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 24 svibnja 2024. Database contains 4917 unique substances/entries.
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205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
Details
210-322-5
612-82-8
Carc. 1B; Acute Tox. 4
Details
277-985-0
74753-18-7
Carc. 1B; Acute Tox. 4
Details
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
C Carcinogenic (article 57a)
Details
237-366-8
13765-19-0
Carc. 1B; Acute Tox. 4
Details
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
Details
210-698-0
621-64-7
Carc. 1B; Acute Tox. 4
Details
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-
Carc. 1B; Acute Tox. 4
Details
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-
Carc. 1B; Acute Tox. 4
Details
-
-
Carc. 1B; Acute Tox. 4
Details
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
C Carcinogenic (article 57a)
Details
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
Details
202-805-4
99-97-8
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT RE 2
Details
202-496-6
96-29-7
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3; STOT SE 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
208-953-6
548-62-9
Carc. 1B; Acute Tox. 4; Eye Dam. 1
Details
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
Details
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
200-541-4
62-55-5
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
433-580-2
214353-17-0
Carc. 1B; Acute Tox. 4; Skin Corr. 1B
Details
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
Details
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
C Carcinogenic (article 57a)
Details
FAP
402-230-0
399-95-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
Details
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-
Carc. 1B; Acute Tox. 4; Skin Sens. 1
Details
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
Details
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
Details
A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-275-9
91995-15-2
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 hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
295-278-5
91995-17-4
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
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
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120°C to 215°C (248°F to 419°F).
295-281-1
91995-20-9
Carc. 1B; Muta. 1B
Details
292-694-9
90989-38-1
Carc. 1B; Muta. 1B
Details
295-551-9
92062-36-7
Carc. 1B; Muta. 1B
Details
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
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
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 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 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 crystallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.
284-898-1
84989-09-3
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
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 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
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

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