Conopco, Inc. (New skin products York, NY) Kraft General Foods, Inc. (Northfield, IL) sunscreen Revlon Consumer Products (NY, NY) nail enamel Rhodia Chimie (Courbevoie, FR) hair and skin care products (sprays, tonic lotions, gels, mousses) Rhone-Poulenc Chimie (Courbevoie Cedex, FR) nail varnishes Unilever Patent Holding B.V. (Vlaardingen, NL) skin and hair care products, antiperspirants

Source: Environmental Working Group.

The Spoils of a Rotten System

Contrary to popular belief, companies are free to use unlim- Phthalates are industrial chemicals in consumer ited amounts in cosmetics. An recognized as toxic products are essentially unregu- environmental release of just 10 substances under lated in the United States. Except pounds of DBP must be reported environmental law, for chemicals added directly to to environmental authorities but companies are food, there is no legal require- under the Superfund law. The ment for health and safety cosmetics industry, in contrast, free to use unlimited testing or human exposure puts hundreds of thousands of amounts in cosmetics. monitoring for any chemical in pounds of DBP into nail polish commerce. The same chemicals, each year, with no requirements ironically, are often tightly for safety testing or reporting to regulated as pollutants. anyone.

For example, phthalates are In the 25 years of the Toxic recognized as toxic substances Substances Control Act, the EPA under environmental law, but has regulated exactly one toxic

ENVIRONMENTAL WORKING GROUP 3 Industry can and does substance in a consumer product, a finding of risk based on data put chemicals into lead in paint. This is largely that the law virtually prohibits it widespread because the agency cannot from collecting. demand the health and safety commercial use tests needed to evaluate a The law also allows industry without meaningful chemical’s safety and risk. Indus- to manufacture and sell new testing for toxicity and try recently agreed to a voluntary chemicals without conducting without any testing program for high produc- any toxicity studies to determine monitoring of people tion volume compounds (chemi- if the chemicals are safe. After a or the environment. cals produced annually in chemical enters the marketplace, amounts of at least one million there is no requirement for pounds), but this program has human monitoring, even for many shortcomings. Many basic those compounds to which tests are not required, such as people are routinely exposed. those for cancer, nervous system damage, and virtually all tests for Except for direct food addi- toxicity to the developing and tives, the Federal Food Drug and immature animal including devel- Cosmetic Act (FDC&A) is no opmental neurotoxicity or effects better (FDA 2000). DBP is on the immature immune system. allowed in food as an indirect About 80 percent of all high additive via food packaging, but production volume chemicals are this use was grandfathered in not covered by the initiative. and has not been subject to modern food safety standards. Pivotal court decisions imple- The FDC&A does not require menting the 1976 Toxic Sub- pre-market safety testing, review, stances Control Act (TSCA) have or approval for cosmetics or the rendered EPA impotent to control compounds used to make them. toxic chemicals in commerce. While manufacturers might study The agency must prove an “un- the short-term effects in lab reasonable risk of injury” to animals of the substances that human health before it can they sell, they almost never remove a chemical from the study long term effects of their market. But EPA is powerless to products. Industry can and does make that finding because the put chemicals into widespread law prohibits the agency from commercial use without mean- requiring safety studies until it ingful testing for toxicity and proves that “substantial” or “sig- without any monitoring of nificant” exposures are occurring. people or the environment. The agency can almost never prove that substantial or signifi- What You Can Do cant exposures are occurring because exposure data are also Researchers are just beginning extremely difficult to obtain. to discover the names of the hundreds of commercial chemi- In other words, EPA cannot cals that contaminate the human regulate a chemical until it makes body. What those chemicals’

4BEAUTY SECRETS actual health effects might be are polish that are DBP-, toluene-, When it comes to the just beginning to be understood. and formaldehyde-free use of potentially toxic In the meantime, scores of new include L’Oréal Paris Jet-Set chemicals in chemicals are introduced into Quick Dry Nail Enamel, manufactured commerce each year, with no Revlon Nail Enamel, Garden consumer products, requirement that they be shown Botanika Natural Color Nail to be safe. Color, and Kiss Products Kiss the official operating Colors, to name a few. principle is use first, This situation is the single test later, or better biggest failure in U.S. environ- Policy Recommendations yet, don’t test at all. mental law and is not likely to be fixed anytime soon. Until it When it comes to the use of is, people can do a few simple potentially toxic chemicals in things to reduce exposure to the manufactured consumer prod- contaminants that we do know ucts, the official operating prin- about. ciple is use first, test later, or better yet, don’t test at all. This § Women who are pregnant, situation is disgraceful and com- nursing or thinking about pletely unacceptable. In the face getting pregnant should look of growing evidence that the for and avoid all personal human population is contami- care products with the word nated with hundreds of poorly phthalate on the label. Some tested hazardous industrial common forms of phthalates chemicals, we recommend the in personal care products are following: dibutyl phthalate, diethyl phthalate, and dimethyl § The chemical industry must phthalate. immediately and completely fund a comprehensive human § Urge manufacturers to biomonitoring initiative in reformulate their products conjunction with the Centers with safer alternative for Disease Control and chemicals. Go to Prevention. The initiative www.ewg.org for a list of would monitor the human phone numbers and e-mail population for all chemicals addresses for some major reasonably likely to be found personal care products in human tissue. The study manufacturers. design must include highly exposed and potentially § If you use nail products, vulnerable sub-populations, choose those that contain and must include enough fewer toxins. Use products individuals to support free of DBP and other statistically meaningful common nail polish toxins conclusions and regulatory like toluene and decisions for all sectors of the formaldehyde. Types of nail population, and all chemicals

ENVIRONMENTAL WORKING GROUP 5 monitored. All of the • The chemical industry and information gathered must be the personal care products made available to the public industry must immediately after it is peer reviewed. label all products contain- ing phthalates and any • The chemical industry must other toxic substance to expand its commitment to which there is human screening of high produc- exposure. Labels must be tion volume chemicals to improved so that they are include tests for carcinoge- legible. nicity, neurotoxicity, immunotoxicity, and endo- • The current exemption for crine system toxicity at all labeling requirements that life stages including gesta- applies to non-retail sales tion, infancy, childhood, of these products to profes- adolescence and adulthood. sionals, must be rescinded.

