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).

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Last updated 24 Abril 2024. Database contains 4917 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU REACH: List of SVHC
EU_BA Directive 2000/54/EC
 
7-methylocta-1,6-diene
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
Details
7-oxa-3-oxiranylbicyclo [4.1.0]heptane; 1,2-epoxy- 4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
Details
7a-ethyl-3,5-bis(1-methylethyl)-2,3,4,5-tetrahydrooxazolo[3,4-c]-2,3,4,5-tetrahydrooxazole
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
Details
8,8-dimethyl-7-isopropyl-6,10-dioxaspiro[4.5]decane
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
Details
8,9,10-trinorborn-2-yl acrylate
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Details
8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
8,9-dinorborn-5-ene-2,3-dicarboxylic anhydride
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
8-amino-7-methylquinoline
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
Details
8-azaspiro[4.5]decane-7,9-dione
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
Details
8-p-menthyl hydroperoxide; p-menthane hydroperoxide
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
Details
9,9-bis(4-hydroxyphenyl)fluorene
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
Details
9-(2-propenyloxy)tricyclo[5.2.1.0(2,6)]dec-3(or-4-)-ene
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
Details
9-[2-(ethoxycarbonyl) phenyl]-3,6-bis(ethylamino)–2,7-dimethylxanthylium chloride; Basic Red 1
213-584-9
989-38-8
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
Details
9-vinylcarbazole
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Details
[(1-methyl-1,2-ethanediyl)bis[nitrilobis(methylene)]]tetrakis(phosphonic acid)
421-940-1
28698-31-9
Eye Dam. 1
Details
[(4S, 5S)-4-benzyl-2-oxo-5-oxazolidinyl]methyl 4-nitrobenzenesulfonate
416-360-0
162221-28-5
Skin Sens. 1
Details
[(dimethylsilylene)bis((1,2,3,3a,7a-η)-1H-inden-1-ylidene)dimethyl]hafnium
M1
422-060-0
137390-08-0
Acute Tox. 2
Details
[(m-tolyloxy)methyl]oxirane
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
Details
[(p-tolyloxy)methyl]oxirane
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
Details
[(tolyloxy)methyl]oxirane; cresyl glycidyl ether
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
Details
[1R-(1-α, 2β,5α)]-mono[5-methyl-2-(1-methylethyl)cyclohexyl]butanedioate
426-890-4
77341-67-4
Eye Dam. 1
Details
[2-[(4-nitrophenyl)amino]ethyl]urea
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
Details
[3-(chlorocarbonyl)-2-methylphenyl]acetate
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
Details
[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride; C.I. Basic Blue 26
219-943-6
2580-56-5
C Carcinogenic (article 57a)
Details
[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl] acetic acid
419-270-1
123599-82-6
Eye Irrit. 2
Details
[carbonato(2-)] tetrahydroxytrinickel
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
[N-(1,1-dimethylethyl)-1,1-dimethyl-1-[(1,2,3,4,5-η)-2,3,4,5-tetramethyl-2,4-cyclopentadien-1-yl]silanaminato(2-)-κN][(1,2,3,4-η)-1,3-pentadiene]-titanium
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
Details
[phosphinyldynetris(oxy)] tris[3-aminopropyl-2-hydroxy-N, N-dimethyl-N-(C6-18)-alkyl] trichlorides
425-520-9
197179-61-6
Eye Dam. 1
Details
[Phthalato(2-)]dioxotrilead
273-688-5
69011-06-9
R Toxic for reproduction (article 57c)
Details
[R-(R*,S*)]-[[2-methyl-1-(1-oxopropoxy)propoxy]-(4-phenylbutyl)phosphinyl] acetic acid, (-)-cinchonidine (1:1) salt
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
Details
[μ-[carbonato(2-)-O:O']]dihydroxy trinickel
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
A 2:1 mixture of: tris(3,5,5-trimethylhexylammonium)-4-amino-3-(4-(4-(2-amino-4-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate; tris(3,5,5-trimethylhexylammonium)-4-amino-3-(4-(4-(4-amino-2-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
Details
A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate
NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
402-850-1
-
Eye Dam. 1
Details
A mixture of isomers of iron (1:2) complexes of a mixture of: isomers of: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-(5-amino-sulfonyl-2-hydroxyphenylazo)benzene (n=2,5,6); isomers of: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-[4-(4-nitro-2-sulfophenylamino)phenylazo]benzene (n=2,5,6)
BROWN JR 543
414-150-3
-
Skin Sens. 1
Details
A mixture of isomers of: 1,1'-[(3,5(or 2,4 or 4,6 or 2,6)-dihydroxy-o(or m or p)-phenylene)bis(azo-meta-phenyleneazo{1-[3-(dimethylamino)propyl]-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl})]dipyridinium-dichloride-dihydrochloride; 1-(1-[3-(dimethylamino)propyl]-5-{3-[x-(4-{1-[3-(dimethylamino)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo}phenylazo)-2,4(or 2,6 or 3,5 or 4,6)-dihydroxyphenylazo]phenylazo}-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium-dichloride-dihydrochloride (where x is variable)
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
-
Skin Sens. 1
Details
A mixture of: ((Z)-3,7-dimethyl-2,6-octadienyl)oxycarbonylpropanoic acid; di-((E)-3,7-dimethyl-2,6-octadienyl) butandioate; di-((Z)-3,7-dimethyl-2,6-octadienyl) butandioate; (Z)-3,7-dimethyl-2,6-octadienyl butandioate; ((E)-3,7-dimethyl-2,6-octadienyl)oxycarbonylpropanoic acid
