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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
231-633-2
7664-38-2
Skin Corr. 1B
233-663-1
10294-56-1
Acute Tox. 4; Skin Corr. 1A
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
215-236-1
1314-56-3
Skin Corr. 1A
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
200-332-8
57-47-6
Acute Tox. 2
202-128-4
92-13-7
Acute Tox. 2
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
245-430-1
23103-98-2
Carc. 2; Acute Tox. 3; Skin Sens. 1
245-704-0
23505-41-1
Acute Tox. 3; Acute Tox. 4
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.
292-653-5
90669-58-2
Carc. 1B
The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C (158°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-654-0
90669-59-3
Carc. 1B
A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40°C to 180°C (104°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-651-4
90669-57-1
Carc. 1B
The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (104°F to 356°F). Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.
269-109-0
68187-57-5
Carc. 1B
263-072-4
61789-60-4
Carc. 1B
215-648-1
1336-36-3
STOT RE 2
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
246-376-1
24634-61-5
Eye Irrit. 2
266-578-3
67118-55-2
yes
233-002-7
10007-85-9
Eye Irrit. 2
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
209-676-3
590-28-3
Acute Tox. 4
231-906-6
7778-50-9
Ox. Sol. 2; 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
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
232-151-5
7789-23-3
Acute Tox. 3
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
234-329-8
11103-86-9
yes
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
223-393-2
3871-99-6
yes
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.

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