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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
ethametsulfuron-methyl (ISO); methyl 2-({[4-ethoxy-6-(methylamino)-1,3,5-triazin-2-yl] carbamoyl}sulfamoyl) benzoate
619-290-0
97780-06-8
Eye Irrit. 2
ethyl (3R)-4-cyano-3-hydroxybutanoate
430-220-6
141942-85-0
Eye Irrit. 2
flubenzimine (ISO);N-[3-phenyl-4,5-bis[(trifluoromethyl)imino]thiazolidin-2- ylidene]aniline
253-703-1
37893-02-0
Eye Irrit. 2
fumaric acid
203-743-0
110-17-8
Eye Irrit. 2
hexasodium 2,2'-vinylenebis((3- sulfonato-4,1-pheny lene)imino(6-(N-cyanoethyl-N-(2-hydroxypropyl)amino)-1,3,5-triazine-4,2-diyl)imino)dibenzene-1,4-disulfonate
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
imazapyr (ISO);2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H- imidazol-2-yl]-3-pyridine carboxylate
617-219-8
81334-34-1
Eye Irrit. 2
methyl acetoacetate
203-299-8
105-45-3
Eye Irrit. 2
N,N'—1,6-hexanediylbis(N-(2,2,6,6-tetramethyl-piperidin-4-yl)-formamide
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
Eye Irrit. 2
N-(1,3-dimethylbutyl)-N'-(phenyl)-1,4-benzoquinonediimine
429-640-2
52870-46-9
Eye Irrit. 2
N-[(benzotriazole-1-yl)methyl)]4-carboxy-benzenesulfonamide
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
pentasodium 5-anilino-3-(4-(4-(6-chloro-4-(3-sulphonatoanilino)-1,3,5-triazin-2-ylamino)-2,5-dimethylphenylazo)-2,5-disulphonatophenylazo)-4-hydroxynaphthalene-2,7-disulphonate
301-312-2
93983-23-4
Eye Irrit. 2
potassium (E,E)-hexa-2,4- dienoate
246-376-1
24634-61-5
Eye Irrit. 2
potassium 3,6-dichloro-o-anisate
233-002-7
10007-85-9
Eye Irrit. 2
profluralin (ISO);N-(cyclopropylmethyl)-α, α,α- trifluoro-2,6-dinitro-N-propyl-p-toluidine
247-656-6
26399-36-0
Eye Irrit. 2
propylene carbonate
203-572-1
108-32-7
Eye Irrit. 2
reaction mass of disodium 6-(2,4-dihydroxyphenylazo)-3-(4-(4-(2,4-dihydroxyphenylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate and disodium 6-(2,4-diaminophenylazo)-3-(4-(4-(2,4-diaminophenylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate and trisodium 6-(2,4-dihydroxyphenylazo)-3-(4-(4-(7-(2,4-dihydroxyphenylazo)-1-hydroxy-3-sulphonato-2-naphthylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
reaction mass of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
reaction mass of: 2-methyl-1-(6-methylbicyclo[2.2.1]hept-5-en-2-yl)pent-1-en-3-ol; 2-methyl-1-(1-methylbicyclo[2.2.1]hept-5-en-2-yl)-pent-1-en-3-ol; 2-methyl-1-(5-methylbicyclo[2.2.1]hept-5-en-2-yl)pent-1-en-3-ol
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
reaction mass of: 4-[(3-decyloxypropyl)(3-isobutoxy-1-isobutoxycarbonyl-3-oxopropyl)amino]-4-oxobutyric acid; 4-[(3-isobutoxy-1-isobutoxycarbonyl-3-oxopropyl)(3-octyloxypropyl)amino]-4-oxobutyric acid
423-750-4
-
Eye Irrit. 2
reaction mass of: disodium hexyldiphenyl ether disulphonate; disodium dihexyldiphenyl ether disulphonate
DOWFAX (R) DRY HYDROTROPE POWDER
429-650-7
147732-60-3
Eye Irrit. 2
sodium 3-(methoxycarbonyl)-4-oxo-3,4,5,6-tetrahydro-2-pyridinolate
418-410-7
139122-78-4
Eye Irrit. 2
sodium carbonate
207-838-8
497-19-8
Eye Irrit. 2
tetra-ammonium 2-[6-[7-(2-carboxylato-phenylazo)-8-hydroxy-3,6-disulfonato-1-naphthylamino]-4-hydroxy-1,3,5-triazin-2-ylamino]benzoate
MJR-580
418-520-5
183130-96-3
Eye Irrit. 2
tetrahydro-2-isobutyl-4-methylpyran-4-ol, mixed isomers (cis and trans)
CIS/TRANS-TIMO; FLOROL; FLOROSA
405-040-6
63500-71-0
Eye Irrit. 2
tetralithium 2-[6-[7-[2-(carboxylato)phenylazo]-8-hydroxy-3,6-disulfonato-1-naphthylamino]-4-hydroxy-1,3,5-triazine-2-ylamino]benzoate
440-460-3
252579-81-0
Eye Irrit. 2
trisodium 1-hydroxynaphthalene-2-azo-4'(5',5''-dimethylbiphenyl)-4''-azo(4''-phenylsulfonyloxybenzene)-2',2'',4-trisulfonate
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
benzophenone-3,3',4,4'-tetracarboxylic dianhydride; 4,4'-carbonyldi(phthalic anhydride)
219-348-1
2421-28-5
Eye Irrit. 2; STOT SE 3
citric acid
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
cyclopentane-1,2,3,4-tetracarboxylic dianhydride
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
1,4,5,6,7,7-hexachlorobicyclo [2,2,1]hept-5-ene-2,3-dicarboxylicanhydride chlorendic anhydride
204-077-3
115-27-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2-phenylphenol (ISO)biphenyl-2-ol; 2-hydroxybiphenyl
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
barium polysulphides
256-814-3
50864-67-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
biphenyl; diphenyl
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
calcium polysulphides
215-709-2
1344-81-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
calcium sulphide
243-873-5
20548-54-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
ethyl 2-cyanoacrylate
230-391-5
7085-85-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
ferbam (ISO); iron tris(dimethyldithiocarbamate)
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
isooctyl acrylate
249-707-8
29590-42-9
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
mecrilate; methyl 2-cyanoacrylate
205-275-2
137-05-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
monoalkyl or monoaryl or monoalkyaryl esters of methacrylic acid with the exception of those specified elsewhere in this Annex
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
monoalkylor monoaryl or monoalkylaryl esters of acrylic acid with the exception of those specified elsewhere in this Annex
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
p-toluenesulphonic acid (containing a maximum of 5 % H2SO4);p-toluenesulphonic acid, (containing more than 5 % H2SO4)
203-180-0
104-15-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
sabadilla (ISO);veratrine
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
silicon tetrachloride
233-054-0
10026-04-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
tetrahydrofuran-2,5-diyldimethanol
203-239-0
104-80-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
trioctyltin compounds, with the exception of those specified elsewhere in this Annex
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
α-bromotoluene; benzyl bromide
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
4-isocyanatosulphonyltoluene; tosyl isocyanate
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
bromelain, juice
232-572-4
9001-00-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
chymotrypsin
232-671-2
9004-07-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
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