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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
salts of 3,3'-dimethoxybenzidine; salts of o-dianisidine
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[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-53-7
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(2-hydroxy-3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-49-1
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-38-8
3,3'-dimethoxybiphenyl-4,4'-ylenediammonium dichloride EC / List no: 243-737-5 | CAS no: 20325-40-0
(1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, sulfate EC / List no: - | CAS no: 56436-30-7
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(2-hydroxy-3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-48-0
(1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, monohydrochloride EC / List no: - | CAS no: 111984-09-9
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Carc. 1B; Acute Tox. 4
salts of 4,4'-carbonimidoylbis[N, N-dimethylaniline]
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Methanaminium, N-(4-(amino(4-(dimethylamino)phenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-methyl-, dodecyl(sulfophenoxy)benzenesulfonate (2:1) EC / List no: - | CAS no: 63428-09-1
4,4'-carbonimidoylbis[N,N-dimethylaniline] acetate EC / List no: 225-801-4 | CAS no: 5089-20-3
4,4'-carbonimidoylbis[N,N-dimethylanilinium] sulphate EC / List no: 282-562-9 | CAS no: 84255-16-3
4,4'-carbonimidoylbis[N,N-dimethylaniline] nitrate EC / List no: 282-561-3 | CAS no: 84255-15-2
4,4'-carbonimidoylbis(N,N-dimethylaniline) monohydrochloride EC / List no: 219-567-2 | CAS no: 2465-27-2
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, mono(dodecylbenzenesulfonate) EC / List no: - | CAS no: 82794-01-2
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, 2-hydroxyethanesulfonate EC / List no: - | CAS no: 86157-51-9
4,4'-bis[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo][1,1'-biphenyl]-2,2'-disulphonic acid, compound with 4,4'-carbonimidoylbis[N,N-dimethylphenylamine] (1:2) EC / List no: 277-106-0 | CAS no: 72939-51-6
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, (2-methoxyethoxy)acetate EC / List no: - | CAS no: 82941-28-4
Decyl hydrogen sulphate, compound with 4,4'-carbonimidoylbis[N,N-dimethylaniline] (1:1) EC / List no: 281-828-1 | CAS no: 84030-53-5
Benzenesulfonic acid, 4-dodecyl-, compd. with 4,4'-carbonimidoylbis(N,N-dimethylbenzenamine) (1:1) EC / List no: - | CAS no: 63589-43-5
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Carc. 2; Acute Tox. 4; Eye Irrit. 2
salts of aconitine
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-
Acute Tox. 2
salts of aniline
show/hide
Anilinetrifluoroboron EC / List no: 211-539-8 | CAS no: 660-53-7
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
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
Anilinium p-tolylsulphonate EC / List no: 237-870-8 | CAS no: 14034-57-2
Anilinium bromide EC / List no: 208-801-9 | CAS no: 542-11-0
Benzenesulfonic acid, 2,2'-dithiobis(5-methyl-, compd. with benzenamine (1:2) EC / List no: - | CAS no: 63468-80-4
Anilinium acetate EC / List no: 208-802-4 | CAS no: 542-14-3
Benzenesulfonic acid, 2(or 4)-methyl-, compd. with benzenamine (1:1) EC / List no: - | CAS no: 70788-38-4
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
salts of atropine
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-
Acute Tox. 2
salts of biphenyl-4-ylamine; salts of xenylamine; salts of 4-aminobiphenyl
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Carc. 1A; Acute Tox. 4
salts of bromoxynil with the exception of those specified elsewhere in this Annex
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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
salts of dichlorprop
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Acute Tox. 4
salts of dinitrophenol
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Acute Tox. 3; STOT RE 2
salts of ephedrine
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Acute Tox. 4
salts of fenoprop; salts of 2-(2,4,5-trichlorophenoxy)propionic acid
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Acute Tox. 4
salts of hydrazine
