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 12 srpnja 2024. Database contains 4917 unique substances/entries.
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A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
232-489-3
8052-41-3
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1
Details
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
Skin Sens. 1
Details
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
Skin Sens. 1
Details
A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20°C to 135°C (58°F to 275°F).
232-453-7
8032-32-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
Refined, partly refined, or unrefined petroleum products produced by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 100°C to 200°C (212°F to 392°F).
232-443-2
8030-30-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
R Toxic for reproduction (article 57c)
Details
A complex combination of hydrocarbons obtained as a semi-solid from dewaxing paraffinic residual oil. It consists predominantly of saturated crystalline and liquid hydrocarbons having carbon numbers predominantly greater than C25.
232-373-2
8009-03-8
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 150°C to 290°C (320°F to 554°F).
232-366-4
8008-20-6
Asp. Tox. 1
Details
The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.
232-361-7
8007-45-2
Carc. 1A
Details
Any of the volatile predominately terpenic fractions or distillates resulting from the solvent extraction of, gum collection from, or pulping of softwoods. Composed primarily of the C10H16 terpene hydrocarbons: α-pinene, β-pinene, limonene, 3-carene, camphene. May contain other acyclic, monocyclic, or bicyclic terpenes, oxygenated terpenes, and anethole. Exact composition varies with refining methods and the age, location, and species of the softwood source.
232-350-7
8006-64-2
Flam. Liq. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 20°C to 120°C (-4°F to 248°F).
232-349-1
8006-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons. It consists predominantly of aliphatic, alicyclic and aromatic hydrocarbons. It may also contain small amounts of nitrogen, oxygen and sulfur compounds. This category encompasses light, medium, and heavy petroleums, as well as the oils extracted from tar sands. Hydrocarbonaceous materials requiring major chemical changes for their recovery or conversion to petroleum refinery feedstocks such as crude shale oils, upgraded shale oils and liquid coal fuels are not included in this definition.
232-298-5
8002-05-9
Carc. 1B
Details
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
Details
232-283-3
8001-35-2
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
Details
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
Details
232-259-2
7803-49-8
Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
232-259-2
7803-49-8
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
Details
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
Details
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
Details
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
Details
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
Details
232-189-2
7789-78-8
Water-react. 1
Details
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
Details
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
Details
232-151-5
7789-23-3
Acute Tox. 3
Details
232-149-4
7789-21-1
Acute Tox. 4; Skin Corr. 1A
Details
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
C Carcinogenic (article 57a)
Details
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details
232-104-9
7786-81-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
Details
232-089-9
7785-87-7
STOT RE 2
Details
232-066-3
7784-42-1
Flam. Gas 1; Press. Gas; Acute Tox. 2; STOT RE 2
Details
232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
232-009-2
7783-56-4
Acute Tox. 3
Details
231-977-3
7783-06-4
Press. Gas; Acute Tox. 2
Details
231-959-5
7782-50-5
Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
231-957-4
7782-49-2
Acute Tox. 3; STOT RE 2
Details
231-956-9
7782-44-7
Ox. Gas 1; Press. Gas
Details
231-954-8
7782-41-4
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1A
Details
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
Details
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
231-908-7
7778-54-3
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1B
Details
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
231-904-5
7778-44-1
C Carcinogenic (article 57a)
Details
231-901-9
7778-39-4
C Carcinogenic (article 57a)
Details
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
Details
231-889-5
7775-11-3
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
231-887-4
7775-09-9
Ox. Sol. 1; Acute Tox. 3
Details

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