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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 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
3a,4,7,7a-tetrahydro-4,7-methanoindene
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
4'-ethoxy-2-benzimidazoleanilide
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
4'-fluoro-2,2-dimethoxyacetophenone
DMA
407-500-1
21983-80-2
Skin Sens. 1
4,4'-(1,3-phenylene-bis(1-methylethylidene))bis-phenol
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
4,4'-(4-iminocyclohexa-2,5-dienylidenemethylene)dianiline hydrochloride; C.I. Basic Red 9
209-321-2
569-61-9
Carc. 1B
4,4'-(oxy-(bismethylene))-bis-1,3-dioxolane
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
4,4'-bi-o-toluidine
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
4,4'-bis(N-carbamoyl-4-methylbenzenesulfonamide)diphenylmethane
B-TUM
418-770-5
151882-81-4
Carc. 2
4,4'-carbonimidoylbis[N, N-dimethylaniline]
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
4,4'-diamino-2-methylazobenzene
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
4,4'-ethylidenediphenyl dicyanate
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1
4,4'-methylene bis(3-chloro-2,6-di-ethylphenylisocyanate)
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1
4,4'-methylenebis(2,6-dimethylphenyl cyanate)
AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
4,4'-methylenebis(2-ethylaniline); 4,4'-methylenebis(2-ethylbenzeneamine)
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
4,4'-methylenebis(2-isopropyl-6-methylaniline)
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
4,4'-methylenebis(N,N'-dimethylcyclohexanamine)
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
4,4'-methylenedi(cyclohexyl isocyanate); dicyclohexylmethane-4,4'-di-isocyanate
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4,4'-methylenediphenyl diisocyanate; diphenylmethane-4,4'-diisocyanate
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
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'-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
4,5-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-(1,4-dioxa-spiro[4.5]dec-8-yl)-cyclohexanone
423-860-2
56309-94-5
Skin Sens. 1
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-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-dichlorophenylazo)-2,6-di-sec-butyl-phenol
MORTRACE ST CONC.
410-600-8
124719-26-2
STOT RE 2; Skin Irrit. 2
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
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