6BEAUTY SECRETS Beauty Secrets

Chemical industry systematically defeats health protections

No pre-market safety testing Administration (OSHA), and was Since the 1950’s, the or approval is required under repeated with the passage and chemical industry has any federal law for chemicals in implementation of the Toxic systematically blocked cosmetics, toys, clothing, car- Substances Control Act (TSCA). efforts to require pets, or construction materials, to name just a few obvious The first chemical health stan- safety studies for the sources of chemical exposure in dards in the United States were compounds it everyday life. This little known adopted by OSHA in 1972. Set in produces. fact is the premeditated result of theory to protect workers, these an orchestrated campaign by the standards were initially created in chemical industry to avoid the 1940’s by representatives from testing and regulation of their the chemical industry operating products. It largely explains why under the auspices of the Ameri- products like hair spray, hair can Council of Governmental and dye, pacifiers, stain repellants, Industrial Hygienists (ACGIH). At glues and children’s toys get on the time the standards were first the market, only to be found to introduced in 1942, ACGIH issued contain highly toxic compounds major caveats regarding their at unsafe levels after decades of application to human health, widespread use. Once these stating that: “[they are] not to be products are on the market, construed as recommended safe there is no practical legal mecha- concentrations” (NCGIH 1942). nism by which health authorities can remove them from com- Toxicity tests on animals had merce, short of a public health barely been invented at that time, disaster or consumer uproar. and the standards themselves were based on rough estimates of OSHA acutely hazardous and lethal levels of exposure. In the words Since the 1950’s, the chemical of the scientist who devised many industry has systematically of them, the so-called threshold blocked efforts to require safety limit values (TLVs) were de- studies for the compounds it signed, “to provide a handy produces. This strategy first yardstick to be used as guidance played out with workplace for the routine control of these standards adopted under the health hazards — not that compli- Occupational Safety and Health ance with the figures listed would

ENVIRONMENTAL WORKING GROUP 7 Passed with virtually guarantee protection against ill statutes, and only one, lead in no regulatory teeth, health” (Cook, 1945). paint, affected a consumer product (Roe et al 1997). TSCA has been an This did not stop the chemical unparalleled failure. industry from promoting TLVs as TSCA is best thought of as a legitimate health standards, and in self-defeating feedback loop. 1972, OSHA adopted TLVs whole- Under the law, all chemicals are sale as the nation’s first set of presumed safe, and the burden enforceable health standards for of proof is on the EPA to dem- chemicals in the workplace. In onstrate that a chemical is the process these “handy yard- causing harm before it can take sticks” took on an aura of respect- any regulatory action. However, ability that belied the fact that the agency cannot require that there was essentially no science to industry conduct the tests support their relevance to human needed to show that a chemical health and safety. The best esti- is causing harm, until the mates are that basic toxicological agency has shown that the data were available for only five compound may present an percent of some 600 industrial "unreasonable risk," or that chemicals for which OSHA had human exposure is "substantial" adopted standards by 1988 or "significant". Substantial (Castleman and Ziem 1994, Roach exposures can almost never be and Rappaport 1990). proven without additional data from industry, and significant TSCA exposures cannot be proven without information on the This process of faux regulation chemical’s toxicity. Of course, was repeated again when the compelling toxicity data are same chemical industry giants almost never available for the teamed up to write the nation’s compound in question or EPA major toxic chemical law, the would not be trying to publish Toxic Substances Control Act a test rule in the first place. (TSCA). Passed with virtually no regulatory teeth, TSCA has been Even if all these hurdles are an unparalleled failure. Of the cleared, which is extremely 62,000 chemicals on the market unlikely, in order to request when TSCA was passed in 1976, basic toxicity data on any single Of the 15,000 EPA has successfully requested chemical the EPA must issue a chemicals marketed in data for 263 compounds. Of the test rule through the process of quantities exceeding 15,000 chemicals marketed in a rulemaking under administra- 10,000 pounds per quantities exceeding 10,000 tive law. This roadblock is pounds per year, EPA has com- unique to TSCA. Under pesti- year, EPA has pleted regulatory actions to limit cide law, or food safety law, completed regulatory use or exposures on just 5, or 0.03 EPA or FDA can request virtu- actions to limit use or percent (3 one hundredths of one ally any test that they need to exposures on just 5, or percent). Four of the five were assess the safety of a com- 0.03 percent. already regulated under other pound.

8BEAUTY SECRETS A defining moment in the injury to human health (Corro- In 1999 the chemical collapse of TSCA occurred in sion Proof Fittings v. EPA, 5th industry agreed to 1990 when EPA attempted to Cir. 1991). Since this decision, conduct basic health issue test rules for the paint EPA has undertaken no addi- screening tests for thinner cumene. The proposed tional major regulatory actions test rules were immediately under the Act. about 3,000 high challenged by the Chemical production volume Manufacturers Association on Under pressure from environ- compounds out of the grounds that EPA had not mentalists and the Clinton ad- universe of more than shown that human exposure ministration, in 1999 the chemi- 75,000 chemicals was “substantial,” the basic cal industry agreed to conduct registered for requirement under Section 4 of basic health screening tests for commercial use today. the Act. The courts upheld the about 3,000 high production CMA argument that the burden volume compounds out of a of proving “substantial” expo- universe of more than 75,000 sure and risk was on the EPA chemicals registered for com- and not the manufacturers mercial use today, 15,000 of (Chemical Manufacturers Ass’n v. which are marketed in quantities EPA, 5th Cir. 1990). exceeding 10,000 pounds per year. This tiny step forward is To date EPA has issued rules entirely voluntary and, even if it requiring toxicity testing for 0.4 is completed, it will not provide percent, or 263, of the 62,000 regulators and public health chemicals on the market when authorities with sufficient infor- the law was passed. And even mation to fully assess the long- when issued, test rules generally term adverse effects of toxic do not require comprehensive chemical exposure. Tests now testing. With barely any data recognized as critical to a full generated via test rules the understanding of a chemical’s agency cannot support a finding toxicity will not be conducted at of substantial risk for any chemi- all under this initiative. These cal, and indeed the agency has include cancer bioassays, studies taken only five final actions on the developing nervous since passage of the law (Roe et system, the immune system, the al 1997). endocrine system, and perhaps most important, human monitor- The final nail in the coffin ing to determine the extent of came in 1991. EPA was trying to human exposure. use TSCA to regulate asbestos, This latter element is critical. arguing that it presented an As discussed below, a string of Tests now recognized “unreasonable risk of injury” to recent discoveries reveal that as critical to a full human health. Again the TSCA human exposure to commercial understanding of a feedback loop prevailed, and the chemicals used in common court ruled that EPA had not met consumer products is almost chemical’s toxicity the burden of providing substan- certainly much more pervasive will not be conducted tial evidence that asbestos pre- than previously thought. This at all under this sented an unreasonable risk of new strata of contamination is in initiative.

ENVIRONMENTAL WORKING GROUP 9 addition to the considerable well- known toxic load of pollutants (such as PCBs, dioxin, and DDT) found in the blood and body fat of virtually all people in the industrialized world.

