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New York Times
November 13, 1998

Chemical Element of Vinyl Toys Causes Liver Damage in Lab Rats

WASHINGTON -- A chemical ingredient of vinyl, used by the toy industry since the early 1980s because an earlier compound caused liver damage in laboratory rats, caused essentially the same problems in rats in tests done in the mid-'90s, a manufacturer of the chemicals acknowledged.

With the environmental organization Greenpeace planning to release a report Friday calling for banning the chemicals in toys, the manufacturer, Aristech Chemical Corp. of Pittsburgh, said the problem was not relevant to humans. Aristech said the new material, a "plasticizer" used to make vinyl soft, causes the same liver damage, but said that in the 15 years since the first substance was eliminated, scientists have learned that the process that causes the liver damage occurs in mice and rats, but not humans. Greenpeace, in its report, plans to say Aristech, a subsidiary of Mitsubishi Corp., knew that the new material was as bad as the old but kept using it. Greenpeace has been on an international campaign against the use of vinyl in toys for more than a year, and has been instrumental in persuading several European countries to consider banning it.

Both substances in question are forms of a class of chemicals called phthalates, (pronounced THAY-lates), which bond with vinyl molecules and make the product flexible. In 1985 a scientific panel reported to the Consumer Product Safety Commission that a type of phthalates called di (2-ethylhexyl) phthalate, or DEHP, caused cancer in animals and might do so in humans. The commission did not ban DEHP but made an agreement with the toy companies that they would switch to diisononyl phthalate, known as DINP, for products like pacifiers and rattles that children might chew on.

Greenpeace tested a variety of toys, including First Years teethers and Hasbro Teletubbies, and found DINP. But Aristech, which conducted some studies of the new material that showed problems in rats, said these were not relevant. It said it had informed the government of the studies' results over the years and had made no secret of the findings in the scientific community.

James Santory, a division manager with the company, said that DEHP was replaced in the early 1980s as a precaution, "not because we thought it was a hazard, but because we didn't know the science." And, he said, the company expected that the replacement substance, DINP, would cause tumors in rats, and it did.

But "the mechanism that causes cancer is not relevant to humans," Santory said. He added that DINP and DEHP are peroxisome proliferators, meaning that they stimulate production of an enzyme that damages the liver, but that this does not happen in higher animals, including guinea pigs, monkeys and humans.

Asked if DINP should be replaced, he said, "unless the science was advanced, the decision would seem to be the same, but we believe the science has advanced. We're talking about a 15-year period of time."

The Consumer Product Safety Commission is still considering the issue, but a preliminary report on the subject said "it is not clear whether peroxisome proliferation is required"to cause cancer.

The issue of vinyl in toys is complicated for several reasons, among them that there is no standard way to etermine how much material in the vinyl a child can realistically be expected to absorb. The standard technique is to give increasing doses to different groups of rats, identify the largest dosage level that does not appear to cause problems, divide that by 100 and set it as the maximum allowable level.

But at Greenpeace, Joe Di Gangi, a biochemist, said, "This one-hundredth is a made-up number, it's a standard they've invented."

Di Gangi said substances that caused cancer in laboratory animals should not be allowed in items that children could chew. He also said DINP had been shown to cause a variety of health problems in rats beyond liver damage that could also be relevant to children.

Some manufacturers have recently decided to stop using vinyl. Santory said this was not because of safety, but for companies making toys, "you don't want to be on the front page of this particular issue."


FRIDAY, NOVEMBER 13, 1998

Greenpeace alerts coalition members: Did Toy Makers and a Government Agency
Hide Evidence of a Cancer-Causing Ingredient in Toys?

HIGH LEVELS OF TOXIC CHEMICAL FOUND IN POPULAR VINYL TOYS

Washington, DC --- Greenpeace today released new test results by an independent lab which found high levels of a toxic chemical in toys and other children's products made of soft vinyl (PVC). The toys containing these chemicals are popular name brand products purchased at mainstream stores such as Toys R Us.

The products include such widely sold items as:

Hasbro's Teletubbies
Baby bottle nipples by Gerber
Teethers by First Years and Gerber
A Disney bib by Disney Babies/Evenflo
A Sesame Street bib by Playskool/Hasbro
Since July, bans of these chemicals in toys have been initiated in Austria, Sweden, Denmark and Norway. In addition, several companies have announced plans to end the use of these chemicals in their products. However, only Lego and Nike have pledged a comprehensive phase-out of vinyl in all of their products.

Vinyl requires more additives than any other plastic because softeners are needed to make it flexible. The vinyl toys tested contained up to by weight of one toxic additive. These additives or plasticizers can migrate from vinyl products during use - meaning they leach into the mouths of children when they are chewed or sucked.

