chemical Class
Phthalates
Chemicals in the class:
Bis(2-ethylhexyl)phthalate, Butyl benzyl phthalate, Di-n-butyl phthalate, Di-n-octyl phthalate, Diethyl phthalate, Dimethyl phthalate, Mono-(2-ethyl-5-hydroxyhexyl)phthalate, Mono-(2-ethyl-5-oxohexyl)phthalate, Mono-(2-ethylhexyl)phthalate, Mono-butyl phthalate, Monobenzyl phthalate, Monoethyl phthalate, Monomethyl phthalate
Summary
Invented in the 1930s, the common industrial chemicals called phthalates (pronounced tha-lates) are used as ingredients in a diverse range of consumer products, from cosmetics to food wraps, toys and building materials. Currently, the chemical industry produces billions of pounds of phthalates each year. They are used as plasticizers to soften plastic, especially PVC plastic, and to make nail polish flexible and chip-resistant; as skin moisturizers and skin penetration enhancers in cosmetics; as an ingredient of fragrance in cosmetics and cleansing products; as components of a broad array of consumer products, from adhesives to inks; and as solvents in a wide range of applications. People are exposed to phthalates daily through their contact with consumer products, via food packaged in plastic, and from indoor air (CDC 2005).
In September 2000, scientists from the Centers for Disease Control and Prevention (CDC) conducted the first accurate measurements of human phthalate exposures, and reported finding phthalates in every one of 289 people tested, at surprisingly high levels (Blount 2000). Levels of some phthalates in U.S. women of childbearing age have been found to exceed the government's safe levels set to protect against birth defects, according to another CDC study (Kohn 2000). Results of phthalate testing in more than 2,500 people ages 6 and above confirmed the CDC's original findings: phthalate exposures are widespread across the population, and women are exposed at higher levels than men (CDC 2003). In a recent study of girls age 6 to 8 spearheaded by Mount Sinai School of Medicine, phthalates were found in every one of 90 girls tested (Wolff 2007). Phthalates are widespread contaminants in the environment as well (Kolpin 2002; Rudel 2003).
Epidemiological studies of ordinary people have linked high phthalate levels to reduced sperm motility and concentration, increased damage to sperm DNA, and alterations in hormone levels in adult men (Duty 2003, 2004, 2005; Hauser 2007). A recent study of 134 births found marked differences in the reproductive systems of baby boys whose mothers had the highest phthalate measurements during pregnancy (Swan 2005). A second study indicated that these mothers' exposures were not extreme, but rather were typical for about one-quarter of all U.S. women (Marsee 2006). Further research documented decreased testosterone levels among baby boys exposed to phthalates in their mother's breast milk (Main 2006).
New epidemiological studies indicate phthalates may produce non-reproductive health effects in people as well. Results from two studies suggest that breakdown products of some phthalates may be associated with alterations in thyroid hormone levels in adult men and pregnant women (Huang 2007; Meeker 2007). In another study, increased levels of certain phthalates were associated with increased waist circumference and insulin resistance in adult men in the United States (Stahlhut 2007). According to the American Heart Association (2007), over 60 million Americans have insulin resistance; 1 in 4 of these people develop Type 2 diabetes. Finally, concentrations of specific phthalates in house dust are associated with asthma, rhinitis, and wheezing in 2 studies of children (Bornehag 2004; Kolarik 2008).
In addition to this epidemiological research on humans, laboratory studies indicate phthalates cause a broad range of birth defects and reproductive impairments in animals exposed in utero and shortly after birth (e.g. Marsman 1995; Wine 1997; Ema 1998; Mylchreest 1998, 1999, 2000; Gray 1999; CERHR 2000). Phthalate exposures damage the testes, prostate gland, epididymis, penis, and seminal vesicles in laboratory animals (e.g. Mylchreest 1998); most of these effects persist throughout the animal's life. Phthalates have also been shown to build up, or bioaccumulate, in the bodies of animals after repeated exposures (Jobling 1995).