10 BEAUTY SECRETS Beauty Secrets

Phthalates

Invented in the 1930’s, the new Center for the Evaluation of Currently the versatile group of common Risk to Human Reproduction chemical industry industrial chemicals called ph- (CERHR). produces billions of thalates (pronounced tha-lates) pounds of phthalates are used as ingredients in a At the same time, scientists at diverse range of consumer the Centers for Disease Control each year. products from cosmetics to food and Prevention (CDC) were wraps, toys and building materi- achieving the first accurate mea- als. Currently the chemical surements of phthalates in industry produces billions of people. Researchers there were pounds of phthalates each year. surprised to find that people have They are used as plasticizers to much higher levels of some soften plastic, as skin moisturiz- phthalates in their bodies than ers and skin penetration enhanc- predicted by previous estimates ers in cosmetics, and as solvents (Blount et al 2000). In October in a wide range of applications. 2000, CDC scientists announced People are exposed to phtha- that levels of some phthalates in lates daily through their contact women of childbearing age, with consumer products and via including dibutyl phthalate (DBP) food and indoor air. and di(2-ethylhexyl) phthalate (DEHP), exceed the government’s In spite of their widespread safe levels set to protect against presence in cosmetics and other birth defects. Estimates based on In October 2000, CDC common consumer products, data from this study indicate that scientists announced industry has only partially stud- for more than 3 million heavily that levels of some ied the health effects of phtha- exposed women of childbearing phthalates in women lates and has never tested for age, exposures to DBP may be 20 the presence of phthalates in times greater than the average of childbearing age, human bodies. Finally, in April exposures in the rest of the popu- including dibutyl 1999, over six decades after lation (Kohn et al 2000). phthalate (DBP) and phthalates were first marketed, di(2-ethylhexyl) the federal government’s Na- This report focuses primarily phthalate (DEHP), tional Institute for Environmental on DBP, a widely used phthalate exceed the Health Sciences (NIEHS) initi- that produces serious reproduc- government’s safe ated a study of the effects of tive and developmental effects in phthalates on the human repro- laboratory animals. But DBP is levels set to protect ductive system through their not the only toxic phthalate to against birth defects.

ENVIRONMENTAL WORKING GROUP 11 At least two decades which people are routinely Effects in immature male ago, scientists began exposed. Many other phthalates animals: DBP exposure dam- building a body of widely detected in human urine ages the testes, prostate gland, by the CDC cause the same birth epididymus, penis, and seminal work indicating that and developmental defects to the vesicles in laboratory animals DBP can be a male reproductive system as (see, for example, Mylchreest et powerful reproductive DBP. Absent evidence to the al, 1998). These effects persist and developmental contrary, it is reasonable to throughout the animal’s life, and toxicant in laboratory assume that the health effects include, specifically: animals, particularly from exposures to multiple § for males. phthalates are additive. Testicular atrophy (the testes produce sperm and male sex Health effects of dibutyl hormones) phthalate § Hypospadias (a defect of the At least two decades ago, penis in which the opening scientists began building a body occurs on the bottom of the of work indicating that DBP can penis instead of the tip) be a powerful reproductive and developmental toxicant in labora- § Undescended testicles – a tory animals, particularly for condition in which the testes males. Early studies focused on fail to descend into the DBP’s ability to cause testicular scrotal sac during pregnancy. atrophy (e.g., Gray et al 1980), but DBP is now known to cause § Ectopic testes – a condition a broad range of birth defects in which testes are grown and lifelong reproductive impair- outside the scrotal sac ment in male laboratory animals exposed in-utero and shortly Early studies focused § Absent testes – testes are not after birth (Ema et al 1998, on DBP’s ability to formed at all Marsman et al 1995, Mylchreest et cause testicular al 1998, 1999, and 2000, Gray et § atrophy. al 1999, Wine et al 1997 ). Absent prostate gland (the prostate gland contributes Scientists believe that the liquid secretions to semen) active toxicant of DBP exposure § is its first breakdown product, Absent or small seminal monobutyl phthalate (MBuP), vesicles (seminal vesicles, which has been shown to harm like the prostate gland, the male reproductive system. contribute liquid secretions The precise mechanism of action to semen) is not known but the pattern of reproductive harm is consistent § Reduced sperm count with other so-called anti-andro- (reduced fertility of offspring) gens or chemicals that interfere with the male hormones called § Malformed or absent androgens. epididymus (the epididymus

12 BEAUTY SECRETS is the structure where sperm population creates a biologically In young lab animals, mature and are stored) plausible presumption that phtha- DBP has been shown lates may be contributing to these to cause permanent Potential health effects of problems. Until proven safe, testicular atrophy and DBP continue to be significant phthalates should be considered for newborn animals who can as potential contributors to the reduced sperm counts. be exposed to DBP by breathing following human health effects: phthalate-contaminated air, by touching things that contain § Declining sperm count: phthalates, or by drinking their Recent analysis of 101 studies mother’s milk, which can con- (1934-1996) by Shanna Swan tain phthalates as a result of her of the University of Missouri exposures. In young lab ani- confirms results of previous mals, DBP has been shown to studies: average sperm counts cause permanent testicular in industrialized countries are atrophy and reduced sperm declining at a rate of about 1 counts (Foster et al 1981, percent each year (Swan et al Marsman 1995). 2000).

In animal tests DBP is also § Hypospadias: Data from the “embryolethal” — causing loss Centers for Disease Control of pregnancy — and prevents show that rates of implantation of the fertilized hypospadias in the U.S. began egg. In lab animals it also climbing in about 1970, and causes “resorption” of some or continued this increase all of the fetuses in a litter, through the 1980s. This where the mother’s body essen- condition is a physical tially dissolves the fetus without deformity of the penis in miscarriage. DBP also causes a which the opening of the In animal tests DBP is range of skeletal and external urethra occurs on the bottom also “embryolethal” – birth defects for male and female of the penis instead of the tip. offspring of animals exposed causing loss of during pregnancy – including (Currently the occurrence of pregnancy — and deformity of vertebra and ribs, hypospadias appears to be prevents implantation stable, at about 30 to 40 cases cleft palate, and fused breast- of the fertilized egg. bone (Ema et al 1994 and 1995). per 10,000 births.) (Paulozzi 1999) Relevance to people § Undescended testicles: This Broad and disturbing trends birth defect, where testicles in human male reproductive fail to completely descend health include many of the same into the scrotum during effects seen in lab animals dosed pregnancy, occurs in 2-5 with phthalates. Although a percent of full-term boys in cause and effect relationship has Western countries. Rates of not been established, the ubiq- the defect increased greatly in uity of phthalates in the human the U.S. in the 1970s and

