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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 srpnja 2024. Database contains 4821 unique substances/entries.
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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
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
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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
436-690-9
220727-26-4
Skin Sens. 1
ALKYL ISOCYANATE SILANE SCD 617
402-290-8
85702-90-5
Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1
-
953-17-3
Acute Tox. 3
X4261
401-850-9
255881-94-8
yes
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
-
2635-50-9
Acute Tox. 3
249-013-5
28434-00-6
Acute Tox. 4
243-193-9
19622-19-6
Acute Tox. 4
618-004-1
87392-12-9
Skin Sens. 1
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
-
68583-35-7
B Bacteria and similar species
425-210-3
169939-84-8
Skin Sens. 1
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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Acute Tox. 3
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-
Acute Tox. 3
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2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1) EC / List no: 258-532-6 | CAS no: 53404-43-6
Dinoseb acetate EC / List no: 220-560-1 | CAS no: 2813-95-8
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
Ammonium 2-sec-butyl-4,6-dinitrophenolate EC / List no: 228-858-3 | CAS no: 6365-83-9
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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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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Acute Tox. 4
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-
Acute Tox. 4
-
-
Carc. 1B; Acute Tox. 4
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-
yes
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Aluminium tris(2,4-dichlorophenoxyacetate) EC / List no: 250-497-5 | CAS no: 31166-18-4
Tetradecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 249-156-3 | CAS no: 28685-18-9
2,4-D-lithium EC / List no: 693-035-1 | CAS no: 3766-27-6
Ammonium 2,4-dichlorophenoxyacetate EC / List no: 218-986-8 | CAS no: 2307-55-3
(2,4-Dichlorophenoxy)acetic acid isopropylamine salt EC / List no: 690-142-5 | CAS no: 5742-17-6
Zinc bis[(2,4-dichlorophenoxy)acetate] EC / List no: 250-495-4 | CAS no: 31166-17-3
Dimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 217-915-8 | CAS no: 2008-39-1
Tris(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 219-911-1 | CAS no: 2569-01-9
Potassium (2,4-dichlorophenoxy)acetate EC / List no: 238-070-1 | CAS no: 14214-89-2
(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 222-752-0 | CAS no: 3599-58-4
Diethylammonium (o,p-dichlorophenoxy)acetate EC / List no: 244-120-3 | CAS no: 20940-37-8
Trimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 229-132-9 | CAS no: 6416-73-5
Bis(2-hydroxyethyl)ammonium 2,4-dichlorophenoxyacetate EC / List no: 227-256-8 | CAS no: 5742-19-8
Sodium 2,4-dichlorophenoxyacetate EC / List no: 220-290-4 | CAS no: 2702-72-9
Dodecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 218-660-5 | CAS no: 2212-54-6
(2,4-Dichlorophenoxy)acetic acid triethylamine salt EC / List no: - | CAS no: 2646-78-8
Acetic acid, (2,4-dichlorophenoxy)-, copper(2) salt EC / List no: - | CAS no: 63034-89-9
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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Acute Tox. 4; Eye Dam. 1
210-313-6
612-52-2
Carc. 1A; Acute Tox. 4
209-030-0
553-00-4
Carc. 1A; Acute Tox. 4
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-
Carc. 1B; Acute Tox. 4; Skin Sens. 1
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Carc. 1B; Acute Tox. 4
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. 2; Acute Tox. 4; Eye Irrit. 2
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-
Acute Tox. 2
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Dianilinium sulphate EC / List no: 208-805-0 | CAS no: 542-16-5
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
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
Anilinetrifluoroboron EC / List no: 211-539-8 | CAS no: 660-53-7
Anilinium p-tolylsulphonate EC / List no: 237-870-8 | CAS no: 14034-57-2
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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
252-984-8
36341-27-2
Carc. 1A; Acute Tox. 4
244-236-4
21136-70-9
Carc. 1A; Acute Tox. 4

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