TABLE I (A)

Total Amounts of Elemental Impurities in Materials (Digestion or Total Pool)

Type of MaterialAmount of Metal in the Material (mg/kg unless noted)Ref.
AlCoCrGeMgMnPbSbSiTi
Acrylonitrile-butadiene-styrene19<0.01<0.01<0.01<0.01260<0.0010.76<0.01NRNR43
Acrylonitrile-butadiene-styreneNR1NRNRNR220NR0.76NRNRNR13, 14
CardboardNRNR2.8NRNRNR0.38NRNRNR31
Cardboard + PE filmNRNR28NRNRNR1.5NRNRNR31
Paper (3 samples)NRNR0.25–0.50NRNRNR0.28–0.35NRNRNR33
Paperboard (3 samples)NRNR0.50–0.64NRNRNR0.67–0.99NRNRNR33
Type 1 glass vial101.6%<0.10.20.5610.21.00.5>30%6.724
Colorless glass281.2%3.6604<0.14.5%79NR1.584.3%NR57
Polyester bottle<0.1<0.1<0.1<0.1<0.1<0.1<0.1151<0.11624
Polycarbonate bottle<0.1<0.1<0.1<0.1<0.1<0.1<0.1<1<0.1<124
Polyethylene terephthalate62058NR144.60.530.24230NRNR13, 14
Polyethylene terephthalateNR35NRNRNR0.1NR140NRNR13, 14
Polyethylene terephthalate0.4017NRNR50NRNR117NRNR13, 14
Polyethylene terephthalate80.7, 62033, 58NR1, 14<1, 5.9NRNR160, 230NRNR21
Polyethylene terephthalateNRNR<0.01NRNRNR<0.01NRNRNR27
Polyethylene terephthalate154.514<1NRNR0.34<0.1189NR<128
Polyethylene terephthalate0.91NR<0.1NRNRNR<0.1NRNR<0.129
Polyethylene terephthalateNRNR16NRNRNR0.15NRNRNR31
Polyethylene terephthalate19<0.01, 62015–58<0.01<0.01–14<0.01, 4.60.11–0.53<0.01–0.24140-230NRNR43
Polyethylene terephthalate2086–010.5–591–9NRNR1–1162–925–13877–10501–547
Polyethylene terephtalate21<0.0935<2.8<2.6<4.20.12NR137<164<1.149
Clear PET bottle260.4216.8NRNR49.70.06NR117<83<0.6749
Low-density polyethylene8.9NRNRNR2.30.1NRNRNRNR13, 14
Low-density polyethylene40.4–8.3NRNRNR<1–23NRNRNRNRNR21
Low-density polyethylene14NRNR1.5NRNRNR1.28<0.29NRNR26
Low-density polyethylene19<0.01–8.9<0.001<0.001<0.01<0.01–270.001–0.011<0.01<0.001NRNR43
Low-density polyethylene22<0.01<0.001<0.12<0.3<0.360.002NR<0.002<22<0.149
Polyethylene1.2NR0.06NRNRNR<0.1NRNR0.0429
PolyethyleneNRNR13NRNRNR0.1NRNRNR31
Polyethylene standard319, 51NRNRNRNRNR<10.82, 6.2NR534, 117420
PolyethyleneNRNR<3.9NRNRNR<3.9NRNRNR27
Polyethylene (5 samples)0.2–760.003–0.0090.008–18NR0.28–110<0.019NR<0.003NR0.17–5.260
Polyethylene3.6NR<1.1NR4.50.180.76NRNR1.161
High-density polyethylene1.5NR1.9NRNRNRNRNR1800.3013, 14
High-density polyethylene34NR3.6NRNRNR4.1NRNRNR13, 14
High-density polyethyleneNRNR3.0NRNRNR0.11NRNRNR31