ENVIRONMENTAL WORKING GROUP 13 In September 2000, 1980s. Men born with this 1. Are young children at CDC scientists defect are at higher risk for risk for harm to the reproduc- tive system? published the results testicular cancer and breast cancer (Paulozzi 1999). of the first human 2. Is the fetus at risk for testing program for § Testicular cancer: This is the developmental effects when the phthalates. most common cancer of mother is exposed? young men in many countries, including the U.S. 3. Are adults at risk for Its incidence continues to effects to the reproductive increase at a rate of about 2 system? to 4 percent each year in industrialized countries, In their June 2000 report although rates appear to have draft CERHR assigned low, minimal, or negligible concern stabilized in the U.S. after a to five phthalates, and higher 20-year increase. Men with concern for only one, DEHP. hypospadias, infertility, and (“Concern” refers to whether undescended testicles – the CERHR believes the chemical is same constellation of a reproductive or developmen- conditions seen in lab animals tal toxicant in people at current exposed to DBP – are at levels of exposure.) greater risk for developing testicular cancer (Toppari et al In September 2000, Dr. 1996 and Moline 2000). Brock and his team of CDC scientists published the results History of recent government of the first human testing pro- They found phthalates studies of phthalates gram for phthalates (Blount et in every person tested, al 2000). The results turned the and at surprisingly In April 1999, CERHR initiated CERHR conclusions of minimal high levels in some a review of the reproductive and concern on end. They found individuals. developmental effects of phtha- phthalates in every person lates in humans. The Center tested, and at surprisingly high chose seven phthalates for ex- levels in some individuals for amination, based on consider- some phthalates. The scientists ation of production volume, concluded that “from a public extent of human exposures, use health perspective, these data in children’s products, or pub- provide evidence that phthalate lished evidence of reproductive exposure is both higher and or developmental toxicity. more common than previously suspected, ” adding that, “Expo- They addressed the following sure data for phthalates is (sic) three questions for each phtha- critically important for human late based on their current under- risk assessment, especially standing of levels of human among potentially susceptible exposure to phthalates: populations.”

14 BEAUTY SECRETS THE PHTHALATE INDUSTRY LEFT IT UP TO THE GOVERNMENT TO FINALLY DEVELOP A TEST METHOD THAT GIVES ACCURATE MEASUREMENTS OF PHTHALATES IN PEOPLE.

Historically, phthalate exposure has been difficult to measure precisely because the compounds are so widely used. Pervasive background contamination during laboratory analyses commonly produced test results where true contamination in body fluids could not be distinguished from phthalates found in laboratory equipment or in cosmetics worn by technicians. Until the CDC published its research in September 2000, it was generally assumed that phthalates detected in biological samples in large part reflected this background contamination.

As the CERHR study of phthalate risk neared completion, independent work led by Dr. John Brock at the Centers for Disease Control and Prevention (CDC) resulted in a new analytical method that would, for the first time, allow for the accurate analysis of phthalates in biological samples free from concerns of background contamination. Brock’s method involves testing urine for human breakdown products, or metabolites, of phthalates. The specific metabolites for which he tests, called the glucaronidated monoesters, are not manufactured by industry. With Brock’s innovative method, issues of background contamination disappear.

Brock and his team measured These results caught both The results caught levels of seven phthalate me- government and industry off both government and guard. Now, government scien- tabolites in the urine of 289 industry off guard. adults. They found metabolites tists are beginning a search for from two of these in 100 percent answers: Are normal body levels of those tested – dibutyl phtha- of phthalates safe for infants and late, or DBP, and benzylbutyl pregnant women? How are phthalate, or BzBP. A metabo- people exposed to phthalates – lite of DBP called monobutyl through which consumer prod- phthalate (MBuP), a potent ucts and via what pathway? reproductive toxin in lab ani- mals, was found at significantly Government scientists pub- higher levels in women of lished a letter in the October childbearing age. Six of the issue of Environmental Health eight highest measured levels Perspectives outlining the signifi- were in this group. CDC postu- cance of the CDC urine study. lates in their paper that high Their analyses showed that the exposures to phthalates in highest exposures measured, in women of childbearing age may women of childbearing age, were arise from the use of cosmetics above federal safety levels set to and beauty products. protect against birth defects.

ENVIRONMENTAL WORKING GROUP 15 If a woman reads the Estimates based on these data So, by design from the chemi- fine print on the back indicate that DBP exposures for cal industry, the federal govern- of every cosmetic up to 3 million women of child- ment treats phthalates with a bearing age may be 20 times bipolar approach. Phthalates are bottle she purchases, higher than for the rest of the recognized as toxic substances she might discover population. under environmental law, but whether the product companies are free to use unlim- contains phthalates. In an effort to determine key ited amounts in cosmetics. However, she won’t routes of exposure, CDC is be- Moreover, the labeling require- know how much ginning work on an extensive ments for cosmetics are riddled phthalates are in the survey to find which products are with loopholes. If a woman causing the high DBP levels in reads the fine print on the back product, or what women of childbearing age. of every cosmetic bottle she health effects her use purchases, she might discover of the product could Phthalates: regulated as toxic whether the product contains possibly have on her pollutants – but OK in consumer phthalates. However, she won’t fetus. products know the quantiy of phthalates in the product, or what health Phthalates are considered a effects her use of the product hazardous waste and are regu- could possibly have on her lated as pollutants in air and fetus. water. In contrast, phthalates are essentially unregulated in food Specifically, FDA’s labeling and cosmetics. (One phthalate, requirements state that all cos- DEHP, which was removed from metics produced or distributed children’s toys more than a for retail sale to consumers for decade ago, is regulated in drink- their personal care bear a list of ing water.) ingredients, ordered by preva- lence (21 CFR 701.3). Cosmetic Under various environmental labeling requirements apply to laws, individual companies are all cosmetics marketed in the limited with regards to how U.S., whether manufactured here much DBP they can release to or abroad. But it’s simple for the environment as pollution industry to hide phthalates in each year. For example, indus- consumer products, as compo- tries must report any spill or nents of fragrances, flavorings — release of DBP over 10 pounds, or chemical mixtures that are and industries using phthalates considered “trade secrets” — all must keep records of their loca- of which are exempt from label- tion and transportation. But FDA ing requirements. does not limit the amount of DBP that can be used in cosmetics and Remarkably, women who other beauty products. And the work in nail and hair salons and FD&C Act does not require that presumably get the highest cosmetic manufacturers or mar- exposures, are not protected keters test their products for even by labeling regulations. safety. Ingredient labeling requirements

