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 lipnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons produced by the distillation of the products from a steam cracking process thereafter treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers in the range of C9 through C10 and boiling in the range of approximately 140°C to 200°C (284°F to 392°F).
292-637-8
90641-13-7
Asp. Tox. 1
Details
The residue remaining from the distillation of recovered naphtha. Composed primarily of naphthalene and condensation products of indene and styrene.
292-636-2
90641-12-6
Carc. 1B; Muta. 1B
Details
The volatile organic liquid condensed from the gas evolved in the low-temperature (less than 700°C (1292°F)) destructive distillation of coal. Composed primarily of C6-10 hydrocarbons.
292-635-7
90641-11-5
Carc. 1B; Muta. 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 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 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
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
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 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 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 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 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 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
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
A complex combination of hydrocarbons produced by the distillation of the products from a steam cracking process treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly greater than C10 and boiling in the range of approximately 150°C to 320°C (302°F to 608°F).
292-621-0
90640-98-5
Asp. Tox. 1
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 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 dewaxed heavy paraffinic distillate with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
292-617-9
90640-95-2
Carc. 1B
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 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 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 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
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 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 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
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
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
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
Details
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
292-602-7
90640-80-5
Carc. 1B
C Carcinogenic (article 57a)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
292-454-3
90622-53-0
Carc. 1B
Details
291-844-0
90481-04-2
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
289-339-5
87741-01-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30°C to 260°C (86°F to 500°F).
289-220-8
86290-81-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
287-504-6
85536-22-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-502-5
85536-20-5
Carc. 1B; Muta. 1B
Details
287-500-4
85536-19-2
Carc. 1B; Muta. 1B
Details
287-498-5
85536-17-0
Carc. 1B; Muta. 1B
Details
287-477-0
85535-85-9
Lact.
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-476-5
85535-84-8
Carc. 2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-471-8
85508-46-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
287-469-7
85508-44-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
287-468-1
85508-43-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
287-196-3
85422-92-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
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.
285-555-9
85117-03-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained from the distillation of a petroleum fraction. It consists predominantly of alkanes and cycloalkanes boiling in the range of approximately minus 20°C to 190°C (-4°F to 374°F).
285-512-4
85116-61-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by fractionation of hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23°C to 195°C (73°F to 383°F).
285-511-9
85116-60-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66°C to 121°C (151°F to 250°F).
285-510-3
85116-59-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 160°C to 180°C (320°F to 356°F).
285-509-8
85116-58-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by fractionation from catalytically reformed hydrodesulfurized naphtha. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 to C13 and boiling in the range of approximately 98°C to 218°C (208°F to 424°F).
285-508-2
85116-57-0
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons predominantly in the range of C8 to C16 and boiling in the range of approximately 120°C to 283°C (284°F to 541°F).
285-507-7
85116-55-8
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to C25 and boiling in the range of approximately 205° C to 400°C (401°F to 752°F).
285-505-6
85116-53-6
Carc. 1B
Details
285-195-2
85049-26-9
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.
285-098-5
85029-74-9
Carc. 1B
Details
The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148°C (298°F).
285-076-5
85029-51-2
Carc. 1B; Muta. 1B
Details
The extract oil boiling in the range of approximately 220°C to 265°C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.
284-901-6
84989-12-8
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from coal tar. It consists of aromatic and polycyclic hydrocarbons, primarily fluorene and acenaphthene.
284-900-0
84989-11-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.
284-899-7
84989-10-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by crystallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.
284-898-1
84989-09-3
Carc. 1B; Muta. 1B
Details
The fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distillation of low-temperature coal tar acids.
284-896-0
84989-07-1
Carc. 1B; Muta. 1B
Details
The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-895-5
84989-06-0
Carc. 1B; Muta. 1B
Details
The fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225°C to 320°C (437°F to 608°F). Composed primarily of polyalkylphenols.
284-893-4
84989-05-9
Carc. 1B; Muta. 1B
Details
The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-892-9
84989-04-8
Carc. 1B; Muta. 1B
Details
The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-891-3
84989-03-7
Carc. 1B; Muta. 1B
Details
The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700°C (1292°F)) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols.
284-881-9
84988-93-2
Carc. 1B; Muta. 1B
Details
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
284-349-6
84852-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
284-032-2
84777-06-0
Repr. 1B
R Toxic for reproduction (article 57c)
Details
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
283-931-7
84776-07-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
283-930-1
84776-06-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Azadirachta indica, Meliaceae.
283-644-7
84696-25-3
Repr. 2; Skin Sens. 1
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills in the approximate range of 200°C to 250°C (392°F to 482°F).
283-484-8
84650-04-4
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150°C to 210°C (302°F to 410°F).
283-483-2
84650-03-3
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
Details
282-714-4
84332-86-5
Carc. 2
Details
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
282-263-3
84145-37-9
Flam. Liq. 3
Details
281-985-6
84082-38-2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
Details
280-084-5
82985-35-1
Eye Dam. 1
Details
279-452-8
80387-97-9
Repr. 1B; Skin Sens. 1
Details
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
Details
278-355-8
75980-60-8
Repr. 1B; Skin Sens. 1B
R Toxic for reproduction (article 57c)
Details
278-305-5
75768-65-9
Repr. 1B
Details
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details

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