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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
(R)-2-chloro-N-(2-ethyl-6-methyl-phenyl)-N-(2-methoxy-1-methyl-ethyl)-acetamide (0-20 %)
-
178961-20-1
Skin Sens. 1
(R)-3-[(1-methylpyrrolidin-2-yl)methyl]-5-[2-(phenylsulfonyl)ethenyl]-1H-indole
430-560-5
180637-89-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
(R)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
(R)-4-hydroxy-3-(3-oxo-1-phenylbutyl)-2-benzopyrone
226-908-9
5543-58-8
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
(R)-5-bromo-3-(1-methyl-2-pyrrolidinyl methyl)-1H-indole
UK-111,975
422-390-5
143322-57-0
Repr. 2; STOT RE 1; Acute Tox. 4; Skin Sens. 1
(R)-butan-2-ol
238-967-8
14898-79-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(R)-p-mentha-1,8-diene; d-limonene
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
(R)-sec-butylamine; (R)-2-aminobutane
236-232-6
13250-12-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
(R)-α-phenylethylammonium(-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
(R, S)-1-[2-amino-1(4-methoxyphenyl)ethyl]cyclohexanol acetate
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(R, S)-2-amino-3,3-dimethylbutane amide
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
(R, S)-2-azabicyclo[2.2.1]hept-5-en-3-one
421-830-3
49805-30-3
Acute Tox. 4; Skin Sens. 1
(R, S)-2-butyloctanedioic acid
2-BUTYLOCTANEDIOIC ACID
431-210-4
50905-10-7
Eye Dam. 1
(R,S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-780-1
103146-25-4
Acute Tox. 4; Skin Sens. 1
(R,S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)3-(hydroxymethyl)benzonitrile hemisulfate
430-790-6
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy} ethyl methyl carbonate; tolpyralate
701-225-3
1101132-67-5
Carc. 2; Repr. 2; STOT RE 2
(RS)-4-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole; medetomidine
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
(S)-(-)-2-acetoxypropionylchloride; (1S)-2-chloro-1-methyl-2-oxoethyl acetate
420-610-4
36394-75-9
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
(S)-2,2-diphenyl-2-(3-pyrrolidinyl)acetonitrile hydrobromide
UK-88,861-04
421-810-4
194602-27-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(S)-2,3-dihydro-1H-indole-2-carboxylic acid
[S]-2-INDOLINE CARBOXYLIC ACID
410-860-2
79815-20-6
Repr. 2; STOT RE 2; Skin Sens. 1
(S)-2-chloropropionic acid
L-2-CHLOROPROPIONIC ACID; L-2-CHLORPROPIONSÄURE
411-150-5
29617-66-1
Acute Tox. 4; Skin Corr. 1A
(S)-3-hydroxy-γ-butyrolactone
434-990-4
7331-52-4
Skin Sens. 1
(S)-3-methyl-2-(2-oxotetrahydropyrimidine-1-yl)butyric acid
430-900-2
192725-50-1
Eye Dam. 1
(S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)-3-(hydroxymethyl)benzonitrile
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
(S)-4-hydroxy-3-(3-oxo-1-phenylbutyl)-2-benzopyrone
226-907-3
5543-57-7
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
(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
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