Phthalates are considered a hazardous waste and are regulated as pollutants when industry releases them into the environment. In contrast, phthalates are essentially unregulated in food, cosmetics, and consumer products. One phthalate, DEHP, is regulated in drinking water. In addition, this phthalate was removed voluntarily from children's toys more than a decade ago. The European Union has banned use of some phthalates in cosmetics and other consumer products, in response to concerns about exposure and toxicity.
Phthalates
Used in soft plastics like PVC, and as a component of fragrance in personal care products and cleaning agents. Phthalate exposure is linked to male reproductive problems in people and animals.
Top health concerns for Phthalates (References)
| health concern or target organ | weight of evidence |
| Reproduction and fertility | unknown |
| Birth defects and developmental delays | unknown |
| Endocrine system | unknown |
Other health concerns for Phthalates (References)
| health concern or target organ | weight of evidence |
| Immune system (including sensitization and allergies) | unknown |
| Gastrointestinal (including liver) | unknown |
| Skin | limited |
| Sense organs | limited |
| Chronic effects, general | unknown |
| Persistent, accumulates in wildlife and/or people | probable |
| Brain and nervous system | strong |
| Cancer | limited |
| Respiratory system | unknown |
Data gaps for Phthalates (References)
Data are insufficient to assess cancer potential.
Violations, restrictions, and warnings for Phthalates (References)
Prohibited for use in cosmetics in the European Union.
Other relevant risk considerations for Phthalates (References)
Wildlife and environmental toxicity.
Toxicity Classifications (References)
| classification | governing entity/references |
| A3- Confirmed animal carcinogen with unknown relevance to humans, ACGIH (American Conference of Governmental Industrial Hygeinists) | Amer Conf of Gov't Industrial Hygienists - Carcinogens |
| B2 Probable human carcinogen - based on sufficient evidence of carcinogenicity in animals (1986) | EPA Integrated Risk Information System (IRIS) |
| Bioaccumulative toxicant under Canada's Accelerated Reduction/Elimination of Toxics program - targeted for elimination or reduction | EC (Environment Canada). 1994. Accelerated Reduction/Elimination of Toxics (ARET). ARET substance list of persistent, bioaccumulative and toxic chemicals. |
| Birth defects - weight of evidence unknown/unassessed | ATSDR, CERHR |
| Cancer hazards: recognized | P65 |
| Cancer hazards: suspected | IRIS |
| Chemicals in this class have been reviewed by the Cosmetics Industry Review panel. (Please see individual chemicals for details.) | Cosmetics Ingredient Review Assessments |
| Chronic effects, general - weight of evidence unknown/unassessed | Stahlhut RW, van Wijngaarden E, Dye TD, Cook S, Swan SH. 2007. Concentrations of urinary phthalate metabolites are associated with increased waist circumference and insulin resistance in adult U.S. males. Environmental health perspectives 115(6): 876-882. |
| Developmental toxicity hazards: recognized | P65 |
| Developmental toxicity hazards: suspected | ATSDR, CERHR, EPA-SARA, JANK, NTP-R, P65-CAND, CERHR, P65-CAND |
| EPA: probable endocrine disruptor | Illinois EPA Chemicals Associated with Endocrine System |
| EPA: suspected endocrine disruptor | Illinois EPA Chemicals Associated with Endocrine System |
| Endocrine system toxicity - weight of evidence unknown/unassessed | Main KM, Mortensen GK, Kaleva MM, Boisen KA, Damgaard IN, Chellakooty M, et al. 2006. Human breast milk contamination with phthalates and alterations of endogenous reproductive hormones in infants three months of age. Environ Health Perspect 114(2): 270-276. |
| Endocrine toxicity hazards: suspected | JNIHS, WWF, BKH, JNIHS, KEIT, WWF, BKH, BRUC, IL-EPA, JNIHS, KEIT, WWF, BRUC, JNIHS |
| Gastrointestinal or liver toxicity hazards: suspected | ATSDR, RTECS, EPA-HEN, OEHHA-CREL, RTECS |
| Gastrointestinal system toxicity - weight of evidence unknown/unassessed | Field EA, Price CJ, Sleet RB, George JD, Marr MC, Myers CB, et al. 1993. Developmental toxicity evaluation of diethyl and dimethyl phthalate in rats. Teratology 48(1): 33-44. |
