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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
(S)-azetidine-2-carboxylic acid; 4-cyanobenzylamide hydrochloride
433-010-2
2135910-74-4
Acute Tox. 4; Skin Sens. 1
(S)-butan-2-ol
224-168-1
4221-99-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(S)-methyl-2-chloropropionate
L (-) CHLOROPROPIONATE DE METHYLE; S (-) CHLOROPROPIONATE DE METHYLE
412-470-8
73246-45-4
Flam. Liq. 3; STOT RE 2; Eye Irrit. 2
(S)-N-tert-butyl-1,2,3,4-tetrahydro-3-isoquinolinecarboxamide
CZ-AMIDE; PTH-TETRAHYDROAMIDE; TETRAHYDROAMIDE (THA)
414-600-9
149182-72-9
Acute Tox. 4
(S)-p-mentha-1,8-diene; l-limonene
227-815-6
5989-54-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(S)-sec-butylamine; (S)-2-aminobutane
208-164-7
513-49-5
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
(S)-α-(acetylthio)benzenepropanoic acid
BMS 187266-02; S-TIPAC
430-300-0
76932-17-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(S)-α-hydroxy-3-phenoxy-benzeneacetonitrile
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
(S,S)-trans-4-(acetylamino)-5,6-dihydro-6-methyl-7,7-dioxo-4H-thieno[2,3-b]thiopyran-2-sulfonamide
TRUSOPT INTERMEDIATE, L-686,771
415-030-3
120298-38-6
Skin Sens. 1
(tetrasodium 1-(4-(3-acetamido-4-(4'-nitro-2,2'-disulfonatostilben-4-ylazo)anilino)-6-(2,5-disulfonatoanilino)-1,3,5-triazin-2-yl)-3-carboxypyridinium) hydroxide
BENACTIVE GOLDEN YELLOW CN-GL; C.I. REACTIVE YELLOW 178; KAYACELON REACT GOLDEN YELLOW CN-GL; SOMAZIN GOLDEN YELLOW CN-GL
404-250-5
115099-55-3
Skin Sens. 1
(tris(chloromethyl)phthalocyaninato)copper(II), reaction products with N-methylpiperazine and methoxyacetic acid
CARTASOL TUERKIS K-ZBL KONC.; CARTASOL TURQUOISE K-JD 2336; CARTASOL TURQUOISE K-JD 2336 CONC.; CARTASOL TURQUOISE K-ZBL CONC.; CARTASOL TÜRKIS K-ZBL FLÜSSIG; CARTASOL TÜRKIS K-ZBL KONZ.; TURQUOISE CARTASOL K-JD 2336 CONC.
401-260-1
118800-27-4
Eye Irrit. 2
(trisodium (2-((3-(6-(2-chloro-5-sulfonato)anilino)-4-(3-carboxypyridinio)-1,3,5-triazin-2-ylamino)-2-oxido-5-sulfonatophenylazo)phenylmethylazo)-4-sulfonatobenzoato)copper(3-)) hydroxide
C.I. REAKTIV-BLAU 216; KAYACELON REACT BLUE CN-BL; KAYACELON REAKT-BLAU CN-BL; UBCNBL
404-670-9
89797-01-3
Skin Sens. 1
(Z)-(2,4-difluorophenyl)piperidin-4-ylmethanone oxime monohydrochloride
424-740-2
138271-16-6
Acute Tox. 4; Eye Dam. 1
(Z)-1,3-dichloropropene
233-195-8
10061-01-5
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
(Z)-1-benzo[b]thien-2-ylethanone oxime hydrochloride
A-83851
410-780-8
1379676-72-8
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
(Z)-13-docosenyl-N,N-bis(2-hydroxyethyl)-N-methyl-ammonium-chloride
CLEARFRAC J508B
426-210-6
120086-58-0
Skin Corr. 1B
(Z)-2-(2-t-butoxycarbonylamino-4-thiazolyl)pent-2-enoic acid
430-100-3
86978-24-7
Acute Tox. 4
(Z)-2-methoxy-4-(prop-1-enyl)phenol
227-633-7
5912-86-7
Skin Sens. 1A
(Z)-2-methoxymino-2-[2-(tritylamino)thiazol-4-yl]acetic acid
431-520-1
64485-90-1
Flam. Sol. 1; Carc. 2
(Z)-but-2-ene
