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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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203-180-0
104-15-4
Skin Corr. 1B
203-403-1
106-49-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
UP 565
411-530-0
15024-10-9
Skin Sens. 1
203-396-5
106-42-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
214-215-4
1114-71-2
Acute Tox. 4
426-590-3
187412-41-5
Skin Sens. 1
235-067-7
12065-90-6
yes
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
436-920-8
172399-10-9
Eye Dam. 1
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
603-902-8
13517-20-9
yes
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
yes
600-419-4
10332-33-9
yes
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.
309-706-6
100684-33-1
Carc. 1B
Residue from the distillation of crude phenanthrene boiling in the approximate range of 340°C to 420°C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.
310-169-5
122070-78-4
Carc. 1B
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
310-154-3
121158-58-5
yes
310-154-3
121158-58-5
yes
203-632-7
108-95-2
Muta. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1B
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
204-557-2
122-60-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
-
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
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
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
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
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
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
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
X4060
404-035-6
1379801-27-0
Skin Sens. 1
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
418-260-2
183196-57-8
Skin Sens. 1
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
233-002-7
10007-85-9
Eye Irrit. 2
V67282
406-500-9
174393-75-0
Skin Sens. 1
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
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
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
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
432-240-0
12056-51-8
Carc. 2
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
203-471-2
107-19-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
205-359-9
139-40-2
Carc. 2
204-062-1
115-07-1
Flam. Gas 1; Press. Gas
204-638-2
123-62-6
Skin Corr. 1B
204-043-8
114-26-1
Acute Tox. 3
204-498-2
121-79-9
Acute Tox. 4; Skin Sens. 1
203-686-1
109-60-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-687-7
109-61-5
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
203-798-0
110-74-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3

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