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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 lipnja 2024. Database contains 4821 unique substances/entries.
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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
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
231-556-4
7632-04-4
yes
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
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
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
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 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
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
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
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
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
231-722-6
7704-34-9
Skin Irrit. 2
263-467-1
62229-08-7
yes
226-218-8
5329-14-6
Eye Irrit. 2; Skin Irrit. 2
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
231-195-2
7446-09-5
Press. Gas; Acute Tox. 3; Skin Corr. 1B
231-639-5
7664-93-9
Skin Corr. 1A
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
220-281-5
2699-79-8
Press. Gas; Acute Tox. 3; STOT RE 2

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