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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 29 April 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
4-methyl-3-oxo-N-phenyl-2-(phenylmethylene)pentanamide
425-860-8
125971-57-5
Skin Sens. 1
potassium tetrasodium bis[(N,N'-n)-1'-(phenylcarbamoyl)-3,5-disulfonatobenzeneazo-1'-prop-1'-ene-2,2'-diolato]chromate(III)
425-830-4
-
Eye Dam. 1
3-ethyl 5 methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
UK-48,340
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
3-chloropropyl chloroformiate
CHLOROFORMIATE DE CHLORO 3 PROPYLE
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-[3-(methylamino)propyl]-1H-benzimidazole
425-760-4
64137-52-6
Eye Dam. 1
product-by-process definition polyazodyestuff obtained by coupling 4-[4-(1-amino-8-hydroxy-3,6-disulfo-2-naphthylazo)phenylsulfonylamino] benzenediazonium with reaction mass of 4-carboxybenzenediazonium and diphenylamine-3-sulfo-4,4'-bisdiazonium, and further coupling of the obtained compounds with reaction mass of naphth-2-ol and 3-aminophenol, sodium salts; sodium chloride
425-740-5
-
Eye Dam. 1
1,6-hexanediammonium, sodium 5-sulfato-1,3-benzenedicarboxylate
425-730-0
51178-75-7
Skin Sens. 1
N-(2-amino-4,6-dichloropyrimidin-5-yl)formamide
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
reaction mass of: (2R, 3R)-3-(2-ethoxyphenoxy)-2-hydroxy-3-phenylpropylammonium methanesulfonate; (2S, 3S)-3-(2-ethoxyphenoxy)-2-hydroxy-3-phenylpropylammonium methanesulfonate
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
[phosphinyldynetris(oxy)] tris[3-aminopropyl-2-hydroxy-N, N-dimethyl-N-(C6-18)-alkyl] trichlorides
425-520-9
197179-61-6
Eye Dam. 1
sodium 4-hydroxy-3-(N'-(2-(2-hydroxyethylenesulfonyl)ethylene)ureido)-5-nitrobenzenesulfonate
425-460-3
1379676-84-2
Skin Sens. 1
1,4,7,10-tetraazacyclododecane
425-450-9
294-90-6
Skin Corr. 1B; Acute Tox. 4
ethynyl cyclopropane
425-430-1
6746-94-7
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
diethylmethoxyborane
425-380-9
7397-46-8
Pyr. Liq. 1; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
3-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-(E)-2-propenal
425-370-4
93957-50-7
Skin Sens. 1
N-benzyl-N-ethyl-(4-(5-nitro-benzo[c]isothiazol-3-ylazo)phenyl)amine
425-300-2
186450-73-7
Skin Sens. 1
tetraammine palladium (II)hydrogen carbonate
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; 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
zinc hexacyanocobaltate(III), tertiary butyl alcohol/polypropylene glycol complex
425-240-7
-
Eye Dam. 1
(1-hydroxydodecylidene)diphosphonic acid
KELCOR; LIPOKEL; SEQUOL
425-230-2
16610-63-2
Skin Corr. 1B
salt of: (1S-cis)-1-amino-2,3-dihydro-1H-inden-2-ol and [R-[R*R*]]-2,3-dihydroxybutanedioic acid
425-210-3
169939-84-8
Skin Sens. 1
methyl 3-amino-4,6-dibromo-2-methyl-benzoate
425-190-6
119916-05-1
STOT RE 2
2-acetoxymethylene-4-acetylphenylacetate
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-butyryl-3-hydroxy-5-thiocyclohexan-3-yl-cyclohex-2-en-1-one
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
cis-1-(3-(4-fluorophenoxy)propyl)-3-methoxy-4-piperidinamine
425-080-8
104860-26-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
2-(3,4-epoxycyclohexyl)ethyltriethoxy silane
425-050-4
10217-34-2
Skin Sens. 1
4-[(3-chlorophenyl)(1H-imidazol-1-yl)methyl]-1,2-benzenediamine dihydrochloride
425-030-5
159939-85-2
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
1,1,3,3-tetramethylbutylperoxypivalate