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Hydrazine, monohydrofluoride EC / List no: - | CAS no: 18220-64-9
Dithiocarbazic acid, compound with hydrazine (1:1) EC / List no: 243-844-7 | CAS no: 20469-71-0
Hydrazine, dihydrobromide, dihydrate EC / List no: - | CAS no: 40849-90-9
Hydrazine, hydriodide (3:2) EC / List no: - | CAS no: 10034-92-1
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
Thiocyanic acid, compd. with hydrazine (1:1) EC / List no: - | CAS no: 24786-78-5
Hydrazinium chloride EC / List no: 220-154-4 | CAS no: 2644-70-4
Hydrazine, phosphate EC / List no: - | CAS no: 23488-13-3
Hydrazine difluoride EC / List no: - | CAS no: 13537-45-6
Hydrazine perchlorate EC / List no: - | CAS no: 27978-54-7
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
Hydrazine, sulfate EC / List no: - | CAS no: 1184-66-3
Hydrazine, nitrate EC / List no: - | CAS no: 37836-27-4
Hydrazine selenate EC / List no: - | CAS no: 73506-32-8
Hydrazinium sulphamate EC / List no: 254-708-1 | CAS no: 39935-03-0
Hydrazine, monohydriodide EC / List no: - | CAS no: 10039-55-1
Hydrazine dihydrochloride EC / List no: 226-283-2 | CAS no: 5341-61-7
Hydrazine, dinitrate EC / List no: - | CAS no: 13464-98-7
Hydrazinium acetate EC / List no: 230-845-2 | CAS no: 7335-65-1
Hydrazinium dihydrogen phosphate EC / List no: 239-919-9 | CAS no: 15823-35-5
Hydrazine, diperchlorate, dihydrate EC / List no: - | CAS no: 73497-82-2
Hydrazine, diperchlorate EC / List no: - | CAS no: 13812-39-0
Hydrazine Acetate EC / List no: 629-465-3 | CAS no: 13255-48-6
Hydrazine, sulfate (2:1), monohydrate EC / List no: - | CAS no: 66375-32-4
Hydrazine, hydrochloride EC / List no: - | CAS no: 14011-37-1
Hydrazinium bromide EC / List no: 237-412-7 | CAS no: 13775-80-9
Compound of carbonic acid with hydrazine(1:2) EC / List no: - | CAS no: 112077-84-6
Hydrazine, phosphate (2:1) EC / List no: - | CAS no: 59779-45-2
Hydrazine tartrate EC / List no: 211-211-4 | CAS no: 634-62-8
Dihydrazinium sulphate EC / List no: 236-688-6 | CAS no: 13464-80-7
Hydrazinium(2+) sulphate EC / List no: 233-110-4 | CAS no: 10034-93-2
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Carc. 1B; Acute Tox. 3; Skin Sens. 1
salts of hydrogen cyanide with the exception of complex cyanides such as ferrocyanides, ferricyanides and mercuric oxycyanide and those specified elsewhere in this Annex
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Acute Tox. 2; Acute Tox. 1
salts of hyoscine
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Acute Tox. 2; Acute Tox. 1
salts of hyoscyamine
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Acute Tox. 2
salts of ioxynil with the exception of those specified elsewhere in this Annex
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Sodium 4-hydroxy-3,5-diiodophenylcyanide EC / List no: 220-995-7 | CAS no: 2961-62-8
3,5-Diiodo-4-hydroxybenzonitrile, lithium salt EC / List no: - | CAS no: 2961-61-7
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Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
salts of mecoprop
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Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
salts of nicotine
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Acute Tox. 2; Acute Tox. 1
salts of oxalic acid (with the exception of those specified elsewhere in this Annex)
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Acute Tox. 4
salts of papaverine
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Acute Tox. 4
Salts of Perfluorobutane sulfonic acid
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yes
Salts of Perfluorohexane-1-sulfonic acid
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1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. With pyrrolidine (1:1) EC / List no: - | CAS no: 1187817-57-7
Iodonium, diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 153443-35-7
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, zinc salt EC / List no: - | CAS no: 70136-72-0
N,N,N-triethylethanaminium tridecafluorohexane-1-sulfonate EC / List no: - | CAS no: 108427-55-0
Sulfonium, bis(4-methylphenyl)phenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 341548-85-4
