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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
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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
-
-
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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2-chloro-4-nitroaniline EC / List no: 204-502-2 | CAS no: 121-87-9
Benzenamine, 3-chloro-5-nitro- EC / List no: - | CAS no: 5344-44-5
2-chloro-6-nitroaniline EC / List no: 212-204-9 | CAS no: 769-11-9
Benzenamine, 4-chloro-N-nitro- EC / List no: - | CAS no: 69732-97-4
3-chloro-4-nitroaniline EC / List no: 642-644-0 | CAS no: 825-41-2
N-chloro-2-nitroaniline EC / List no: - | CAS no: 59483-60-2
3-chloro-2-nitroaniline EC / List no: 261-782-9 | CAS no: 59483-54-4
Benzenamine, chloronitro- EC / List no: - | CAS no: 41587-36-4
4-chloro-2-nitroaniline EC / List no: 201-925-4 | CAS no: 89-63-4
2-chloro-5-nitroaniline EC / List no: 228-498-7 | CAS no: 6283-25-6
4-chloro-3-nitroaniline EC / List no: 211-231-3 | CAS no: 635-22-3
5-chloro-2-nitroaniline EC / List no: 216-661-5 | CAS no: 1635-61-6
Benzenamine, 2-chloro-3-nitro- EC / List no: - | CAS no: 3970-41-0
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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
-
-
Carc. 1B; Skin Sens. 1
239-056-8
14977-61-8
Ox. Liq. 1; Carc. 1B; Muta. 1B; Skin Corr. 1A; Skin Sens. 1
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
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
-
-
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
-
-
P Parasites
-
-
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
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
433-460-1
210880-92-5
Acute Tox. 4
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
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
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
215-273-3
1317-42-6
Skin Sens. 1
-
-
F Fungi
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
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
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
405-400-2
54253-62-2
Acute Tox. 4; Eye Dam. 1
204-810-7
126-90-9
Skin Sens. 1B
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
68583-16-4
B Bacteria and similar species
-
-
B Bacteria and similar species
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
-
572-48-5
Acute Tox. 3
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
B Bacteria and similar species
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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
-
-
F Fungi
-
-
F Fungi
-
-
P Parasites
-
-
P Parasites
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
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
220-130-3
2636-26-2
Acute Tox. 4
223-099-4
3734-95-0
Acute Tox. 2; Acute Tox. 3
CSDCA
419-150-7
113136-77-9
Acute Tox. 4
427-230-8
5571-36-8
Repr. 1B; STOT RE 2
431-730-1
4277-06-9
Skin Irrit. 2; Skin Sens. 1
203-806-2
110-82-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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
CHMMS; CHMS; DYNASYLAN 9407; Z-6187
402-140-1
17865-32-6
Skin Irrit. 2
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
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
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
428-340-9
238088-70-5
Skin Irrit. 2
CHLOROFORMIATE DE CYCLOPENTYLE; CYCLOPENTYLCHLORFORMIAT
411-460-0
50715-28-1
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
-
-
P Parasites
405-230-9
101205-02-1
Repr. 2
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
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
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
601-785-8
121552-61-2
Skin Sens. 1
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
218-827-2
2244-16-8
Skin Sens. 1
432-960-5
124655-09-0
Acute Tox. 4
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
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
-
1563-67-3
Acute Tox. 3
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
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
212-758-1
867-27-6
Acute Tox. 3

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