Researchers have reported for the first time that
they have found a highly significant link between
human exposure to chemicals used in consumer
products and adverse changes in the genitals of baby
boys.
The sons whose mothers' urine contained higher
levels of phthalates, a family of compounds used to
soften vinyl and other plastics, were more likely to
show the physical changes, according to the
University of Rochester study released Thursday.
A second study, released Wednesday, looked at
another chemical, bisphenol A, and found that
pregnant lab animals exposed to very low levels of
it produced offspring with impaired mammary-gland
development. The exposure levels in the study,
conducted by researchers at the Tufts University
School of Medicine, were 2,000 times lower than the
Environment Protection Agency's safe dose for the
chemical.
The EPA and the National Institutes of Health
contributed funds for the studies to learn more
about possible ill health effects from these
industrial chemicals, which are produced in billions
of pounds worldwide.
In low levels, neither is illegal in the United
States, but the California Legislature is
considering two separate bills that would place
curbs on the chemicals.
The legislation is opposed by representatives of
the chemical- manufacturing industry, who criticized
the new studies Thursday, saying they don't document
a link to testicular or breast cancer in humans.
Bisphenol A has been used for decades in tough
polycarbonate plastic. Polycarbonate plastic makes
up the hard, brittle drinking water bottles, which
may be clear or tinted, sold under the name of
Nalgene and other brands, as well as baby bottles
and tableware. The chemical is also used in dental
sealants, medical devices and in the resin lining of
most food cans.
Phthalates are used in soft vinyl products and
some perfumes, shampoos, soaps, makeup, pesticides,
pill coatings and paints. Two forms, DBP and DEHP,
are listed as reproductive toxicants and carcinogens
by the state EPA, and the European Union has banned
both in cosmetics. The chemical has been found at
low levels in milk, drinking water and household
dust.
Lead author of the phthalates study, Dr. Shanna
H. Swan, professor in obstetrics and gynecology at
the University of Rochester School of Medicine and
Dentistry, launched her study based on previous
animal studies.
In clinical settings in Los Angeles, Minneapolis
and Columbia, Mo., researchers examined 134 babies
ages 3 months to 24 months, assessing the
development of male genitals and the distance
between the anus and the genitals.
In animals, the "ano-genital" distance has served
as an important marker, associated with immediate
physiological changes in the reproductive system, as
well as later changes at puberty and adulthood,
including alterations in behavior.
In the study, published in Environmental Health
Perspectives, the researchers sent the urine from 85
of the pregnant mothers to the Centers for Disease
Control in Atlanta for testing of phthalates.
The researchers found that the boys' ano-genital
distance was significantly associated with the level
of metabolites, or breakdown products, of four
commonly used phthalates in their mothers' urine.
"These changes are seen at phthalate levels below
those found in one- quarter of the female population
of the United States,'' Swan said at a telephone
press conference.
Twenty-one percent of the boys with short
ano-genital distances had incomplete testicular
descent, compared to 8 percent of other boys, and a
short ano-genital distance was significantly
correlated with a smaller penis.
The strongest associations were seen when the
mother was exposed to high levels of multiple
phthalates. Eleven of the 12 boys with the highest
exposure to these phthalates had a short ano-genital
distance.
Swan said the study's sample was relatively small
but the results "highly significant,'' indicating a
need for additional study with a larger body of
subjects. The researchers also want to follow the
134 boys to adulthood.
Marian Stanley, manager of the Phthalate Esters
Panel, an industry group, said, "The authors are not
reporting any negative health effect on the male
reproductive system.'' The ano-genital distance "has
no known significance, and is in fact a biomarker of
exposure only.'' The distance could be a natural
variability, she said.
In the bisphenol A study, published in the
journal Endocrinology, Tufts University School of
Medicine researchers said they used extremely low
levels of the chemical, yet still found changes in
patterns of mammary-gland development at the time of
puberty in the rodents.
The researchers said the changes in the mammary
glands in the lab animals when exposed to bisphenol
A were consistent with changes that in humans are
associated with a higher risk of breast cancer, such
as an increase in the number of "terminal end buds''
in the tissue.
Steve Hentges, a spokesman for the American
Plastics Council, said the study only hypothesizes
that mammary gland problems in rodents would portend
breast cancer in humans.
Because the EPA's safe-dose is based on oral
exposure to humans, it can't be compared to the
level given to the lab animals, Hentges said, which
get their doses by inoculation.