EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).

Last updated 15 listopada 2024. Database contains 4918 unique substances/entries.
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Dithiocarbazic acid, compound with hydrazine (1:1) EC / List no: 243-844-7 | CAS no: 20469-71-0
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
Hydrazinium chloride EC / List no: 220-154-4 | CAS no: 2644-70-4
1,2,4-triazolidine-3,5-dione, compound with hydrazine (1:1) EC / List no: 264-246-2 | CAS no: 63467-96-9
Hydrazinium dihydrogen phosphate EC / List no: 239-919-9 | CAS no: 15823-35-5
Hydrazine tartrate EC / List no: 211-211-4 | CAS no: 634-62-8
Hydrazine, hydriodide (3:2) EC / List no: - | CAS no: 10034-92-1
Hydrazine Acetate EC / List no: 629-465-3 | CAS no: 13255-48-6
Hydrazinium acetate EC / List no: 230-845-2 | CAS no: 7335-65-1
Hydrazinium sulphamate EC / List no: 254-708-1 | CAS no: 39935-03-0
Hydrazine dihydrobromide EC / List no: 245-543-6 | CAS no: 23268-00-0
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
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
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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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Potassium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-998-3 | CAS no: 2961-68-4
Sodium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-997-8 | CAS no: 2961-67-3
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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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Benzidine EC / List no: 202-199-1 | CAS no: 92-87-5
Salts of benzidine EC / List no: - | CAS no: -
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Carc. 1A; Acute Tox. 4
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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 p-tolylsulphonate EC / List no: 237-870-8 | CAS no: 14034-57-2
Anilinium chloride EC / List no: 205-519-8 | CAS no: 142-04-1
Anilinium bromide EC / List no: 208-801-9 | CAS no: 542-11-0
Anilinetrifluoroboron EC / List no: 211-539-8 | CAS no: 660-53-7
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 dihydrogen phosphate EC / List no: 253-680-8 | CAS no: 37832-42-1
Phthalic acid, compound with aniline (1:1) EC / List no: 256-856-2 | CAS no: 50930-79-5
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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
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4,4'-bi-o-toluidine sulphate EC / List no: 277-985-0 | CAS no: 74753-18-7
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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
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2-naphthylammonium chloride EC / List no: 210-313-6 | CAS no: 612-52-2
2-naphthylammonium acetate EC / List no: 209-030-0 | CAS no: 553-00-4
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Carc. 1A; Acute Tox. 4
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Acute Tox. 4; Eye Dam. 1
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Diethylammonium (o,p-dichlorophenoxy)acetate EC / List no: 244-120-3 | CAS no: 20940-37-8
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
(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate EC / List no: 222-752-0 | CAS no: 3599-58-4
Bis(2-hydroxyethyl)ammonium 2,4-dichlorophenoxyacetate EC / List no: 227-256-8 | CAS no: 5742-19-8
Ammonium 2,4-dichlorophenoxyacetate EC / List no: 218-986-8 | CAS no: 2307-55-3
Dimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 217-915-8 | CAS no: 2008-39-1
Trimethylammonium 2,4-dichlorophenoxyacetate EC / List no: 229-132-9 | CAS no: 6416-73-5
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
Tetradecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 249-156-3 | CAS no: 28685-18-9
Dodecylammonium (o,p-dichlorophenoxy)acetate EC / List no: 218-660-5 | CAS no: 2212-54-6
Zinc bis[(2,4-dichlorophenoxy)acetate] EC / List no: 250-495-4 | CAS no: 31166-17-3
Aluminium tris(2,4-dichlorophenoxyacetate) EC / List no: 250-497-5 | CAS no: 31166-18-4
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
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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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2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1) EC / List no: 258-532-6 | CAS no: 53404-43-6
Binapacryl EC / List no: 207-612-9 | CAS no: 485-31-4
Sodium 2-(1-methylpropyl)-4,6-dinitrophenolate EC / List no: 252-331-7 | CAS no: 35040-03-0
Ammonium 2-sec-butyl-4,6-dinitrophenolate EC / List no: 228-858-3 | CAS no: 6365-83-9
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
Dinoseb acetate EC / List no: 220-560-1 | CAS no: 2813-95-8
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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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C Carcinogenic (article 57a)
M Mutagen (article 57b)
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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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Rosin
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.
EC / List no: 232-475-7 | CAS no: 8050-09-7
Tall-oil rosin
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.
EC / List no: 232-484-6 | CAS no: 8052-10-6
Resin acids and Rosin acids EC / List no: 277-299-1 | CAS no: 73138-82-6
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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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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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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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