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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 lipnja 2024. Database contains 4821 unique substances/entries.
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204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
212-758-1
867-27-6
Acute Tox. 3
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
258-256-6
52918-63-5
Acute Tox. 3
-
1563-67-3
Acute Tox. 3
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
208-764-9
541-02-6
yes
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
201-248-4
80-08-0
Acute Tox. 4
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
432-960-5
124655-09-0
Acute Tox. 4
218-827-2
2244-16-8
Skin Sens. 1
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 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.
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
601-785-8
121552-61-2
Skin Sens. 1
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
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
261-043-0
57966-95-7
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
236-049-1
13121-70-5
Acute Tox. 4
269-855-7
68359-37-5
Acute Tox. 2; Acute Tox. 3
269-855-7
68359-37-5
Acute Tox. 2
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
405-230-9
101205-02-1
Repr. 2
-
-
P Parasites
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
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
428-340-9
238088-70-5
Skin Irrit. 2
204-435-9
120-92-3
Flam. Liq. 3; Eye Irrit. 2; Skin Irrit. 2
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
206-016-6
287-92-3
Flam. Liq. 2
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
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
CHMMS; CHMS; DYNASYLAN 9407; Z-6187
402-140-1
17865-32-6
Skin Irrit. 2
203-629-0
108-91-8
Flam. Liq. 3; Repr. 2; Acute Tox. 4; Skin Corr. 1B
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
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
203-631-1
108-94-1
Flam. Liq. 3; Acute Tox. 4
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
203-806-2
110-82-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
431-730-1
4277-06-9
Skin Irrit. 2; Skin Sens. 1
427-230-8
5571-36-8
Repr. 1B; STOT RE 2
CSDCA
419-150-7
113136-77-9
Acute Tox. 4
223-099-4
3734-95-0
Acute Tox. 2; Acute Tox. 3
220-130-3
2636-26-2
Acute Tox. 4
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
244-544-9
21725-46-2
Acute Tox. 4
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
202-704-5
98-82-8
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
-
-
P Parasites
-
-
P Parasites
-
-
F Fungi
-
-
F Fungi
206-083-1
299-86-5
Acute Tox. 4
231-720-5
7700-17-6
Acute Tox. 3
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
208-622-6
535-89-7
Acute Tox. 2
-
-
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.
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
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
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 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 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 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
-
-
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.
-
572-48-5
Acute Tox. 3
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
200-285-3
56-72-4
Acute Tox. 2; Acute Tox. 4
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
201-378-1
81-82-3
STOT RE 2
-
-
B Bacteria and similar species
-
68583-16-4
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
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.
204-810-7
126-90-9
Skin Sens. 1B
KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
405-400-2
54253-62-2
Acute Tox. 4; Eye Dam. 1
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
231-842-9
7758-89-6
Acute Tox. 4
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
STOT RE 2
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
SUBSTANCE S171393
427-390-9
-
Skin Sens. 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.
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
-
-
F Fungi
215-273-3
1317-42-6
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
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
620-395-9
12737-30-3
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
261-346-8
58591-45-0
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
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; 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
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
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
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
433-460-1
210880-92-5
Acute Tox. 4
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
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
216-935-4
1702-17-6
Eye Dam. 1
-
-
P Parasites
-
-
P Parasites
617-258-0
81777-89-1
Acute Tox. 4
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
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
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
-
-
F Fungi
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
242-161-1
18283-82-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
226-394-6
5392-40-5
Skin Irrit. 2; Skin Sens. 1
205-859-7
156-59-2
Flam. Liq. 2; Acute Tox. 4
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
231-187-9
7443-70-1
Acute Tox. 4
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
426-020-3
51229-78-8
Flam. Sol. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
425-080-8
104860-26-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
216-906-6
1694-82-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
ARGOLD; CINMETHYLIN; WL 95481
402-410-9
87818-31-3
Acute Tox. 4
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
204-454-2
121-20-0
Acute Tox. 4
246-948-0
25402-06-6
Acute Tox. 4
232-671-2
9004-07-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
207-803-7
495-54-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2
264-409-8
63681-54-9
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
208-545-8
532-82-1
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
281-549-5
83968-67-6
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
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
239-056-8
14977-61-8
Ox. Liq. 1; Carc. 1B; Muta. 1B; Skin Corr. 1A; 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
-
-
Carc. 1B; Skin Sens. 1
231-801-5
7738-94-5
yes
282-714-4
84332-86-5
Carc. 2
244-663-6
21923-23-9
Acute Tox. 2; Acute Tox. 3
207-902-5
500-28-7
Acute Tox. 4
217-637-7
1918-13-4
Acute Tox. 4
227-011-5
5598-13-0
Skin Sens. 1
220-864-4
2921-88-2
Acute Tox. 3
202-925-7
101-21-3
Carc. 2; STOT RE 2
204-105-4
115-78-6
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
215-316-6
1321-23-9
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
221-437-5
3091-32-5
Acute Tox. 4
239-592-2
15545-48-9
Carc. 2; Repr. 2
246-698-2
25168-05-2
Acute Tox. 4
217-588-1
1897-45-6
Carc. 2; Acute Tox. 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
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
246-691-4
25167-80-0
Acute Tox. 4
223-003-0
3691-35-8
Repr. 1B; Acute Tox. 1; STOT RE 1
show/hide
Benzenamine, 3-chloro-5-nitro- EC / List no: - | CAS no: 5344-44-5
2-chloro-4-nitroaniline EC / List no: 204-502-2 | CAS no: 121-87-9
Benzenamine, 2-chloro-3-nitro- EC / List no: - | CAS no: 3970-41-0
Benzenamine, chloronitro- EC / List no: - | CAS no: 41587-36-4
4-chloro-3-nitroaniline EC / List no: 211-231-3 | CAS no: 635-22-3
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-2-nitroaniline EC / List no: 261-782-9 | CAS no: 59483-54-4
N-chloro-2-nitroaniline EC / List no: - | CAS no: 59483-60-2
4-chloro-2-nitroaniline EC / List no: 201-925-4 | CAS no: 89-63-4
5-chloro-2-nitroaniline EC / List no: 216-661-5 | CAS no: 1635-61-6
3-chloro-4-nitroaniline EC / List no: 642-644-0 | CAS no: 825-41-2
2-chloro-5-nitroaniline EC / List no: 228-498-7 | CAS no: 6283-25-6
-
-
Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-817-4
74-87-3
Flam. Gas 1; Press. Gas; Carc. 2; STOT RE 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
200-830-5
75-00-3
Flam. Gas 1; Press. Gas; Carc. 2
247-109-1
25567-67-3
Acute Tox. 3; STOT RE 2
200-431-6
59-50-7
Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; STOT SE 3; Skin Sens. 1B
208-110-2
510-15-6
Acute Tox. 4
203-628-5
108-90-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
-
-
Acute Tox. 3; STOT RE 2
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
203-467-0
107-14-2
Acute Tox. 3
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
203-472-8
107-20-0
Carc. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
SEL DE VILSMEIER-HAACK
425-970-6
3724-43-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1A
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
203-480-1
107-30-2
Flam. Liq. 2; Carc. 1A; Acute Tox. 4

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