MS6119
415-190-4
-
Skin Sens. 1
Details
A mixture of: (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(2-(bis(2-hydroxyethyl)amino)ethoxycarbonylmethyl)hexadec-4-enoate; (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(2-(bis(2-hydroxyethyl)amino)ethoxycarbonylmethyl)tetradec-4-enoate; (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(3-methoxypropylcarbamoylmethyl)hexadec-4-enoate; (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(3-methoxypropylcarbamoylmethyl)tetradec-4-enoate
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
-
Skin Irrit. 2; Eye Dam. 1
Details
A mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione; a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
Details
A mixture of: 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl) 12-(1''H,1''H,2''H,2''H-tridecafluorooctyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl) 12-(1''H,1''H,2''H,2''H-heptdecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl) 12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl) 12-(1''H,1''H,2''H,2''H-pentacosafluorotetradecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl) 12-(1''H,1''H,2''H,2''H-heptadecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl) 12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate
HFR-990
423-180-6
-
STOT RE 2
Details
A mixture of: 2-(9-methyl-1,3,8,10-tetraoxo-2,3,9,10-tetrahydro-(1H,8H)-anthra[2,1,9-def: 6,5,10-d'e'f']diisoquinolin-2-ylethansulfonic acid; potassium 2-(9-methyl-1,3,8,10-tetraoxo-2,3,9,10-tetrahydro-(1H,8H)-anthra[2,1,9-def: 6,5,10-d'e'f']diisoquinolin-2-ylethansulfate
PIGMENTADDITIV P
411-310-4
-
Eye Dam. 1
Details
A mixture of: 3-(N-(3-dimethylaminopropyl)-(C4-8)perfluoroalkylsulfonamido)propionic acid; N-[dimethyl-3-(C4-8-perfluoroalkylsulfonamido)propylammonium propionate; 3-(N-(3-dimethylpropylammonium)-(C4-8)perfluoroalkylsulfonamido)propionic acid propionate
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
Details
A mixture of: 3-cyano-5-(2-cyano-4-nitro-phenylazo)-2-(2-hydroxyethylamino)-4-methyl-6-[3-(2-phenoxyethoxy)propylamino]pyridine; 3-cyano-5-(2-cyano-4-nitro-phenylazo)-6-(2-hydroxyethylamino)-4-methyl-2-[3-(2-phenoxyethoxy)propylamino]pyridine; 3-cyano-5-(2-cyano-4-nitro-phenylazo)-2-amino-4-methyl-6-[3-(3-hydroxypropoxy)propylamino]pyridine; 3-cyano-5-(2-cyano-4-nitro-phenylazo)-6-amino-4-methyl-2-[3-(3-methoxypropoxy)propylamino]pyridine
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
Details
A mixture of: 4,4',4''-[(2,4,6-trioxo-1,3,5(2H,4H,6H)-triazine-1,3,5-triyl)tris[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)iminocarbonyloxy-2,1-ethanediyl(ethyl)amino]]trisbenzenediazoniumtri[bis(2-methylpropyl)naphthalenesulfonate]; 4,4',4'',4'''-[[5,5'-[carbonylbis[imino(1,5,5-trimethyl-3,1-cyclohexanediyl)methylene]]-2,4,6-trioxo-1,3,5(2H,4H,6H)-triazine-1,1',3,3'-tetrayl]tetrakis[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)iminocarbonyloxy-2,1-ethanediyl(ethyl)amino]]tetrakisbenzenediazoniumtetra[bis(2-methylpropyl)naphthalenesulfonate]
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
Details
A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]
CASSIFFIX
422-040-1
426218-78-2
Eye Irrit. 2; Skin Irrit. 2
Details
A mixture of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
Details
A mixture of: bis(tris(2-(2-hydroxy(1-methyl)ethoxy)ethyl)ammonium) 7-anilino-4-hydroxy-3-(2-methoxy-5-methyl-4-(4-sulfonatophenylazo)phenylazo)naphthalene-2-sulfonate; bis(tris(2-(2-hydroxy(2-methyl)ethoxy)ethyl)ammonium) 7-anilino-4-hydroxy-3-(2-methoxy-5-methyl-4-(4-sulfonatophenylazo)phenylazo)naphthalene-2-sulfonate
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
Details
A mixture of: calcium bis(C10-14 branched alkyl salicylate); calcium bis(C18-30-alkyl salicylate); calcium C10-14 branched alkylsalicylato-C18-30-alkyl salicylate; calcium bis (C10-14 branched alkyl phenolate); calcium bis (C18-30-alkyl phenolate); calcium C10-14 branched alkylphenolato-C18-30-alkyl phenolate; C10-14 branched alkyl phenol; C18-30-alkyl phenol
SP 7077
430-180-1
-
Skin Irrit. 2
Details
A mixture of: dicalcium (bis(2-hydroxy-5-tetra-propenylphenylmethyl)methylamine)dihydroxide; tri-calcium (tris(2-hydroxy-5-tetra-propenylphenylmethyl)methylamine)tri-hydroxide; poly[calcium ((2-hydroxy-5-tetrapropenyl-phenylmethyl)methylamine)hydroxide]
OLOA 224 (OIL FREE)
420-470-4
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
A mixture of: disodium (6-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-oxidophenylazo)-1-naphtholato)(1-(5-chloro-2-oxidophenylazo)-2-naphtholato)chromate(1-); trisodium bis(6-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-oxidophenylazo)-1-naphtholato)chromate(1-)
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
Details
A Mixture of: disodium 6-(2,4-dihydroxyphenylazo)-3-(4-(4-(2,4-dihydroxyphenylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate; disodium 6-(2,4-diaminophenylazo)-3-(4-(4-(2,4-diaminophenylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate; trisodium 6-(2,4-dihydroxyphenylazo)-3-(4-(4-(7-(2,4-dihydroxyphenylazo)-1-hydroxy-3-sulphonato-2-naphthylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
Details
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