EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 23 srpnja 2024. Database contains 4821 unique substances/entries.
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232-966-6
9068-59-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
232-734-4
9012-54-8
Resp. Sens. 1
232-671-2
9004-07-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-650-8
9002-07-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-645-0
9001-98-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-629-3
9001-75-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-627-2
9001-73-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-599-1
9001-33-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-589-7
9001-22-3
Resp. Sens. 1
232-572-4
9001-00-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
232-565-6
9000-90-2
Resp. Sens. 1
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
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
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
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
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
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
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
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
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
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
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
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
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
232-283-3
8001-35-2
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
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
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
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
232-189-2
7789-78-8
Water-react. 1
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
232-151-5
7789-23-3
Acute Tox. 3
232-149-4
7789-21-1
Acute Tox. 4; Skin Corr. 1A
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
yes
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
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
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
232-089-9
7785-87-7
STOT RE 2
232-066-3
7784-42-1
Flam. Gas 1; Press. Gas; Acute Tox. 2; STOT RE 2
232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
yes
232-009-2
7783-56-4
Acute Tox. 3
231-977-3
7783-06-4
Flam. Gas 1; Press. Gas; Acute Tox. 2
231-959-5
7782-50-5
Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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