Press release Phthalate Ester Panel

PHIL

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PRESS RELEASE PHTHALATE ESTER PANEL

Answer of the CMA Phthalate Ester Panel to the Greenpeace (USA) allegations.

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PRNewswire
13-NOV-98

WASHINGTON, Nov. 13 /PRNewswire/-- The following statement was issued today by Chemical Manufacturers Association Phthalate Esters Panel: Greenpeace has issued a press release and report that purport to show that the phthalate ester principally used in children's toys (DINP) poses human health hazards. Greenpeace is wrong. The following explains why.

  1. Exposure is minimal. Greenpeace compares chewing on a toy to squeezing a sponge, and seeks to imply that the phthalate ester comes out of the toy just like water comes out of a sponge. In fact, the amount that comes out of the toy is extremely small. The amounts that come out are measured in micrograms. A microgram is one millionth of a gram, and a gram is less than one-tenth of an ounce.
  2. There is no human cancer hazard. Greenpeace suggests that DINP in toys poses a cancer hazard. DINP has been shown to cause liver tumors in rats and mice that are fed very high doses every day for their lifetimes. This finding was not a surprise. DINP is what is known as a "peroxisome proliferator," meaning that it causes a component in the liver cells of mice and rats to multiply. If the rats or mice are exposed to large amounts of a peroxisome proliferator for a long period, the liver cell changes eventually lead to tumor formation. Peroxisome proliferators do not act in humans the same way as in rodents. This has been demonstrated numerous times using primates as a model for humans and using human cells in culture. The potential for peroxisome proliferators (including many FDA-approved drugs) to cause cancer in humans was considered at a 1995 international symposium that included approximately 100 scientists from government agencies, academia and industry, including leading researchers in the field from the United States and Europe. Those scientists concluded "that it is unlikely that peroxisome proliferators are carcinogenic to humans under anticipated conditions and levels of exposure."(a) Numerous other articles in the peer-reviewed scientific literature support the view that peroxisome proliferators such as the phthalate esters are not human carcinogens at any likely level of exposure.(b)
  3. There is no developmental or reproductive hazard. Greenpeace implies that DINP poses a hazard to the reproductive organs. This view is not supported by the scientific evidence. In fact, the U.S. Consumer Product Safety Commission (CPSC) preliminary report on DINP concluded that commercially-available DINP "is not a developmental or reproductive toxin." (c) Additionally, RIVM, the Dutch governmental science institute, has concluded that "there is no proof of any effect of the phthalates di-isononylphthalate (DINP) and di-isodecylphthalate (DIDP) on reproduction and on male fertility in particular."(d)
  4. Recent studies show that DINP does not mimic estrogen. Greenpeace cites a 1997 paper to imply a possible hazard based on the potential for DINP to mimic the hormone estrogen.(e) That paper reported the results from a "test tube" study, in which DINP "showed extremely weak estrogenic activity" (DINP was more than 1 million times less potent than human estrogen).(f) DINP has not shown estrogenic activity in other "test tube" studies. In addition, such "test tube" experiments are used as screening tools-- the more critical studies for endocrine effects are conducted in live animals. In such live animal tests, which have recently been conducted, DINP does not show estrogenic activity.(g)
  5. There is no reason to believe that DINP in toys poses other health hazards. A report recently prepared by a Dutch Consensus Group (DCG) recently examined this issue.(h) The DCG report evaluated the potential for young children to be exposed to DINP in excess of an acceptable daily intake (ADI) level. The value the DCG used for the ADI was 0.1 milligrams per kilogram body weight per day (mg/kg/day). The report stated that for children between 12 and 36 months of age, no exceedance of the ADI would occur.(i) For children under 12 months, the report stated, "In 99% of the cases the exposure would remain below 0.1 mg/kg/day. In 95% of the cases the exposure would remain under 0.04 mg/kg/day."(j) Although the report found a statistical possibility that the exposure for a child under 12 months might exceed the ADI, it stated that that possibility is "so rare that the statistical likelihood cannot be estimated on the basis of the current data."(k) Moreover, the ADI used by DCG was based on studies conducted in 1986 which showed no effects in rats at 17 mg/kg/day. More recent studies using additional dose levels have now established that the ADI should be considerably higher. Specifically, these studies show that no adverse effects are seen in rats and mice at levels up to 90 mg/kg/day. Using the same safety factors applied by the DCG, these studies support an ADI of approximately 0.9 mg/kg/day-- a 9-fold increase. We are aware of no credible data that suggests that toys would produce exposures that exceed this new ADI.

