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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 24 April 2024. Database contains 4821 unique substances/entries.
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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
methyl 2-chlorosulfonyl-4-(methanesulfonylaminomethyl) benzoate
443-120-2
393509-79-0
Eye Dam. 1
triphenyl(phenylmethyl)phosphonium 1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1)
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
methyl 2-(acetylamino)-3-chloropropionate
442-860-3
87333-22-0
Skin Sens. 1
1,1-dimethylethyl 4'-(bromomethyl)biphenyl-2-carboxylate
442-850-9
114772-40-6
Skin Sens. 1
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
reaction mass of: 2-{3,6-bis-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl[}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,3-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,4-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3,6-bis-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (2-10 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,4-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,5-dimethylphenyl)-methylamino]-6-[(2-ethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2,4-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,3-dimethylphenyl)-methylamino]-6-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %); 2-{3-[(2,4-dimethylphenyl)-methylamino]-6-[(2,5-dimethylphenyl)-methylamino]-xanthylium-9-yl}-benzenesulfonate (7-20 %)
442-800-6
-
Skin Irrit. 2
cobalt lithium nickel oxide
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
reaction mass of: 1,2-dimethylpropylidene dihydroperoxide; dimethyl 1,2-benzenedicarboxylate
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction mass of: 2-(2-((oxo(phenyl)acetyl)oxy)ethoxy)ethyl oxo(phenyl)acetate; (2-(2-hydroxyethoxy)ethyl)oxo(phenyl)acetate
442-300-8
-
Skin Sens. 1
reaction mass of: 3-[5-(4-ethenesulfonylbutyrylamino)-2-sulfophenylazo]-5-4-chloro-[6-(4-(3-amino-5-hydroxy-2,7-disulfonaphthalene-4-ylazo)-3-sulfophenylamino]-1,3,5-triazin-2-ylamino)-4-hydroxynaphthalene-2,7-disulfonic acid, sodium salt; 3-[5-(4-(2-chloroethanesulfonyl)butyrylamino)-2-sulfophenylazo]-5-4-chloro-[6-(4-(3-amino-5-hydroxy-2,7-disulfonaphthalene-4-ylazo)-3-sulfophenylamino]-1,3,5-triazin-2-ylamino)-4-hydroxynaphthalene-2,7-disulfonic acid, sodium salt
442-290-5
457624-86-1
Eye Dam. 1
2-{4-[4-[4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino]phenylazophenylazo}naphthalene-4,6,8-trisulfonate, trisodium salt
442-230-8
321679-52-1
Eye Dam. 1
pentasodium N-[5-[[4-[[3-[(aminocarbonyl)amino]-4-[(3,6,8-trisulfonatonaphthalen-2-yl)azo]phenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-2-sulfonato-4-[[4-[[-2-(oxysulfonato)ethyl] sulfonyl]phenyl]azo]phenyl]-3-aminopropanoic acid
442-030-0
321912-47-4
Eye Dam. 1
3,4-dihydroxy-5-nitrobenzaldehyde
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
6,6'-bis(diazo-5,5', 6,6'-tetrahydro-5,5'-dioxo)[methylene-bis(5-(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulphonyloxy)-6-methyl-2-phenylene]di(naphthalene-1-sulfonate)
441-550-5
-
Self-react. C; Carc. 2
3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)aniline
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
(S)-α-hydroxy-3-phenoxy-benzeneacetonitrile
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
ammonium 2-cocoyloxyethanesulfonate
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
1-ethoxy-2,3-difluorobenzene
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt
440-770-9
371921-63-0
Eye Dam. 1
(2-methylpropyl)lithium; isobutyllithium
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
reaction mass of: 3-[3-carbamoyl-5-(5-{4-chloro-6[4-(2-sulfonatooxyethylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl]propanoic acid, trisodium salt; 3-[3-carbamoyl-5-(5-{4-chloro-6-[4-(vinylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-1,2-dihydro-6-hydroxy-4-methyl-2oxo-1-pyridyl]propanoicacid, disodium salt
440-510-4
-
Eye Dam. 1; Skin Sens. 1
