Dibutyl phthalate (DBP) was at one time a very common ingredient in many nail polishes. It is used as a plasticizer and is a key component in some fragrances because of its unique properties. But phthalates have become one of the demon ingredients in cosmetics since the Centers for Disease Control and Prevention (CDC, www. cdc. gov) published the National Report on Human Exposure to Environmental Chemicals—Results for Mono-butyl phthalate [which is] (metabolizedfrom Dibutylphthalate). Basically, the CDC found measurable levels of phthalate in the urine of the participants in a study looking at the issue of phthalates. However, the CDC stated that “Finding a measurable amount of one or more phthalate metabolites in urine does not mean that the level of one or more phthalates causes an adverse health effect. Whether phthalates at the levels of metabolites reported here are a cause for health concern is not yet known; more research is needed” (Sources: CDC, www. cdc. gov/ nceh/dls/report/results/Mono-butylPhthalate. htm; and Environmental Health Perspectives, December 2000, volume 108, issue 12).
Adult health is one thing, but since then growing research has shown a far more serious concern when children have a detectable amount of phthalates in their system. A study published in the medical journal Pediatrics (February 2008, pages 260-268) was shocking to many women when it found a link between baby skin-care products and phthalates being absorbed by the infant; the report concluded: “Phthalate exposure is widespread and variable in infants. Infant exposure[s] to lotion, powder, and shampoo were significantly associated with increased urinary concentrations of monoethyl phthalate, monomethyl phthalate, and monoisobutyl phthalate, and associations increased with the number of products used. This association was strongest in young infants, who may be more vulnerable to developmental and reproductive toxicity of phthalates given their immature metabolic system capability and increased dosage per unit body surface area.”
In 1985, the Cosmetic Ingredient Review (CIR) board (www. cir-safety. org/) deemed dibutyl phthalate safe for use in cosmetic products. In 2001, the CIR reviewed new data on the use of three phthalate esters (also known as phthalates) in cosmetics, and on November 19, 2002, the CIR board announced its decision to not reopen the safety assessment of the dibutyl phthalate group of ingredients. Their summary on this issue states that “New data on acute and short-term toxicity were consistent with previously available data.” They went on to say that “The developmental effects of phthalates seen in rodents raise questions about the potential for human health risk. However, these effects seen in rodents are at much higher exposure levels than humans are likely to encounter and they are subject to the species difference in the metabolism of phthalate diesters.” They also concluded that human exposure to dibutyl and diethyl phthalate was below the reference dose levels set by the U. S. Environmental Protection Agency.
Other research concluded similarly, saying “that levels of concern are minimal to negligible in most situations…” (Source: Reproductive Toxicology, August-September 2004, pages 761-764). And a study reported in Regulatory Toxicology and Pharmacology, December 2008, pages 232-242, concluded that “The results of the cumulative risk assessments for both a US and a German population show that the hazard index is below one. Thus it is unlikely that humans are suffering adverse developmental effects from current environmental exposure to these phthalate esters.”
Despite the fact that the CTFA and CIR maintain that phthalates are safe, the Food and Drug Administration (FDA), Health Canada, and other governmental health agencies around the world remain suspicious. Though the FDA and Health Canada have not restricted the use of phthalates, both agencies have made strong comments regarding their risk and safety. An FDA report titled Aggregate Exposures to Phthalates in Humans stated that “Manufacturers consistently argue that there is no evidence that anyone has been harmed by phthalates. As we note, however, and as confirmed by the NTP [National Toxicology Program] panel and FDA, no study has ever examined the impact of phthalates [on human reproduction] … Lack of evidence can hardly be used as evidence of safety when no one has ever [studied the issue on humans].”
The report went on to observe, “The increasing incidence of hypospadias, undescended testes, testicular cancer, and declining sperm counts in the US and many other parts of the world suggests that a closer look at many reproductive tract toxicants and endocrine disrupters is urgently needed in people. With respect to phthalates, however, evidence from relevant animal studies and from limited studies of non-reproductive tract impacts in hospitalized patients is sufficient to require phasing out the use of many of the phthalates.” The Health Canada panel reached a similar conclusion, stating “the status quo is not an acceptable option” (Source: Aggregate Exposures to Phthalates in Humans, July 2002, www. fda. gov/ohrms/dockets/dailys/02/Dec02/120502/02d-0325-c000018-02-vol1.pdf).
This explains why many cosmetics companies are actively seeking or have already begun using alternatives to phthalates. It could be argued that, at the levels presently used, phthalates pose no health risk. Although there is no concrete human evidence to suggest phthalates are harmful, the lack of studies in this area continues to leave the issue open to debate and perhaps does indicate that a “better safe than sorry” approach is wise.