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 03 Maio 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
 
(6-(4-hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazin-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
Details
(6R-trans)-1-((7-ammonio-2- carboxylato-8-oxo-5-thia-1- azabicyclo-[4.2.0]oct-2-en-3- yl)methyl)pyridinium iodide
423-260-0
100988-63-4
Muta. 2; Skin Sens. 1
Details
(6β)-6,19-epoxyandrost-4-ene-3,17-dione
433-490-3
6563-83-3
Skin Sens. 1
Details
(9S)-9-amino-9-deoxyerythromycin
E.M.A.
406-790-7
26116-56-3
Eye Dam. 1
Details
(benzothiazol-2-ylthio)methyl thiocyanate; TCMTB
244-445-0
21564-17-0
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
(benzothiazol-2-ylthio)succinic acid
(2-BENZOTHIAZOLYLTHIO)BERNSTEINSÄURE; BTTBS; HALOX 650; IRGACOR 252
401-450-4
95154-01-1
Skin Sens. 1
Details
(C16 or C18-n-alkyl)(C16 or C18-n-alkyl)ammonium 2-((C16 or C18-n-alkyl)(C16 or C18-n-alkyl)carbamoyl)benzenesulphonate
OA 8523
402-460-1
-
Skin Irrit. 2; Skin Sens. 1
Details
(E)-(7R,11R)-3,7,11,15-tetramethylhexadec-2-ene-1-ol
616-221-6
7541-49-3
Skin Irrit. 2
Details
(E)-2-butenal; (E)-crotonaldehyde
204-647-1
123-73-9
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
(E)-2-methoxy-4-(prop-1-enyl)phenol
227-678-2
5932-68-3
Skin Sens. 1A
Details
(E)-3,7-dimethyl-2,6-octadienylhexadecanoate
HEXAROSE
421-370-3
3681-73-0
Skin Irrit. 2
Details
(E)-3-(2-chlorophenyl)-2-(4-fluorophenyl)propenal
DPP
410-980-5
112704-51-5
Eye Irrit. 2; Skin Sens. 1
Details
(E)-3-(4-(4-fluorophenyl)-5-methoxymethyl-2,6-bis(1-methoxymethyl)pyridin-3-yl)prop-2-enal
PYRIDYLACROLEIN
426-330-9
177964-68-0
Eye Irrit. 2; Skin Sens. 1
Details
(E)-3-[1-[4-[2-(dimethylamino)ethoxy]phenyl]-2-phenylbut-1-enyl]phenol
CP-166,221
428-010-4
82413-20-5
Carc. 2; Repr. 1B; Skin Sens. 1
Details
(E)-3-methyl-5-cyclopentadecen-1-one
429-900-5
101151-17-1
Skin Sens. 1
Details
(E)-but-2-ene
210-855-3
624-64-6
Flam. Gas 1; Press. Gas
Details
(E, Z)-4-chlorophenyl(cyclopropyl)ketone O-(4-nitrophenylmethyl)oxime
NCC ETHER
406-100-4
94097-88-8
Skin Sens. 1
Details
(E,E)-3,7,11-trimethyldodeca-1,4,6,10-tetraen-3-ol
423-240-1
125474-34-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
(E-E)-3,3'-(1,4-phenylenedimethylidene)bis(2-oxobornane-10-sulfonic acid)
MEXORYL SX; SX 32
410-960-6
92761-26-7
Eye Dam. 1
Details
(ethyl-1,2-ethanediyl)[-2-[[[(2-hydroxyethyl)methylamino]acetyl]-propyl]ω-(nonylphenoxy)poly]oxy-(methyl-1,2-ethanediyl)
TFA-4713
418-960-8
-
Skin Corr. 1B; Skin Sens. 1
Details
(ethyl-3-oxobutanoato-O'1,O'3)(2-dimethylaminoethanolato)(1-methoxypropan-2-olato)aluminium(III), dimerised
AOC 1020X
402-370-2
149057-70-5
Flam. Liq. 3; Eye Dam. 1
Details
(isodecanoato-O)(isononanoato-O)nickel
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
(isodecanoato-O)(isooctanoato-O)nickel
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
(isononanoato-O)(isooctanoato-O)nickel
287-471-8
85508-46-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
(isononanoato-O)(neodecanoato-O)nickel
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
(isooctanoato-O)(neodecanoato-O)nickel
