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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 rujna 2024. Database contains 4821 unique substances/entries.
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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
Press. Gas; Skin Corr. 1A
233-109-9
10034-85-2
Skin Corr. 1B
233-113-0
10035-10-6
Skin Corr. 1B; STOT SE 3
233-113-0
10035-10-6
Press. Gas; Skin Corr. 1A; 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
601-305-7
114311-32-9
Repr. 2
428-040-8
138261-41-3
Acute Tox. 3
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
216-881-1
1689-83-4
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
-
115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115850-69-6
Repr. 1B; Acute Tox. 4; STOT RE 2
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
604-209-3
140923-17-7
Carc. 2
IVAX
401-920-9
100181-71-3
Skin Irrit. 2; Skin Sens. 1
203-745-1
110-19-0
Flam. Liq. 2
203-417-8
106-63-8
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ZOLDINE RD-4
419-850-2
148348-13-4
Skin Corr. 1B
ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
402-580-4
111439-76-0
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
234-284-4
11066-49-2
yes
204-662-3
123-92-2
Flam. Liq. 3
203-769-2
110-45-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-322-1
105-68-0
Flam. Liq. 3
203-561-1
108-21-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-301-7
105-48-6
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
417-970-1
1379932-74-7
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1
431-540-9
170573-32-7
Skin Irrit. 2
604-222-4
141112-29-0
Repr. 2
242-624-8
18854-01-8
Acute Tox. 3
A complex combination of hydrocarbons obtained from the distillation of petroleum and subsequent hydrotreatment. It consists predominantly of alkanes, cycloalkanes and alkylbenzenes having carbon numbers predominantly in the range of C12 through C16 and boiling in the range of approximately 230°C to 270°C (446°F to 518°F).
309-944-0
101631-19-0
Asp. Tox. 1
604-351-6
143390-89-0
Carc. 2
215-630-3
1335-32-6
Carc. 2; Repr. 1A; STOT RE 2
237-486-0
13814-96-5
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
236-542-1
13424-46-9
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
236-542-1
13424-46-9
yes
236-542-1
13424-46-9
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
233-245-9
10099-74-8
yes
215-267-0
1317-36-8
yes
234-853-7
12036-76-9
yes
239-290-0
15245-44-0
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
239-290-0
15245-44-0
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
239-290-0
15245-44-0
yes
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
235-038-9
12060-00-3
yes
235-727-4
12626-81-2
yes
BLEIMETHANSULFONAT; LEAD (II) METHANESULFONATE; LEAD METHANE SULPHONATE; LEAD SALT FP
401-750-5
17570-76-2
Repr. 1A; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
yes
204-961-9
129-73-7
Carc. 2; Muta. 2
204-811-2
126-91-0
Skin Sens. 1B
BLUE 14 52 200
411-140-0
125328-86-1
Eye Dam. 1; Skin Sens. 1
LI-BIT
411-690-1
111337-53-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
ACID RED FC 70013
414-250-7
149564-66-9
Acute Tox. 4; Eye Dam. 1
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
REACTIVE BLUE FC 05 717
401-560-2
108624-00-6
Skin Sens. 1
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C32 and produces a finished oil with a viscosity in the order of 17cSt to 23cSt at 40°C (104°F).
309-875-6
101316-70-5
Carc. 1B

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