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 17 srpnja 2024. Database contains 4917 unique substances/entries.
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307-451-5
97659-46-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
Details
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
Details
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
Details
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
Details
301-323-2
93983-68-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C (167°F to 392°F).
309-984-9
101896-26-8
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300°C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70°C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.
310-165-3
121620-46-0
Carc. 1B; Muta. 1B
Details
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135°C to 210°C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.
309-971-8
101794-90-5
Carc. 1B; Muta. 1B
Details
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235°C to 255°C (455°F to 491°F).
309-972-3
101794-91-6
Carc. 1B; Muta. 1B
Details
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225°C to 255°C (437°F to 491°F).
309-985-4
101896-27-9
Carc. 1B; Muta. 1B
Details
The oil obtained from condensation of the vapors from the heat treatment of pitch. Composed primarily of two- to four-ring aromatic compounds boiling in the range of 200°C to greater than 400°C (392°F to greater than 752°F).
309-855-7
101316-49-8
Carc. 1B
Details
The liquid product of condensation of vapors emitted during the digestion of coal in a liquid solvent and boiling in the range of approximately 30°C to 300°C (86°F to 572°F). Composed primarily of partly hydrogenated condensed-ring aromatic hydrocarbons, aromatic compounds containing nitrogen, oxygen and sulfur, and their alkyl derivatives having carbon numbers predominantly in the range of C4 through C14.
302-688-0
94114-52-0
Carc. 1B; Muta. 1B
Details
Distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 300°C (86°F to 572°F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 through C14. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.
302-689-6
94114-53-1
Carc. 1B; Muta. 1B
Details
Distillate from the hydrogenation of hydrocracked middle distillate from 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 280°C (356°F to 536°F). Composed primarily of hydrogenated two- ring carbon compounds and their alkyl derivatives having carbon numbers predominantly in the range of C9 through C14.
302-693-8
94114-57-5
Carc. 1B; Muta. 1B
Details
Distillate obtained from the 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 300°C (356°F to 572°F. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present.
302-692-2
94114-56-4
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120°C to 130°C (248°F to 266°F).
309-862-5
101316-56-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the treatment of a petroleum oil fraction with activated charcoal for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C28.
309-667-5
100683-97-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained by distillation of catalytic cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-938-8
101631-13-4
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of steam cracking heavy residues. It consists predominantly of highly alkylated heavy aromatic hydrocarbons boiling in the range of approximately 250°C to 400°C (482°F to 752°F).
309-939-3
101631-14-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the solvent treatment of a distillate from hydrocracked petroleum distillates. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).
307-010-7
97488-73-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C16 and boiling in the range of approximately 120°C to 283°C (248°F to 541°F).
309-864-6
101316-58-9
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by treating a petroleum stock with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C25 and boiling in the range of approximately 150°C to 400°C (302°F to 752°F).
309-863-0
101316-57-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate stocks. It consists of hydrocarbons having carbon numbers predominantly in the range of C12 through C21 and boiling in the range of approximately 200°C to 360°C (392°F to 680°F).
309-865-1
101316-59-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of petroleum with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
309-668-0
100683-98-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of petroleum with bleaching earth for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
309-669-6
100683-99-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent dearomatization of the residue of hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).
305-589-0
94733-09-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of a hydrogenated petroleum distillate with a solvent. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C19 through C40 and boiling in the range of approximately 390°C to 550°C (734°F to 1022°F).
307-011-2
97488-74-9
Carc. 1B
Details
305-588-5
94733-08-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by distillation of steam cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-940-9
101631-15-6
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of the polymerized C8 through C12 fraction from steam-cracked petroleum distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
305-750-5
95009-23-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of thermal-cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-866-7
101316-61-4
Asp. Tox. 1
Details
308-208-6
97925-95-6
Repr. 1B
Details
Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240°C to 260°C (464°F to 500°F). Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.
310-171-6
122070-80-8
Carc. 1B; Muta. 1B
Details
A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiliing range of 225°C to 255°C (437°F to 491°F). Composed primarily of substituted dinuclear aromatic hydrocarbons.
310-170-0
122070-79-5
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85°C-195°C (185°F-383°F).
309-868-8
101316-63-6
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons from the base-free fraction from the distillation of coal tar, boiling in the range of approximately 250°C to 280°C (482°F to 536°F). It consists predominantly of biphenyl and isomeric dimethylnaphthalenes.
310-189-4
122384-77-4
Carc. 1B
Details
309-867-2
101316-62-5
Carc. 1B; Muta. 1B
Details
The residue from low temperature coal tar oils after an alkaline wash, such as aqueous sodium hydroxide, to remove crude coal tar acids. Composed primarily of hydrocarbons and aromatic nitrogen bases.
310-191-5
122384-78-5
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallization process. It is composed primarily of naphthalene and alkyl naphthalenes.
310-167-4
121620-48-2
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.
310-166-9
121620-47-1
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of heavy naphthic solvent petroleum extract with bleaching earth. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C10 and boiling in the range of approximately 80°C to 180°C (175°F to 356°F).
308-261-5
97926-43-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-672-2
100684-02-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-673-8
100684-03-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-675-9
100684-05-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-674-3
100684-04-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treatment of Foot's oil with sulfuric acid. It consists predominantly of branched-chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-225-7
93924-31-3
Flam. Gas 1; Press. Gas; Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of Foots oil with activated carbon for the removal of trace constituents and impurities. It consists predominantly of saturated straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-126-0
97862-76-5
Carc. 1B
Details

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