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
(methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1'dipyridinium dichloride dihydrochloride
CARTASOL GEEL M-GL CONC.; CARTASOL GELB M-GL FLÜSSIG (ZUBEREITUNG); CARTASOL GELB M-GL KONZ.; CARTASOL YELLOW M-GL CONC.; HM 2580
401-500-5
118658-99-4
Carc. 1B
Details
(N-benzyl-N, N,N-tributyl)ammonium 4-dodecylbenzenesulfonate
TICA 118
422-200-0
178277-55-9
Skin Corr. 1B; Acute Tox. 4
Details
(N-benzyl-N-ethyl)amino-3-hydroxyacetophenone hydrochloride
ETILEFRONE. HCL
401-840-4
55845-90-4
Eye Dam. 1
Details
(R)-1,2,3,4-tetrahydro-6,7-dimethoxy-1-veratrylisoquinoline hydrochloride
R-THP
415-110-8
54417-53-7
Acute Tox. 4
Details
(R)-1-cyclohexa-1,4-dienyl-1-methoxycarbonyl-methylammoniumchloride
444-320-2
-
Acute Tox. 4
Details
(R)-2-(4-hydroxyphenoxy)propanoic acid
D-HPPA; HPOPS
407-960-3
94050-90-5
Eye Dam. 1
Details
(R)-2-chloro-N-(2-ethyl-6-methyl-phenyl)-N-(2-methoxy-1-methyl-ethyl)-acetamide (0-20 %)
-
178961-20-1
Skin Sens. 1
Details
(R)-3-[(1-methylpyrrolidin-2-yl)methyl]-5-[2-(phenylsulfonyl)ethenyl]-1H-indole
430-560-5
180637-89-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
(R)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
Details
(R)-4-hydroxy-3-(3-oxo-1-phenylbutyl)-2-benzopyrone
226-908-9
5543-58-8
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
Details
(R)-5-bromo-3-(1-methyl-2-pyrrolidinyl methyl)-1H-indole
UK-111,975
422-390-5
143322-57-0
Repr. 2; STOT RE 1; Acute Tox. 4; Skin Sens. 1
Details
(R)-butan-2-ol
238-967-8
14898-79-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
Details
(R)-p-mentha-1,8-diene; d-limonene
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
Details
(R)-α-phenylethylammonium(-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
Details
(R, S)-1-[2-amino-1(4-methoxyphenyl)ethyl]cyclohexanol acetate
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
(R, S)-2-amino-3,3-dimethylbutane amide
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
(R, S)-2-azabicyclo[2.2.1]hept-5-en-3-one
421-830-3
49805-30-3
Acute Tox. 4; Skin Sens. 1
Details
(R, S)-2-butyloctanedioic acid
2-BUTYLOCTANEDIOIC ACID
431-210-4
50905-10-7
Eye Dam. 1
Details
(R,S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-780-1
103146-25-4
Acute Tox. 4; Skin Sens. 1
Details
(R,S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)3-(hydroxymethyl)benzonitrile hemisulfate
430-790-6
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
(RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy} ethyl methyl carbonate; tolpyralate
701-225-3
1101132-67-5
Carc. 2; Repr. 2; STOT RE 2
Details
(RS)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole; medetomidine
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
Details
(S)-(-)-2-acetoxypropionylchloride; (1S)-2-chloro-1-methyl-2-oxoethyl acetate
420-610-4
36394-75-9
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
(S)-2,2-diphenyl-2-(3-pyrrolidinyl)acetonitrile hydrobromide
UK-88,861-04
421-810-4
194602-27-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
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