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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 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
chlordimeform hydrochloride; N'-(4-chloro-o-tolyl)-N,N-dimethylformamidine monohydrochloride; N2-(4-chloro-o-tolyl)-N1,N1-dimethylformamidine hydorchloride
243-269-1
19750-95-9
Carc. 2; Acute Tox. 4
di-allate (ISO); S-(2,3-dichloroallyl)-N,N-diisopropylthiocarbamate
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
monuron (ISO); 3-(4-chlorophenyl)-1,1-dimethylurea
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
naphthalene
202-049-5
91-20-3
Carc. 2; Acute Tox. 4
tralkoxydim (ISO); 2-(N-ethoxypropanimidoyl)-3-hydroxy-5-mesitylcyclohex-2-en-1-one
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
methyl iodide; iodomethane
200-819-5
74-88-4
Carc. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 3; Skin Irrit. 2
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 2; Acute Tox. 4; Eye Dam. 1
4,4'-carbonimidoylbis[N, N-dimethylaniline]
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
salts of 4,4'-carbonimidoylbis[N, N-dimethylaniline]
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4,4'-carbonimidoylbis[N,N-dimethylaniline] nitrate EC / List no: 282-561-3 | CAS no: 84255-15-2
Benzenesulfonic acid, 4-dodecyl-, compd. with 4,4'-carbonimidoylbis(N,N-dimethylbenzenamine) (1:1) EC / List no: - | CAS no: 63589-43-5
4,4'-bis[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo][1,1'-biphenyl]-2,2'-disulphonic acid, compound with 4,4'-carbonimidoylbis[N,N-dimethylphenylamine] (1:2) EC / List no: 277-106-0 | CAS no: 72939-51-6
4,4'-carbonimidoylbis[N,N-dimethylanilinium] sulphate EC / List no: 282-562-9 | CAS no: 84255-16-3
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, (2-methoxyethoxy)acetate EC / List no: - | CAS no: 82941-28-4
Decyl hydrogen sulphate, compound with 4,4'-carbonimidoylbis[N,N-dimethylaniline] (1:1) EC / List no: 281-828-1 | CAS no: 84030-53-5
4,4'-carbonimidoylbis[N,N-dimethylaniline] acetate EC / List no: 225-801-4 | CAS no: 5089-20-3
Methanaminium, N-(4-(amino(4-(dimethylamino)phenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-methyl-, dodecyl(sulfophenoxy)benzenesulfonate (2:1) EC / List no: - | CAS no: 63428-09-1
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, mono(dodecylbenzenesulfonate) EC / List no: - | CAS no: 82794-01-2
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, 2-hydroxyethanesulfonate EC / List no: - | CAS no: 86157-51-9
4,4'-carbonimidoylbis(N,N-dimethylaniline) monohydrochloride EC / List no: 219-567-2 | CAS no: 2465-27-2
-
-
Carc. 2; Acute Tox. 4; Eye Irrit. 2
trisodium nitrilotriacetate
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
3,5,5-trimethylcyclohex-2-enone; isophorone
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
diethylcarbamoyl chloride
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,4,6-trichlorophenol
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
folpet (ISO);N-(trichloromethylthio)phthalimide
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea
206-354-4
330-54-1
Carc. 2; Acute Tox. 4; STOT RE 2
2,2'-methylenediphenyl diisocyanate; diphenylmethane-2,2'-diisocyanate
219-799-4
2536-05-2
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'-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
methylenediphenyl diisocyanate
247-714-0
26447-40-5
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
o-(p-isocyanatobenzyl)phenyl isocyanate; diphenylmethane-2,4'-diisocyanate
227-534-9
5873-54-1
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
1-vinyl-2-pyrrolidone
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
UVCB condensation product of: tetrakis-hydroxymethylphosphonium chloride, urea and distilled hydrogenated C16-18 tallow alkylamine
ITC 826 CONCENTRATE
422-720-8
166242-53-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
fuberidazole (ISO);2-(2-furyl-)-1H-benzimidazole
