EU-MEDICAL_DEVICES-ANX_I_7_8

Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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Last updated 24 April 2024. Database contains 4753 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
(2,5-dioxopyrrolidin-1-yl)-9H-fluoren-9-ylmethyl carbonate
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
(2,6-xylyloxy) acetic acid
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
(2-(1,3-dioxolan-2-yl)ethyl)triphenylphosphonium bromide
DWS
404-940-6
86608-70-0
Acute Tox. 4; Eye Dam. 1; STOT RE 2
(2-(aminomethyl)phenyl)acetylchloride hydrochloride
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
(2-butyl-5-nitrobenzofuran-3-yl)[4-(3-dibutylaminopropoxy)phenyl]methanone
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
(2-chloroethyl)(3-hydroxypropyl)ammonium chloride
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
(2-ethylhexanoato-O)(isodecanoato-O)nickel
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(2-ethylhexanoato-O)(isononanoato-O)nickel
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(2-methylpropyl)lithium; isobutyllithium
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
(2R)-2-amino-2-phenylacetamide
420-370-0
6485-67-2
Eye Irrit. 2; Skin Sens. 1
(2R*, 3S*)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (1R)-10-camphorsulfonate
UK-103,449-BV
427-100-0
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(2R, 3S, 4R, 5R, 7R, 9R, 10R,11S, 12S, 13R)-10-[(4-dimethylamino-3-hydroxy-6-methyltetrahydropyran-2-yl)oxy]-2-ethyl-3,4,12-trihydroxy-9-methoxy-3,5,7,9,11,13-hexamethyl-6,14-dioxo-1-oxacyclotetradecane
433-820-6
118058-74-5
Eye Irrit. 2
(2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
(2R,3S)-N-(3-amino-2-hydroxy-4-phenylbutyl)-N-isobutyl-4-nitrobenzenesulfonamide hydrochloride
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
(2R,6aS,12aS)-1,2,6,6a,12,12a-hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one, rotenone
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol; mefentrifluconazole
822-682-6
1417782-03-6
Skin Sens. 1
(2S)-5-(benzyloxy)-2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)-5-oxopentanoic acid
443-560-5
88784-33-2
Eye Irrit. 2
(2S, 5R)-6,6-dibromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
(3'-carboxymethyl-5-(2-(3-ethyl-3H-benzothiazol-2-ylidene)-1-methyl-ethylidene)-4,4'-dioxo-2'-thioxo-(2,5')bithiazolidinyliden-3-yl)-acetic acid
CIN 10094329; SENSIBILISATOR KF 693 PINA; SENSITIZER KF 693 PINA
422-240-9
166596-68-5
Eye Dam. 1; Skin Sens. 1
(3-aminophenyl)pyridin-3-ylmethanone
428-230-0
79568-06-2
STOT RE 2
(3-chloro-2-hydroxypropyl); trimethylammonium chloride ...%
222-048-3
3327-22-8
Carc. 2
(3-chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone
T 1569; T001569
423-290-4
66938-41-8
Muta. 2
(3S, 4aS, 8aS)-N-tert-butyldecahydro-3-isoquinolinecarboxamide
420-380-5
136465-81-1
Acute Tox. 4; Eye Dam. 1
(3S, 6R, 9S, 12R, 15S, 18R, 21S,24R)-6,18-dibenzyl-3,9,15,21-tetraisobutyl-4,10,12,16,22,24-hexamethyl-1,7,13,19-tetraoxa-4,10,16,22-tetraazacyclo-tetracosane-2,5,8,11,14,17,20,23-octaone
444-350-6
133413-70-4
Eye Irrit. 2
(3S,4aS,8aS)-2-[(2R,3S)-3-amino-2-hydroxy-4-phenylbutyl]-N-tert-butyldecahydroisoquinoline-3-carboxamide
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
(3β, 5α, 6β)-3-(acetyloxy)-5-bromo-6-hydroxy-androstan-17-one
17-KETOBROMOHYDRINE
419-790-7
4229-69-0
Skin Sens. 1
(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
(4-aminophenyl)-N-methylmethylensulfonamide hydrochloride
SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
(4-ammonio-m-tolyl)ethyl(2-hydroxyethyl)ammonium sulphate; 4-(N-ethyl-N-2-hydroxyethyl)-2-methylphenylenediamine sulphate
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
(4-ethoxyphenyl)(3-(4-fluoro-3-phenoxyphenyl)propyl)dimethylsilane
SILANEOPHAN
405-020-7
105024-66-6
Repr. 1B
(4-hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride
SULPHAZINE
406-090-1
81880-96-8
Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
(4-phenylbutyl)phosphinic acid
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1
(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
(4aS-cis-)-6-benzyl-octahydropyrrolo[3.4-b]pyridine
425-930-8
151213-39-7
Skin Corr. 1B; Acute Tox. 4; STOT RE 2
(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
(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
(6β)-6,19-epoxyandrost-4-ene-3,17-dione
433-490-3
6563-83-3
Skin Sens. 1
(9S)-9-amino-9-deoxyerythromycin
E.M.A.
406-790-7
26116-56-3
Eye Dam. 1
(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
(benzothiazol-2-ylthio)succinic acid
(2-BENZOTHIAZOLYLTHIO)BERNSTEINSÄURE; BTTBS; HALOX 650; IRGACOR 252
401-450-4
95154-01-1
Skin Sens. 1
(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
(E)-(7R,11R)-3,7,11,15-tetramethylhexadec-2-ene-1-ol
616-221-6
7541-49-3
Skin Irrit. 2
(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
(E)-2-methoxy-4-(prop-1-enyl)phenol
227-678-2
5932-68-3
Skin Sens. 1A
(E)-3,7-dimethyl-2,6-octadienylhexadecanoate
HEXAROSE
421-370-3
3681-73-0
Skin Irrit. 2
(E)-3-(2-chlorophenyl)-2-(4-fluorophenyl)propenal
DPP
410-980-5
112704-51-5
Eye Irrit. 2; Skin Sens. 1
(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
(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
(E)-3-methyl-5-cyclopentadecen-1-one
429-900-5
82356-51-2
Skin Sens. 1
(E)-but-2-ene
210-855-3
624-64-6
Flam. Gas 1; Press. Gas
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