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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 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
tetrasodium 4-hydroxy-5-[4-[3-(2-sulfatoethanesulfonyl)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]-3-(1-sulfonatonaphthalen-2-ylazo)naphthalene-2,7-disulfonate
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
tetrasodium 4-amino-5-hydroxy-6-(4-(2-(2-(sulfonatooxy)ethylsulfonyl)ethylcarbamoyl)phenylazo)-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
tetrasodium 4-amino-3,6-bis(5-(6-chloro-4-(2-hydroxyethylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxynaphthalene-2,7-sulfonate (containing > 35 % sodium chloride and sodium acetate)
BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046
400-510-7
85665-98-1
Eye Dam. 1; Skin Sens. 1
tetrasodium 4-[4-chloro-6-(4-methyl-2-sulfophenylamino)-1,3,5-triazin-2-ylamino]-6-(4,5-dimethyl-2-sulfophenylazo)-5-hydroxynaphthalene-2,7-disulfonate
AZO MONOCHLOROTRIAZINYL REACTIVE DYE; PROCION RED PX-6B COLOUR; SUBSTANCE S161057
415-400-4
148878-22-2
Eye Dam. 1; Skin Sens. 1
tetrasodium 4,4'-bis{4-[4-(2-hydroxyethylamino)-6-(4-sulfonatoanilino)-1,3,5-triazin-2-ylamino]phenylazo}stilbene-2,2'-disulfonate
429-230-3
371921-41-4
Eye Dam. 1
tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]; C.I. Direct Blue 6
220-012-1
2602-46-2
Carc. 1B; Repr. 2
tetrasodium 3,3'-(piperazine-1,4-diylbis((6-chloro-1,3,5-triazine-2,4-diyl)imino(2-acetamido)-4,1-phenyleneazo))bis(naphthalene-1,5-disulphonate)
AMARELO INDOSOL SF-2RL; INDOSOL GELB SF-2RL; INDOSOL YELLOW SF-2RL; JAUNE INDOSOL SF-2RL; JAUNE WK 1913; SOLAR GOLDEN YELLOW R; YELLOW WK 1913
400-010-9
81898-60-4
Skin Sens. 1
tetrasodium 2-(6-chloro-4-(4-(2,5-dimethyl-4-(2,5-disulphonatophenylazo)phenylazo)-3-ureidoanilino)-1,3,5-triazin-2-ylamino)benzene-1,4-disulphonate
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate
432-550-6
243858-01-7
Eye Dam. 1
tetrasodium 10-amino-6,13-dichloro-3-(3-(4-(2,5-disulfonatoanilino)-6-fluoro-1,3,5-triazin-2-ylamino)prop-3-ylamino)-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate
BLEU DIOXAZINA ST 7005; BLEU DIOXAZINE ST 7005; DIOXAZIN BLAU ST 7005; DIOXAZINE BLUE ST 7005
402-590-9
109125-56-6
Eye Dam. 1
tetrasodium 1,2-bis(4-fluoro-6- [5-(1-amino-2-sulfonatoanthra chinon-4-ylamino)-2,4,6- trimethyl-3-sulfonatopheny lamino]-1,3,5-triazin-2- ylamino)ethane
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
tetrasodium (c-(3-(1-(3-(e-6-dichloro-5-cyanopyrimidin-f-yl(methyl)amino)propyl)-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)-4-sulfonatophenylsulfamoyl)phthalocyanine-a, b,d-trisulfonato(6-))nickelato II, where a is 1 or 2 or 3 or 4,b is 8 or 9 or 10 or 11,c is 15 or 16 or 17 or 18, d is 22 or 23 or 24 or 25 and where e and f together are 2 and 4 or 4 and 2 respectively
BRILLANTGREEN K-RWA 6083; BRILLIANT GREEN K-RWA 6083
410-160-7
148732-74-5
Eye Irrit. 2; Skin Sens. 1
tetrapropan-2-yl (dichloromethanediyl)bis(phosphonate)
430-630-5
10596-22-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
tetrapotassium 4-[5-[3-carboxylato-4,5-dihydro-5-oxo1-(4-sulfonatophenyl)pyrazol-4-ylidene]-3-(piperidinocarbonyl)penta-1,3-dienylidene]-5-hydroxy-1-(4-sulfonatophenyl)pyrazole-3-carboxylate
430-390-1
845730-14-5
Acute Tox. 4
tetrapotassium 2-(4-(5-(1-(2,5- disulfonatophenyl)-3-ethoxycar bonyl-5-hydroxypyrazol-4- yl)penta-2,4-dienylidene)-3- ethoxycarbonyl-5-oxo-2-pyra zolin-1-yl)benzene-1,4- disulfonate
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
tetraphosphorus trisulphide; phosphorus sesquisulphid
215-245-0
1314-85-8
Flam. Sol. 2; Water-react. 1; Acute Tox. 4
tetramethylthiuram monosulphide
202-605-7
97-74-5
Acute Tox. 4; Skin Sens. 1
tetramethylene diacrylate; 1,4-butyleneglycol diacrylate
213-979-6
1070-70-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
