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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 30 kolovoza 2024. Database contains 4821 unique substances/entries.
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282-714-4
84332-86-5
Carc. 2
231-801-5
7738-94-5
yes
215-607-8
1333-82-0
Ox. Sol. 1; Carc. 1A; Muta. 1B; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
yes
239-056-8
14977-61-8
Ox. Liq. 1; Carc. 1B; Muta. 1B; Skin Corr. 1A; Skin Sens. 1
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
208-545-8
532-82-1
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
264-409-8
63681-54-9
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
207-803-7
495-54-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2
232-671-2
9004-07-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
246-948-0
25402-06-6
Acute Tox. 4
204-454-2
121-20-0
Acute Tox. 4
216-906-6
1694-82-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
231-187-9
7443-70-1
Acute Tox. 4
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
205-859-7
156-59-2
Flam. Liq. 2; Acute Tox. 4
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
242-161-1
18283-82-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-064-6
64741-62-4
Carc. 1B
A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-782-0
68333-26-6
Carc. 1B
216-935-4
1702-17-6
Eye Dam. 1
204-385-8
120-32-1
Carc. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1; Eye Dam. 1; STOT RE 2
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
215-273-3
1317-42-6
Skin Sens. 1
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
231-842-9
7758-89-6
Acute Tox. 4
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
204-810-7
126-90-9
Skin Sens. 1B
201-378-1
81-82-3
STOT RE 2
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
200-285-3
56-72-4
Acute Tox. 2; Acute Tox. 4
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
208-622-6
535-89-7
Acute Tox. 2
224-030-0
4170-30-3
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
231-720-5
7700-17-6
Acute Tox. 3
206-083-1
299-86-5
Acute Tox. 4
202-704-5
98-82-8
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
206-992-3
420-04-2
Carc. 2; Repr. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1; Skin Sens. 1; Eye Dam. 1
244-544-9
21725-46-2
Acute Tox. 4
220-130-3
2636-26-2
Acute Tox. 4
223-099-4
3734-95-0
Acute Tox. 2; Acute Tox. 3
203-806-2
110-82-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
203-631-1
108-94-1
Flam. Liq. 3; Acute Tox. 4
235-527-7
12262-58-7
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
235-527-7
12262-58-7
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
203-629-0
108-91-8
Flam. Liq. 3; Repr. 2; Acute Tox. 4; Skin Corr. 1B
220-279-4
2699-11-8
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
220-279-4
2699-11-8
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
206-016-6
287-92-3
Flam. Liq. 2
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
204-435-9
120-92-3
Flam. Liq. 3; Eye Irrit. 2; Skin Irrit. 2
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
269-855-7
68359-37-5
Acute Tox. 2; Acute Tox. 3
269-855-7
68359-37-5
Acute Tox. 2
236-049-1
13121-70-5
Acute Tox. 4
261-043-0
57966-95-7
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; STOT RE 2
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
218-827-2
2244-16-8
Skin Sens. 1
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
201-248-4
80-08-0
Acute Tox. 4
208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
208-764-9
541-02-6
yes
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
258-256-6
52918-63-5
Acute Tox. 3
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3

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