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, cesium salt (1:1) EC / List no: - | CAS no: 92011-17-1
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, yttrium(3+) salt (3:1) EC / List no: - | CAS no: 41242-12-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, neodymium(3+) salt (3:1) EC / List no: - | CAS no: 41184-65-0
Methanaminium, N-[4-[[4-(dimethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1310480-27-3
N,N,N-tributylbutan-1-aminium tridecafluorohexane-1-sulfonate EC / List no: - | CAS no: 108427-54-9
Methanaminium, N,N,N-trimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1) EC / List no: - | CAS no: 189274-31-5
Iodonium, bis[4-(1,1-dimethylpropyl)phenyl]-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic EC / List no: - | CAS no: 421555-74-0
Dibenzo[k,n][1,4,7,10,13]tetraoxathiacyclopentadecinium, 19-[4-(1,1-dimethylethyl)phenyl]-6,7,9,10,12,13-hexahydro-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 928049-42-7
Quinolinium, 1-(carboxymethyl)-4-[2-[4-[4-(2,2-diphenylethenyl)phenyl]-1,2,3,3a,4,8b-hexahydrocyclopent[b]indol-7-yl]ethenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1462414-59-0
Sulfonium, [4-[(2-methyl-1-oxo-2-propen-1-yl)oxy]phenyl]diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 911027-68-4
Sulfonium, (thiodi-4,1-phenylene)bis[diphenyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:2) EC / List no: - | CAS no: 421555-73-9
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, sodium salt EC / List no: - | CAS no: 82382-12-5
Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 | CAS no: 3871-99-6
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt (1:1) EC / List no: - | CAS no: 55120-77-9
Sulfonium, tris[4-(1,1-dimethylethyl)phenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 425670-70-8
Sulfonium, triphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 144116-10-9
Iodonium, bis[4-(1,1-dimethylethyl)phenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 213740-81-9
Sulfonium, [4-[(2-methyl-1-oxo-2-propenyl)oxy]phenyl]diphenyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1), polymer with 2-ethyltricyclo[3.3.1.13,7]dec-2-yl 2-methyl-2-propenoate, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl 2-methyl-2-propenoate and tetrahydro-2-oxo-3-furanyl 2-methyl-2-propenoate EC / List no: - | CAS no: 911027-69-5
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1) EC / List no: 274-462-9 | CAS no: 70225-16-0
Phosphonium, triphenyl(phenylmethyl)-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1000597-52-3
Methanaminium, N-[4-[[4-(dimethylamino)phenyl][4-(phenylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1310480-28-4
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, scandium(3+) salt (3:1) EC / List no: - | CAS no: 350836-93-0
Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1310480-24-0
Gamma-Cyclodextrin, compd. with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid ion(1-)(1:1) EC / List no: - | CAS no: 1329995-69-8
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd.with 2-methyl-2-propanamine (1:1) EC / List no: - | CAS no: 202189-84-2
Beta-Cyclodextrin, compd. with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid ion(1-)(1:1) EC / List no: - | CAS no: 1329995-45-0
Ammonium perfluorohexane-1-sulphonate EC / List no: 269-511-6 | CAS no: 68259-08-5
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, gallium salt (9CI) EC / List no: - | CAS no: 341035-71-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with N,N-diethylethanamine (1:1) EC / List no: - | CAS no: 72033-41-1
Sulfonium, (4-methylphenyl)diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 910606-39-2
Iodonium, bis[(1,1-dimethylethyl)phenyl]-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1) (9CI) EC / List no: - | CAS no: 866621-50-3
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-
yes
salts of physostigmine
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-
Acute Tox. 2
salts of picric acid
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-
Unst. Expl.; Acute Tox. 3
salts of pilocarpine
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-
Acute Tox. 2
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