CPSC Releases Study on Phthalates in Teethers, Rattles and Other Children's Products

December 2, 1998
Release Number:

The U.S. Consumer Product Safety Commission (CPSC) today released the results of a study of a chemical, diisononyl phthalate (DINP) used to soften some plastic toys and children's products. The study concludes that few if any children are at risk from the chemical because the amount that they ingest does not reach a level that would be harmful. Generally, the amount ingested does not even come close to a harmful level. Therefore, the Commission staff is not recommending a ban on these products.

This study is the most comprehensive evaluation of phthalates in children's products conducted to date. However, the study identified several areas of uncertainty where additional scientific research is needed. As a precaution while more scientific work is done, the CPSC staff requested industry to remove phthalates from soft rattles and teethers. About 90 percent of manufacturers have indicated that they have or will remove phthalates from soft rattles and teethers by early 1999. In addition, until reformulated products are available, major retailers have removed teethers and rattles containing phthalates from store shelves. CPSC staff also has asked the industry to find a substitute for phthalates in other products intended for children under 3 years old that are likely to be mouthed or chewed.

Pacifiers and feeding bottle nipples are made of latex or silicone and do not contain phthalates. However, one pacifier and two models of feeding bottle nipples manufactured by the Gerber Products Company contained a related phthalate. The Gerber pacifier and nipples that contained phthalates are the Clear and Soft lines sold through 1998. Gerber has stopped making these products and is removing phthalates from all future production. Gerber has directed retailers to remove the phthalate-containing pacifier and nipples from store shelves. If you have one of the Gerber Clear and Soft pacifiers or nipples, dispose of them. No other Gerber pacifiers or nipples are involved since they do not contain phthalates.

Existing studies in laboratory animals indicate that in high doses, DINP damages the liver, kidneys and other organs in mice and rats. Other studies indicate that high doses may cause liver tumors in mice and rats. However, scientists do not agree about whether the cancer risk translates to humans. Up to now, there has been no comprehensive study of how much phthalate can leach out of children's products. The potential for toxic effects in humans depends on the amount of the chemical that comes out of the products when they are mouthed or chewed and the amount of time a child spends each day putting these products in his or her mouth. Even though DINP may be present in a plastic toy or children's product, it must come out in significant amounts to pose a hazard. CPSC's study found that the amount of DINP in a product does not relate to the amount that leaches out.

The CPSC established a level used internationally as an acceptable daily intake level for DINP. For a measure of safety, this level is 100 times less than the amount found not to cause any adverse health effects in laboratory animals. CPSC scientists tested 31 different children's products that contained DINP and found that the amount that is released from the product when mouthed can vary widely, but is generally well below the level that could cause harmful effects. The CPSC used human adult volunteers to help determine how much of the chemical is released when the plastic is chewed or sucked. Using this data and estimating the amount of time children spend mouthing products that may contain DINP, allowed CPSC to estimate the risk to children. Based on this work, the CPSC study concludes that few if any children are at risk from DINP.

CPSC data show that children under the age of one year old are the most likely to mouth or chew soft plastic teethers, rattles or toys. As a precaution, parents of young children who mouth these products for long periods of time may wish to dispose of them.

The CPSC staff is taking the following steps:

  1. Recommending that a Chronic Hazard Advisory Panel made up of independent scientists be formed to carry out an additional scientific assessment of potential risk, including whether phthalates pose a cancer risk to humans.
  2. Undertaking further study to determine the amount of time that children mouth products that could contain phthalates.
  3. Continuing testing to determine the amount of phthalates released from children's products.