424-980-8
22288-41-1
Flam. Liq. 2; Org. Perox. D; Skin Irrit. 2; Skin Sens. 1
2,4-diamino-5-[4-[(2-sulfoxyl ethyl)sulfonyl]phenylazo]benzenesulfonic acid
424-870-1
27624-67-5
Expl. 1.1; Eye Dam. 1
7-amino-4-hydroxy-2-naphthalenesulfonic acid, coupled with 5 (or 8) -amino-8 (or 5)-[[4-[[4-[[4-amino-6(or 7)-sulfo-1-naphthyl]azo]phenyl]amino]-3-sulfophenyl]azo]-2-naphthalenesulfonic acid and 4-hydroxy-7-(phenylamino)-2-naphthalenesulfonic acid, sodium salt
424-850-0
189702-72-5
Eye Dam. 1
(Z)-(2,4-difluorophenyl)piperidin-4-ylmethanone oxime monohydrochloride
424-740-2
138271-16-6
Acute Tox. 4; Eye Dam. 1
tetrabutylammonium 2-amino-6-iodopurinate
424-710-9
156126-48-6
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-amino-4-bromo-5-chlorobenzoic acid
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
2,5-dioxopyrrolidin-1-yl N-{[methyl[[2-(1-methylethyl)-4-thiazoly]methyl]amino]carbonyl}-L-Valinate
424-660-8
-
STOT RE 2; Eye Dam. 1; Skin Sens. 1
1-phenyl-3-(p-toluenesulfonyl)urea
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one hydrochloride
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
N-[6,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6-oxo-1H-purin-2-yl]acetamide
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
3-(2-chloroethyl)-6,7,8,9-tetra-hydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one monohydrochloride
424-530-0
93076-03-0
Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-chloro-3-trifluoromethylpyridine
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
reaction product of: C.I. Leuco Sulfur Black 1 with (3-chloro-2-hydroxypropyl)trimethylammonium chloride
424-510-1
-
Eye Dam. 1
N-methylbenzene-1,2-diammonium hydrogen phosphate
424-460-0
283167-56-6
Acute Tox. 4; Skin Sens. 1
vanadium(IV) oxide hydrogen phosphate hemihydrate, lithium, zinc, molybdenum, iron and chlorine-doped
424-390-0
93280-40-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1
2-ethyl-2,3-dihydro-2-methyl-1H-perimidine
424-380-6
43057-68-7
Acute Tox. 4; STOT RE 2
18-methylnonadecyl 2,2-dimethylpropanoate
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
reaction mass of: pentasodium; 5-amino-3-(5-{4-chloro-6-[4-(2-sulfoxyethoxysulfonato)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-6-[5-(2,3-dibromopropionylamino)-2-sulfonatophenylazo]-4-hydroxynaphthalene-2,7-disulfonate; pentasodium 5-amino-6-[5-(2-bromoacryloylamino)-2-sulfonatophenylazo]-3-(5-{4-chloro-6-[4-(2-sulfoxyethoxysulfonato)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-4-hydroxynaphthalene-2,7-disulfonate; tetrasodium 5-amino-3-[5-{4-chloro-6-[4-(vinylsulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo]-6-[5-(2,3-dibromopropionylamino)-2-sulfonatophenylazo]-4-hydroxynaphthalene-2,7-disulfonate
MARINE REN 600
424-320-9
180778-23-8
Eye Dam. 1
3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
reaction mass of: methyl {[5-acetylamino-4-(2-chloro-4-nitrophenylazo)phenyl]methoxycarbonylmethylamino}acetate; methyl {[5-acetylamino-4-(2-chloro-4-nitrophenylazo)phenyl]ethoxycarbonylmethylamino}acetate
424-290-7
188070-47-5
Skin Sens. 1
R-1-chloro-2,3-epoxypropane
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
reaction mass of isomers of: sodium [(2-hydroxyethylsulfamoyl){][}2-(2-piperazin-1-ylethylamino)ethylsulfamoyl][2-(4-aminoethylpiperazine-1-yl)ethylsulfamoyl{](sulfamoyl)[}(sulfonatophthalocyaninato)]copper(II)
SUBSTANCE S166075
424-270-8
-
Eye Dam. 1
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