16 BEAUTY SECRETS do not apply to products used provide any information on the Women who work in only by beauty professionals in health effects that concern scien- nail and hair salons the workplace. The 1997 U.S. tists today – birth defects in male and presumably get Economic Census shows that offspring. The study included the highest exposures, over 407,000 people are em- only adult male rats, and death ployed in the more than 81,000 was the only health effect stud- are not protected even beauty salons across the country. ied. Irrespective of the fact that by labeling These employees, primarily the study examined only the regulations. women including what is likely most crude endpoint, the results a large percentage of women of are of marginal relevance to real childbearing age, are exposed to world human exposures, and do DBP in beauty products daily, not provide a sufficient scientific with no knowledge of it and no basis to establish a safe exposure option for choosing alternate level under contemporary stan- products. dards applied to pesticides or food additives regulated under The federal government has federal law. EPA admits that the “low” confidence in their safe study has many deficiencies. In daily dose value for DBP their documentation of the RfD the agency states “The Oral RfD Ten years ago, using a study for dibutyl phthalate may change published in 1953, the Environ- in the near future pending the mental Protection Agency (EPA) outcome of a further review now established a “safe” daily dose of being conducted by the Oral RfD DBP, called the Reference Dose, Work Group” (EPA 1990). or RfD. Even then, the EPA characterized this pivotal study Nonetheless, the current RfD as weak, and their confidence in is derived from a “safe” dose in the RfD as “low.” Ten years this study of 125 mg of chemical later the agency has not revised ingested per kilogram of body the safe dose, nor required new weight (mg/kg) – the dose that studies to strengthen its knowl- was shown to induce no addi- edge of DBP toxicity. tional deaths relative to the control group. A study pub- The CDC found that high-end lished this year (2000) found that DBP exposures in women of exposures at this level, thought childbearing age are above the previously to produce no effects, federal safe daily dose (Kohn et in fact cause birth defects in al 2000). If the safe daily dose male pups, including extra value were brought up to mod- nipples in a third of the pups ern standards, even more (Mylchresst et al 2000). This women in the CDC study group study found a “safe” dose, called would fall into the zone of a no observed adverse effect concern. level, or NOAEL, of 50 mg/kg – 60 percent lower than the dose The study supporting the RfD that is currently the basis for the is archaic in design and does not RfD.

ENVIRONMENTAL WORKING GROUP 17 18 BEAUTY SECRETS Beauty Secrets

Phthalates in cosmetics and beauty products

It is remarkable that such a Several points became clear Women have no heavily used chemical, with during our product search. First, practical way to known toxicity, can be so poorly alternatives to phthalates are choose products that regulated. For example, Procter readily available to industry, as are phthalate-free. & Gamble holds a patent which only a fraction of any given type proposes to add 5 milligrams of of cosmetic or beauty product DBP to each dose of an oral contains phthalates. pharmaceutical. A woman of average weight (140 pounds) Second, women have no ingesting this tablet would get a practical way to choose products daily dose of DBP that is 80 that are phthalate-free. Some percent of her current allowable cosmetics contain ingredient daily dose defined by the RfD. labels on the outside of the She would get double the dose product, but the print is so small that would be allowed if the RfD as to be nearly unreadable, and a were updated to protect the typical shopper will not know male fetus from birth defects, that “dibutyl phthalate” is the assuming no other exposure to same thing as “butyl ester” or DBP in other products. even possibly “plasticizer.” Other products, such as more expen- The Environmental Working sive perfumes, contain ingredient Group conducted a web-based labels inside the packaging analysis to locate consumer where they cannot be read until products, particularly cosmetics after the product is purchased. and beauty aids, containing We found still other products on phthalates. We found both store shelves, particularly im- dibutyl phthalate (DBP) and ported products, that lacked diethyl phthalate (DEP) in nu- ingredient labels altogether, in merous products, and direct violation of federal regula- butylbenzyl phthalate (BBP) in a tions. smaller number of products. Ultimately we limited our search Third, with information cur- to DBP, because it is a more rently in the public arena, it is potent reproductive and devel- nearly impossible to develop opmental toxin than DEP, and is anything approaching a compre- found in a greater number of hensive list of cosmetic and products than BBP. beauty products that contain

ENVIRONMENTAL WORKING GROUP 19 The results of our phthalates. This would require a the Environmental Working analysis only scratch product-by-product, label-by- Group (EWG) shopped at a local the surface of what label search of every single Rite-Aid, surfed the on-line store cosmetic and personal care box Drugstore.com, and searched the will be a daunting task and bottle sold in the United U.S. patent office records for for CDC as they try to States. The results of our analysis products that contain DBP in the define exactly where only scratch the surface of what patent application. We found women of will be a daunting task for CDC that DBP may be used in a childbearing age are as they try to define exactly broad range of beauty and being exposed to where women of childbearing personal care products, includ- phthalates. age are being exposed to phtha- ing shampoos and conditioners, lates. lotions, hair growth formula- tions, antiperspirants, and sun- As a first step in discovering screen. It can even be used in some of the beauty and personal gum, candy and pharmaceuticals care products that contain DBP, taken orally.

Table 3. A limited online drugstore label search by EWG found DBP in 37 nail products from 22 companies, including Cover Girl, Maybelline, and MaxFactor products.

Manufacturer or parent company, and Name brand Product distributor shown in italics Location Black Radiance U.S.A. Black Radiance Nail Color AM Cosmetics, Inc. North Arlington, NJ 07031 Bon Bons Bon Bons (nail polish) Bari Cosmetics, Ltd Greenwich, CT 06831 Chanel Nail Colour Chanel, Inc. New York, NY 10019 Christian Dior Nail Enamel Parfums Christian Dior Paris, France Club Monaco Nail Color Club Monaco Cosmetics Toronto, Canada Cosmar Cosmar Press&Go Nails Kit Cosmar Corporation Huntington Beach, CA 92647 Cover Girl Cover Girl Nail Slicks Procter & Gamble Inc. (Noxell Corp ) Hunt Valley, MD 21030 Hard Candy Nail Enamel Hard Candy, Inc. Beverly Hills, CA 90211 Loud Music Nail Enamel Sel-Leb Marketing Patterson, NJ 07524 M M Professional Nail Polish Professional Makeup Company Hollywood, CA 90028 Max Factor Diamond Hard Nail Enamel Procter & Gamble Inc. (Max Factor & Co. ) Hunt Valley, MD 21030 Maybelline Express Finish Fast-Dry Nail Enamel L'Oréal USA (Maybelline LLC ) New York, NY 10017 Ultimate Wear (nail enamel) L'Oréal USA (Maybelline LLC ) New York, NY 10017 Salon Finish Nail Enamel) L'Oréal USA (Maybelline LLC ) New York, NY 10017 Nailene Professional Solutions Acrylic Tough Polish Shield Pacific World Corp. Lake Forest, CA 92630 PROfessional Solutions Acrylic Polish Shield Pacific World Corp. Lake Forest, CA 92630 PROfessional Solutions Calcium Growth Builder Pacific World Corp. Lake Forest, CA 92630 Nail Paints Art Kit Pacific World Corp. Lake Forest, CA 92630 NARS Nail Polish Agora Cosmetics, Inc. New York, NY 10012 Naturistics 90 Second Dry Super Fast Nail Color Del Laboratories, Inc (Naturalistics Div. ) Farmingdale, NY 11735 Nutra Nail Nutra Nail Maximum Strengthener CCA Industries, Inc. E Rutherford, NJ 07073 Nutra Nail Calcium Nail thickener CCA Industries, Inc. E Rutherford, NJ 07073 Nutra Nail Iron Shield Nail Hardener CCA Industries, Inc. E Rutherford, NJ 07073 Oil of Olay Nail Lacquer Procter & Gamble Inc. Hunt Valley, MD 21030 Orly Orly Salon Nails Nail Color Orly International Inc. Los Angeles, CA 91311 Sally Hansen Color Fast! One Coat Fast-Dry Enamel Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 Maximum Support Strengthen & Grow Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 No More Breaks Restructurizing Strengthener Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 Hard as Nails with Nylon Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 Triple Strong Advanced Gel Nail Fortifier Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 Thicken Up! Strengthening Nail Thickener Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 Ultimate Shield Fortifyng Base & Top Coat Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 Hard as Nails Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 Instant Strength Calcium Gel Nail Fortifier Del Laboratories, Inc (Sally Hansen Div. ) Farmingdale, NY 11735 Tony & Tina Tony & Tina Nail Enamel Tony & Tina, Inc. New York, NY 10012 Urban Decay Nail Enamel Urban Decay Costa Mesa, CA 92627 Wet 'n' Wild Wet 'n' Wild Nail Color AM Cosmetics, Inc. North Arlington, NJ 07031 Source: Environmental Working Group.

