Scientific Report Supports Continued Use of Phthalates In Children's Products

NEW YORK, N.Y. - A recently published scientific article in the peer-reviewed journal, Regulatory Toxicology and Pharmacology 30:140-155 (1999), concluded that a plasticizer [diisononyl phthalate (DINP)] widely used to impart softness and flexibility to vinyl-plastics in children's toys is "essentially without risk."

In fact, according to this report, the youngest children (3- to 12-month-old infants) are exposed to levels of DINP 11-42 times below the acceptable daily intake (ADI). This means that exposure levels of DINP were from 1100- to 4200-fold lower than the no-observed-adverse-effect level (NOAEL) in test animals. These risk assessment conclusions result in ample margins of safety for children who may be exposed to DINP.

The article, "The Potential Health Effects of Phthalate Esters in Children's Toys: A Review and Risk Assessment," evaluated the potential risks of DINP, one of several phthalate esters incorporated into normally rigid plastic products. This substance, which has come under scrutiny by Greenpeace, several European Union countries, the U.S. Consumer Product Safety Commission (CPSC), and Health Canada, is re-assessed by the authors of this article using the latest toxicology and exposure data available.

Co-authors Chris F. Wilkinson, Ph.D., and James C. Lamb, Ph.D., DABT, concluded "with a high degree of confidence that the use of DINP in soft PVC toys and other children's products does not present a significant risk to children." They conducted a comprehensive review of the data, using the exposure criteria developed by the CPSC and the most current toxicological studies. Drs. Wilkinson and Lamb found that earlier evaluations of children's risk were flawed by overly conservative estimates of hazard and exposure, which had raised unfounded concerns in both the regulatory community and with consumers. For example, these scientists noted that:

• Greenpeace's initial allegations regarding the potential health hazards posed by phthalate esters in toys and other children's products were based on highly exaggerated estimates of exposure to DINP; and
  
  
• The ADIs for DINP used by Health Canada and the CPSC were overly conservative and did not reflect the results of the latest toxicology studies.

According to the authors of this report, "when appropriate ADI values and more realistic estimates of exposure are employed, the exposure values for children exposed to DINP through mouthing of soft products is acceptable."

Moreover, the CPSC's final conclusion, which was overly conservative as noted above, still found that "few, if any, children are at risk from the chemical [DINP] because the amount they ingest does not reach a level that would be harmful." The results of the report by Drs. Wilkinson and Lamb also are consistent with the findings of a Blue Ribbon Panel convened by former Surgeon General C. Everett Koop. This panel of 17 scientists agreed that a child would have to suck on a plastic toy for a decade before reaching even the so-called "no effect level."

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Toy Manufacturers of America, Inc. (TMA®) is the Manhattan-based national trade association for producers and importers of toys, games and children's entertainment products.