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 04 listopada 2024. Database contains 4917 unique substances/entries.
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202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
Details
DIETHYLDIMETHYLAMMONIUMHYDROXIDE
419-400-5
95500-19-9
Acute Tox. 4; Skin Corr. 1A
Details
301-323-2
93983-68-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
213-546-1
973-21-7
Acute Tox. 3
Details
213-482-4
957-51-7
Acute Tox. 4
Details
DIDA
402-360-8
92511-22-3
Eye Dam. 1
Details
The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C (662°F to 752°F). Consists predominantly of tri- and polynuclear aromatics and heterocyclic hydrocarbons.
295-304-5
91995-42-5
Carc. 1B
Details
Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752°F). Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.
292-607-4
90640-86-1
Carc. 1B
Details
This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m-, and p-cresol and boiling in the range of 140°C to 215°C (284°F to 419°F).
292-609-5
90640-87-2
Carc. 1B; Muta. 1B
Details
The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-610-0
90640-88-3
Carc. 1B; Muta. 1B
Details
A complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.
295-310-8
91995-49-2
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230°C to 255°C (446°F to 491°F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.
295-309-2
91995-48-1
Carc. 1B; Muta. 1B
Details
The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-611-6
90640-89-4
Carc. 1B; Muta. 1B
Details
The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.
292-612-1
90640-90-7
Carc. 1B; Muta. 1B
Details
The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri- and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300°C to 470°C (572°F to 878°F). The product may also contain heteroatoms.
295-312-9
91995-51-6
Carc. 1B
Details
The redistillate obtained from the fractional distillation of pitch distillate and boiling in the range of approximately 380°C to 410°C (716°F to 770°F). Composed primarily of tri- and polynuclear aromatic hydrocarbons and heterocyclic compounds.
295-313-4
91995-52-7
Carc. 1B
Details
The redistillate obtained from the fractional distillation of bituminous coal high temperature tar and pyrolysis residual oils and boiling in the range of approximately 190°C to 270°C (374°F to 518°F). Composed primarily of substituted dinuclear aromatics.
295-295-8
91995-35-6
Carc. 1B; Muta. 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 from the distillation of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C16 and boiling in the range of approximately 200°C to 300°C (392°F to 572°F).
295-294-2
91995-34-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a redistillate from the fractional distillation of bituminous coal high temperature tar and residual oils that are obtained by the pyrolytic production of alkenes and alkynes from petroleum products or natural gas. It consists predominantly of indene and boils in a range of approximately 160°C to 190°C (320°F to 374°F).
295-292-1
91995-31-2
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained from the distillation of a petroleum feedstock. It consists predominantly of hydrocarbons having carbon numbers of C5 through C7, rich in C6, and boiling in the range of approximately 60°C to 70°C (140°F to 158°F).
296-903-4
93165-19-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by dewaxing heavy paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantely in the range of C20 through C50 and produces a finished oil with a viscosity of equal to or greater than 100 SUS at 100°F (19cST at 40°C). It contains relatively few normal paraffins.
292-613-7
90640-91-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by dewaxing light paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
292-614-2
90640-92-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained from an intensive treatment of dewaxed distillate by hydrogenation in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C25 through C39 and produces a finished oil with a viscosity of approximately 44cSt at 50°C.
295-300-3
91995-39-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained from an intensive treatment of dewaxed distillate by hydrogenation in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C21 through C29 and produces a finished oil with a viscosity of approximately 13cSt at 50°C.
295-301-9
91995-40-3
Carc. 1B
Details
A complex combination of hydrocarbons obtained by distillation of heat-soaked steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.
295-302-4
91995-41-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the subjection of a petroleum fraction to several of the following steps: filtration, centrifugation, atmospheric distillation, vacuum distillation, acidification, neutralization, and clay treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C20.
292-615-8
90640-93-0
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 liquid hydrocarbons obtained by recrystallization of dewaxed hydrocracked solvent-refined petroleum distillates.
295-306-6
91995-45-8
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 220°C to 450°C (428°F to 842°F). This stream is likely to contain organic sulfur compounds.
295-990-6
92201-59-7
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 190°C to 340°C (374°F to 644°F). This stream is likely to contain organic sulfur compounds.
295-991-1
92201-60-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treating a light distillate from steam-cracked naphtha. It consists predominantly of aromatic hydrocarbons.
295-311-3
91995-50-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as the raffinates from a solvent extraction process of hydrotreated light distillate from steam-cracked naphtha.
295-315-5
91995-53-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by treating dewaxed heavy paraffinic distillate with neutral or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
292-616-3
90640-94-1
Carc. 1B
Details
A complex combination of hydrocarbons resulting from treatment of dewaxed light paraffinic distillate with natural or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.
292-618-4
90640-96-3
Carc. 1B
Details
A complex combination of hydrocarbons produced by treating a dewaxed light paraffinic distillate with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.
292-620-5
90640-97-4
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 treating a petroleum fraction with hydrogen in the presence of a catalyst and removing the aromatic hydrocarbons by solvent extraction. It consists predominantly of naphthenic hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of between 13-15cSt at 40°C.
295-316-0
91995-54-9
Carc. 1B
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
202-607-8
97-77-8
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
619-290-0
97780-06-8
Eye Irrit. 2
Details
308-208-6
97925-95-6
Repr. 1B
Details
202-075-7
91-53-2
Acute Tox. 4
Details
ECPA
427-630-2
99469-99-5
Eye Dam. 1
Details
427-110-5
948991-29-5
Acute Tox. 4; STOT RE 2
Details

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