20 BEAUTY SECRETS Our product label searches in Table 4. Proctor and Gamble holds more phthalate-related electronic and real-world drug- cosmetic patents than any other company (37 of 105 stores showed that, for the patents analyzed). consumer, the products most Number of Products for which DBP is proposed as easily found that contain DBP Assignee patents essential or possible additive The Procter & Gamble (Cincinnati, OH) 37 lotion, hairspray, mousse, gel, lotion, are nail enamels and hardeners. cream, pomade, hair spray, conditioner, spritz, hair tonic, facial moisturizers, In a limited label search of nail foundations, lipsticks, mascaras, nail polishes, oral pharmaceuticals, hair loss products on online drugstore treatments web sites, EWG found DBP in a L'Oréal (Bureau D. A. Casalonga-Josse) 10 hair and nail products Lever Brothers Company (New York, NY) 4 deodorant, skin and hair cleansers wide variety of name brand LVMH Recherche (FR) 4 nail varnish items, including Cover Girl and Shiseido Co., Ltd. (Tokyo, JP) 4 skin cream for pharmaceuticals or night cream Maybelline nail enamels (Table Kirker Enterprises, Inc. (Paterson, NJ) 3 nail enamel Mansouri; Zari (828 Port Walk Pl., Redwood 3 skin lotions 3). Shores, CA 94065) Maybelline Cosmetics Corporation (Wilmington, 3 nail enamel DE) Woodward Laboratories, Inc. (Los Alamitos, CA) 3 nail products

The difficulty of compiling Almell, Ltd. (Dallas, TX) 2 nail products comprehensive lists of phthalate- Astra Aktiebolag (Sodertalje, SE) 2 lotions and skin creams Bar-Shalom; Daniel (Rypevaenget 213, DK-2980 2 product to treat or prevent baldness containing cosmetics, from label Kokkedal, DK); Bukh; Niels (Strandvejen 122, DK- 2900 Hellerup, DK) searches alone, led us to conduct Focal, Inc. (Lexington, MA) 2 in creams, gels, powders, etc applied to skin a web-based patent search to Perio Products, Ltd. (Jerusalem, IL); Yissum 2 product to treat tooth and gum disease Research Development Company of the Hebrew discover which companies University of Jerusalem (Jerusalem, IL) claimed cosmetic-related inven- Akzo Nobel NV (Arnhem, NL) 1 fabric softeners and personal care compositions tions that included phthalates as Anheuser-Busch, Incorporated (St. Louis, MO) 1 gelled antiperspirant ingredients. As of October 5, Chesebrough-Pond's USA Co., Division of 1 product to treat or prevent baldness Conopco, Inc. (Greenwich, CT) 2000, the U.S. Patent and Trade- Colgate Palmolive Company (New York, NY) 1 antiperspirant and deodorant gels Digestive Care Inc. (Lebanon, NJ) 1 coating ingredient for oral mark Office had records of 309 pharmaceutical patents related to cosmetics that Eastman Chemical Company (Kingsport, TN) 1 nail products included DBP as an essential or E-L Management Corp. (New York, NY) 1 foundation, blushes, eye shadow, lipstick Elizabeth Arden Co., Division of Conopco, Inc. 1 skin products optional ingredient, or as an (New York, NY) ingredient in an example prod- Goldiner; Arthur (1565 Strand Way, Oceano, CA 1 custom fit teeth 93445); Camplese; Linda (1565 Strand Way, uct formulation. Thirty-eight Oceano, CA 93445) Henkel Kommanditgesellschaft auf Aktien 1 skin care and hair care formulations individual companies or inven- (Duesseldorf, DE) tors hold 105 recent cosmetic- Kao Corporation (Tokyo, JP) 1 emulsion for general cosmetics Kao Corporation (Tokyo, JP); Taiyo Kagaku Co., 1 hair care products related patents that propose DBP Ltd. (Yokkaichi, JP) Kraft General Foods, Inc. (Northfield, IL) 1 sunscreen as an additive (Table 4). Laboratoires Virbac (Carros, FR) 1 added to stabilize drugs Minnesota Mining and Manufacturing Company 1 general cosmetics and personal care (St. Paul, MN) products In some patents, companies Mitsui Toatsu Chemicals, Inc. (Tokyo, JP) 1 hair care products gave information on the percent Resler; Renee (3046 E. Marlette, Phoenix, AZ 1 nail products 85016) by weight of DBP proposed to Revlon Consumer Products (NY, NY) 1 nail enamel Rhodia Chimie (Courbevoie, FR) 1 hair and skin care products (sprays, tonic be added to the product. DBP lotions, gels, mousses) in nail polishes tends to be Rhone-Poulenc Chimie (Courbevoie Cedex, FR) 1 nail varnishes Unilever Patent Holding B.V. (Vlaardingen, NL) 1 skin and hair care products, added at about five percent by antiperspirants weight (for example, Maybelline Wacker-Chemie GmbH (DE) 1 nail varnish Warner-Lambert Company (Morris Plains, NJ) 1 chewing gum and candy nail enamel patent 5972095), but Witco Corporation (Greenwich, CT) 1 conditioning products for skin and hair

DBP in other products ranged Source: Environmental Working Group. up to 20 percent, in a night cream invented by the Japanese