223-404-0
3878-19-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
imiprothrin (ISO); reaction mass of: [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl)imidazolidin-3-yl]methyl(1R)-trans-chrysanthemate
428-790-6
72963-72-5
Carc. 2; Acute Tox. 4; STOT SE 2
tetramethrin (ISO); (1,3-dioxo-1,3,4,5,6,7-hexahydro-2H-isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate
231-711-6
7696-12-0
Carc. 2; Acute Tox. 4; STOT SE 2
2,6-xylidine; 2,6-dimethylaniline
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
reaction products of diisopropanolamine with formaldehyde (1:4)
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
tributyl phosphate
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
N, N-dimethylanilinium tetrakis(pentafluorophenyl)borate
B1; N,N-DIMETHYLANILINUM TETRAKIS(PENTAFLUOROPHENYL)BORATE; TÉTRAKIS(PENTAFLUOROPHÉNYL)BORATE DE N,N-DIMÉTHYLANILINIUM
422-050-6
118612-00-3
Carc. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
alachlor (ISO); 2-chloro-2',6'-diethyl-N-(methoxymethyl)acetanilide
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
etridiazole (ISO); 5-ethoxy-3-trichloromethyl-1,2,4-thiadiazole
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
(4-phenylbutyl)phosphinic acid
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1
1,4-dichlorobenzene; p-dichlorobenzene
203-400-5
106-46-7
Carc. 2; Eye Irrit. 2
amisulbrom (ISO); 3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
molybdenum trioxide
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
3-(4-chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
morpholine-4-carbonyl chloride
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
N-2-naphthylaniline; N-phenyl-2-naphthylamine
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
leucomalachite green; N, N,N',N'-tetramethyl-4,4'-benzylidenedianiline
204-961-9
129-73-7
Carc. 2; Muta. 2
o-phenylenediamine
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
o-phenylenediamine dihydrochloride
210-418-7
615-28-1
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Aniline
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
salts of aniline
show/hide
Anilinium bromide EC / List no: 208-801-9 | CAS no: 542-11-0
Phthalic acid, compound with aniline (1:1) EC / List no: 256-856-2 | CAS no: 50930-79-5
Dianilinium sulphate EC / List no: 208-805-0 | CAS no: 542-16-5
Anilinetrifluoroboron EC / List no: 211-539-8 | CAS no: 660-53-7
Benzenesulfonic acid, 2,2'-dithiobis(5-methyl-, compd. with benzenamine (1:2) EC / List no: - | CAS no: 63468-80-4
Anilinium dihydrogen phosphate EC / List no: 253-680-8 | CAS no: 37832-42-1
Anilinium p-tolylsulphonate EC / List no: 237-870-8 | CAS no: 14034-57-2
Anilinium chloride EC / List no: 205-519-8 | CAS no: 142-04-1
Benzenesulfonic acid, 2(or 4)-methyl-, compd. with benzenamine (1:1) EC / List no: - | CAS no: 70788-38-4
Anilinium acetate EC / List no: 208-802-4 | CAS no: 542-14-3
Aniline EC / List no: 200-539-3 | CAS no: 62-53-3
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-
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
1-chloro-4-nitrobenzene
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
1,4-dihydroxybenzene; hydroquinone; quinol
204-617-8
123-31-9
Carc. 2; Muta. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1-(1-naphthylmethyl)quinolinium chloride
CIB R634
406-220-7
65322-65-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
thiophanate-methyl (ISO); dimethyl (1,2-phenylenedicarbamothioyl)biscarbamate; dimethyl 4,4'-(o-phenylene) bis(3-thioallophanate)
245-740-7
23564-05-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Sens. 1
C.I. Solvent Yellow 14; 1-phenylazo-2-naphthol
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
methylmercuric chloride
204-064-2
115-09-3
Carc. 2; Repr. 1A; Lact.; Acute Tox. 2; STOT RE 1
lead acetate, basic
215-630-3
1335-32-6
Carc. 2; Repr. 1A; STOT RE 2
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