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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity not less than 100 SUS at 100°F (19cSt at 40°C).
265-169-7
64742-65-0
Carc. 1B
A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 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.
265-168-1
64742-64-9
Carc. 1B
A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-159-2
64742-56-9
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-097-6
64741-96-4
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-090-8
64741-88-4
Carc. 1B
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst and removing the aromatic hydrocarbons by solvent extraction. It consists predominantly of naphthenic hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of between 13-15cSt at 40°C.
295-316-0
91995-54-9
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19 cSt at 40°C). It contains relatively few normal paraffins.
265-098-1
64741-97-5
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-091-3
64741-89-5
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302°F to 653°F).
265-093-4
64741-91-9
Carc. 1B
270-738-8
68477-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
270-736-7
68477-53-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
270-737-2
68477-54-3
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C7 through C16 and boiling in the range of approximately 90°C to 290°C (190°F to 554°F).
265-194-3
64742-91-2
Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C7 and boiling in the range of approximately -88°C to 99°C (-127°F to 210°F).
270-077-5
68410-05-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302°F to 653°F).
265-088-7
64741-86-2
Carc. 1B
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerized C5 olefins and boiling in the range of approximately 33°C to 184°C (91°F to 363°F).
271-632-4
68603-01-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons, predominantly isoamylenes such as 2-methyl-1-butene and 2-methyl-2-butene and boiling in the range of approximately 31°C to 40°C (88°F to 104°F).
271-634-5
68603-03-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approximately 33°C to 60°C (91°F to 140°F).
271-631-9
68603-00-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and boiling in the range of approximately 270°C to 600°C (518°F to 1112°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
274-685-1
70592-78-8
Carc. 1B
A complex combination of hydrocarbons from the multiple distillation of products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C10 through C18.
270-662-5
68475-80-9
Carc. 1B
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons.
265-052-0
64741-51-1
Carc. 1A
205-259-5
149-26-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-607-8
97-77-8
Acute Tox. 4; STOT RE 2; Skin Sens. 1
206-054-3
298-04-4
Acute Tox. 1; Acute Tox. 2
233-036-2
10025-67-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
225-875-8
5131-24-8
Skin Irrit. 2; Skin Sens. 1
231-201-3
7446-18-6
Acute Tox. 2; STOT RE 1; Skin Irrit. 2
222-098-6
3347-22-6
Acute Tox. 4
206-354-4
330-54-1
Carc. 2; Acute Tox. 4; STOT RE 2
215-239-8
1314-62-1
Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3
207-944-4
502-55-6
Acute Tox. 4
208-601-1
534-52-1
Muta. 2; Acute Tox. 2; Acute Tox. 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
219-196-6
2385-85-5
Carc. 2; Repr. 2; Lact.; Acute Tox. 4
208-762-8
540-97-6
yes
214-620-6
1166-52-5
Skin Sens. 1
205-570-6
142-90-5
STOT SE 3
216-474-9
1593-77-7
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
250-778-2
31717-87-0
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
219-459-5
2439-10-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
227-197-8
5707-69-7
Acute Tox. 3
200-449-4
60-00-4
Eye Irrit. 2
241-178-1
17109-49-8
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
204-079-4
115-29-7
Acute Tox. 2; Acute Tox. 4
205-660-5
145-73-3
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-959-8
129-67-9
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
220-472-3
2778-04-3
Acute Tox. 3
200-775-7
72-20-8
Acute Tox. 2; Acute Tox. 3
206-080-5
299-42-3
Acute Tox. 4
212-073-8
759-94-4
Acute Tox. 4
200-014-9
50-14-6
Acute Tox. 2; Acute Tox. 3; STOT RE 1

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