ENVIRONMENTAL WORKING GROUP 21 Scientists in Hamburg, company Shiseido (patent num- useful for nail polish. After nail Germany showed that ber 5891846) (Table 5). polish is applied, some of the water-soluble ingredients volatilize and leave Why the cosmetic industry adds behind a film that is the coating components of the phthalates to their products over the nail. DBP is one of the polish, like DBP, are ingredients left behind, reducing dissolved out of the Multiple chemical properties of brittleness and cracking in the polish each time they DBP make it a useful additive in polish. contact water. many types of cosmetics. These properties include its ability to If the DBP stayed intact in the impart flexibility to thin films for polish, women might absorb mascara and nail polish, its oily negligible amounts of the chemi- texture that makes skin feel soft, cal into their bodies. But a and its ability to make lotions group of scientists in Hamburg, penetrate deeper into the skin Germany showed that water- (Table 6). soluble components of the polish, like DBP, are dissolved DBP as a plasticizer in nail out of the polish each time they enamel contact water, a conclusion they reached after measuring the The plasticizing and film- leaching of DBP from nail polish formation properties of DBP that had dried for three days. In make the chemical particularly fact, one of the reasons nail

Table 5. Consumer products ranging from skin cream to oral pharmaceuticals can contain up to 20 percent DBP, according to example product formulations given in company patents.

DBP in product Company Product by weight Procter & Gamble (Cincinnati, OH) long wear nail polish 7% Shiseido Company, Ltd. (Tokyo, JP) oil essence 10% Woodward Laboratories, Inc (Los Alamitos, CA) nail coating 3.4% L'Oreal (France) treatment base for nails 3.8% Procter & Gamble (Cincinnati, OH) pump hair spray 0.2% Kirker Enterprises, Inc (Paterson, NJ) nail enamel 7% Maybelline Cosmetics Corporation (Wilmington, DE) nail enamel 5% Shiseido Company, Ltd. (Tokyo, JP) night cream 5% LVMH Recherche (France) nail enamel 6-8% Shiseido Company, Ltd. (Tokyo, JP) skin cream 20% Wacker-Chemie GmbH (Denmark) nail varnish 2% L'Oreal (France) nail varnish 5% Digestive Care Inc. (Lebanon, NJ) coating for oral drugs2% Kao Corporation (Tokyo, JP) cosmetic emulsion 7% Procter & Gamble (Cincinnati, OH) oral drugs5 mg per dosage unit Anheuser-Busch, Incorporated (St. Louis, MO) antiperspirant gel 10% Source: Environmental Working Group.

22 BEAUTY SECRETS polish eventually chips is that it Table 6. DBP is used in cosmetics most often as a becomes brittle as DBP is plasticizer, to reduce brittleness and cracking, but is also leached out of the film. This used to soften and moisturize skin, and as a penetration means that every time a woman enhancer. washes her hands, DBP is Percent of patents in washed out of her nail polish which DBP serves that and contacts her skin. The Function of DBP in cosmetic product function scientists conclude that “water- soluble components… attain the Plasticizer 49% Humectant 24% skin during extensive but tran- Solvent 16% sient contact.” Therefore, a Coalescent 4% woman wearing nail polish not Penetration enhancer 2% only can absorb DBP through Emollient 2% her nail, but also has multiple Gastric-acid resistant polymer coating 1% "oily material" 1% opportunities to absorb DBP directly through her skin. Source: Environmental Working Group.

Since the 1940’s scientists have known that nail polish contains allergenic ingredients such as DBP can cause the im- The well-known (Sainio et al 1997). Some com- mune system to respond to French cosmetics panies are beginning to study chemical exposures with immu- company L’Oréal, in formulations of nail polish that nological reactions that are harm- patent number have reduced quantities of DBP, ful, varying from hives to life- because of concerns over aller- threatening responses such as 5,676,935, claims gic reactions. The well-known anaphylactic shock, where low “Nowadays, it is French cosmetics company blood pressure and breathing preferable to use L’Oréal, in patent number difficulties can result in death. plasticizers other than 5,676,935, claims “Nowadays, it phthalates in varnishes is preferable to use plasticizers L’Oréal USA is still using DBP for reasons of other than phthalates in var- in their nail products – for ex- allergy…” nishes for reasons of allergy…” ample, in their Maybelline Ex- In fact, allergic responses to press Finish Fast-Dry, Ultimate DBP can be severe. In a 1999 Wear, and Salon Finish nail case study published in the enamels that EWG found on the journal Dermatology, the authors shelves of a Rite-Aid drugstore in describe a case of anaphylactic Washington DC, in September shock, a severe allergic reaction, 2000. Even DBP’s well-recog- in a patient exposed to DBP in nized effects on the immune the coating of an oral pharma- system have not been enough to ceutical (Gall et al 1999). change manufacturers’ practices.

The ability of DBP to cause DBP as a “penetration enhancer” allergic reactions means that the chemical can induce a state of Both Elizabeth Arden Com- hypersensitivity in the immune pany (New York, New York) and system. Environmental antigens Chesebrough Ponds (Greenwich,

ENVIRONMENTAL WORKING GROUP 23 Industry continues to Connecticut) hold patents for high levels of DBP in women of use DBP specifically cosmetics in which DBP is pro- childbearing age, postulates that for its ability to absorb posed as a penetration enhancer. dermal absorption is playing a role: “Dermal absorption also deep into the skin. Elizabeth Arden proposes DBP occurs at a significant rate for as an additive to skin care prod- phthalates with short side chains ucts, where DBP is used to get such as …DBP…,” citing the more of the product deeper into same rat study as evidence the skin: “improving [the (Blount et al 2000). product’s] delivery through the stratum corneum to its site of Regardless of how various action in the epidermis.” Simi- government agencies are inter- larly, Chesebrough Ponds pro- preting the dermal absorption poses that DBP can be added to study in rats, industry continues a hair growth formulation for to use DBP specifically for its men to help the formulation ability to absorb deep into the penetrate deeper into the scalp to skin. the site of action at the hair follicles. DBP as a humectant and emollient Research from the chemical giant Zeneca gives more evidence DBP is listed as a humectant that DBP acts as a penetration or emollient in patents from enhancer. Their work shows that Procter & Gamble Company when DBP is added to products (Cincinnati, OH), Lever Brothers for the skin, allergic reactions are Company Inc (New York, NY), more severe (in this case, to Colgate Palmolive Company ingredients other than DBP). The (New York, NY), Kraft General scientists postulate that the en- Foods (Northfield, IL), Anheuser- hanced allergic reactions stem Busch, Incorporated (St Louis, from DBP’s ability to deliver the MO) and four other companies. chemicals deeper into the skin Humectants are skin moisturiz- (Dearman et al 1996). ers; emollients soften the skin. Information in patents from The use of DBP as a penetra- these major companies indicate tion enhancer stands in direct that DBP is added to skin care contrast to CERHR’s assertion that products because its oily texture “Dermal contact with products gives the impression that the containing DBP is possible, but skin itself is soft and moisturized, absorption through the skin is when in fact it is the DBP resi- most likely minimal.” The Center due that makes the skin feel this cites a study of DBP migration way. through rat skin. CDC, on the other hand, upon discovering

24 BEAUTY SECRETS Beauty Secrets

References

Blount BC, MJ Silva, SP Caudill, LL Needham, JL Pirkle, EJ Sampson, GW Lucier, RJ Jackson, JW Brock. October 2000. Levels of seven urinary phthalate metabolites in a human reference population. Environmental Health Perspectives. 108(10):979-982.