High-density polyethylene50.5–39NR<1–4.3NRNRNRNRNRNRNR21
High-density polyethylene bottle1289<0.1<0.1<0.1<0.1<0.1<0.1<0.1<0.1386024
High-density polyethylene14NRNR219NRNRNR122244.1NRNR26
High-density polyethylene14NRNR0.72NRNRNR<0.13<0.29NRNR26
High-density polyethylene19<0.01–41<0.001<0.01–3.6<0.001<0.01–7.80.001–0.014<0.01–4.1<0.01NRNR43
High-density polyethylene231.52<0.0021.88<0.18<0.420.004NR<0.0041800.2649
PE/PP blend14NRNR23.1NRNRNR160<0.29NRNR26
PE/PET/PE laminateNRNR0.33NRNRNR0.531.8NRNR48
Polypropylene26NRNRNRNRNRNRNRNRNR13, 14
Polypropylene28NR0.30NR0.50NRNRNRNR3313, 14
Polypropylene613–115NR<1–1.3NR<44NRNRNRNRNR21
PolypropyleneNRNR<3.9NRNRNR5.5NRNRNR27
PolypropyleneNRNR3.5NRNRNR0.32NRNRNR31
Polypropylene199–32<0.01<0.01–0.4<0.01<0.010.001–0.003<0.01<0.01NRNR43
Polypropylene (5 samples)25–720.001–0.007<0.1–0.14NR<5–100<0.003–0.34NR0.001–0.007NR<0.7–6860
PolypropyleneNRNR0.31NRNRNR1.06<0.001NRNR48
Polypropylene2528<0.005<0.17<0.740.450.006NR<0.005<1123349
Polystyrene1100.59NRNR23NRNR0.26NRNR13, 14
PolystyreneNRNRNRNRNRNRNRNRNRNR13, 14
Polystyrene (white)44NRNRNR0.50NRNR0.10NR280013, 14
Polystyrene7<0.3–190.60NRNR<1–23NRNRNRNRNR21
PolystyreneNRNR<3.9NRNRNR<3.9NRNRNR27
PolystyreneNRNR1.7NRNRNR0.62NRNRNR31
Polystyrene19<0.01–110<0.01<0.01<0.01<0.01–460.002<0.01<0.01–0.26NRNR43
Polysytrene24<0.12<0.003<0.3<0.2<0.51<0.002NR<0.008<32<0.1249
White polystyrene27440.068NDND0.50.020NR0.12<262282749
PolymethylmethacrylateNRNRNRNR5.4NRNRNRNRNR13, 14
Polymethylmethacrylate9NRNRNRNR<1–5.2NRNRNRNRNR21
Polymethylmethacrylate19<0.01<0.01<0.01<0.01<0.01–6.5<0.01–0.01<0.01<0.01NRNR43
Polytetrafluoroethylene16NR<0.012.25NR0.900.15NRNRNRNR32
Polytetrafluoroethylene17NR<0.010.01NR0.240.05NRNRNRNR32
Polytetrafluoroethylene18NR<0.011.37NR0.540.09NRNRNRNR32
Chlorobutyl rubber470,000NRNRNRNRNRNRNRNRNR13, 14
Chlorobutyl rubber2500–25,000NRNRNRNRNRNRNRNRNR15
Chlorobutyl rubber600–4700NRNRNRNRNRNRNRNRNR42
Bromobutyl rubber110.13%0.22.6<0.10.93%7.81.1<0.1140.81%24
Laminated polyolefinNRNR0.30NRNRNR1.11.8NRNR13, 14
Laminated polyolefinNRNR0.30NRNRNR1.1NRNRNR13, 14
Multi-layer polyolefinNRNR28NRNRNR0.21NRNRNR31
Multi-layer polyolefinNRNR3.3NRNRNR0.08NRNRNR31
Prefilled syringe130.38%<0.54<0.53<0.5<5<5418024
Polyvinyl chloride (2 samples)NRNR<1, 150NRNRNR112, 157NRNRNR58
Polyvinyl chlorideNRNRNRNRNRNRNRNRNRNR59