"When children suck and chew on soft vinyl toys, it is similar to squeezing a sponge. Water comes out of a sponge, just as these toxic softeners can leach out of a toy," said Joe Di Gangi, Greenpeace scientist and author of the report. "The toy industry is unnecessarily putting young children at risk during one of the most vulnerable periods of their development. Safer non-vinyl, PVC-free products are widely available today."

The plasticizer (DINP) found in the vinyl tested toys has been shown to be toxic when ingested by animals with health effects ranging from liver and kidney damage to reproductive abnormalities and possibly cancer. A recent study also indicates that DINP has the capacity to weakly mimic the hormone estrogen.

In 1986, the Consumer Product Safety Commission (CPSC) and the U.S. toy industry agreed to virtually eliminate the presence of a similar plasticizer in children's vinyl products. Since then DINP has been used as a substitute without full health testing. Today a growing number of reports by industry and government on the toxicity of DINP have spurred demands for safe alternatives to vinyl.

Joseph Di Gangi
Greenpeace
417 S. Dearborn
Suite 420
Chicago IL 60605
(312) 554-1029 phone
(312) 554-1224 fax
Joe.Di.Gangi@dialb.greenpeace.org



Nancy Chuda, Executive Director
Children's Health Environmental Coalition (CHEC)
PO Box 846, Malibu, CA 90265
ph: 310-589-2233, fax: 310-589-5856
www.checnet.org

Contact: Rick Hind/Greenpeace (202) 319-2445
Joe Di Gangi/Greenpeace (312) 554-1029
For more information: www.Greenpeaceusa.org (video, stills and slides available)

Summary

Chemical industry data indicates that DINP, a major ingredient in soft vinyl toys, is carcinogenic. Though the data was partially published in 1996 and 1997, the Consumer Product Safety Commission (CPSC) did not include it in their March 10, 1998 assessment of DINP which concluded that DINP was not a carcinogen. DINP came into wide use in 1986 as a substitute for DEHP after government agencies found that DEHP was carcinogenic. Instead of recalling toys, the CPSC entered into a voluntary agreement with the Toy Manufacturers of America (TMA) to remove DEHP from new vinyl toys. Despite having evidence that these compounds are released from vinyl into saliva, the CSPC allowed MA companies to substitute DINP for DEHP without testing it first for safety. Citing data from the Environmental Protection Agency (EPA), the CPSC admitted in their March 1998 assessment that "One type of DINP that was never commercialized was toxic at 5-fold doses than other types of DINP and also was carcinogenic. It is conceivable that one or more existing types of DINP for which data are unavailable could also be more toxic and/or carcinogenic."

Industry data shows that DINP is carcinogenic

Studies conducted in 1996 and 1997 by DINP manufacturer Aristech Chemical Corp. revealed that DINP caused increased incidence of liver carcinoma, liver adenoma, transitional cell carcinoma in the kidneys, and mononuclear cell leukemia in rats and mice. In addition, the study demonstrated that DINP caused reduction of testes weights and reduced white blood cell counts. In 1986, a study by the EPA indicated that one isomer (chemical variant) of DINP-4 also increased the incidence of liver carcinoma in rats. The CPSC claimed the isomer was never commercialized but admitted that "It is conceivable that one or more existing types of DINP for which data are unavailable could also be more toxic and/or carcinogenic." Neither Aristech study was included in the CPSC assessment of DINP's carcinogenicity.

DINP is used to soften vinyl

DINP is a member of a family of compounds called phthalates (THAY-lates) which are used to soften vinyl (DINP is diisononyl phthalate). Since vinyl is a hard, brittle plastic, chemical softeners like phthalates are required to make it pliable. DINP and other phthalates are not chemically attached to the plastic and CPSC studies show that phthalates are easily released from vinyl toys into saliva. , The toy industry and phthalate manufacturers admit that vinyl leaches phthalates. ,

DINP is widely present in children's products

A 1998 Greenpeace investigation revealed the presence of DINP in popular vinyl children's products. The products were purchased in September from national chain stores and included items designed for infants and toddlers such as First Years teethers, Gerber nipples, a Hasbro Teletubbies doll, and a Sesame St. bib. Table 1 shows the latest Greenpeace test results on an assortment of popular vinyl children's toys in the US. The vinyl products contained from 3-40% DINP by weight. Recently, NBC in Chicago (WMAQ) also found DINP in a variety of popular vinyl teethers and toys. A 1997 Greenpeace study of vinyl toys from 17 countries found that most of them contained 10-40% DINP by weight.