The following manufacturers have stopped or will stop using phthalates in teethers and rattles by early 1999:

Chicco
Little Tikes
Disney
Mattel (Fisher-Price ARCOTOYS, Tyco Preschool)
Evenflo
Safety 1st
The First Years
Sassy
Gerber
Shelcore Toys
Hasbro (incl. Playskool)

The following retailers have removed phthalate-containing teethers, rattles, pacifiers, and bottle nipples from store shelves:

Toys-R-Us
Walmart
Sears
Target
K-Mart
ShopKo Stores, Inc.
Warner Brothers Studio Stores

This study is the most comprehensive evaluation of phthalates in children's products conducted to date. However, the study identified several areas of uncertainty where additional scientific research is needed. As a precaution while more scientific work is done, the CPSC staff requested industry to remove phthalates from soft rattles and teethers. About 90 percent of manufacturers have indicated that they have or will remove phthalates from soft rattles and teethers by early 1999. In addition, until reformulated products are available, major retailers have removed teethers and rattles containing phthalates from store shelves. CPSC staff also has asked the industry to find a substitute for phthalates in other products intended for children under 3 years old that are likely to be mouthed or chewed.

Pacifiers and feeding bottle nipples are made of latex or silicone and do not contain phthalates. However, one pacifier and two models of feeding bottle nipples manufactured by the Gerber Products Company contained a related phthalate. The Gerber pacifier and nipples that contained phthalates are the Clear and Soft lines sold through 1998. Gerber has stopped making these products and is removing phthalates from all future production. Gerber has directed retailers to remove the phthalate-containing pacifier and nipples from store shelves. If you have one of the Gerber Clear and Soft pacifiers or nipples, dispose of them. No other Gerber pacifiers or nipples are involved since they do not contain phthalates.

Existing studies in laboratory animals indicate that in high doses, DINP damages the liver, kidneys and other organs in mice and rats. Other studies indicate that high doses may cause liver tumors in mice and rats. However, scientists do not agree about whether the cancer risk translates to humans. Up to now, there has been no comprehensive study of how much phthalate can leach out of children's products. The potential for toxic effects in humans depends on the amount of the chemical that comes out of the products when they are mouthed or chewed and the amount of time a child spends each day putting these products in his or her mouth. Even though DINP may be present in a plastic toy or children's product, it must come out in significant amounts to pose a hazard. CPSC's study found that the amount of DINP in a product does not relate to the amount that leaches out.

The CPSC established a level used internationally as an acceptable daily intake level for DINP. For a measure of safety, this level is 100 times less than the amount found not to cause any adverse health effects in laboratory animals. CPSC scientists tested 31 different children's products that contained DINP and found that the amount that is released from the product when mouthed can vary widely, but is generally well below the level that could cause harmful effects. The CPSC used human adult volunteers to help determine how much of the chemical is released when the plastic is chewed or sucked. Using this data and estimating the amount of time children spend mouthing products that may contain DINP, allowed CPSC to estimate the risk to children. Based on this work, the CPSC study concludes that few if any children are at risk from DINP.

CPSC data show that children under the age of one year old are the most likely to mouth or chew soft plastic teethers, rattles or toys. As a precaution, parents of young children who mouth these products for long periods of time may wish to dispose of them.

The CPSC staff is taking the following steps:

  1. Recommending that a Chronic Hazard Advisory Panel made up of independent scientists be formed to carry out an additional scientific assessment of potential risk, including whether phthalates pose a cancer risk to humans.
  2. Undertaking further study to determine the amount of time that children mouth products that could contain phthalates.
  3. Continuing testing to determine the amount of phthalates released from children's products.

The following manufacturers have stopped or will stop using phthalates in teethers and rattles by early 1999:

Chicco
Little Tikes
Disney
Mattel (Fisher-Price ARCOTOYS, Tyco Preschool)
Evenflo
Safety 1st
The First Years
Sassy
Gerber
Shelcore Toys
Hasbro (incl. Playskool)

The following retailers have removed phthalate-containing teethers, rattles, pacifiers, and bottle nipples from store shelves:

Toys-R-Us
Walmart
Sears
Target
K-Mart
ShopKo Stores, Inc.
Warner Brothers Studio Stores