Released on June 18, 1998, from www.rachel.org
EXPERIMENTING ON CHILDREN
by Charlie Cray
of the Environmental Research Foundation
Health authorities in several European countries, including
Austria, Belgium, Denmark, Germany, and the Netherlands have
recommended a ban on soft PVC toys, such as teething rings and
The Spanish government requested action by the
European Union (EU) in March, 1998. PVC, or polyvinyl chloride
(also known as vinyl), is a common plastic that frequently
contains toxic additives. Despite its well-publicized goal to
"protect children's health," the Clinton administration is
lobbying aggressively to avert a European ban on PVC toys.
At issue are a family of chemicals called phthalates (pronounced
"thalates"). Phthalates (phthalic esters or benzenedicarboxylic
acid esters) are used primarily as plasticizers added to PVC to
make it soft and elastic. Plasticizers account for more than
half the weight of some flexible PVC products. About 95% of
phthalates are used in PVC.
Since they are not chemically bound to the PVC polymer itself,
phthalates readily leach out of PVC products. Up to 1% of the
phthalate content of PVC products is released each year. As a
result of their continuous release during the production, use and
disposal of PVC products, phthalates are often described as the
"most abundant man-made environmental pollutants." (See REHW
Although phthalates vary in toxicity, the most widely-used
phthalates such as DEHP [di(2-ethylhexyl)phthalate] have been
linked in animal studies to a variety of illnesses, including
reproductive damage and damage to the kidneys and liver.
Several agencies, including U.S. EPA [Environmental Protection
Agency], have labeled DEHP a probable human carcinogen. One
recent study found a strong correlation between testicular cancer
and exposure to PVC in workers who make PVC products. The authors
of the study suspect that phthalates may play a role in their
Other studies suggest that phthalates or their metabolites can
interact synergistically with other common chemical
contaminants, may be slightly estrogenic (which means they
may play a role as endocrine disrupters), can affect blood
pressure and heart rate, and may cause asthma when absorbed on
The simple truth about phthalate toxicity is revealed by the
warning label on a bottle of DINP, the phthalate most commonly
found in toys. The label on a bottle of DINP sold to an
experimental laboratory says, "May cause cancer; harmful by
inhalation, in contact with skin, and if swallowed; possible risk
of irreversible effects; avoid exposure; and wear suitable
protective clothing, gloves, and eye/face protection." On
the other hand, a typical PVC teething ring or bath duck
containing about 40% by weight of DINP either has no label or
carries a label that reads "Non-Toxic."
Although no standard method exists for the investigation of
release of phthalates from toys, a group of Danish scientists
found significant migration of phthalates used in toys.
Soon after, some of Denmark's biggest retailers took
precautionary action by pulling a number of chewable PVC toys off
theit shelves. Since then, a number of retailers in Spain,
Sweden Italy, Germany, the Netherlands and Belgium have stopped
selling PVC teething toys.
No major U.S. retailers have taken similar precautionary action,
chiefly because the U.S. Consumer Product Safety Commission
(CPSC), which is responsible for toy safety regulations, has yet
to take a position.
In the mid-'80s, after the CPSC looked into
the leaching of DEHP from teethers, the toy and chemical
corporations deflected restrictions on the use of PVC by
voluntarily substituting another phthalate for DEHP.
When the EU was asked to restrict PVC toys, it called upon its
own Scientific Committee, which investigated and then issued a
report in April 1998. The report acknowledged that the EU's
assessment "did not take into account that more than one
phthalate may occur in children's toys or that there may be
additional exposures through food, air and by dermal contact to
these phthalates." Nevertheless, the EU's Scientific
Committee found that two common phthalate plasticizers used to
make flexible toys (DINP and DEHP) leached from PVC toys at
levels of concern.
Phthalates migrate into food from plastic food wraps. A recent
survey of U.S. cheeses by CONSUMER REPORTS magazine found that
phthalates and adipates (another PVC plasticizer) directly
migrate from commercial PVC and PVDC plastic wrapping into
cheeses. "In the cheeses [Consumer Reports] found:
"...very heavy migration (50 to 160 parts per million) of the
adipate plasticizer DEHA into cheeses in deli cling wrap. People
who ate several ounces of this cheese every day could get doses
nearly as high as those linked to a host of health problems in
"...moderate migration (1 to 4 parts per million) of the most
common phthalate, DEHP, into some of the shrink-wrapped cheeses
and into two waxed cheeses with clear plastic overwrap."
The June CONSUMER REPORTS says, "It's impossible to say whether a
tiny serving of plasticizers is risky. If you want to play it
safe, buy one of the wraps we found to be free of suspect
plasticizers, or buy any polyethylene wrap." A sensible
recommendation that would help reduce exposure.
The toy and PVC industries point to the use of PVC in medical
devices to suggest that its use in toys and food wraps is safe.