tetramethylammonium hydrogen phthalate
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 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
tetralithium 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo)naphthalene-2,7-disulfonate
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
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
Tetralead trioxide sulphate
235-380-9
12202-17-4
yes
tetrakis(trimethylhexadecylammonium) hexa-mu-oxotetra-mu3-oxodi-mu5-oxotetradecaoxooctamolybdate(4-)
TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
tetrakis(tetramethylammonium); 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo)naphthalene-2,7-disulfonate
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1
tetrakis(tetramethylammonium)3,3'-(6-(2-hydroxyethylamino)1,3,5-triazine-2,4-diylbisimino(2-methyl-4,1-phenyleneazo))bisnaphthalene-1,5-disulfonate
DIRECT YELLOW 86 TETRAMETHYLAMMONIUM SALT; YELLOW DYE FOR PAINTJET PRINT CARTRIDGE
405-950-3
131013-83-7
Acute Tox. 3
tetrakis(dimethylditetradecylammonium) hexa-μ-oxotetra-μ3-oxodi-μ5-oxotetradecaoxooctamolybdate(4-)
SUBSTANCE TP-415; SUBSTANZ TP-415; TP-415
404-760-8
117342-25-3
Acute Tox. 3; Eye Dam. 1
tetrakis(1,2,2,6,6-pentamethyl-4-piperidyl)-1,2,3,4-butanetetracarboxylate
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
tetrahydrothiopyran-3-carboxaldehyde
THTPA
407-330-8
61571-06-0
Repr. 1B; Eye Dam. 1
tetrahydrothiophene-1,1-dioxide; sulpholane
204-783-1
126-33-0
Acute Tox. 4
tetrahydrothiophene
203-728-9
110-01-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
tetrahydrophthalic anhydride
247-570-9
26266-63-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydromethylphthalicanhydride
234-290-7
11070-44-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydrofuran-2,5-diyldimethanol
203-239-0
104-80-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
tetrahydrofuran
203-726-8
109-99-9
Flam. Liq. 2; Carc. 2; Eye Irrit. 2; STOT SE 3
tetrahydro-4-methylphthalicanhydride
251-823-9
34090-76-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
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
tetrahydro-2-furyl-methanol; tetrahydrofurfuryl alcohol
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one; dimethyl propyleneurea
230-625-6
7226-23-5
Repr. 2; Acute Tox. 4; Eye Dam. 1
tetrafluoroethylene
204-126-9
116-14-3
Carc. 1B
Tetraethyllead
201-075-4
78-00-2
yes
tetraethyl silicate; ethyl silicate
201-083-8
78-10-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
tetraethyl N, N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate
429-270-1
136210-30-5
Skin Sens. 1
tetradecylammonium bis(1-(5-chloro-2-oxidophenylazo)-2-naphtholato)chromate(1-)
KAYASET BLACK T-2
405-110-6
88377-66-6
STOT RE 2
Tetradecane, chloro derivs.
-
198840-65-2
yes
tetracyclohexylstannane
215-910-5
1449-55-4
Acute Tox. 4
tetracopper hexahydroxide sulphate hydrate
682-362-5
12527-76-3
Acute Tox. 4
tetracopper hexahydroxide sulphate
215-582-3
1333-22-8
Acute Tox. 4
tetraconazole (ISO); (±) 2-(2,4-dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether
TETRACONAZOLE
407-760-6
112281-77-3
Acute Tox. 4
tetrachloroplatinates with the exception of those specified elsewhere in this Annex
show/hide
Disodium tetrachloroplatinate EC / List no: 233-051-4 | CAS no: 10026-00-3
Platinate(2-), tetrachloro-, dihydrogen, (SP-4-1) EC / List no: - | CAS no: 17083-70-4
Diammonium tetrachloroplatinate EC / List no: 237-499-1 | CAS no: 13820-41-2
Diamminetetrachloroplatinum EC / List no: 240-930-6 | CAS no: 16893-05-3
Tetraammineplatinum tetrachloroplatinate EC / List no: 237-501-0 | CAS no: 13820-46-7
Dirubidium tetrachloroplatinate EC / List no: 237-503-1 | CAS no: 13820-56-9
Dipotassium tetrachloroplatinate EC / List no: 233-050-9 | CAS no: 10025-99-7
-
-
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
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