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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
(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
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