Yet phthalates DO leach from medical products, often resulting in
high exposures to particularly vulnerable individuals, including
people with suppressed immune systems, pregnant women, and
children. Estimates of exposure levels indicate that
hemophiliacs may be exposed to 1 to 2 milligrams per day (mg/day)
and dialysis patients may receive doses as high as 40 mg/day. In
one study, seven out of twelve samples of lung tissue, taken at
autopsy from patients who had received transfusions of stored
blood, contained DEHP at concentrations of 13.4 to 91.5
milligrams per kilogram (mg/kg) (dry weight).
Preliminary evidence has linked illnesses to high levels of
exposure to phthalates from medical devices. For instance,
unusual lung disorders were observed in pre-term infants
artificially ventilated with PVC respiratory tubes. Infants
in neonatal intensive care units are regularly exposed to DEHP
following blood transfusions or respiratory oxygenation. As the
authors of one study put it, "whether such exposure leads to
increased morbidity is not known, although elevated levels of
DEHP have been associated with necrotizing enterocolitis and
cholestasis. There is no appropriate risk assessment for neonatal
infants who are exposed to this compound."
While high levels of phthalates appear to be leaching from
products such as medical devices, toys and packaging (products
coming directly in contact with humans or food), these are just a
small part of the widespread dispersion of phthalates into the
environment. The Swedish EPA estimates that "the greatest spread
of phthalates should occur from the outside use of coated fabric
and coated plating, and from (automobile) underseal compound. As
an estimate, these products are responsible for 90% of phthalate
emissions..." Other studies have shown that plasticizers are
extracted from PVC flooring when it is washed and from textiles
imprinted with PVC. Phthalates are also found in leachate
from landfills (released from buried PVC).
Only a total phase-out of flexible PVC products can address the
global spread of phthalates. Such a large-scale phase-out is
feasible because alternatives exist for nearly every use of
PVC. In most cases, the alternatives are cost-effective.
For instance, PVC-free intravenous solution bags are cheaper than
The plastics industry is also developing a new
generation of high-performance polyolefins (chlorine-free
plastics such as polypropylene and polyethylene) which industry
analysts contend will soon be cost competitive with PVC in
applications "where the plasticizer cost has a significant impact
on total end use cost" (for example, flexible PVC with phthalate
additives). None of these other plastics requires PVC's
extensive use of toxic additives.
Since PVC products are common, the immediate goal should be to
change the composition of products that people (especially
children) contact directly. Thus, banning PVC teething rings
would set an important precautionary precedent. In May the
government of Sweden proposed a ban on the use of phthalates in
all toys for children under age 3.
As cable traffic between the Department of Commerce and the U.S.
EU delegation reveals, the U.S. has pressured the EU to not take
any action until studies by the Consumer Product Safety
Commission are completed. A draft of the CPSC's report (which
relies almost exclusively on data provided by phthalate
manufacturers) concludes that DINP can be regarded as toxic under
the Federal Hazardous Substances Act but additional information
is needed on the release of DINP from children's products before
the CPSC could recommend action.
Thus, although there is no standard testing procedure to measure
phthalates released when children suck or chew on PVC toys, and
though countries such as Denmark, and the EU's Scientific
Committee, have concluded that phthalates leach from toys at
levels of concern, more data are needed before the CPSC will make
up its mind.
Meanwhile, the nation's children are being used as guinea pigs.
Sources of Research:
 James Gerstenzang, "U.S. Urges European Union to Avert Toy
Restrictions," LOS ANGELES TIMES, May 28, 1998, p. A1.
 T.J. Wams, "Diethylhexylphthalate as an Environmental
Contaminant--A Review," SCIENCE OF THE TOTAL ENVIRONMENT Vol. 66
(October 1987), pgs. 1-16.
 Cadogan, D.F. and others, AN ASSESSMENT OF THE RELEASE,
OCCURRENCE AND POSSIBLE EFFECTS OF PLASTICIZERS IN THE
ENVIRONMENT (Brussels, Belgium: European Council for Plasticisers
and Intermediates, 1993).
 Agency for Toxic Substances and Disease Registry,
TOXICOLOGICAL PROFILE FOR DI (2-ETHYLHEXYL) PHTHALATE [TP-92/05]
(Atlanta, Ga.: Agency for Toxic Substances and Disease Registry,
 Lennart Hardell and others, "Occupational exposure to
polyvinyl chloride as a risk factor for testicular cancer
evaluated in a case-control study," INTERNATIONAL JOURNAL OF
CANCER Vol. 73 (1997), pgs. 828-830.
 M.G. Narotsky and others, "Nonadditive Developmental Toxicity
in Mixtures of Trichloroethylene, Di(2-ethylhexyl) Phthalate
[sic], and Heptachlor in a 5 X 5 X 5 Design," FUNDAMENTAL AND
APPLIED TOXICOLOGY Vol. 27 (1995), pgs. 203-216.
 Catherine A. Harris and others, "The Estrogenic Activity of
Phthalate Esters IN VITRO," ENVIRONMENTAL HEALTH PERSPECTIVES
Vol. 105, No. 8 (August 1997), pgs. 802-811. And see Susan
Jobling and others, "A Variety of Environmentally Persistent
Chemicals, Including Some Phthalate Plasticizers, Are weakly
Estrogenic," ENVIRONMENTAL HEALTH PERSPECTIVES Vol. 103, No. 6
(June 1995), pgs. 582-587.
