EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10
EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10
Medical Devices Regulation - Hazardous Substances
EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020
This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).
Last updated 26 srpnja 2024. Database contains 4917 unique substances/entries.
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ADDITIV 104
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412-780-3
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1380226-46-9
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Skin Irrit. 2; Skin Sens. 1 |
Details | ||
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432-200-2
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1379679-02-3
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STOT SE 3; Skin Irrit. 2; Eye Dam. 1 |
Details | |||
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439-540-0
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-
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Skin Irrit. 2; Skin Sens. 1 |
Details | |||
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431-120-5
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-
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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1 |
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SHC 3000
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401-530-9
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-
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Flam. Sol. 1; STOT SE 1; Acute Tox. 4 |
Details | ||
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TYZOR ZEC
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417-110-3
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1379678-99-5
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Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1 |
Details | ||
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YELLOW MGI 1301
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424-250-9
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-
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Eye Dam. 1 |
Details | ||
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E-101
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420-310-3
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-
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Acute Tox. 4 |
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R633
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406-230-1
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224635-63-6
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Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1 |
Details | ||
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PES-SOLID
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420-070-1
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-
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Org. Perox. D; Acute Tox. 4; Skin Corr. 1A |
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424-510-1
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-
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Eye Dam. 1 |
Details | |||
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PRODUKT 1245
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420-980-7
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-
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Eye Dam. 1 |
Details | ||
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PDN 2287
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417-450-2
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-
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1 |
Details | ||
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428-630-5
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-
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Skin Sens. 1 |
Details | |||
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500-033-5
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25068-38-6
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1 |
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939-460-0
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1471311-26-8
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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939-460-0
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1471311-26-8
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
Details | |||
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426-860-0
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191877-09-5
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Eye Dam. 1 |
Details | |||
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432-440-8
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220444-73-5
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Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1 |
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-
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Carc. 1B; Muta. 2; Acute Tox. 4; Acute Tox. 3; STOT RE 2; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A |
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-
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-
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Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A |
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ORGANOTUNGSTEN COMPOUND CONCENTRATE
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408-250-6
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121754-49-2
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Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1 |
Details | ||
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MP-2000; MP-2000X
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406-620-1
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129217-90-9
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Skin Sens. 1 |
Details | ||
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FCC 963
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410-880-1
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147170-38-5
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Acute Tox. 4; Skin Corr. 1B |
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231-768-7
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7723-14-0
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Flam. Sol. 1 |
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Zirconia Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium, silicon and zirconium are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm). c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight
EC / List no:
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| CAS no:
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Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium and silicon are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm) c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight
EC / List no:
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| CAS no:
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Glass, oxide, chemicals
This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
EC / List no:
266-046-0
| CAS no:
65997-17-3
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-
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Carc. 1B |
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232-645-0
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9001-98-3
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1 |
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A complex combination of hydrocarbons obtained by the treatment of solvent-dewaxed petroleum residual oils with activated charcoal for the removal of trace polar constituents and impurities.
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309-710-8
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100684-37-5
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Carc. 1B |
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294-843-3
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91770-57-9
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Carc. 1B |
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A complex combination of hydrocarbons obtained by treatment of solvent-dewaxed petroleum residual oils with bleaching earth for the removal of trace polar constituents and impurities.
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309-711-3
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100684-38-6
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Carc. 1B |
Details | ||
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A complex combination of hydrocarbons obtained by treatment of a residual oil with a natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
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265-143-5
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64742-41-2
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Carc. 1B |
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A complex residuum from the atmospheric distillation of the butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
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270-795-9
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68478-16-0
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
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A complex combination of hydrocarbons produced by solvent removal of paraffins from the residue of the distillation of acid-treated, hydrocracked heavy paraffins and boiling approximately above 380°C (716°F).
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295-499-7
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92061-86-4
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Carc. 1B |
Details | ||
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292-656-1
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90669-74-2
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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 greater than C25 and boiling above approximately 400°C (752°F).
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265-160-8
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64742-57-0
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Carc. 1B |
Details | ||
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A complex combination of hydrocarbons obtained as the solvent soluble fraction from C3 - C4 solvent deasphalting of a residuum. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
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265-096-0
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64741-95-3
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Carc. 1B |
Details | ||
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A complex combination of hydrocarbons obtained by removal of long, branched chain hydrocarbons from a residual oil by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400°C (752°F).
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265-166-0
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64742-62-7
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Carc. 1B |
Details | ||
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A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2cSt. at 100°C.
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298-754-0
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93821-66-0
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Carc. 1B |
Details | ||
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A complex combination of hydrocarbons obtained as the solvent insoluble fraction from solvent refining of a residuum using a polar organic solvent such as phenol or furfural. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
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265-101-6
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64742-01-4
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Carc. 1B |
Details | ||
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The residue from the fraction distillation of crude anthracene boiling in the approximate range of 340°C to 400°C (644°F to 752°F). It consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.
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295-505-8
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92061-92-2
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Carc. 1B; Muta. 1B |
Details | ||
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The residue from the fractional distillation of wash oil boiling in the approximate range of 270°C to 330°C (518°F to 626°F). It consists predominantly of dinuclear aromatic and heterocyclic hydrocarbons.
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295-506-3
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92061-93-3
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Carc. 1B |
Details | ||
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Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752°F to 846°F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.
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295-507-9
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92061-94-4
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Carc. 1B |
Details | ||
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A cohesive powder composed of coal mineral matter and undissolved coal remaining after extraction of coal by a liquid solvent.
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302-681-2
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94114-46-2
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Carc. 1B |
Details | ||
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A complex residuum from the distillation of streams from various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C4 through C5, predominantly butane and boiling in the range of approximately -11.7°C to 27.8°C (11°F to 82°F).
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271-010-2
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68513-66-6
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
Details | ||
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A complex residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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265-045-2
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64741-45-3
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Carc. 1B |
Details | ||
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A complex residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200°C (392°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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269-777-3
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68333-22-2
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Carc. 1B |
Details | ||
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A complex residuum from the distillation of butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
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270-791-7
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68478-12-6
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
Details | ||
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A complex residuum from the catalytic reforming of C6-8 feed. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
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270-794-3
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68478-15-9
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Carc. 1B; Muta. 1B; Asp. Tox. 1 |
Details | ||
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A complex combination of hydrocarbons produced as the residual fraction from the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200°C (392°F).
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295-511-0
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92061-97-7
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Carc. 1B |
Details | ||
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A complex residuum from the distillation of catalytic reformer fractionator residue. It boils approximately above 399°C (750°F).
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270-792-2
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68478-13-7
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Carc. 1B |
Details | ||