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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.
310-166-9
121620-47-1
Carc. 1B; Muta. 1B
The product obtained by treatment of coal tar oil alkaline extract with CO2 and CaO. Composed primarily of CaCO3, Ca(OH)2, Na2CO3 and other organic and inorganic impurities.
292-629-4
90641-06-8
Carc. 1B; Muta. 1B
The residue obtained from chemical oil extracted after the removal of naphthalene by distillation composed primarily of two to four membered condensed ring aromatic hydrocarbons and aromatic nitrogen bases.
277-567-8
73665-18-6
Carc. 1B; Muta. 1B
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
A complex combination of hydrocarbons obtained by the treatment of heavy naphthic solvent petroleum extract with bleaching earth. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C10 and boiling in the range of approximately 80°C to 180°C (175°F to 356°F).
308-261-5
97926-43-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as the extract from the solvent extraction of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C8 and boiling in the range of approximately 100°C to 200°C (212°F to 392°F).
295-331-2
91995-68-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of organic compounds produced by cold acid unit extraction of saturated and unsaturated aliphatic hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly pentanes and amylenes. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.
270-741-4
68477-61-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 220°C (194°F to 428°F).
265-099-7
64741-98-6
Asp. Tox. 1
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-111-0
64742-11-6
Carc. 1B
An aromatic concentrate produced by adding water to heavy naphthenic distillate solvent extract and extraction solvent.
272-175-3
68783-00-6
Carc. 1B
A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40°C.
297-827-4
93763-10-1
Carc. 1B
A complex combination of hydrocarbons obtained by treating a heavy naphthenic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of at least 19cSt at 40°C (100 SUS at 100°F).
292-631-5
90641-07-9
Carc. 1B
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-103-7
64742-04-7
Carc. 1B
A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contact or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more 4-6 membered ring aromatic hydrocarbons.
296-437-1
92704-08-0
Carc. 1B
A complex combination of hydrocarbons produced by treating a heavy paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C21 through C33 and boiling in the range of approximately 350°C to 480°C (662°F to 896°F).
292-632-0
90641-08-0
Carc. 1B
A complex combination of hydrocarbons obtained as the extract from a solvent extraction of heavy paraffinic distillate.
272-342-0
68814-89-1
Carc. 1B
A complex combination of hydrocarbons obtained as the extract from solvent extraction of intermediate paraffinic top solvent distillate that is treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
295-335-4
91995-73-2
Carc. 1B
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-102-1
64742-03-6
Carc. 1B
A complex combination of hydrocarbons obtained by treating the extract, obtained from a solvent extraction process, with hydrogen in the presence of a catalyst under conditions primarily to remove sulfur compounds. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
295-338-0
91995-75-4
Carc. 1B
A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C15 through C30. This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-104-2
64742-05-8
Carc. 1B
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-672-2
100684-02-4
Carc. 1B
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-673-8
100684-03-5
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction of a light paraffin distillate and treated with hydrogen to convert the organic sulfur to hydrogen sulfide which is eliminated. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C40 and produces a finished oil with a viscosity of greater than 10cSt at 40°C.
295-340-1
91995-77-6
Carc. 1B
A complex combination of hydrocarbons produced by treating a light paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C26 and boiling in the range of approximately 280° to 400°C (536°F to 752°F).
292-633-6
90641-09-1
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction from light vacuum petroleum gas oil. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-341-7
91995-78-7
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oils treated with bleaching earth for removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-675-9
100684-05-7
Carc. 1B
A complex combination of hydrocarbons, obtained by solvent extraction from light vacuum petroleum gas oils and treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
295-342-2
91995-79-8
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction of light vacuum petroleum gas oil treated with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C13 through C30.
309-674-3
100684-04-6
Carc. 1B
A complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40°C.
