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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 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
4,4'-oxybis(benzenesulfonylazide)
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
4,4'-oxybis(ethylenethio)diphenol
DD-63
404-590-4
90884-29-0
Skin Sens. 1
4,4'-oxydianiline and its salts; p-aminophenyl ether
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
4,4'-oxydianiline and its salts; p-aminophenyl ether
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
4,4'-thiodi-o-cresol
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
4,4'-thiodianiline and its salts
-
-
Carc. 1B; Acute Tox. 4
4,4'-thiodianiline and its salts
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
4,4,5,5,5-pentafluoropentan-1-ol
421-360-9
148043-73-6
Acute Tox. 4
4,4,5,5-tetrachloro-1,3-dioxolan-2-one
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
4,4-dimethoxybutylamine
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
4,4-isobutylethylidenediphenol
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
4,5-dichloro-2-octyl-2H-isothiazol-3-one; [DCOIT]
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
4,8,12-trimethyltrideca-3,7,11-trienoic acid, mixed isomers
HOMOFARNESYLSÄURE
403-000-2
91853-67-7
Skin Irrit. 2
4-(1(or 4 or 5 or 6)-methyl-8,9,10-trinorborn-5-en-2- yl)pyridine, reaction mass of isomers
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
-
-
yes
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
621-341-7
2315-61-9
yes
4-(1,1,3,3-tetramethylbutyl)phenol; 4-tert-octylphenol
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
4-(1,4-dioxa-spiro[4.5]dec-8-yl)-cyclohexanone
423-860-2
56309-94-5
Skin Sens. 1
4-(1-ethyl-1-methylhexyl)phenol
257-907-1
52427-13-1
yes
4-(1-oxo-2-propenyl)-morpholine
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-(2,6-dimethylheptan-2-yl)phenol
635-388-6
521947-27-3
yes
4-(2-chloro-4-trifluoromethyl)phenoxy-2-fluoroaniline hydrochloride
WL 125892
402-190-4
113674-95-6
STOT RE 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-(2-cyano-3-phenylamino acryloyloxymethyl)-cyclohexyl-methyl 2-cyano-3-phenylamino)-acrylate
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
4-(2-methylacryloyloxy)phenyl4-allyloxybenzoate
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1
4-(3,4,5,6-tetramethyloctan-2-yl)phenol
-
-
yes
4-(3,4,5-trimethylheptyl)phenol
272-233-8
68784-25-8
yes
4-(3,4-dichlorophenylazo)-2,6-di-sec-butyl-phenol
MORTRACE ST CONC.
410-600-8
124719-26-2
STOT RE 2; Skin Irrit. 2
4-(3,5-dimethylheptan-3-yl)phenol
635-389-1
186825-36-5
yes
4-(3,6-dimethylheptan-3-yl)phenol
635-391-2
142731-63-3
yes
4-(3-ethylheptan-2-yl)phenol
635-696-0
186825-39-8
yes
4-(4,4-dimethyl-3-oxo-pyrazolidin-1-yl)-benzoic acid
CARBODIM
413-120-7
107144-30-9
Acute Tox. 4
4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
250-863-4
31906-04-4
Skin Sens. 1A
4-(4-nitrophenylazo)-2,6-di-sec-butyl-phenol
MORTRACE SB CONC.
410-610-2
111850-24-9
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
4-(4-tolyloxy)biphenyl
JKY-120
405-730-7
51601-57-1
STOT RE 2
4-(5-(5-[1-(4-carboxyphenyl)hexahydro-2,4,6-trioxopyrimidin-5-ylidene]penta-1,3-dienyl)-1,2,3,4-tetrahydro-6-hydroxy-2,4-dioxopyrimidin-1-yl)benzoic acid-triethylamine salt
426-900-7
203118-12-1
STOT SE 3
4-(cyanomethyl)-4-methylmorpholin-4-ium hydrogen sulfate
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
4-(trans-4-propylcyclohexyl)acetophenone
4-(4-PROPYLCYCLOHEXYL)-ACETOPHENON
406-700-6
78531-61-0
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
4-[(3-hydroxypropyl)amino]-3-nitrophenol
PLAKATROT Z; ROT BN
406-305-9
92952-81-3
Skin Irrit. 2
4-[2-(1-methyl-2-(4-morpholinyl)ethoxy)ethyl]morpholine
M.E.M.P.E.
407-940-4
111681-72-2
Eye Dam. 1
4-[3-(diethoxymethylsilylpropoxy)-2,2,6,6-tetramethyl]piperidine
PSL 6
411-400-3
102089-33-8
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
4-[4-(1,3-dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy-5-nitroanthraquinone
ANTHRACHINON BLAU 27 HD
406-057-1
114565-66-1
Carc. 2; Skin Sens. 1
4-[4-(2,2-dimethyl-propanamido)]phenylazo-3-(2-chloro-5-(2-(3-pentadecylphenoxy)butylamido)anilino)-1-(2,4,6-trichlorophenyl)-2-pyrazoline-5-one
420-220-4
92771-56-7
Skin Sens. 1
4-[4-(2-ethylhexyloxy)phenyl](1,4-thiazinane-1,1-dioxide)
CIN 10097929
418-320-8
133467-41-1
Acute Tox. 4
4-[4-amino-5-hydroxy-3-(4-(2-sulfoxyethylsulfonyl)phenylazo)-2,7-disulfonapht-6-ylazo]-6-[3-(4-amino-5-hydroxy-3-(4-(2-sulfoxyethylsulfonyl)phenylazo)-2,7-disulfonapht-6-ylazo]phenylcarbonylamino]benzenesulfonic acid, sodium salt
NAVY DER 7850
417-640-5
161935-19-9
Eye Dam. 1; Skin Sens. 1
4-[N-ethyl-N-(2-hydroxyethyl)amino]-1-(2-hydroxyethyl)amino-2-nitrobenzene, monohydrochloride
NITROBLAU; NITROBLUE
407-020-2
132885-85-9
Acute Tox. 4; Skin Sens. 1
4-amino-2-(aminomethyl)phenol dihydrochloride
OXAMITOL
412-510-4
135043-64-0
Acute Tox. 4; Skin Sens. 1
4-amino-3-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-1-naphthalene sulfonic acid
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
4-amino-3-fluorophenol
FAP
402-230-0
399-95-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
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