Table XIV

Extracted Elemental Impurities Reported for Miscellaneous Plastics

ElementConcentration (mg/kg unless noted)Extraction DetailsCommentsRef.
SolventConditions
Polystyrene
Al<0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 19 mg/kg21
Co<0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 0.6 mg/kg21
Cu0.0063% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 16 mg/kg21
Mg<0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 23 mg/kg21
Zn0.0043% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 67 mg/kg21
Polyethylene Terephthalate
Al0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 620 mg/kg21
0.16 mg/LpH 6.8 bufferPET bottle, 40 °C for 23 weeks, 10 mL in 75 mL bottleBottles tested223
0.16 mg/L0.1% EDTA
Ca0.24Low pH (≈3)Sealed vessel, 55 °C for 5 days, 0.25 g sample/mL solventSee footnote 512
0.07High pH (≈9)
0.14 mg/LpH 6.8 bufferPET bottle, 40 °C for 23 weeks, 10 mL in 75 mL bottleBottles tested223
Co<0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 58 mg/kg21
Ge<0.0013% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 14 mg/kg21
Mg0.0033% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 5.9 mg/kg21
Pb0.03 mg/L0.1% EDTAPET bottle, 40 °C for 23 weeks, 10 mL in 75 mL bottleBottles tested223
Sb0.0033% acetic acidSealed vessel, 40 °C for 10 days, 0.15 g sample/mL solventTotal pool = 160 mg/kg21
343 ng/LWaterPET bottles; tested samples of bottled waterMedian value of 35 products30
<0.002Water, olive oil, 3% acetic acid, ethanolPET resin, 40 °C for 10 days, 2.8 cm2/50 mL solventTotal pool of Sb = 200 mg/kg44
89–2570 ng/LWaterPET bottles with water from several sources (69 brands)Commercial products tested51
Ethylene Vinyl Acetate
Al7.5High pH (≈9)Sealed vessel, 121 °C for 1 h, 0.08 g sample/mL solventSee footnote 112
0.70Ethanol/waterSealed vessel, 55 °C for 3 days, 0.08 g sample/mL solventSee footnote 112
4 μg/LWaterFilled bag, ambient temperature, 24 hBag size = 3000 mL50
B5.2Low pH (≈3)Sealed vessel, 121 °C for 1 h, 0.08 g sample/mL solventSee footnote 112
2.3Ethanol/waterSealed vessel, 55 °C for 3 days, 0.08 g sample/mL solventSee footnote 112
Ca1.6Low pH (≈3)Sealed vessel, 121 °C for 1 h, 0.08 g sample/mL solventSee footnote 112
1.3High pH (≈9)
Na7.5Low pH (≈3)
S1.9High pH (≈9)
Si1.6Low pH (≈3)
Cyclic Olefin Copolymer
Al0.07pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventComponent of prefilled35
B0.86Low pH (≈3)Sealed vessel, 121 °C for 1 h, 0.08 g sample/mL solventSee footnote 612
5.7High pH (≈9)
Ba<0.1pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe340
Br0.54pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventMolded part435
0.02pH 9.5
Ca0.11High pH (≈9)Sealed vessel, 121 °C for 1 h, 0.08 g sample/mL solventSee footnote 612
0.3pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe340
0.81pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventMolded part435
1.7pH 9.5
Fe0.24pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventMolded part435
Mg<0.1pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe340
0.16pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventMolded part435
0.15pH 9.5
Na0.96pH 2.5
Sr<0.1pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe340
Zn0.3pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe340
0.07pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventMolded part435
0.03pH 9.5
Zr<0.03pH 2–12Sealed vessel, 121 °C for 1 h, 0.07 g sample/mL solventComponent of prefilled syringe340
  • Notes:

  • 1 Elements that were not extracted in reportable levels included Ag, As, Ba, Be, Bi, Cd, Co, Cr, Cu, Fe, Ge, Li, Mg, Mn, Mo, Ni, Pb, Sb, Se, Sn, Sr, Ti, V, Zn, and Zr.

  • 2 Elements that were extracted in reportable levels included Cd, Co, Cr, Cu, Fe, Mg, Mn, Ni, V, and Zn.

  • 3 Elements that were not extracted in reportable levels, generally 1 μg/g, included Ag, As, Bi, Co, Cr, Cu, Mo, Ni, Sb, Se, Sn, and V.

  • 4 Elements that were not extracted in reportable levels (<0.01 μg/g) included As, Ba, Co, Cr, Cu, K, Mn, Mo, Ni, Pb, Si, Sb, Sr, Ti, and V.

  • 5 Elements that were not extracted in reportable levels included Ag, Al, As, B, Ba, Be, Bi, Ca, Cd, Co, Cr, Cu, Fe, Ge, Li, Mg, Mn, Mo, Na, Ni, P, Pb, S, Sb, Se, Si, Sn, Sr, Ti, V, Zr, and Zn.

  • 6 Elements that were not extracted in reportable levels included Ag, Al, As, Ba, Be, Bi, Cd, Co, Cr, Cu, Fe, Ge, Li, Mg, Mn, Mo, Na, Ni, P, Pb, S, Sb, Se, Si, Sn, Sr, Ti, V, Zn, and Zr.