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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 maggio 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
(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
(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
701-394-3
1782069-81-1
yes
(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
(5-chloro-2-methoxy-4-methyl-3-pyridyl) (4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone
692-456-8
688046-61-9
Carc. 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
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