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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 svibnja 2024. Database contains 4821 unique substances/entries.
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205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
220-623-3
2836-04-6
Acute Tox. 3
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
429-640-2
52870-46-9
Eye Irrit. 2
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
423-840-3
14691-89-5
Acute Tox. 4
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
UM-229
407-070-5
142859-67-4
Skin Sens. 1
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
UC-129
403-790-9
108673-51-4
Skin Sens. 1
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
211-952-3
719-96-0
Skin Irrit. 2
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
NOP; SURFADONE LP-100 SURFACTANT
403-700-8
2687-94-7
Skin Corr. 1B
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
DS 100
415-060-7
1379678-87-1
Eye Dam. 1; Skin Sens. 1
423-530-8
152828-23-4
STOT RE 1; Acute Tox. 4
BENZANILID-DISPERSE-INTERMEDIATE ZP 9955
411-590-8
70693-57-1
Skin Corr. 1B
427-880-2
90357-53-2
STOT RE 2
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
429-120-5
208535-04-0
Eye Dam. 1
425-300-2
186450-73-7
Skin Sens. 1
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
209-669-5
590-01-2
Flam. Liq. 3
EP 389
407-730-2
104958-67-0
Eye Irrit. 2; Skin Sens. 1
DISPERSOL YELLOW XF
407-970-8
75511-91-0
Skin Sens. 1
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
PREVENTOL VP OC 3061
423-990-1
149118-66-1
Acute Tox. 4; Eye Dam. 1
202-411-2
95-33-0
Skin Sens. 1
DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE
421-130-8
156679-41-3
Eye Dam. 1; Skin Sens. 1
220-250-6
2687-91-4
Repr. 1B
437-720-3
227085-51-0
Eye Dam. 1
CATALYST 4017
407-780-5
4186-71-4
Acute Tox. 4
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
DTBA
401-980-6
-
Skin Irrit. 2; Skin Sens. 1
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
N-HEXYLLITHIUM
404-950-0
21369-64-2
Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
817-852-1
1228284-64-7
Carc. 2; Repr. 2
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
N-METHYL-4-(P-FORMYLSTYRYL)-PYRIDINIUM METHYLSULFATE; SBQ; SBQ-SALZ
418-240-3
74401-04-0
Skin Sens. 1
211-795-0
696-44-6
Acute Tox. 3; STOT RE 2
207-531-9
479-45-8
Expl. 1.1; Acute Tox. 3; STOT RE 2
429-340-1
186295-11-4
Acute Tox. 4; Eye Dam. 1
210-260-9
611-21-2
Acute Tox. 3; STOT RE 2
210-769-6
623-08-5
Acute Tox. 3; STOT RE 2
201-182-6
79-16-3
Repr. 1B
yes
202-870-9
100-61-8
Acute Tox. 3; STOT RE 2
424-460-0
283167-56-6
Acute Tox. 4; Skin Sens. 1
204-624-6
123-39-7
Repr. 1B; Acute Tox. 4
431-060-1
153719-38-1
Acute Tox. 4; Skin Sens. 1
-
-
Repr. 1B
688-331-2
874967-67-6
Carc. 2
426-150-0
121246-28-4
Skin Sens. 1
218-130-3
2051-79-8
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
205-547-0
142-59-6
Acute Tox. 4; STOT SE 3; Skin Sens. 1
-
-
P Parasites
206-098-3
300-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
The residue remaining from the distillation of recovered naphtha. Composed primarily of naphthalene and condensation products of indene and styrene.
292-636-2
90641-12-6
Carc. 1B; Muta. 1B
Fraction of the distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 180°C (86°F to 356°F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 to C9. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.
302-690-1
94114-54-2
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately minus 10°C to 230°C (14°F to 446°F).
265-089-2
64741-87-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
271-635-0
68603-08-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-185-8
68783-09-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the catalytic dewaxing of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35°C to 230°C (95°F to 446°F).
265-170-2
64742-66-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by fractionation from catalytically reformed hydrodesulfurized naphtha. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 to C13 and boiling in the range of approximately 98°C to 218°C (208°F to 424°F).
285-508-2
85116-57-0
Asp. Tox. 1
A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66°C to 121°C (151°F to 250°F).
285-510-3
85116-59-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30°C to 220°C (90°F to 430°F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.
273-271-8
68955-35-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 230°C (149°F to 446°F).
265-122-0
64742-22-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately minus 20°C to 190°C (-4°F to 374°F).
265-123-6
64742-23-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons resulting from treatment of full-range straight-run naphtha with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately -20°C to 220°C (-4°F to 429°F).
271-262-3
68527-21-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons resulting from treatment of light straight-run naphtha with a natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 93°C to 180°C (200°F to 356°F).
271-263-9
68527-22-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 with some butanes and boiling in the range of approximately 35°C to 200°C (95°F to 428°F).
271-267-0
68527-27-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated 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).
265-066-7
64741-64-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of products from a fluid coker. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C15 and boiling in the range of approximately 43°C to 250°C(110°F-500°F).
270-991-4
68513-02-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of the products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35°C to 230°C (95°F to 446°F).
272-895-8
68919-37-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately minus 20°C to 220°C (-4°F to 428°F).
265-042-6
64741-42-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 to C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 150°C to 220°C (302°F to 428°F).
265-067-2
64741-65-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a catalytic cracked petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 60°C to 200°C (140°F to 392°F).
295-431-6
92045-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by a distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 230°C (148°F to 446°F). It contains a relatively large proportion of unsaturated hydrocarbons.
265-055-7
64741-54-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-070-9
64741-68-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from the distillation of products from a fluid coker. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C6 through C15 and boiling in the range of approximately 157°C to 288°C (315°F to 550°F).
269-778-9
68333-23-3
Asp. Tox. 1
A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12, and boiling in the range of approximately 65°C to 230°C (148°F to 446°F).
265-079-8
64741-78-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from a distillation process of crude petroleum. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
309-945-6
101631-20-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 230°C (149°F to 446°F).
265-041-0
64741-41-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 220°C (148°F to 428°F).
265-085-0
64741-83-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23°C to 196°C (73°F to 385°F).
309-879-8
101316-76-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30°C to 250°C (86°F to 482°F).
295-433-7
92045-52-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of hydrodesulfurized and dearomatized light petroleum fractions. It consists predominantly of C7 paraffins and cycloparaffins boiling in a range of approximately 90°C to 100°C (194°F to 212°F).
295-434-2
92045-53-9
Carc. 1B; Muta. 1B; Asp. Tox. 1

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