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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 29 March 2024. Database contains 4821 unique substances/entries.
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
206-117-5
302-17-0
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
240-016-7
15879-93-3
Acute Tox. 4; Acute Tox. 3; STOT SE 3
200-349-0
57-74-9
Carc. 2; Acute Tox. 4
205-601-3
143-50-0
Carc. 2; Acute Tox. 3
228-200-5
6164-98-3
Carc. 2; Acute Tox. 4
243-269-1
19750-95-9
Carc. 2; Acute Tox. 4
201-599-3
85-34-7
Acute Tox. 4
602-782-4
122453-73-0
Acute Tox. 3; Acute Tox. 4
201-246-3
80-06-8
Acute Tox. 4
238-413-5
14437-17-3
Acute Tox. 4
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
207-432-0
470-90-6
Acute Tox. 2; Acute Tox. 3
216-920-2
1698-60-8
Skin Sens. 1
231-959-5
7782-50-5
Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
233-162-8
10049-04-4
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
233-162-8
10049-04-4
Acute Tox. 3; Skin Corr. 1B
246-538-1
24934-91-6
Acute Tox. 1; Acute Tox. 2
213-666-4
999-81-5
Acute Tox. 4
203-480-1
107-30-2
Flam. Liq. 2; Carc. 1A; Acute Tox. 4
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
SEL DE VILSMEIER-HAACK
425-970-6
3724-43-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1A
203-472-8
107-20-0
Carc. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
203-467-0
107-14-2
Acute Tox. 3
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
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Acute Tox. 3; STOT RE 2
203-628-5
108-90-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
208-110-2
510-15-6
Acute Tox. 4
200-431-6
59-50-7
Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; STOT SE 3; Skin Sens. 1B
247-109-1
25567-67-3
Acute Tox. 3; STOT RE 2
200-830-5
75-00-3
Flam. Gas 1; Press. Gas; Carc. 2
200-663-8
67-66-3
Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
200-817-4
74-87-3
Flam. Gas 1; Press. Gas; Carc. 2; STOT RE 2
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Benzenamine, 4-chloro-N-nitro- EC / List no: - | CAS no: 69732-97-4
Benzenamine, 3-chloro-5-nitro- EC / List no: - | CAS no: 5344-44-5
5-chloro-2-nitroaniline EC / List no: 216-661-5 | CAS no: 1635-61-6
2-chloro-5-nitroaniline EC / List no: 228-498-7 | CAS no: 6283-25-6
Benzenamine, chloronitro- EC / List no: - | CAS no: 41587-36-4
3-chloro-2-nitroaniline EC / List no: 261-782-9 | CAS no: 59483-54-4
2-chloro-4-nitroaniline EC / List no: 204-502-2 | CAS no: 121-87-9
4-chloro-2-nitroaniline EC / List no: 201-925-4 | CAS no: 89-63-4
Benzenamine, 2-chloro-3-nitro- EC / List no: - | CAS no: 3970-41-0
2-chloro-6-nitroaniline EC / List no: 212-204-9 | CAS no: 769-11-9
N-chloro-2-nitroaniline EC / List no: - | CAS no: 59483-60-2
4-chloro-3-nitroaniline EC / List no: 211-231-3 | CAS no: 635-22-3
3-chloro-4-nitroaniline EC / List no: 642-644-0 | CAS no: 825-41-2
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Acute Tox. 2; Acute Tox. 1; STOT RE 2
223-003-0
3691-35-8
Repr. 1B; Acute Tox. 1; STOT RE 1
246-691-4
25167-80-0
Acute Tox. 4
204-818-0
126-99-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
217-588-1
1897-45-6
Carc. 2; Acute Tox. 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
246-698-2
25168-05-2
Acute Tox. 4
239-592-2
15545-48-9
Carc. 2; Repr. 2
221-437-5
3091-32-5
Acute Tox. 4
215-316-6
1321-23-9
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
204-105-4
115-78-6
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-925-7
101-21-3
Carc. 2; STOT RE 2
220-864-4
2921-88-2
Acute Tox. 3
227-011-5
5598-13-0
Skin Sens. 1
217-637-7
1918-13-4
Acute Tox. 4
207-902-5
500-28-7
Acute Tox. 4
244-663-6
21923-23-9
Acute Tox. 2; Acute Tox. 3
282-714-4
84332-86-5
Carc. 2
231-801-5
7738-94-5
yes
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Carc. 1B; Skin Sens. 1
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
304-236-8
94247-67-3
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
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
ARGOLD; CINMETHYLIN; WL 95481
402-410-9
87818-31-3
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
425-080-8
104860-26-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
426-020-3
51229-78-8
Flam. Sol. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
422-660-2
7480-35-5
Eye Dam. 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
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F Fungi
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
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
617-258-0
81777-89-1
Acute Tox. 4
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P Parasites
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P Parasites
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
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species

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