 Gail Rock and others, "Hypotension and cardiac arrest in rats
after infusion of mono(2-ethylhexyl)phthalate (MEHP), a
contaminant of stored blood," NEW ENGLAND JOURNAL OF MEDICINE
Vol. 316 (May 7, 1987), pgs. 1218-1219.
 Leif Oie and others, "Residential Exposure to Plasticizers
and Its Possible Role in the Pathogenesis of Asthma,"
ENVIRONMENTAL HEALTH PERSPECTIVES Vol. 105, No. 9 (September
1997), pgs. 972-978.
 Matthew Wald, "Lead Content is Found High in Plastic Items,"
NEW YORK TIMES, October 10, 1997, pg. unknown. And see Joe Di
Gangi, LEAD AND CADMIUM IN VINYL CHILDREN'S PRODUCTS (Washington,
D.C.: Greenpeace, 1997).
 K. Vinkelsoe and others, "Migration of Phthalates from
Teethering [sic] Rings," Department for Environmental Chemistry,
Danmarks Miljoundersogelser, Frederiksborgvej 399, 4000 Roskilde,
Denmark. Telephone +45 4630 1200; fax: +45 4630 1114. April 15,
 PHTHALATES IN TOYS, OPINION OF THE EU SCIENTIFIC COMMITTEE
ON TOXICITY, ECOTOXICITY AND THE ENVIRONMENT (Brussels, Belgium:
European Union, April 24, 1998).
 "Hormone Mimics: They're in our food; should we worry?"
CONSUMER REPORTS, June, 1998, pg. 52-55. See also, J.H. Petersen
and others, "PVC cling film in contact with cheese: health
aspects related to global migration and specific migration of
DEHA," FOOD ADDITIVES AND CONTAMINANTS Vol. 12, No. 2 (March
1995), pgs. 245-253.
 Charlotte Nilsson, editor, PHTHALIC ACID ESTERS USED AS
PLASTIC ADDITIVES, VOLUME 2: COMPARISON OF TOXICOLOGICAL EFFECTS
[No. 12/94] (Solna, Sweden: Swedish National Chemicals
 B. Roth and others, "Di-(2-ethylhexyl)-pththalate as
plasticizer in PVC respiratory tubing systems: indications of
hazardous effects on pulmonary function in mechanically
ventilated, preterm infants," EUROPEAN JOURNAL OF PEDIATRICS Vol.
147 (1988), pgs. 41-46.
 S.L. Plonait and others, "Exposure of newborn infants to
di-(2-ethylhexyl)-phthalate and 2-ethylhexanoic acid following
exchange transfusion with polyvinylchloride catheters,"
TRANSFUSION Vol. 33, No. 7 (1993), pgs. 598-605.
 Swedish National Chemicals Inspectorate, ADDITIVES IN PVC;
MARKING OF PVC; REPORT ON COMPLETION OF A GOVERNMENT TASK (Solna,
Sweden: Swedish National Chemicals Inspectorate, June 28, 1996
 J. Vikelsoe and E. Johansen, "Phthalates emitted when
washing floors and textiles containing PVC." Place of
publication and publisher unknown. Cited in Swedish National
Chemicals Inspectorate, ADDITIVES IN PVC; MARKING OF PVC; REPORT
ON COMPLETION OF A GOVERNMENT TASK (Solna, Sweden: Swedish
National Chemicals Inspectorate, June 28, 1996.
 Danish Technological Institut [sic], ENVIRONMENTAL ASPECTS
OF PVC (Copenhagen, Denmark: Danish Technological Institut,
November 1995), pg. 91.
 See, for example, Danish Technical Institute, PVC AND
ALTERNATIVE MATERIALS [Ministry of the Environment Report
18/1993] (Copenhagen: Ministry of the Environment, Danish
Environmental Protection Agency [Strandgade 29, DK-1401
Copenhagen, Denmark], 1993.
 Conversation with Dan Rice, Midwest Sales Representative,
McGaw, Inc., April 1997. Telephone: (800) 345-7744 ext. 4230 or
 Robert B. Wilson, SRI International, "The Impact of
Metallocenes on PVC," unpublished paper presented at the World
Vinyl Forum, September 1997. SRI International, 333 Ravenswood
Avenue, Menlo Park, CA 94025. Telephone (650) 326-6200.
 Memorandum from Michael A. Babich, Ph.D., Chemist, Division
of Health Sciences, U.S. Consumer Product Safety Commission, to
Ronald L. Medford, Assistant Executive Director for Hazard
Identification and Reduction, March 10 1998.
Descriptor terms: pvc; polyvinyl chloride; vinyl; plastics;
carcinogens; di(2-ethylhexyl)phthalate; dehp; adipate;
plasticizers; deha; food safety; consumer product safety
commission; cpsc; toys; children; blood; phthalates; european
union; eu; hazardous substances act; testicular cancer;
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