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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 listopada 2024. Database contains 4821 unique substances/entries.
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Acute Tox. 4
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Acute Tox. 2
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Acute Tox. 2
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Unst. Expl.; Acute Tox. 3
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Acute Tox. 2
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yes
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yes
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Acute Tox. 4
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Acute Tox. 4
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Acute Tox. 2; Acute Tox. 1
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Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
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3,5-Diiodo-4-hydroxybenzonitrile, lithium salt EC / List no: - | CAS no: 2961-61-7
Sodium 4-hydroxy-3,5-diiodophenylcyanide EC / List no: 220-995-7 | CAS no: 2961-62-8
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Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
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Acute Tox. 2
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Acute Tox. 2; Acute Tox. 1
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Acute Tox. 2; Acute Tox. 1
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Hydrazinium chloride EC / List no: 220-154-4 | CAS no: 2644-70-4
Hydrazinium bromide EC / List no: 237-412-7 | CAS no: 13775-80-9
Dihydrazinium sulphate EC / List no: 236-688-6 | CAS no: 13464-80-7
Hydrazinium acetate EC / List no: 230-845-2 | CAS no: 7335-65-1
Hydrazinium(2+) sulphate EC / List no: 233-110-4 | CAS no: 10034-93-2
Hydrazine dihydrochloride EC / List no: 226-283-2 | CAS no: 5341-61-7
1,2,4-triazolidine-3,5-dione, compound with hydrazine (1:1) EC / List no: 264-246-2 | CAS no: 63467-96-9
Hydrazine dihydrobromide EC / List no: 245-543-6 | CAS no: 23268-00-0
Dithiocarbazic acid, compound with hydrazine (1:1) EC / List no: 243-844-7 | CAS no: 20469-71-0
Hydrazine Acetate EC / List no: 629-465-3 | CAS no: 13255-48-6
Hydrazinium dihydrogen phosphate EC / List no: 239-919-9 | CAS no: 15823-35-5
Hydrazine, hydriodide (3:2) EC / List no: - | CAS no: 10034-92-1
Hydrazine tartrate EC / List no: 211-211-4 | CAS no: 634-62-8
Hydrazinium sulphamate EC / List no: 254-708-1 | CAS no: 39935-03-0
Nitroformic acid, compound with hydrazine (1:1) EC / List no: 244-023-6 | CAS no: 20773-28-8
Hydrazinium nitrate EC / List no: 236-690-7 | CAS no: 13464-97-6
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Carc. 1B; Acute Tox. 3; Skin Sens. 1
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Acute Tox. 4
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Acute Tox. 4
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Acute Tox. 3; STOT RE 2
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Acute Tox. 4
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Sodium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-997-8 | CAS no: 2961-67-3
Potassium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-998-3 | CAS no: 2961-68-4
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Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
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Carc. 1A; Acute Tox. 4
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Acute Tox. 2
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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
Aniline EC / List no: 200-539-3 | CAS no: 62-53-3
Anilinium acetate EC / List no: 208-802-4 | CAS no: 542-14-3
Phthalic acid, compound with aniline (1:1) EC / List no: 256-856-2 | CAS no: 50930-79-5
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
Anilinium p-tolylsulphonate EC / List no: 237-870-8 | CAS no: 14034-57-2
Anilinetrifluoroboron EC / List no: 211-539-8 | CAS no: 660-53-7
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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
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Carc. 1B; Acute Tox. 4
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Carc. 1B; Acute Tox. 4; Skin Sens. 1
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Acute Tox. 4; Eye Dam. 1
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Trimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 229-132-9 | CAS no: 6416-73-5
Dimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 217-915-8 | CAS no: 2008-39-1
Aluminium tris(2,4-dichlorophenoxyacetate) EC / List no: 250-497-5 | CAS no: 31166-18-4
Sodium 2,4-dichlorophenoxyacetate EC / List no: 220-290-4 | CAS no: 2702-72-9
Zinc bis[(2,4-dichlorophenoxy)acetate] EC / List no: 250-495-4 | CAS no: 31166-17-3
Acetic acid, (2,4-dichlorophenoxy)-, copper(2) salt EC / List no: - | CAS no: 63034-89-9
Bis(2-hydroxyethyl)ammonium 2,4-dichlorophenoxyacetate EC / List no: 227-256-8 | CAS no: 5742-19-8
Diethylammonium (o,p-dichlorophenoxy)acetate EC / List no: 244-120-3 | CAS no: 20940-37-8
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
Tetradecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 249-156-3 | CAS no: 28685-18-9
Tris(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 219-911-1 | CAS no: 2569-01-9
Ammonium 2,4-dichlorophenoxyacetate EC / List no: 218-986-8 | CAS no: 2307-55-3
Dodecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 218-660-5 | CAS no: 2212-54-6
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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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Sodium 2-(1-methylpropyl)-4,6-dinitrophenolate EC / List no: 252-331-7 | CAS no: 35040-03-0
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
Ammonium 2-sec-butyl-4,6-dinitrophenolate EC / List no: 228-858-3 | CAS no: 6365-83-9
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
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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
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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
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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.
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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.

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