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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 22 srpnja 2024. Database contains 4821 unique substances/entries.
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202-848-9
100-40-3
Carc. 2
B-TUM
418-770-5
151882-81-4
Carc. 2
218-817-8
2243-62-1
Carc. 2
692-456-8
688046-61-9
Carc. 2
222-048-3
3327-22-8
Carc. 2
-
-
Carc. 1B; Skin Sens. 1
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
219-603-7
2475-45-8
Carc. 1B; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
204-273-9
118-74-1
Carc. 1B; STOT RE 1
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
226-009-1
5216-25-1
Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
244-959-5
22398-80-7
Carc. 1B; Repr. 2; STOT RE 1
202-480-9
96-13-9
Carc. 1B; Repr. 2; Acute Tox. 3; Acute Tox. 4
yes
220-012-1
2602-46-2
Carc. 1B; Repr. 2
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
217-406-0
1836-75-5
Carc. 1B; Repr. 1B; Acute Tox. 4
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
209-765-7
592-62-1
Carc. 1B; Repr. 1B
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
231-846-0
7758-97-6
Carc. 1B; Repr. 1A; STOT RE 2
yes
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 2
215-147-8
1306-23-6
Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4
yes
221-221-0
3033-77-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
210-013-5
602-01-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
231-152-8
7440-43-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
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Monteponite (CdO) EC / List no: - | CAS no: 12139-21-8
215-146-2
1306-19-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
yes
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; 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
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
203-441-9
106-91-2
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; STOT RE 1; Eye Dam. 1; Skin Corr. 1C; Skin Sens. 1
209-128-3
556-52-5
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
DAISO CCS-1S-E; S-GLYTO
417-210-7
70987-78-9
Carc. 1B; Muta. 2; Eye Dam. 1; Skin Sens. 1
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
204-557-2
122-60-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
274-357-8
70161-44-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
-
-
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
-
-
Carc. 1B; Muta. 2; Acute Tox. 4; Acute Tox. 3; STOT RE 2; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
200-001-8
50-00-0
Carc. 1B; Muta. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
257-622-2
52033-74-6
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
200-444-7
59-88-1
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
248-259-0
27140-08-5
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; 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
204-427-5
120-80-9
Carc. 1B; Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
202-987-5
101-90-6
Carc. 1B; Muta. 2; Acute Tox. 3; Acute Tox. 4; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
221-627-8
3165-93-3
Carc. 1B; Muta. 2; Acute Tox. 3
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
205-886-4
191-30-0
Carc. 1B; Muta. 2
205-878-0
189-64-0
Carc. 1B; Muta. 2
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
202-110-6
91-95-2
Carc. 1B; Muta. 2
205-877-5
189-55-9
Carc. 1B; Muta. 2
435-960-3
-
Carc. 1B; Muta. 1B; Skin Sens. 1
MAGME(R) 200 MONOMER
403-230-3
77402-05-2
Carc. 1B; Muta. 1B; Skin Corr. 1B; Skin Sens. 1
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
232-489-3
8052-41-3
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1
A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-185-4
64742-82-1
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
231-889-5
7775-11-3
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
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Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
233-331-6
10124-36-4;31119-53-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
show/hide
cadmium chloride (CdCl2), hydrate (2:5) EC / List no: 640-998-0 | CAS no: 7790-78-5
233-296-7
10108-64-2
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
202-479-3
96-12-8
Carc. 1B; Muta. 1B; Repr. 1A; Acute Tox. 3; STOT RE 2
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C (275°F to 410°F).
265-199-0
64742-95-6
Carc. 1B; Muta. 1B; Asp. Tox. 1

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