209-673-7
590-18-1
Flam. Gas 1; Press. Gas
(Z)-octadec-9-enylamine
204-015-5
112-90-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
(±) trans—3,3-dimethyl-5-(2,2,3-trimethyl-cyclopent-3-en-1-yl)-pent-4-en-2-ol
POLYSANTOL
411-580-3
107898-54-4
Skin Irrit. 2
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one
253-242-6
36861-47-9
yes
(±)-1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
(±)-1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
(±)-1-methyl-4-(1-methylvinyl)cyclohexene;dipentene; limonene
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(±)-1-methyl-4-(1-methylvinyl)cyclohexene;dipentene; limonene
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(±)-4-(3-chlorophenyl)-6-[(4-chlorophenyl)hydroxy(1-methyl-1H-imidazol-5-yl)methyl]-1-methyl-2(1H)-quinolin
430-730-9
-
Eye Dam. 1
(±)-4-[2-[[3-(4-hydroxyphenyl)-1-methylpropyl]amino]-1-hydroxyethyl]phenol hydrochloride
PAYLEAN; RACTOPAMINE HYDROCHLORIDE
415-170-5
90274-24-1;99095-19-9
Acute Tox. 4; Skin Sens. 1
(±)-4-[2-[[3-(4-hydroxyphenyl)-1-methylpropyl]amino]-1-hydroxyethyl]phenol hydrochloride
PAYLEAN; RACTOPAMINE HYDROCHLORIDE
415-170-5
90274-24-1;99095-19-9
Acute Tox. 4; Skin Sens. 1
(±)-[(R*,R*) and (R*,S*)]-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran
T001446
419-600-2
99199-90-3
Skin Sens. 1
(±)-butan-2-ol;butan-2-ol
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(±)-butan-2-ol;butan-2-ol
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(±)-trans-4-(4-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
BRL 44742
415-550-0
109887-53-8
Acute Tox. 4; Eye Dam. 1
(±)-α-[(2-acetyl-5-methylphenyl)-amino]-2,6-dichlorobenzene-aceto-nitrile
T001769
419-290-9
780757-44-0
Skin Sens. 1
(η-cumene)-(η-cyclopentadienyl)iron(II) hexafluoroantimonate
CG 24-020; FERROCEN-SBF6
407-840-0
100011-37-8
Acute Tox. 4; Eye Dam. 1
(η-cumene)-(η-cyclopentadienyl)iron(II) trifluoromethane-sulfonate
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
1,1',1'-nitrilotripropan-2-ol; triisopropanolamine
204-528-4
122-20-3
Eye Irrit. 2
1,1'-(1,3-phenylenedioxy)bis(3-(2-(prop-2-enyl)phenoxy)propan-2-ol)
COMPIMIDE™ 121
405-840-5
110866-35-8
Skin Sens. 1
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
1,1'-iminodipropan-2-ol; di-isopropanolamine
203-820-9
110-97-4
Eye Irrit. 2
1,1,1,3,3-pentafluorobutane
430-250-1
406-58-6
Flam. Liq. 2
1,1,1-trichloroethane; methyl chloroform
200-756-3
71-55-6
Acute Tox. 4
1,1,2,2-tetrabromoethane
201-191-5
79-27-6
Acute Tox. 2; Eye Irrit. 2
1,1,2,2-tetrachloroethane
201-197-8
79-34-5
Acute Tox. 2; Acute Tox. 1
1,1,2-trichloroethane
201-166-9
79-00-5
Carc. 2; Acute Tox. 4
1,1,3,3-tetrabutyl-1,3-ditinoxydicaprylate
D 28-283
419-430-9
56533-00-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
1,1,3,3-tetramethylbutylperoxypivalate
424-980-8
22288-41-1
Flam. Liq. 2; Org. Perox. D; Skin Irrit. 2; Skin Sens. 1
1,1-dichloro-1-nitroethane
209-854-0
594-72-9
Acute Tox. 3
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