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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
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208-519-6
531-85-1
Carc. 1A; Acute Tox. 4
208-520-1
531-86-2
Carc. 1A; Acute Tox. 4
244-236-4
21136-70-9
Carc. 1A; Acute Tox. 4
252-984-8
36341-27-2
Carc. 1A; Acute Tox. 4
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-
Acute Tox. 2
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Anilinium p-tolylsulphonate EC / List no: 237-870-8 | CAS no: 14034-57-2
Anilinium acetate EC / List no: 208-802-4 | CAS no: 542-14-3
Aniline EC / List no: 200-539-3 | CAS no: 62-53-3
Anilinium bromide EC / List no: 208-801-9 | CAS no: 542-11-0
Anilinium dihydrogen phosphate EC / List no: 253-680-8 | CAS no: 37832-42-1
Anilinium chloride EC / List no: 205-519-8 | CAS no: 142-04-1
Phthalic acid, compound with aniline (1:1) EC / List no: 256-856-2 | CAS no: 50930-79-5
Anilinetrifluoroboron EC / List no: 211-539-8 | CAS no: 660-53-7
Dianilinium sulphate EC / List no: 208-805-0 | CAS no: 542-16-5
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Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
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-
Acute Tox. 2
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-
Carc. 2; Acute Tox. 4; Eye Irrit. 2
265-294-7
64969-36-4
Carc. 1B; Acute Tox. 4
277-985-0
74753-18-7
Carc. 1B; Acute Tox. 4
210-322-5
612-82-8
Carc. 1B; Acute Tox. 4
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-
Carc. 1B; Acute Tox. 4
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-
Carc. 1B; Acute Tox. 4; Skin Sens. 1
210-313-6
612-52-2
Carc. 1A; Acute Tox. 4
209-030-0
553-00-4
Carc. 1A; Acute Tox. 4
-
-
Acute Tox. 4; Eye Dam. 1
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(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 222-752-0 | CAS no: 3599-58-4
Zinc bis[(2,4-dichlorophenoxy)acetate] EC / List no: 250-495-4 | CAS no: 31166-17-3
Sodium 2,4-dichlorophenoxyacetate EC / List no: 220-290-4 | CAS no: 2702-72-9
Potassium (2,4-dichlorophenoxy)acetate EC / List no: 238-070-1 | CAS no: 14214-89-2
Acetic acid, (2,4-dichlorophenoxy)-, copper(2) salt EC / List no: - | CAS no: 63034-89-9
Tris(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 219-911-1 | CAS no: 2569-01-9
Trimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 229-132-9 | CAS no: 6416-73-5
Dodecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 218-660-5 | CAS no: 2212-54-6
Aluminium tris(2,4-dichlorophenoxyacetate) EC / List no: 250-497-5 | CAS no: 31166-18-4
Dimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 217-915-8 | CAS no: 2008-39-1
Ammonium 2,4-dichlorophenoxyacetate EC / List no: 218-986-8 | CAS no: 2307-55-3
Diethylammonium (o,p-dichlorophenoxy)acetate EC / List no: 244-120-3 | CAS no: 20940-37-8
Bis(2-hydroxyethyl)ammonium 2,4-dichlorophenoxyacetate EC / List no: 227-256-8 | CAS no: 5742-19-8
Tetradecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 249-156-3 | CAS no: 28685-18-9
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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yes
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-
Carc. 1B; Acute Tox. 4
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-
Acute Tox. 4
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-
Acute Tox. 4
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2-tert-butyl-4,6-dinitrophenyl acetate EC / List no: 221-706-7 | CAS no: 3204-27-1
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-
Repr. 1B; Acute Tox. 2; Acute Tox. 3
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Dinoseb acetate EC / List no: 220-560-1 | CAS no: 2813-95-8
Ammonium 2-sec-butyl-4,6-dinitrophenolate EC / List no: 228-858-3 | CAS no: 6365-83-9
Binapacryl EC / List no: 207-612-9 | CAS no: 485-31-4
2-sec-butyl-4,6-dinitrophenol, compound with 1-aminopropan-2-ol (1:1) EC / List no: 275-931-0 | CAS no: 71735-19-8
2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1) EC / List no: 258-532-6 | CAS no: 53404-43-6
Sodium 2-(1-methylpropyl)-4,6-dinitrophenolate EC / List no: 252-331-7 | CAS no: 35040-03-0
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Repr. 1B; Acute Tox. 3; Eye Irrit. 2
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Acute Tox. 3
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-
Acute Tox. 3
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-
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
425-210-3
169939-84-8
Skin Sens. 1
200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
618-004-1
87392-12-9
Skin Sens. 1
243-193-9
19622-19-6
Acute Tox. 4
249-013-5
28434-00-6
Acute Tox. 4
-
2635-50-9
Acute Tox. 3
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
X4261
401-850-9
255881-94-8
yes
-
953-17-3
Acute Tox. 3
ALKYL ISOCYANATE SILANE SCD 617
402-290-8
85702-90-5
Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1
436-690-9
220727-26-4
Skin Sens. 1
R-GLYCIDOL
404-660-4
57044-25-4
Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
232-475-7
8050-09-7
Skin Sens. 1
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
Skin Sens. 1
277-299-1
73138-82-6
Skin Sens. 1
203-585-2
108-46-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
233-940-7
10453-86-8
Acute Tox. 4
A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
270-796-4
68478-17-1
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).
308-733-0
98219-64-8
Carc. 1B
A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
270-984-6
68512-62-9
Carc. 1B
A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
272-187-9
68783-13-1
Carc. 1B
A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C24 and boiling above approximately 390°C (734°F).
292-658-2
90669-76-4
Carc. 1B

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