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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 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-(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
4-amino-N,N-diethylaniline; N,N-diethyl-p-phenylendiamine
202-214-1
93-05-0
Acute Tox. 3; Skin Corr. 1B
4-amino-N,N-dimethylaniline; 3-amino-N,N'-dimethylaniline
202-807-5
99-98-9
Acute Tox. 3
4-aminoazobenzene; 4-phenylazoaniline
200-453-6
60-09-3
Carc. 1B
yes
4-aminophenol
204-616-2
123-30-8
Muta. 2; Acute Tox. 4
4-benzyl-2,6-dihydroxy-4-aza-heptylene bis (2,2-dimethyloctanoate)
VMZ95005
418-100-1
172964-15-7
Skin Sens. 1
4-bromo-2-chlorofluorobenzene
4-BROM-2-CHLORFLUORBENZOL; 4-BROMO-2-CHLOROFLUOROBENZENE
405-580-2
60811-21-4
Acute Tox. 4; Skin Irrit. 2
4-chloro-3,5-dimethylphenol
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
4-chloro-o-cresol; 4-chloro-2-methylphenol
216-381-3
1570-64-5
Acute Tox. 3; Skin Corr. 1A
4-chloro-o-toluidine
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
4-chloro-o-toluidine hydrochloride
221-627-8
3165-93-3
Carc. 1B; Muta. 2; Acute Tox. 3
4-chloroaniline
203-401-0
106-47-8
Carc. 1B; Acute Tox. 3; Skin Sens. 1
4-chlorobutyl veratrate
CHLORO ESTER; CHLOROESTER
410-950-1
69788-75-6
Skin Sens. 1
4-chlorophenol
203-402-6
106-48-9
Acute Tox. 4
4-chlorophenyl cyclopropyl ketone O-(4-aminobenzyl)oxime
ACC ETHER
405-260-2
94050-51-8
Acute Tox. 4; Skin Sens. 1
4-chlorophenylisocyanate
203-176-9
104-12-1
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
4-chlorotoluene
203-397-0
106-43-4
Acute Tox. 4
4-CPA (ISO); 4-chlorophenoxyacetic acid
204-581-3
122-88-3
Acute Tox. 4
4-cyclohexyl-2-methyl-2-butanol
CORANOL
420-630-3
83926-73-2
Eye Dam. 1
4-dichloroacetyl-1-oxa-4-azaspiro[4.5]decane
401-130-4
71526-07-3
Skin Sens. 1
4-dimethylaminobenzenediazonium 3-carboxy-4-hydroxybenzenesulfonate
DIAZO-A-SALICYLSULFONATE
404-980-4
124737-31-1
Self-react. C; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-ethoxyaniline; p-phenetidine
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
4-ethyl-2-methyl-2-isopentyl-1,3-oxazolidine
ZOLDINE (R) MS-52
410-470-2
137796-06-6
Skin Corr. 1B; Skin Sens. 1
4-ethylamino-3-nitrobenzoic acid
RO 827
412-090-2
2788-74-1
Acute Tox. 4; Skin Sens. 1
4-fluoro-3-trifluoromethylphenol
432-560-0
61721-07-1
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
4-formylphenylboronic acid
438-670-5
87199-17-5
Skin Sens. 1
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