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 May 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
 
(4-(1-methylethyl)phenyl)-(4-methylphenyl)iodonium tetrakis(pentafluorophenyl)borate(1-)
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
Details
(4-ethoxyphenyl)(3-(4-fluoro-3-phenoxyphenyl)propyl)dimethylsilane
SILANEOPHAN
405-020-7
105024-66-6
Repr. 1B
Details
(4aR*,8aR*)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef][2]benzazepin-6-one
428-690-2
1668-86-6
Acute Tox. 4; Eye Irrit. 2
Details
(4aS-cis-)-6-benzyl-octahydropyrrolo[3.4-b]pyridine
425-930-8
151213-39-7
Skin Corr. 1B; Acute Tox. 4; STOT RE 2
Details
(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
(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)-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-methyl-5-cyclopentadecen-1-one
429-900-5
101151-17-1
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
(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
(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
(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)-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, 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)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-780-1
103146-25-4
Acute Tox. 4; 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
(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
(S)-3-methyl-2-(2-oxotetrahydropyrimidine-1-yl)butyric acid
430-900-2
192725-50-1
Eye Dam. 1
Details
(S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
Details
(S)-N-tert-butyl-1,2,3,4-tetrahydro-3-isoquinolinecarboxamide
CZ-AMIDE; PTH-TETRAHYDROAMIDE; TETRAHYDROAMIDE (THA)
414-600-9
149182-72-9
Acute Tox. 4
Details
(S,S)-trans-4-(acetylamino)-5,6-dihydro-6-methyl-7,7-dioxo-4H-thieno[2,3-b]thiopyran-2-sulfonamide
TRUSOPT INTERMEDIATE, L-686,771
415-030-3
120298-38-6
Skin Sens. 1
Details
(tetrasodium 1-(4-(3-acetamido-4-(4'-nitro-2,2'-disulfonatostilben-4-ylazo)anilino)-6-(2,5-disulfonatoanilino)-1,3,5-triazin-2-yl)-3-carboxypyridinium) hydroxide
BENACTIVE GOLDEN YELLOW CN-GL; C.I. REACTIVE YELLOW 178; KAYACELON REACT GOLDEN YELLOW CN-GL; SOMAZIN GOLDEN YELLOW CN-GL
404-250-5
115099-55-3
Skin Sens. 1
Details
(tris(chloromethyl)phthalocyaninato)copper(II), reaction products with N-methylpiperazine and methoxyacetic acid
CARTASOL TUERKIS K-ZBL KONC.; CARTASOL TURQUOISE K-JD 2336; CARTASOL TURQUOISE K-JD 2336 CONC.; CARTASOL TURQUOISE K-ZBL CONC.; CARTASOL TÜRKIS K-ZBL FLÜSSIG; CARTASOL TÜRKIS K-ZBL KONZ.; TURQUOISE CARTASOL K-JD 2336 CONC.
401-260-1
118800-27-4
Eye Irrit. 2
Details
(Z)-(2,4-difluorophenyl)piperidin-4-ylmethanone oxime monohydrochloride
424-740-2
138271-16-6
Acute Tox. 4; Eye Dam. 1
Details
(Z)-1,3-dichloropropene
233-195-8
10061-01-5
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
(Z)-1-benzo[b]thien-2-ylethanone oxime hydrochloride
A-83851
410-780-8
1379676-72-8
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
(Z)-13-docosenyl-N,N-bis(2-hydroxyethyl)-N-methyl-ammonium-chloride
CLEARFRAC J508B
426-210-6
120086-58-0
Skin Corr. 1B
Details
(Z)-octadec-9-enylamine
204-015-5
112-90-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
Details
(±) trans—3,3-dimethyl-5-(2,2,3-trimethyl-cyclopent-3-en-1-yl)-pent-4-en-2-ol
POLYSANTOL
411-580-3
107898-54-4
Skin Irrit. 2
Details
(±)-1-methyl-4-(1-methylvinyl)cyclohexene;dipentene; limonene
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
Details
(±)-1-methyl-4-(1-methylvinyl)cyclohexene;dipentene; limonene
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
Details
(±)-butan-2-ol;butan-2-ol
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
Details
(±)-butan-2-ol;butan-2-ol
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
Details
(±)-trans-4-(4-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
BRL 44742
415-550-0
109887-53-8
Acute Tox. 4; Eye Dam. 1
Details
(η-cumene)-(η-cyclopentadienyl)iron(II) hexafluoroantimonate
CG 24-020; FERROCEN-SBF6
407-840-0
100011-37-8
Acute Tox. 4; Eye Dam. 1
Details
(η-cumene)-(η-cyclopentadienyl)iron(II) trifluoromethane-sulfonate
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
Details
1,1',1'-nitrilotripropan-2-ol; triisopropanolamine
204-528-4
122-20-3
Eye Irrit. 2
Details
1,1'-(1,3-phenylenedioxy)bis(3-(2-(prop-2-enyl)phenoxy)propan-2-ol)
COMPIMIDE™ 121
405-840-5
110866-35-8
Skin Sens. 1
Details
1,1'-iminodipropan-2-ol; di-isopropanolamine
203-820-9
110-97-4
Eye Irrit. 2
Details
1,1-diethoxyethane; acetal
203-310-6
105-57-7
Flam. Liq. 2; Eye Irrit. 2; Skin Irrit. 2
Details
1,1-diisopropoxycyclohexane
413-740-8
1132-95-2
Skin Corr. 1B
Details
1,1-dimethylethyl 4'-(bromomethyl)biphenyl-2-carboxylate
442-850-9
114772-40-6
Skin Sens. 1
Details
1,2,3,4-tetrahydronaphthalene
204-340-2
119-64-2
Eye Irrit. 2; Skin Irrit. 2
Details
1,2,4-trichlorobenzene
204-428-0
120-82-1
Acute Tox. 4; Skin Irrit. 2
Details
1,2-bis(2-methoxyethoxy)ethane; TEGDME; triethylene glycol dimethyl ether; triglyme
203-977-3
112-49-2
Repr. 1B
R Toxic for reproduction (article 57c)
Details
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