297-829-5
93763-11-2
Carc. 1B
A complex combination of hydrocarbons obtained as the extract from the re-extraction of solvent-refined heavy paraffinic distillate. It consists of saturated and aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
272-180-0
68783-04-0
Carc. 1B
A complex combination of hydrocarbons obtained as a fraction of the distillation of an extract from the solvent extraction of light paraffinic top petroleum distillates that is subjected to a sulfuric acid refining. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
295-339-6
91995-76-5
Carc. 1B
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
603-520-1
131807-57-3
STOT RE 2
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
292-966-7
91031-62-8
yes
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
294-302-1
91697-41-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
294-785-9
91770-03-5
Skin Irrit. 2
205-419-4
140-56-7
Acute Tox. 3; Acute Tox. 4
244-848-1
22224-92-6
Acute Tox. 2; Eye Irrit. 2
262-095-7
60168-88-9
Repr. 2; Lact.
238-134-9
14255-88-0
Acute Tox. 4
MAGISTER* F ACARICIDAL CHEMICAL
410-580-0
120928-09-8
Acute Tox. 3; Acute Tox. 4
236-407-7
13356-08-6
Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
206-082-6
299-84-3
Acute Tox. 4
204-524-2
122-14-5
Acute Tox. 4
223-188-8
3766-81-2
Acute Tox. 4
202-271-2
93-72-1
Acute Tox. 4; Skin Irrit. 2
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
276-696-7
72490-01-8
Carc. 2
254-485-0
39515-41-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
200-231-9
55-38-9
Muta. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1
212-984-0
900-95-8
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-990-6
76-87-9
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
232-599-1
9001-33-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
FLOCOUMAFEN
421-960-0
90035-08-8
Repr. 1B; Acute Tox. 1; STOT RE 1
605-127-0
158062-67-0
Acute Tox. 4
274-125-6
69806-50-4
Repr. 1B
616-669-2
79241-46-6
Repr. 2
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
253-703-1
37893-02-0
Eye Irrit. 2
-
4301-50-2
Acute Tox. 1; Acute Tox. 2
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
FLUFENOXURON
417-680-3
101463-69-8
Lact.
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
600-425-7
103361-09-7
Repr. 2
205-912-4
206-44-0
yes
231-954-8
7782-41-4
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1A
-
-
Acute Tox. 2
205-631-7
144-49-0
Acute Tox. 2
240-898-3
16872-11-0
Skin Corr. 1B
-
-
Acute Tox. 4
241-034-8
16961-83-4
Skin Corr. 1B
232-149-4
7789-21-1
Acute Tox. 4; Skin Corr. 1A
243-547-2
20153-50-8
Acute Tox. 4
243-546-7
20153-49-5
Acute Tox. 4
FLUQUINCONAZOLE
411-960-9
136426-54-5
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Irrit. 2
262-661-3
61213-25-0
Repr. 1B; Acute Tox. 4; Skin Sens. 1
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
276-439-9
72178-02-0
Acute Tox. 4
213-408-0
944-22-9
Acute Tox. 1; Acute Tox. 2
A complex combination of hydrocarbons obtained by treatment of Foot's oil with sulfuric acid. It consists predominantly of branched-chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-225-7
93924-31-3
Flam. Gas 1; Press. Gas; Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of Foots oil with activated carbon for the removal of trace constituents and impurities. It consists predominantly of saturated straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-126-0
97862-76-5
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of branched chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-226-2
93924-32-4
Flam. Gas 1; Press. Gas; Carc. 1B
295-394-6
92045-12-0
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of Foots oil with silicic acid for removal of trace constituents and impurities. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-127-6
97862-77-6
Carc. 1B
A complex combination of hydrocarbons obtained as the oil fraction from a solvent deoiling or a wax sweating process. It consists predominantly of branched chain hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
265-171-8
64742-67-2
Carc. 1B
614-346-0
68157-60-8
Carc. 2
200-001-8
50-00-0
Carc. 1B; Muta. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
500-036-1
25214-70-4
yes
300-298-5
93925-00-9
yes
294-145-9
91673-30-2
Skin Sens. 1
200-842-0
75-12-7
Repr. 1B
yes

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