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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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EW 400; GLUCOPROTAMIN
403-950-8
164907-72-6
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
yes
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
213-997-4
1071-83-6
Eye Dam. 1
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
600-130-3
100784-20-1
Repr. 1B
-
12035-71-1
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
213-831-0
1024-57-3
Carc. 2; Acute Tox. 3; STOT RE 2
203-767-1
110-43-0
Flam. Liq. 3; Acute Tox. 4
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
204-608-9
123-19-3
Flam. Liq. 3; Acute Tox. 4
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
203-838-7
111-14-8
Skin Corr. 1B
204-129-5
116-16-5
Acute Tox. 4
204-273-9
118-74-1
Carc. 1B; STOT RE 1
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
203-852-3
111-27-3
Acute Tox. 4
203-523-4
107-83-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
RED SF-PE 3534
410-180-6
157627-99-1
Eye Dam. 1
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
233-109-9
10034-85-2
Skin Corr. 1B
233-109-9
10034-85-2
Press. Gas; Skin Corr. 1A
233-113-0
10035-10-6
Press. Gas; Skin Corr. 1A; STOT SE 3
233-113-0
10035-10-6
Skin Corr. 1B; STOT SE 3
The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 120°C (158°F to 248°F).
309-745-9
100801-63-6
Carc. 1B; Muta. 1B
The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70°C to 120°C (158°F to 248°F).
309-748-5
100801-65-8
Carc. 1B; Muta. 1B
The oil obtained from the heat treatment of polystyrene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 210°C (158°F to 410°F).
309-749-0
100801-66-9
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by distillation of steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly C5.
310-012-0
102110-14-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of the products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers of C5 and dicyclopentadiene and boiling in the range of approximately 30°C to 170°C (86°F to 338°F).
310-013-6
102110-15-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained during the sorptions of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80°C to 135°C (176°F to 275°F).
309-870-9
101316-66-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of hydrotreated naphtha followed by solvent extraction. It consists predominantly of saturated hydrocarbons and boiling in the range of approximately 65°C to 70°C (149°F to 158°F).
309-871-4
101316-67-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140°C to 210°C (284°F to 410°F).
309-974-4
101794-97-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
309-987-5
101896-28-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
215-605-7
1333-74-0
Flam. Gas 1; Press. Gas
2-BUTANEDIOIC ACID, MONOAMIDE WITH N-(9-OCTADECENYL)-3-AMINO
402-970-4
148292-42-6
Skin Sens. 1
SICORIN E 10197
403-750-0
113036-91-2
Acute Tox. 4
641-410-5
130066-44-3
Skin Sens. 1A
242-818-2
19098-16-9
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
233-154-4
10046-00-1
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
236-691-2
13465-08-2
Expl. 1.1; Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
202-933-0
101-31-5
Acute Tox. 2

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