| Group C: Possible human carcinogen (EPA classification) | EPA Integrated Risk Information System (IRIS) |
| Group D: Not classifiable as to human carcinogenicity (EPA classification) | EPA Integrated Risk Information System (IRIS) |
| Hazardous air pollutant under Clean Air Act | EPA Hazardous Air Pollutants |
| IARC 3: mixed or limited evidence on human cancer potential (International Agency for Research on Carcinogens) | Inter'l Agency for Research on Cancer (IARC) Carcinogens |
| Immune system toxicity - weight of evidence unknown/unassessed | Bornehag, C. G., Sundell J., Weschler, C.J., Sigsgaard, T., Lundgren, B., Hasselgren, M., Hägerhed-Engman, L. (2004). "The Association between Asthma and Allergic Symptoms in Children and Phthalates in House Dust: A Nested Case-Control Study." Environ Health Perspect 112: 5 |
| Known to be neurotoxic to humans, suspected developmental neurotoxin | Chemicals known to be neurotoxic to humans |
| Limited evidence in humans - immune system toxicity | Bornehag C, Sundell J, Weschler CJ. The association between asthma and allergic symptoms in children and phthalates in house dust: a nested case-control study. Environmental Health Perspectives 112: 1393-1397 (2004)., Bornehag C, Sundell J, Weschler CJ. The association between asthma and allergic symptoms in children and phthalates in house dust: a nested case-control study. Environmental Health Perspectives 112: 1393-1397 (2004). |
| May be toxic to the reproductive system (European Union classification); May cause harm to the unborn child; Limited evidence of reproductive toxicity (European Union classification); Possible risk of impaired fertility; Dangerous for the environment; Very toxic to aquatic organisms | European Union - Classification & Labelling |
| May be toxic to the reproductive system (European Union classification); May impair fertility | European Union - Classification & Labelling |
| May cause harm to the unborn child; Possible risk of impaired fertility; Dangerous for the environment; Very toxic to aquatic organisms | European Union - Classification & Labelling |
| May cause sensitization by skin contact, with allergic reaction in skin or lungs; | National Library of Medicine HazMap |
| Persistent, bioaccumulative toxicant - Limited or emerging evidence in open scientific literature | Emerging PBTs from peer-reviewed literature |
| Persistent, bioaccumulative toxicant - Oslo-Paris (OSPAR) Convention for the Protection of the Marine Environment of the North-East Atlantic, chemical of concern | OSPAR (2002). OSPAR List of Substances of Possible Concern. Secondary OSPAR List of Substances of Possible Concern. Secondary OSPAR. Place Published, OSPAR Convention for the Protection of the Marine Environement of North-East Atlanic. |
| Priority substance in EU water policy | European Union - Water Framework Directive |
| Priority water pollutant under the Clean Water Act | EPA Water Quality Standards Database |
| Prohibited in EU cosmetics: must not form part of the composition of cosmetic products | European Union - Banned or Restricted in Cosmetics |
| Reasonably anticipated to be a human carcinogen (National Toxicology Program classification) | NTP Report on Carcinogens, 11th Edition |
| Reproductive toxicity hazards: recognized | P65 |
| Reproductive toxicity hazards: suspected | ATSDR, EPA-SARA, NTP-R, P65-CAND, CERHR |
| Respiratory system toxicity - weight of evidence unknown/unassessed | Bornehag C, Sundell J, Weschler CJ. The association between asthma and allergic symptoms in children and phthalates in house dust: a nested case-control study. Environmental Health Perspectives 112: 1393-1397 (2004)., Bornehag, C. G., Sundell J., Weschler, C.J., Sigsgaard, T., Lundgren, B., Hasselgren, M., Hägerhed-Engman, L. (2004). "The Association between Asthma and Allergic Symptoms in Children and Phthalates in House Dust: A Nested Case-Control Study." Environ Health Perspect 112: 5 |
| Respiratory toxicity hazards: suspected | EPA-HEN, OEHHA-CREL, RTECS |
| Skin or sense organ toxicity hazards: suspected | EPA-HEN, HAZMAP |
| Toxic, U.S. Environmental Protection Agency Toxics Release Inventory programs | EPA Toxic Release Inventory (1999) |