Castleman, BI, and GE Ziem. 1994. American Conference of Gov- ernmental Industrial Hygienists: Low Threshold of Credibility. Ameri- can Journal of Industrial Medicine. 26:133-143.

Center for the Evaluation of Risks to Human Reproduction (CERHR), National Toxicology Program, U.S. Department of Health and Human Services. October 2000. NTP-CERHR Expert Panel Re- port on Di n Butyl Phthalate. NTP-CERHR-DBP-00.

Dearman RJ, Cumberbatch M, J Hilton, HM Clowes, I Fielding, JR Heylings, I Kimber. 1996. Influence of dibutyl phthalate on dermal sensitization to fluorescien isothiocyanate. Fundam Appl Toxicol 1996 Sep;33(1):24-30.

Ema M, Amano H, Ogawa Y. 1994. Characterization of the devel- opmental toxicity of di-n-butyl phthalate in rats. Toxicology 86:163- 174.

Ema M, Kurosaka R, Amano H, Ogawa Y. 1995. Comparative developmental toxicity of n-butyl benzyl phthalate and di-n-butyl phthalate in rats. Arch Environ Contam Toxicol 28:223-228(1995).

Ema M, Miyawaki E, Kawashima K. 1998. Further evaluation of developmental toxicity of di-n-butyl phthalate following administration during late pregnancy in rats. Toxicol Lett:87-93(1998).

Environmental Protection Agency (EPA). 1990. Integrated Risk Information System. Dibutyl phthalate, CASRN 84-74-2. October 1990. Available online at http://www.epa.gov/ngispgm3/iris/

ENVIRONMENTAL WORKING GROUP 25 Foster PM, BG Lake, LV Thomas, MW Cook, SD Gangolli. 1981. Studies on the testicular effects and zinc excretion produced by vari- ous isomers of monobutyl-o-phthalate in the rat. Chem Biol Interact 1981 Mar 1;34(2):233-8.

Gall H, Kohler A, and Peter RU. 1999. Anaphylactic shock reac- tion to dibutyl-phthalate-containing capsules. Dermatology. 199(2):169-70.

Gray LE, Jr, Wolf C, Lambright C, Mann P, Price M, Cooper RL, Ostby J. 1999. Administration of potentially antiandrogenic pesticides (procymidone, linuron, iprodione, chlozolinate, p,p’-DDE, and ketoconazole and toxic substance (dibutyl- and diethylhexyl phtha- late, PCB 169, and ethane dimethane sulphonate) during sexual differentiation produces diverse profiles of reproductive malforma- tions in the male rat. Toxicol Ind Health 15:94-118(1999).

Kohn MC, Parham F, Masten SA, Portier CJ, Shelby MD, Brock JW, Needham LL. October 2000. Human Exposure Estimates for Phtha- lates. Environmental Health Perspectives 108(10).

Marsman DS. 1995. NTP technical report on toxicity studies of dibutyl phthalate (CAS No. 84-74-2) administered in feed to F344 rats and B6C3F1 mice. NIH Publication 95-3353. Research Triangle Park: National Toxicology Program.

Moline JM, Golden A, Bar-Chama N, Smith E, Rauch M, Chapin R, Perreault S, Schrader S, Suk W, Landrigan P. September 2000. Expo- sure to hazardous substances ad male reproductive health: a research framework. Environmental Health Perspectives. 108(9).

Mylchreest E, Cattley RC, Foster PM. 1998. Male reproductive tract malformations in rats following gestational and lactational exposure to di(n-butyl) phthalate: An antiandrogenic mechanism? Toxicol Sci 43:47-60(1998).

Mylchreest E, Sar M, Cattley RC, Foster PMD. 1999. Disruption of androgen-regulated male reproductive development by di(n-butyl) phthalate during late gestation in rats is different from flutamide. Toxicol Appl Pharmacol 156:81-95(1999).

Mylchreest E, Wallace DG, Cattley RC, Foster P. 2000. Dose- dependent alternations in androgen-regulated male reproductive development in rats exposed to di_n-butyl) phthalate during late gestation. Toxicol Sci(2000).

26 BEAUTY SECRETS Paulozzi LJ. 1999. International trends in rates of hypospadias and cryptorchidism. Environmental Health Perspectives. 107(4). April 1999.

Roach, SA and SM Rappaport. 1990. But they are not thresholds: A critical analysis of the documentation of threshold limit values. American Journal of Industrial Medicine. 17:727-753.

Roe D, Pease W, Florini K, and. Silbergeld E. 1997. Toxic Igno- rance. Environmental Defense. Washington DC. Summer 1997.

Sainio EL, Engstrom K, Henriks-Eckerman ML, Kanerva L. 1997. Allergenic ingredients in nail polishes. Contact Dermatitis Oct;37(4):155-62.

Swan SH, Elkin EP, Fenster L. 2000. The question of declining sperm density revisited: An analysis of 101 studies published 1934- 1996. Environmental Health Perspectives. 108(10). October 2000.

Toppari, J, Larsen JC, Christiansen P, Giwercman A, Grandjean P, Guillette Lj Jr, Jegou B, Jensen, TK, Jouannet P, Keiding N, Leffers H, McLachlan JA, Meyer O, Muller J, Meyts, E R-D, Scheike T, Sharpe R, Sumpter J, Skakkebaek NE. August 1996. Male reproductive health and environmental xenoestrogens. Environmental Health Perspec- tives. 104. Supplement 4.

Wine R, Li L_H, Barnes LH, Gulati DK, Chapin RE. 1997. Repro- ductive toxicity of di-n-butyl phthalate in a continuous breeding protocol in Sprague-Dawley rats. Environ Health Perspect 105:102- 107 91997).

ENVIRONMENTAL WORKING GROUP 27 E NVIRONMENTAL TM W ORKING GROUP

1718 Connecticut Ave., NW Suite 600 Washington, DC 20009 tel 202-667-6982 • fax 202-232-2592 [email protected] • www.ewg.org