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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 srpnja 2024. Database contains 4821 unique substances/entries.
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236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
231-633-2
7664-38-2
Skin Corr. 1B
-
17169-61-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
233-663-1
10294-56-1
Acute Tox. 4; Skin Corr. 1A
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
215-236-1
1314-56-3
Skin Corr. 1A
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
200-332-8
57-47-6
Acute Tox. 2
202-128-4
92-13-7
Acute Tox. 2
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
607-329-4
24151-93-7
Acute Tox. 4
245-430-1
23103-98-2
Carc. 2; Acute Tox. 3; Skin Sens. 1
245-704-0
23505-41-1
Acute Tox. 3; Acute Tox. 4
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to 180°C (176°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
310-162-7
121575-60-8
Carc. 1B
The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140° to 170°C (284°F to 392°F) according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.
302-650-3
94114-13-3
Carc. 1B
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.
292-653-5
90669-58-2
Carc. 1B
The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C (158°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-654-0
90669-59-3
Carc. 1B
A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40°C to 180°C (104°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-651-4
90669-57-1
Carc. 1B
The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (104°F to 356°F). Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.
269-109-0
68187-57-5
Carc. 1B
263-072-4
61789-60-4
Carc. 1B
432-400-1
10102-09-7
Skin Corr. 1A
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
215-648-1
1336-36-3
STOT RE 2
618-541-1
9036-19-5
yes
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
X4060
404-035-6
1379801-27-0
Skin Sens. 1
-
299-45-6
Acute Tox. 2; Acute Tox. 1
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
246-376-1
24634-61-5
Eye Irrit. 2
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
418-260-2
183196-57-8
Skin Sens. 1
266-578-3
67118-55-2
yes
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
233-002-7
10007-85-9
Eye Irrit. 2
426-300-5
-
Eye Dam. 1
V67282
406-500-9
174393-75-0
Skin Sens. 1
426-620-5
619297-89-1
Eye Dam. 1
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
209-676-3
590-28-3
Acute Tox. 4
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
232-151-5
7789-23-3
Acute Tox. 3
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
234-329-8
11103-86-9
yes
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
223-393-2
3871-99-6
yes
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
253-390-1
37199-66-9
Skin Corr. 1B
-
5787-96-2
Acute Tox. 3; STOT RE 2
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
425-830-4
-
Eye Dam. 1
432-240-0
12056-51-8
Carc. 2
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
266-994-5
67747-09-5
Acute Tox. 4
BROWN JR 547
419-260-5
-
Eye Dam. 1

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