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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 22 srpnja 2024. Database contains 4821 unique substances/entries.
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418-410-7
139122-78-4
Eye Irrit. 2
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
-
4312-97-4
Acute Tox. 4
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
BISULPHITE ADDUCT; GR59658A
406-190-5
54322-20-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
425-460-3
1379676-84-2
Skin Sens. 1
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
247-852-1
26628-22-8
Acute Tox. 2
LU20
405-450-5
66531-87-1
Skin Sens. 1
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
207-838-8
497-19-8
Eye Irrit. 2
231-887-4
7775-09-9
Ox. Sol. 1; Acute Tox. 4
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
yes
213-030-6
917-61-3
Acute Tox. 4
616-541-6
7789-12-0
yes
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
231-587-3
7646-69-7
Water-react. 1
231-665-7
7681-38-1
Eye Dam. 1
231-548-0
7631-90-5
Acute Tox. 4
215-185-5
1310-73-2
Skin Corr. 1A
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1
231-673-0
7681-57-4
Acute Tox. 4; Eye Dam. 1
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
218-953-8
2302-17-2
Skin Sens. 1
274-357-8
70161-44-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
231-555-9
7632-00-0
Ox. Sol. 3; Acute Tox. 3
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
239-172-9
15120-21-5
yes
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-511-9
7601-89-0
Ox. Sol. 1; Acute Tox. 4
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
-
-
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
-
-
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-556-4
7632-04-4
yes
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
435-350-7
141250-43-3
Eye Dam. 1
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
219-007-7
2312-76-7
Acute Tox. 3; STOT RE 2
233-267-9
10102-18-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
287-500-4
85536-19-2
Carc. 1B; Muta. 1B
287-498-5
85536-17-0
Carc. 1B; Muta. 1B
287-502-5
85536-20-5
Carc. 1B; Muta. 1B
The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130°C to 210°C (266°F to 410°F) Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.
266-013-0
65996-79-4
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C11 through C16 and boiling in the range of approximately 190°C to 290°C (374°F to 554°F).
265-200-4
64742-96-7
Asp. Tox. 1
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 165°C to 290°C (330°F to 554°F).
265-198-5
64742-94-5
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235°C to 290°C (455°F to 554°F).
309-881-9
101316-80-7
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180°C to 240°C (356°F to 464°F).
309-882-4
101316-81-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175°C to 220°C (347°F to 428°F).
309-884-5
101316-82-9
Asp. Tox. 1
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73°C to 85°C (163°F to 185°F).
295-529-9
92062-15-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 35°C to 160°C (95°F to 320°F).
265-192-2
64742-89-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C(275°F to 410°F).
270-988-8
68512-78-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C (275°F to 410°F).
265-199-0
64742-95-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
265-191-7
64742-88-7
STOT RE 1; Asp. Tox. 1
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
-
-
F Fungi
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
B Bacteria and similar species
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
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
P Parasites
-
-
P Parasites
427-930-3
250639-69-1
Skin Sens. 1
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
269-710-8
68310-42-9
Acute Tox. 2
269-439-5
68239-26-9
Acute Tox. 2
200-319-7
57-24-9
Acute Tox. 1; Acute Tox. 2
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
STYRENE SULPHONYL CHLORIDE
404-770-2
2633-67-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
807-366-8
946578-00-3
Acute Tox. 4
231-722-6
7704-34-9
Skin Irrit. 2
616-572-5
7790-84-3
yes

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