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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 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
reaction mass of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate; trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate
DYE K
402-660-9
-
Repr. 1B
reaction mass of: disodium 7-(2,4-difluoropyrimidin-6-ylamino)-4-hydroxy-3-(4-methoxy-2-sulfonatophenylazo)naphthalene-2-sulfonate; disodium; 7-(4,6-difluoropyrimidin-2-ylamino)-4-hydroxy-3-(4-methoxy-2-sulfonatophenylazo)naphthalene-2-sulfonate
426-840-1
-
Eye Dam. 1
reaction mass of: dodecanoic acid; poly(1-7)lactate esters of dodecanoic acid
PRICARE
411-860-5
-
Skin Sens. 1
reaction mass of: endo-2-methyl-exo-3-methyl-exo-2-[(exo-3-methylbicyclo[2.2.1]hept-exo-2-yl)methyl]bicyclo[2.2.1]heptane; exo-2-methyl-exo-3-methyl-endo-2-[(endo-3-methylbicyclo[2.2.1]hept-exo-2-yl)methyl]bicyclo[2.2.1]heptane
434-420-4
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: hexyldioctylphosphineoxide; dihexyloctylphosphineoxide; trioctylphosphineoxide
CYANEX (R) EXTRACTANT; CYANEX 923 EXTRACTANT
403-470-9
-
Skin Corr. 1B
reaction mass of: mono-and di-glycerols of canola oil; canola oil acid amide of branched 1,3-propanediamine, N-[3-(tridecyloxy)-propyl]; N, N-diorgano dithiocarbamate molybdenum complex
434-240-6
-
Skin Sens. 1
reaction mass of: monosodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; disodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; trisodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; tetrasodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate
REACTIVE YELLOW FC 75560
419-450-8
-
Skin Sens. 1
reaction mass of: N, N'-Ethane-1,2-diylbis(decanamide); 12-Hydroxy-N-[2-[1-oxydecyl)amino]ethyl]octadecanamide; N, N'-Ethane-1,2-diylbis(12hydroxyoctadecanamide)
430-050-2
-
Skin Sens. 1
reaction mass of: N-(3-(trimethoxysilyl)propyl)ethylenediamine; N-benzyl-N-(3-(trimethoxysilyl)propyl)ethylenediamine; N-benzyl-N'-[3-(trimethoxysilyl)propyl]ethylenediamine; N, N'-bis-benzyl-N'-[3-(trimethoxysilyl)propyl]ethylenediamine; N, N,N'-tris-benzyl-N'-[3-(trimethoxysilyl)propyl]ethylenediamine; N, N-bis-benzyl-N'-[3-(trimethoxysilyl)propyl]ethylenediamine
414-340-6
-
Flam. Liq. 3; Acute Tox. 4; STOT SE 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: N-(3-dimethylamino-4-methyl-phenyl)-benzamide; N-(3-dimethylamino-2-methyl-phenyl)-benzamide; N-(3-dimethylamino-3-methyl-phenyl)-benzamide
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
-
STOT RE 2
reaction mass of: N-[3-hydroxy-2-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide; N-[2,3-bis-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide; methacrylamide; 2-methyl-N-(2-methylacryloylaminomethoxymethyl)-acrylamide; N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 2
reaction mass of: N-aminoethylpiperazonium mono-2,4,6-trimethylnonyldiphenyl ether di-sulfonate; N-aminoethylpiperazonium di-2,4,6-trimethylnonyldiphenyl ether di-sulfonate
COMPLEXING AGENT BN
410-650-0
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: O, O',O''-(methylsilanetriyl)tris(4-methyl-2-pentanone oxime) (3 stereoisomers)
423-580-0
-
STOT RE 2
reaction mass of: O,O',O'',O'''-silanetetrayl tetrakis(4-methyl-2-pentanone oxime) (3 stereoisomers)
423-010-0
-
Eye Dam. 1
reaction mass of: pentasodium; 2-[[8-[[4-chloro-6-[[4-(2-sulfonatethylsulfonyl)]phenyl]amino]-1,3,5-triazin-2-yl]amino-1-hydroxy-3,6-disulfonato-2-naphthalenyl]azo]naphthalene-1,5-disulfonate; 2-[[8-[[4-chloro-6-[[4-[[2-ethenyl]sulfonyl]phenyl]amino]1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulfonato-2-naphthalenyl]azo]naphthalene-1,5-disulfonate
450-010-8
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: pentasodium; 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate; tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; tetrasodium - 4-amino-5-hydroxy-6-(E)-2-sulfonato-4-}2-(sulfonatooxy)ethylsulfonyl{phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
432-100-9
-
Eye Dam. 1
reaction mass of: pentasodium; 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl]azo]-7-sulfonato-1naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]-6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonatophenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
COLUMBIADUNKELBLAU R
415-350-3
-
Eye Dam. 1
reaction mass of: potassium N-[3-(dimethyloxidoamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane sulfonamidate; N-[3-(dimethyloxidoamino)propyl]-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluorooctane; sulfonamide
422-500-1
-
STOT RE 2
reaction mass of: potassium o-toluenephosphonate; potassium m-toluenephosphonate; potassium p-toluenephosphonate
433-860-4
-
Eye Irrit. 2; Skin Sens. 1
reaction mass of: sodium 1-tridecyl-4-allyl-(2 or 3)-sulfobutanedioate; sodium 1-dodecyl-4-allyl-(2 or 3)-sulfobutanedioate
EVAPORATED ELEMINOL JS-2 MATERIAL
410-230-7
-
Skin Corr. 1B; Skin Sens. 1
reaction mass of: sodium 2-(C12-18-n-alkyl)amino-1,4-butandioate; sodium 2-octadecenyl-amino-1,4-butandioate
TASP
411-250-9
-
Skin Sens. 1
reaction mass of: sodium 4,5-dihydro-2-[(propionato)(C6-18)alkyl]-3H-imidazolium-N-ethylphosphate; disodium 4,5-dihydro-2-[(dipropionato)(C6-18)alkyl]-3H-imidazolium-N-ethylphosphate
427-740-0
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: sodium/potassium (3-(4-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-methoxy-3-sulfonatophenylazo)-2-oxidophenylazo)-2,5,7-trisulfonato-4-naphtholato)copper(II); sodium/potassium (3-(4-(5-(5-chloro-4,6-difluoropyrimidin-2-ylamino)-2-methoxy-3-sulfonatophenylazo)-2-oxidophenylazo)-2,5,7-trisulfonato-4-naphtholato)copper(II)
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
-
Skin Sens. 1
reaction mass of: tetradecanoic acid; poly(1-7)lactate esters of tetradecanoic acid
PRICARE
411-910-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: tetrasodium 3-(1,5-disulfonatonaphthalene-2-ylazo)-4-hydroxy-7-{4-chloro-6-[4-(2-sulfoxyethylsulfonyl)phenylamino]-1,3,5-triazine-2-ylamino}naphthalene-2-sulfonate; 3-(2,5-disulfophenylazo)-4-hydroxy-7-{4-chloro-6-[4-(2-sulfoxyethylsulfonyl)phenylamino{-1,3,5-triazine-2-ylamino}naphthalene-2-sulfonic acid, sodium salt
429-440-5
-
Eye Dam. 1
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