Table VIII

Extracted Elemental Impurities Reported for Plasticized Polyvinyl Chloride (PVC)

ElementConcentration (mg/kg unless noted)Extraction DetailsCommentsRef.
SolventConditions
AlNR1–6.4Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NR–0.30High pH (≈9)
NREthanol/water
0.14pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
<0.01pH 9.5
4–12 μg/LWaterFilled PVC bags, ambient temperature for 24 h500 mL and 1000 mL bags used50
As0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
<0.01pH 9.5
BNR–4.6Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NRHigh pH (≈9)
NR–0.60Ethanol/water
Br1.3pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
0.08pH 9.5
CaNR–5.0Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NR–2.5High pH (≈9)
NR–4.9Ethanol/water
1.5pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
<0.01pH 9.5
2.0WaterVarious extraction methods, 0.02–0.04 g sample/mL solventResin756
28.1pH 2.5
468Isopropyl alcohol (IPA)/water
160IPA
6.9Isohexane
Cr0.02pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
<0.01pH 9.5
Cu<0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
0.01pH 9.5
0.8WaterVarious extraction methods, 0.02–0.04 g sample/mL solventResin656
2.8pH 2.5
12.5pH 9.5
0.5IPA/water
0.5Isohexane
FeNRLow pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NRHigh pH (≈9)
NREthanol/water
0.35pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 sample/mL solventResin535
0.15pH 9.5
MgNR–9.7Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NR–7.7High pH (≈9)
NR–7.6Ethanol/water
0.26pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
0.21pH 9.5
Mo<0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
0.01pH 9.5
Mn0.02pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
<0.01pH 9.5
NaNR–5.2Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07 0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NA2High pH (≈9)
NR–2.1Ethanol/water
0.60pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
Ni0.4WaterVarious extraction methods, 0.02–0.04 g sample/mL solventResin656
0.7pH 2.5
0.4pH 9.5
0.7IPA/water
0.4IPA
PNRLow pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NAHigh pH (≈9)
NREthanol/water
Pb1.6 mg/LAqueous buffersCut strips extracted at 60 °C for 10 days, 1 cm2/2 mL solventSample was a blood transfusion bag16
0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
<0.01pH 9.5
1.4pH 2.5Various extraction methods, 0.02–0.04 g sample/mL solventResin656
SNR–1.2Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NR–3.7High pH (≈9)
NREthanol/water
Sb<0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
0.01pH 9.5
Se0.4IPA/waterVarious extraction methods, 0.02-0.04 g sample/mL solventResin756
0.6pH 9.5
0.6Isohexane
SiNR–6.9Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NR–0.29High pH (≈9)
NR–0.10Ethanol/water
Sr0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
0.02pH 9.5
Ti0.3WaterVarious extraction methods, 0.02–0.04 g sample/mL solventResin656
0.6pH 9.5
0.8IPA
0.4Isohexane
V0.01pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
<0.01pH 9.5
ZnNR–19Low pH (≈3)Sealed vessel, 55 °C for 4 days, 0.07–0.1 g sample/mL solvent12 materials tested; resins, parts, films312
NR–0.58High pH (≈9)
17–77Ethanol/water
2.9 mg/LAqueous buffersCut strips extracted at 60 °C for 10 days, 1 cm2/2 mL solventSample was a blood transfusion bag16
1.3pH 2.5Sealed vessel, 121 °C for 1 h, 0.025 g sample/mL solventResin535
0.43pH 9.5
4.5WaterVarious extraction methods, 0.02–0.04 g sample/mL solventResin656
95pH 2.5
71.6pH 9.5
766IPA/water
355IPA
20.3Isohexane

  • Notes:

  • ↵1 NR = Not reported: not extracted at reportable levels (generally less than 0.01 μg/g).

  • ↵2 NA = Not applicable; element was a component of the extracting solvent.

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

  • ↵5 Elements that were not extracted in reportable levels (<0.01 μg/g) included Ba, Co, K, Ni, Si, and Ti.

  • ↵6 Elements that were not extracted in reportable levels (<0.3 μg/g) included Ag, As, Ba, Cd, Co, Cr, Hg, Ir, Mo, Ni, Pb, Pd, Pt, Os, Rh, Ru, Se, Si, Sb, Sn, and V.

  • ↵7 Elements that were not extracted in reportable levels (<0.3 μg/g) included Ag, As, Ba, Cd, Co, Cr, Hg, Ir, Mo, Ni, Pb, Pd, Pt, Os, Rh, Ru, Si, Sb, Sn, and V.