Exposure to DINP is harmful

DINP is not acutely toxic. However, animal studies indicate that longer exposures to DINP damage the liver and kidneys and affect reproductive organs. , , , In addition, DINP weakly mimics estrogen in human cell lines indicating possible endocrine disruption. The reproductive and developmental toxicity of DINP has not been well-characterized. The CPSC used data from DINP manufacturers (including Exxon and BASF) to conclude that DINP was not a reproductive toxicant. As stated above, the agency also claimed that a carcinogenic isomer of DINP was never commercialized. Overall, the CPSC concluded in its preliminary assessment of DINP that "DINP may be regarded as `toxic' under the FHSA (Federal Hazardous Substances Act), based on sufficient evidence of liver and kidney toxicity in animals."

Scientists are warned about contact with DINP

Manufacturers warn laboratory scientists about DINP as follows: "harmful by inhalation, in contact with skin and if swallowed", "possible risk of irreversible effects", and "may cause cancer". In contrast toy makers label vinyl children's toys containing large amounts of DINP as "non-toxic".

DINP replaced DEHP in vinyl children's products

DEHP is another member of the phthalate family that was widely used in toys until government agencies found in the early eighties that it was carcinogenic (DEHP is di(2-ethylhexyl) phthalate). Instead of recalling vinyl toys, the Consumer Product Safety Commission (CPSC) quietly entered into a voluntary agreement with the toy industry to limit DEHP content in new vinyl toys to 3% (3 parts-per-100). This level of DEHP was not shown to be safe. The EPA regulates DEHP in drinking water at a level of 6 parts-per-billion (ppb), similar to the 5 ppb level for the carcinogen benzene. The CPSC-TMA agreement caused toy makers to shift from DEHP to DINP as the chemical softener in vinyl toys. However, DINP was not tested by the CPSC for safety despite EPA data which indicated that at least one isomer of DINP was carcinogenic. Later the agency revealed that there are up to 100 isomers or chemical variations of DINP and that only five had been studied for any toxic effects. The agency stated in its 1998 report that "The sources and composition of the DINP in children's products, especially imports, are unknown." The CPSC permitted the substitution of DINP despite uncertainty about the effects of untested isomers and the indication that at least one isomer was carcinogenic. The industry and the CPSC have not informed the public of their findings.

DINP and DEHP are both carcinogenic

The carcinogenicity of DINP resembles the carcinogenicity of DEHP. Figures 1 and 2 compare the data only for liver carcinoma in theAristech study (DINP) and a 1982 study of DEHP by the National Toxicology Program (NTP) . The Figures show that both phthalates are similarly carcinogenic in both rats and mice. DINP also caused other types of cancer that were not observed in the NTP study of DEHP. These included: increased incidence of liver adenoma in male and female mice, increased incidence of transitional cell carcinoma in the kidneys of male rats, and increased incidence of mononuclear cell leukemia in male and female rats.

Action by foreign governments

Four European countries are planning or have already implemented bans on DINP and/or vinyl toys (Sweden, Denmark, Austria, and Norway). The CPSC has not "regulated" phthalates in children's products since the 1986 agreement with the toy industry.

Vinyl should be regulated as a material

The current regulatory system has not protected children. Each toxic chemical added to vinyl is "innocent until proven guilty". A materials policy would declare vinyl an inappropriate material for children's products since it requires so many toxic additives to make it useful. This policy would have prevented the switch from DEHP to DINP and would prevent the substitution of another potentially toxic softener to replace DINP. A materials-based regulatory policy would be proactive instead of reactive, precautionary instead of reckless, and efficient instead of disorganized. The wide availability of safer, alternative materials makes eliminating vinyl children's products a realistic goal and an ethical obligation.

Recommendations

  1. Parents should not purchase vinyl or PVC products to which children might be exposed. Vinyl children's products should be returned to the manufacturer or retailer.
  2. Retailers, distrubutors, and manufacturers should remove vinyl children's products from the market.
  3. The Consumer Product Safety Commission should regulate vinyl as a material. Vinyl children's products containing phthalates, lead, cadmium, or other untested or toxic additives should be recalled by the agency.
  4. Retailers and trademark licensers should not market vinyl products to which children might be exposed. This should be made explicit in future sales and licensing agreements.
  5. The plastics industry and toy manufacturers, through trade associations such as the Society of Plastics Industry and the Toy Manufacturers of America, should adopt an industry-wide standard against manufacturing children's products with vinyl.



Joseph Di Gangi

Greenpeace
417 S. Dearborn
Suite 420
Chicago IL 60605
(312) 554-1029 phone
(312) 554-1224 fax
Joe.Di.Gangi@dialb.greenpeace.org



Nancy Chuda, Executive Director
Children's Health Environmental Coalition (CHEC)
PO Box 846, Malibu, CA 90265
ph: 310-589-2233, fax: 310-589-5856
www.checnet.org

CHEC is for Children and Other Living Things
By putting our children's environmental health first, we protect our future.