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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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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
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
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
EP 389
407-730-2
104958-67-0
Eye Irrit. 2; Skin Sens. 1
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
PREVENTOL VP OC 3061
423-990-1
149118-66-1
Acute Tox. 4; Eye Dam. 1
DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE
421-130-8
156679-41-3
Eye Dam. 1; Skin Sens. 1
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
817-852-1
1228284-64-7
Carc. 2; Repr. 2
429-340-1
186295-11-4
Acute Tox. 4; Eye Dam. 1
202-870-9
100-61-8
Acute Tox. 3; STOT RE 2
204-624-6
123-39-7
Repr. 1B; Acute Tox. 4
431-060-1
153719-38-1
Acute Tox. 4; Skin Sens. 1
426-150-0
121246-28-4
Skin Sens. 1
205-547-0
142-59-6
Acute Tox. 4; STOT SE 3; Skin Sens. 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 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 by subjecting a petroleum naphtha 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 C5 through C8 and boiling in the range of approximately 20°C to 130°C (68°F to 266°F).
309-976-5
101795-01-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
215-657-0
1338-02-9
Flam. Liq. 3; Acute Tox. 4
205-073-4
132-67-2
Acute Tox. 4
240-841-2
16812-54-7
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
239-086-1
14998-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
242-522-3
18718-11-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-511-8
14507-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
237-396-1
13770-89-3
Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 4; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-753-4
14708-14-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
235-723-2
12619-90-8
Carc. 1A; STOT RE 1; Skin Sens. 1
234-493-0
12007-00-0
Carc. 1A; STOT RE 1; Skin Sens. 1
238-766-5
14721-18-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
235-103-1
12068-61-0
Carc. 1A; STOT RE 1; Skin Sens. 1
238-596-1
14550-87-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
236-665-0
13462-88-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-646-5
15586-38-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
233-071-3
10028-18-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
235-008-5
12054-48-7
Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
236-666-6
13462-90-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
16039-61-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
236-068-5
13138-45-9
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
234-823-3
12035-36-8
Carc. 1A; STOT RE 1; Skin Sens. 1
237-124-1
13637-71-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
237-563-9
13842-46-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
235-379-3
12201-89-7
Carc. 1A; STOT RE 1; Skin Sens. 1
237-205-1
13689-92-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-278-2
14332-34-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
234-348-1
11113-74-9
Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
215-215-7
1313-99-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-323-5
11099-02-8
Carc. 1A; STOT RE 1; Skin Sens. 1
-
11132-10-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-125-2
15060-62-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
215-216-2
1314-05-2
Carc. 1A; STOT RE 1; Skin Sens. 1
234-349-7
11113-75-0
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
235-260-6
12142-88-0
Carc. 1A; STOT RE 1; Skin Sens. 1
239-974-9
15852-21-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-967-0
15851-52-2
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
234-824-9
12035-38-0
Carc. 1A; STOT RE 1; Skin Sens. 1
235-752-0
12653-76-8
Carc. 1A; STOT RE 1; Skin Sens. 1
234-825-4
12035-39-1
Carc. 1A; STOT RE 1; Skin Sens. 1
239-876-6
15780-33-3
Carc. 1A; STOT RE 1; Skin Sens. 1
238-032-4
14177-51-6
Carc. 1A; STOT RE 1; Skin Sens. 1
242-533-3
18721-51-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
237-138-8
13654-40-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
233-263-7
10101-96-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
240-235-8
16083-14-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
217-682-2
1929-82-4
Acute Tox. 4
238-076-4
14216-75-2
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
DABCO X-412
413-670-8
103969-79-5
Eye Irrit. 2; Skin Sens. 1
217-406-0
1836-75-5
Carc. 1B; Repr. 1B; Acute Tox. 4
233-272-6
10102-44-0
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
203-931-2
112-05-0
Skin Irrit. 2; Eye Irrit. 2
VULKANISATIONSBESCHLEUNIGER VP KA 9124
404-380-2
110799-28-5
Skin Sens. 1
ASIL-322; OS-5200
421-870-1
156145-66-3
Repr. 2; Acute Tox. 4; STOT RE 2
KENODOX
404-300-6
116753-76-5
Org. Perox. C
432-750-3
109202-58-6
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
434-350-4
103122-66-3
Flam. Liq. 3; Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
204-695-3
124-30-1
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
203-892-1
111-65-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
204-677-5
124-07-2
Skin Corr. 1C
PROCION BRILLIANT ORANGE H-EXL; S156745
412-960-1
148878-21-1
Eye Dam. 1; Skin Sens. 1
213-853-0
1034-01-1
Acute Tox. 4; Skin Sens. 1
214-197-8
1113-02-6
Acute Tox. 3; Acute Tox. 4
215-235-6
1314-41-6
yes
237-560-2
13840-56-7
Repr. 1B
yes
205-634-3
144-62-7
Acute Tox. 4
604-430-5
144651-06-9
STOT RE 2
LUCHEM HA-R 100; LUPERSOL HA-R 100
413-230-5
122035-71-6
Eye Dam. 1; Skin Sens. 1
203-430-9
106-75-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
241-427-4
17404-66-9
yes
203-254-2
104-94-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-405-2
106-51-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-398-6
106-44-5
Acute Tox. 3; Skin Corr. 1B
202-810-1
100-01-6
Acute Tox. 3; STOT RE 2
203-199-4
104-40-5
yes
203-404-7
106-50-3
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-180-0
104-15-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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