Greenpeace has launched a global campaign against all uses of vinyl. Their attacks on vinyl toys appear to be part of that campaign. Last year, Greenpeace claimed that children were exposed to dangerous levels of lead and cadmium from children's toys. That claim was rejected by the U.S. Consumer Product Safety Commission (CPSC). The Phthalate Esters Panel believes the current allegations about phthalate esters are equally groundless.

The Phthalate Esters Panel is working cooperatively with the CPSC, providing them with data and research on DINP so that the safety of phthalate esters in vinyl toys can be evaluated using the best science available.

DINP has been extensively tested over a period of many years, using state- of-the-art testing procedures. Based on this research, the producers strongly believe that DINP is safe and does not pose a hazard to children's health when properly used in vinyl toys.

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References:

(a) Cattley, R.C., DeLuca, J., Elcombe, C., et al. (1998). Do Peroxisome Proliferating Compounds Pose a Hepatocarcinogenic Hazard to Humans? Reg. Toxicol. Pharmacol. 27:47-60.

(b) E.g., Ashby, J., A. Brady, C.R., Elcombe, et al. (1994). Mechanistically-based Human Hazard Assessment of Peroxisome Proliferator- Induced Hepatocarcinogenesis. Human & Exptl. Toxicol. 13:(Suppl. 2), S1-S117; Bentley, P., Calder, I., Elcombe, C., Grasso, P., Stringer, D., and Weigand, H. (1993). Hepatic Peroxisome Proliferation in Rodents and Its Significance for Humans. Chem. Toxicol. 13:857-907; Lake, B.G. (1995). Mechanisms of Hepatocarcinogenicity of Peroxisome-Proliferating Drugs and Chemicals. Ann. Rev. Pharmacol. Toxicol. 35:483-507; Williams, G.M., and Perrone, C. (1996). Mechanism-based Risk Assessment of Peroxisome Proliferating Rodent Hepatocarcinogens. Ann. N.Y. Acad. Sci. 804:554-72; Huber, W.W., B. Grasl-Kraupp, and R. Schulte-Herman (1996). Hepatocarcinogenic Potential of Di(2-ethylhexyl) Phthalate in Rodents and Its Implications on Human Risk. Crit. Rev. Toxicol. 26:365-481.

(c) CPSC, Preliminary Hazard Assessment of Diisononyl Phthalate (DINP) in Children's Products, Memorandum from M. Babich to R. Medford (Mar. 10, 1998), page 10. .

(d) RIVM, Consensus consultations on phthalate release from PVC baby toys (Press Release) (on the Internet at www.minvws.nl (click the following sequence of links: volksgezondheid; preventie en bescherming; folders & factsheets; beleid en achtergrond; consultations on phthalate release from PVC baby toys).

(e) Harris, C.A., Henttu, P., Parker, M.G., and Sumpter, J.P. (1997). The Estrogenic Activity of Phthalate Esters In Vitro. Environ. Health Persp. 105:802-811.

(f) Id.

(g) Zacharewski, T.R., Clemons, J.H., Meek, M.D., Wu, Z.F., Fielden, M.R., and Matthews, J.B. (1998). Examination of the In-vitro and In-vivo Estrogenic Activities of Eight Commercial Phthalate Esters. Toxicological Sciences (accepted for publication May 19, 1998).

(h) RIVM (Rijksinstituut voor Volsgezondheid en Milieu), Phthalate release from soft PVC baby toys: Report from the Dutch Consensus Group, RIVM report 613320 002, W.H. Konemann, ed. (September 1998).
The full test report can be downloaded from the Ministery of Public Health in The Netherlands in .pdf format.

(i) Id. at 8.

(j) Id.

(k) Id.

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