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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 May 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
2-(formylamino)-3-thiophenecarboxylic acid; 2-formamido-3-thiophenecarboxylic acid
431-930-9
43028-69-9
Acute Tox. 4; Skin Sens. 1
4,4'-oxybis(benzenesulfonylazide)
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
barium calcium cesium lead samarium strontium bromide chloride fluoride iodide europium doped
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
dodecyldiphenyl phosphate
431-760-5
27460-02-2
Skin Irrit. 2
cyclohexadeca-1,9-diene
431-730-1
4277-06-9
Skin Irrit. 2; Skin Sens. 1
methyl 3-amino-2,2,3-trimethylbutyrate
431-720-7
90886-53-6
Skin Corr. 1B; Acute Tox. 4
1,1-dimethylpropyl 3,5,5-trimethylperoxyhexanoate
LUPEROX 570
431-610-9
68860-54-8
Org. Perox. D; Skin Sens. 1
benzoic acid, N-tert-butyl-N'-(4-chlorobenzoyl)hydrazide
431-600-4
112226-61-6
Skin Sens. 1
isostearic acid monoisopropanolamide
431-540-9
170573-32-7
Skin Irrit. 2
N,N-bis(cocoyl-2-oxypropyl)-N,N-dibutylammonium bromide
431-530-4
1380226-29-8
Skin Corr. 1A; Skin Sens. 1
(Z)-2-methoxymino-2-[2-(tritylamino)thiazol-4-yl]acetic acid
431-520-1
64485-90-1
Flam. Sol. 1; Carc. 2
imidazo[1,2-b]pyridazin hydrochloride
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
3,4,3', 4'-tetraphenyl-1,1'-ethandiylbispyrol-2,5-dione
431-500-0
226065-73-2
Skin Sens. 1
1-(chlorophenylmethyl)-2-methylbenzene
431-450-1
41870-52-4
Skin Irrit. 2
reaction mass of: 3-{5-[3-(4-{1,6-dihydro-2-hydroxy-4-methyl-1-[3-(methylammonio)propyl]-6-oxo-3-pyridylazo[}benzamido)phenylazo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(methyl)ammonium di(acetate); 3-{5-[4-(3-{1,6-dihydro-2-hydroxy-4-methyl-1-[3-(methylammonio)propyl]-6-oxo-3-pyridylazo}benzamido]phenylazo-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(dimethyl)ammonium di(acetate); 3-{5-[3-(4-{1-[3-(dimethylammonio)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo}benzamido)phenylazo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(dimethyl)ammoniumdi(acetate)
431-440-5
-
Eye Dam. 1
diethyl[(p-ethoxyanilino)methylene]malonate
431-430-0
103976-28-9
Acute Tox. 4
2-cyclopentene-1-acetic acid, 3-hydroxy-2-pentyl-, methyl ester acetate
431-400-7
57374-49-9
Skin Sens. 1
(R, S)-2-butyloctanedioic acid
2-BUTYLOCTANEDIOIC ACID
431-210-4
50905-10-7
Eye Dam. 1
4-(cyanomethyl)-4-methylmorpholin-4-ium hydrogen sulfate
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1-methyl-3-phenyl-1-piperazine
431-180-2
5271-27-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
reaction product of thioglycerol and mercaptoacetic acid consisting mainly of 3-mercapto-1,2-bismercaptoacetoxypropane and oligomers of this substance
431-120-5
-
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
N-nitro-N-(3-methyl-3,6-dihydro-2H-1,3,5-oxadiazin-4-yl)amine
431-060-1
153719-38-1
Acute Tox. 4; Skin Sens. 1
3-(benzo[b]thien-2-yl)-5,6-dihydro-1,4,2-oxathiazine-4-oxide
431-030-6
163269-30-5
Acute Tox. 3; STOT RE 2; Eye Dam. 1
2-(7-ethyl-1H-indol-3-yl)ethanol
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethanone methanesulfonate
431-010-7
154486-26-7
Acute Tox. 4; Eye Dam. 1
1-[3-[(dimethylamino)methyl]-4-hydroxyphenyl]ethanone
430-920-1
73096-98-7
Acute Tox. 4; Eye Dam. 1
(2,6-xylyloxy) acetic acid
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
(S)-3-methyl-2-(2-oxotetrahydropyrimidine-1-yl)butyric acid
430-900-2
192725-50-1
Eye Dam. 1
sodium 2-[[4-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]phenyl]sulfonyl]ethyl sulfate
430-890-1
81992-66-7
Skin Sens. 1
4-hexadecyl-1-phenylpyrazolidin-3-one
430-840-7
202483-63-4
Skin Sens. 1
9-(2-propenyloxy)tricyclo[5.2.1.0(2,6)]dec-3(or-4-)-ene
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
3-(2-bromopropionoyl)-4,4-dimethyl-1,3-oxazolan-2-one
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-isobutyl-2-isopropyl-1,3-dimethoxypropane
430-800-9
129228-21-3
Skin Irrit. 2
(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
(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
(S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
(R)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
(±)-4-(3-chlorophenyl)-6-[(4-chlorophenyl)hydroxy(1-methyl-1H-imidazol-5-yl)methyl]-1-methyl-2(1H)-quinolin
430-730-9
-
Eye Dam. 1
bis(2-ethylhexyl)-4,5-epoxycyclohexane-1,2-dicarboxylate
430-700-5
10138-36-0
Skin Sens. 1
reaction mass of: 1-(4-isopropylphenyl)-1-phenylethane; 1-(3-isopropylphenyl)-1-phenylethane; 1-(2-isopropylphenyl)-1-phenylethane
430-690-2
52783-21-8
Skin Irrit. 2
tetrapropan-2-yl (dichloromethanediyl)bis(phosphonate)
430-630-5
10596-22-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
(2,4-diaminopteridin-6-yl)methanol hydrobromide
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
2,2-dialkyl-4-hydroxymethyl1,3-dioxolane; reaction products with ethylene oxide (alkyl is C1-12 and the sum to C13, average degree of ethoxylation is 3,5)
430-580-4
-
Skin Irrit. 2
(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
4-mesyl-2-nitrotoluene
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
2-bromomalonaldehyde
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
(+)-(1S, 2S, 3S, 5R)-2,6,6-trimethylbicyclo[3.1.1]heptane-3-spiro-1'-(cyclohex-2'-en-4'-one)
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
tetrapotassium 4-[5-[3-carboxylato-4,5-dihydro-5-oxo1-(4-sulfonatophenyl)pyrazol-4-ylidene]-3-(piperidinocarbonyl)penta-1,3-dienylidene]-5-hydroxy-1-(4-sulfonatophenyl)pyrazole-3-carboxylate
430-390-1
845730-14-5
Acute Tox. 4
N-[1-(S)-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-N-carboxyanhydride
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
(S)-α-(acetylthio)benzenepropanoic acid
BMS 187266-02; S-TIPAC
430-300-0
76932-17-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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