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 22 srpnja 2024. Database contains 4917 unique substances/entries.
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T 1569; T001569
423-290-4
66938-41-8
Muta. 2
Details
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
Details
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
Details
LU20
405-450-5
66531-87-1
Skin Sens. 1
Details
266-362-9
66441-23-4
Skin Sens. 1
Details
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
Details
613-911-9
66230-04-4
Acute Tox. 3; STOT SE 1; STOT RE 2; Skin Sens. 1
Details
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
Details
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
Details
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
Details
200-629-2
66-71-7
Acute Tox. 3
Details
200-628-7
66-56-8
Acute Tox. 3; STOT RE 2
Details
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
C Carcinogenic (article 57a)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
The distillate from coal tar having an approximate distillation range of 100°C to 450°C (212°F to 842°F). Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.
266-027-7
65996-92-1
Carc. 1B
Details
The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.
266-026-1
65996-91-0
Carc. 1B
Details
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.
266-025-6
65996-90-9
Carc. 1A
Details
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
266-024-0
65996-89-6
Carc. 1A
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
The residue obtained from coal tar oil by an alkaline wash such as aqueous sodium hydroxide after the removal of crude coal tar acids. Composed primarily of naphthalenes and aromatic nitrogen bases.
266-021-4
65996-87-4
Carc. 1B; Muta. 1B
Details
The extract from coal tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.
266-020-9
65996-86-3
Carc. 1B; Muta. 1B
Details
The reaction product obtained by neutralizing coal tar oil alkaline extract with an acidic solution, such as aqueous sulfuric acid, or gaseous carbon dioxide, to obtain the free acids. Composed primarily of tar acids such as phenol, cresols, and xylenols.
266-019-3
65996-85-2
Carc. 1B; Muta. 1B
Details
The reaction product obtained by neutralizing coal tar base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.
266-018-8
65996-84-1
Carc. 1B; Muta. 1B
Details
The extract from coal tar oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
266-017-2
65996-83-0
Carc. 1B; Muta. 1B
Details
The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C (266°F to 410°F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.
266-016-7
65996-82-9
Carc. 1B; Muta. 1B
Details
The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130°C to 210°C (266°F to 410°F) Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.
266-013-0
65996-79-4
Carc. 1B; Muta. 1B
Details
The volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents.
266-012-5
65996-78-3
Carc. 1B; Muta. 1B
Details
265-974-3
65907-30-4
Acute Tox. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
211-535-6
659-49-4
Acute Tox. 4
Details
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
Details
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
Details
MEM
418-250-8
65756-41-4
Muta. 2
Details
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
Details
433-490-3
6563-83-3
Skin Sens. 1
Details
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
CIB R634
406-220-7
65322-65-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
265-697-8
65321-67-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
265-667-4
65277-42-1
Repr. 1B; Acute Tox. 3; STOT RE 2
Details
BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
407-130-0
65232-89-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
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65229-23-4
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
Skin Irrit. 2; Eye Dam. 1
Details
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
Details
265-610-3
65195-55-3
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
Details
211-479-2
650-51-1
STOT SE 3
Details
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
Details
265-294-7
64969-36-4
Carc. 1B; Acute Tox. 4
Details
420-370-0
6485-67-2
Eye Irrit. 2; Skin Sens. 1
Details
229-352-5
6485-40-1
Skin Sens. 1
Details
229-335-2
6477-64-1
R Toxic for reproduction (article 57c)
Details
A complex combination of organic compounds, predominantly high molecular weight carboxylic acids, obtained by the air oxidation of petrolatum.
265-206-7
64743-01-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C11 through C16 and boiling in the range of approximately 190°C to 290°C (374°F to 554°F).
265-200-4
64742-96-7
Asp. Tox. 1
Details

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