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 30 svibnja 2024. Database contains 4917 unique substances/entries.
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202-598-0
97-64-3
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
Details
202-597-5
97-63-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
Details
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
R Toxic for reproduction (article 57c)
Details
The redistillate from the fractional distillation of dephenolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220°C to 230°C (428°F to 446°F). It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons.
295-329-1
91995-66-3
Carc. 1B; Muta. 1B
Details
The aqueous extract produced by an acidic wash of alkali-washed carbolic oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.
292-622-6
90640-99-6
Carc. 1B; Muta. 1B
Details
The aqueous extract produced by an acidic wash of alkali-washed napthalene oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.
292-623-1
90641-00-2
Carc. 1B; Muta. 1B
Details
An acid sludge by-product of the sulphuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.
298-725-2
93821-38-6
Carc. 1B; Muta. 1B
Details
The redistillate from the distillate, freed of tar acids and tar bases, from bituminous coal high temperature tar boiling in the approximate range of 90°C to 160°C (194°F to 320°F). It consists predominantly of benzene, toluene and xylenes.
295-323-9
91995-61-8
Carc. 1B; Muta. 1B
Details
The residue from toluene extraction of dried brown coal.
294-285-0
91697-23-3
Carc. 1B
Details
The oil resulting from the acid washing of alkali-washed carbolic oil to remove the minor amounts of basic compounds (tar bases). Composed primarily of indene, indan and alkylbenzenes.
292-624-7
90641-01-3
Carc. 1B; Muta. 1B
Details
The first fraction from the distillation of aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oil boiling substantially below 145°C (293°F). Composed primarily of C7 and C8 aliphatic and aromatic hydrocarbons.
292-625-2
90641-02-4
Carc. 1B; Muta. 1B
Details
The distillate from aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oils, having an approximate boiling range of 155°C to 180°C (311°F to 356°F). Composed primarily of indene, indan and trimethylbenzenes.
292-626-8
90641-03-5
Carc. 1B; Muta. 1B
Details
The distillate from alkali-washed naphthalene oil having an approximate distillation range of 180°C to 220°C (356°F to 428°F). Composed primarily of naphthalene, alkylbenzenes, indene and indan.
292-627-3
90641-04-6
Carc. 1B; Muta. 1B
Details
The residue from the distillation of alkali-washed naphthalene oil having an approximate distillation range of 220°C to 300°C (428°F to 572°F). Composed primarily of naphthalene, alkylnaphthalenes and aromatic nitrogen bases.
292-628-9
90641-05-7
Carc. 1B; Muta. 1B
Details
The product obtained by treatment of coal tar oil alkaline extract with CO2 and CaO. Composed primarily of CaCO3, Ca(OH)2, Na2CO3 and other organic and inorganic impurities.
292-629-4
90641-06-8
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 the extract from the solvent extraction of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C8 and boiling in the range of approximately 100°C to 200°C (212°F to 392°F).
295-331-2
91995-68-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
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 C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40°C.
297-827-4
93763-10-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treating a heavy naphthenic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of at least 19cSt at 40°C (100 SUS at 100°F).
292-631-5
90641-07-9
Carc. 1B
Details
A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contact or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more 4-6 membered ring aromatic hydrocarbons.
296-437-1
92704-08-0
Carc. 1B
Details
A complex combination of hydrocarbons produced by treating a heavy paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C21 through C33 and boiling in the range of approximately 350°C to 480°C (662°F to 896°F).
292-632-0
90641-08-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the extract from solvent extraction of intermediate paraffinic top solvent distillate that is treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
295-335-4
91995-73-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treating the extract, obtained from a solvent extraction process, with hydrogen in the presence of a catalyst under conditions primarily to remove sulfur compounds. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
295-338-0
91995-75-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction of a light paraffin distillate and treated with hydrogen to convert the organic sulfur to hydrogen sulfide which is eliminated. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C40 and produces a finished oil with a viscosity of greater than 10cSt at 40°C.
295-340-1
91995-77-6
Carc. 1B
Details
A complex combination of hydrocarbons produced by treating a light paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C26 and boiling in the range of approximately 280° to 400°C (536°F to 752°F).
292-633-6
90641-09-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction from light vacuum petroleum gas oil. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-341-7
91995-78-7
Carc. 1B
Details
A complex combination of hydrocarbons, obtained by solvent extraction from light vacuum petroleum gas oils and treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-342-2
91995-79-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained from a solvent dewaxed 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 C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40°C.
297-829-5
93763-11-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulfuric acid refining. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
295-339-6
91995-76-5
Carc. 1B
Details
292-966-7
91031-62-8
R Toxic for reproduction (article 57c)
Details
294-302-1
91697-41-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
294-785-9
91770-03-5
Skin Irrit. 2
Details
202-271-2
93-72-1
Acute Tox. 4; Skin Irrit. 2
Details
212-984-0
900-95-8
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
232-599-1
9001-33-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
FLOCOUMAFEN
421-960-0
90035-08-8
Repr. 1B; Acute Tox. 1; STOT RE 1
Details
213-408-0
944-22-9
Acute Tox. 1; Acute Tox. 2
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
A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of branched chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-226-2
93924-32-4
Flam. Gas 1; Press. Gas; Carc. 1B
Details
295-394-6
92045-12-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of Foots oil with silicic acid for removal of trace constituents and impurities. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-127-6
97862-77-6
Carc. 1B
Details
300-298-5
93925-00-9
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
294-145-9
91673-30-2
Skin Sens. 1
Details
619-377-3
98886-44-3
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
Details
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).
295-396-7
92045-14-2
Carc. 1B
Details
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.
302-695-9
94114-59-7
Carc. 2
Details
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.
302-694-3
94114-58-6
Carc. 2
Details
202-626-1
98-00-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3
Details

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