EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
In Vitro Diagnostic Medical Devices Directive - Hazardous Substances
EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998
This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.
Last updated 23 dubna 2024. Database contains 4821 unique substances/entries.
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294-145-9
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91673-30-2
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Skin Sens. 1 |
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200-842-0
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75-12-7
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Repr. 1B |
yes |
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244-879-0
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22259-30-9
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Acute Tox. 2; Skin Sens. 1 |
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245-656-0
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23422-53-9
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Acute Tox. 2; Skin Sens. 1 |
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200-579-1
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64-18-6
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Skin Corr. 1A |
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268-755-0
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68134-59-8
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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239-946-6
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15843-02-4
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1 |
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219-818-6
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2540-82-1
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Acute Tox. 4 |
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254-320-2
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39148-24-8
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Eye Dam. 1 |
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619-377-3
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98886-44-3
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Acute Tox. 3; Acute Tox. 4; Skin Sens. 1 |
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244-437-7
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21548-32-3
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Acute Tox. 1; Acute Tox. 2 |
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-
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-
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B Bacteria and similar species |
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-
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-
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B Bacteria and similar species |
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223-404-0
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3878-19-1
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Carc. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1 |
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A complex combination of light gases produced by distillation of crude oil and by catalytic reforming of naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately -217°C to -12°C (-423°F to 10°F).
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270-670-9
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68476-29-9
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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A combination of light gases. It consists predominantly of hydrogen and/or low molecular weight hydrocarbons.
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270-667-2
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68476-26-6
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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A complex combination of hydrocarbons obtained by the distillation of crude petroleum. It consists predominantly of aliphatic, aromatic and cycloaliphatic hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
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295-396-7
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92045-14-2
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Carc. 1B |
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A distillate oil having a minimum viscosity of 32.6 SUS at 37.7°C (100°F) to a maximum of 37.9 SUS at 37.7°C (100°F).
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270-671-4
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68476-30-2
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Carc. 2 |
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A distillate oil having a minimum viscosity of 45 SUS at 37.7°C (100°F) to a maximum of 125 SUS at 37.7°C (100°F).
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270-673-5
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68476-31-3
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Carc. 2 |
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A distillate oil having a minimum viscosity of 900 SUS at 37.7°C (100°F) to a maximum of 9000 SUS at 37.7°C (100°F).
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271-384-7
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68553-00-4
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Carc. 1B |
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The liquid product from various refinery streams, usually residues. The composition is complex and varies with the source of the crude oil.
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270-675-6
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68476-33-5
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Carc. 1B |
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270-674-0
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68476-32-4
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Carc. 1B |
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Diesel engine fuel produced by the hydrogenation of the middle distillate fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 200°C to 280°C (392°F to 536°F). Composed primarily of hydrogenated two-ring hydrocarbons and their alkyl derivatives having carbon numbers predominantly in the range of C11 through C14.
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302-695-9
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94114-59-7
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Carc. 2 |
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A distillate oil having a minimum viscosity of 32.6 SUS at 37.7°C (100°F) to a maximum of 40.1 SUS at 37.7°C (100°F).
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270-676-1
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68476-34-6
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Carc. 2 |
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A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 163°C to 357°C (325°F to 675°F).
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269-822-7
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68334-30-5
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Carc. 2 |
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Jet engine fuel produced by hydrogenation of the middle distillate fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 225°C (356°F to 473°F). Composed primarily of hydrogenated two-ring hydrocarbons and their alkyl derivatives having carbon numbers predominantly in the range of C10 through C12.
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302-694-3
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94114-58-6
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Carc. 2 |
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203-743-0
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110-17-8
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Eye Irrit. 2 |
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260-875-1
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57646-30-7
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Acute Tox. 4 |
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203-727-3
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110-00-9
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Flam. Liq. 1; Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2 |
yes |
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265-974-3
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65907-30-4
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Acute Tox. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1 |
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202-626-1
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98-00-0
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Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3 |
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262-302-0
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60568-05-0
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Carc. 2 |
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-
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-
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B Bacteria and similar species |
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215-114-8
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1303-00-0
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Repr. 1B; Carc. 1B; STOT RE 1 |
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603-804-5
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134237-52-8
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yes |
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-
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-
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B Bacteria and similar species |
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A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230°C to 400°C (446°F to 752°F).
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265-112-6
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64742-12-7
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Carc. 1B |
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A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230°C to 400°C (446°F to 752°F).
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265-129-9
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64742-29-6
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Carc. 1B |
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A complex combination of hydrocarbons obtained by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C35 and boiling in the range of approximately 121°C to 510°C (250°F to 950°F).
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272-184-2
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68783-08-4
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Carc. 1B |
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A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and boiling in the range of approximately 350°C to 600°C (662°F to 1112°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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265-058-3
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64741-57-7
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Carc. 1B |
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A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C13 through C50 and boiling in the range of approximately 230°C to 600°C (446°F to 1112°F). This stream is likely to contain 5 wt. % or more of 4- to 6- membered condensed ring aromatic hydrocarbons.
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265-162-9
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64742-59-2
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Carc. 1B |
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A complex combination of hydrocarbons obtained by hydrodesulfurization of heavy coker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range C18 to C44 and boiling in the range of approximately 304°C to 548°C (579°F to 1018° F). Likely to contain 5% or more of 4- to 6- membered condensed ring aromatic hydrocarbons.
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285-555-9
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85117-03-9
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Carc. 1B |
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A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and boiling in the range of approximately 350°C to 600°C (662°F to 1112°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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265-189-6
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64742-86-5
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Carc. 1B |
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A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230°C to 400°C (446°F to 752°F).
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265-182-8
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64742-79-6
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Carc. 1B |
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A complex combination of hydrocarbons obtained by catalytic dehydrosulfurization of thermal-cracked light vacuum petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C14 through C20 and boiling in the range of approximately 270°C to 370°C (518°F to 698°F).
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308-278-8
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97926-59-5
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Carc. 1B |
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A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C11 through C25 and boiling in the range of approximately 205°C to 400°C (401°F to 752°F).
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265-092-9
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64741-90-8
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Carc. 1B |
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A complex combination of hydrocarbons produced by distillation of the products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C9 and boiling in the range of from approximately 205°C to 400°C (400°F to 752°F)
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271-260-2
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68527-18-4
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Carc. 1B |
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295-411-7
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92045-29-9
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Carc. 1B |
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A complex combination of hydrocarbons obtained from the redistillation of the effluents from the treatment of paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C27 and boiling in the range of approximately 330°C to 340°C (626°F to 644°F).
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308-128-1
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97862-78-7
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Carc. 1B |
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A distillate obtained from the redistillation of a complex combination of hydrocarbons obtained by the distillation of the effluents from a severe catalytic hydrotreatment of paraffins. It boils in the range of approximately 190°C to 330°C (374°F to 594°F).
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300-227-8
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93924-33-5
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Carc. 1B |
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