trisodium 5-{[4-chloro-6-(1-naphthylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[(E)-(4-methoxy-2-sulfonatophenyl)diazenyl]-2,7-naphthalenedisulfonate
440-480-2
341026-59-3
Eye Dam. 1; Skin Sens. 1
tetralithium 2-[6-[7-[2-(carboxylato)phenylazo]-8-hydroxy-3,6-disulfonato-1-naphthylamino]-4-hydroxy-1,3,5-triazine-2-ylamino]benzoate
440-460-3
252579-81-0
Eye Irrit. 2
2,6,6,7,8,8-hexamethyldecahydro-2H-indeno[4,5-b]furan
440-030-5
338735-71-0
Skin Irrit. 2; Eye Dam. 1
reaction product of diphenylamine, phenothiazine, and alkenes, branched (C8-10, C9-rich)
439-540-0
-
Skin Irrit. 2; Skin Sens. 1
3,3,4,4-tetrafluoro-4-iodo-1-butene
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
(2,3-dimethylbut-2-yl)-trimethoxysilane
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
4-formylphenylboronic acid
438-670-5
87199-17-5
Skin Sens. 1
reaction mass of: triammonium; 6-amino-3-((2,5-diethoxy-4-(3-phosphonophenyl)azo)phenyl)azo-4-hydroxy-2-naphthalenesulfonate; diammonium 3-((4-((7-amino-1-hydroxy-3-sulfo-naphthalen-2-yl)azo)-2,5-diethoxyphenyl)azo)benzoate
438-310-7
-
Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
N-ethyl-3-trimethoxysilyl-2-methyl-propanamine
437-720-3
227085-51-0
Eye Dam. 1
pentasodium 7-(4-(4-(3-(2-sulfatoethanesulfonyl)phenylamino)-6-(4-(2-sulfatoethanesulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
436-920-8
172399-10-9
Eye Dam. 1
reaction mass of trisodium 3-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate; trisodium 3-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate
436-890-6
-
Eye Dam. 1
S-(3-(triethoxysilyl)propyl)octanethioate
436-690-9
220727-26-4
Skin Sens. 1
reaction mass of: dimethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate; diethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate; methyl ethyl (2-(hydroxymethylcarbamoyl)ethyl)phosphonate
435-960-3
-
Carc. 1B; Muta. 1B; Skin Sens. 1
N'-(1,3-dimethylbutylidene)-3-hydroxy-2-naphthohydrazide
435-860-1
214417-91-1
Skin Sens. 1
alkenes, C12-14, hydroformylation products, distn. residues, C-(hydrogen sulfobutanedioates), disodium salts
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
alkyl(rapeseed oil), bis(2-hydroxyethyl)ammonium fluoride
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
methyl-5-nitrophenyl-guanidine
435-500-1
152460-07-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
N, N-(dimethylamino)thioacetamide hydrochloride
435-470-1
27366-72-9
Repr. 1B
reaction mass of: methyl 3-((1E)-2-methylprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; methyl 3-((1Z)-2-methylprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate (20:80)
435-450-0
5460-63-9
Skin Sens. 1
reaction mass of: 3-[[4-chloro-6-[[7-[(1,5-disulfo-2-naphthalenyl)azo]-8-hydroxy-3,6-disulfo1-naphthalenyl]amino]-1,3,5-triazin-2-yl]amino]-5-[[4-chloro-6-[[8-hydroxy-3,6-disulfo-7-[(2-sulfophenyl)azo]-1-naphthalenyl]amino]-1,3,5-triazin-2yl]amino]benzoic acid; 3,5-bis[[4-chloro-6-[[7-[(1,5-disulfo-2-naphthalenyl)azo]-8-hydroxy-3,6-disulfo-1-naphthalenyl]amino]-1,3,5-triazin-2-yl]amino]benzoic acid
435-440-6
-
Eye Dam. 1
sodium salt of 4-amino-3,6-bis[[5-[[4-chloro-6-[(2-methyl-4-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]azo]-5-hydroxy-2,7-naphthalenedisulfonic acid
435-350-7
141250-43-3
Eye Dam. 1
reaction mass of:5-endo-butyl-bicyclo[2.2.1]hept-2-ene; 5-exo-butyl-bicyclo[2.2.1]hept-2-ene (80:20)
435-180-3
-
Asp. Tox. 1; Skin Irrit. 2
2-chloro-N-(4-methylphenyl)acetamide
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
ethyl 6,8-dichlorooctanoate
6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
435-080-1
1070-64-0
Skin Sens. 1
N, N',N''-tris(2-methyl-2,3-epoxypropyl)-perhydro-2,4,6-oxo-1,3,5-triazine
435-010-8
26157-73-3
Muta. 2
5-endo-hexyl-bicyclo[2.2.1]hept-2-ene
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
(S)-3-hydroxy-γ-butyrolactone
434-990-4
7331-52-4
Skin Sens. 1
2,4-dihydro-4-(4-(4-(4-hydroxyphenyl)-1-piperazinyl)phenyl)-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one
434-820-9
106461-41-0
STOT RE 2
ethyl N2-dodecanoyl-l-argininate hydrochloride
434-630-6
60372-77-2
Eye Dam. 1
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