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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 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
ε-caprolactam
203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
α[2-[[[(2-hydroxyethyl)methylamino]acetyl]amino]propyl]-ω nonylphenoxy)poly[oxo(methyl-1,2-ethanediyl)]
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
α-hydroxypoly(methyl-(3-(2,2,6,6-tetramethylpiperidin-4-yloxy)propyl)siloxane)
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
α-cypermethrin (ISO); racemate comprising (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; (S)-α-cyano-3-phenoxybenzyl(1R, 3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3
α-chlorotoluene; benzyl chloride
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α-bromotoluene; benzyl bromide
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
α-[3-(1-oxoprop-2-enyl)l-1-oxypropyl]dimethoxysilyloxy-ω-[3(1-oxoprop-2-enyl)-1-oxypropyl]dimethoxysilyl poly(dimethylsiloxane)
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol; C.I. Solvent Blue 4
229-851-8
6786-83-0
yes
α, α-dimethylbenzyl hydroperoxide; cumene hydroperoxide
201-254-7
80-15-9
Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
α, α-dichlorotoluene; benzylidene chloride; benzal chloride
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α, α, α-trifluorotoluene; benzotrifluoride
202-635-0
98-08-8
Flam. Liq. 2
α, α, α-trichlorotoluene; benzotrichloride
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
α, α, α,4-tetrachlorotoluene; p-chlorobenzotrichloride
226-009-1
5216-25-1
Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
zoxamide (ISO); (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide
605-037-1
156052-68-5
Skin Sens. 1
zirconium powder (pyrophoric);zirconium powder, dry (non pyrophoric)
231-176-9
7440-67-7
Water-react. 1; Pyr. Sol. 1
zirconium powder (pyrophoric);zirconium powder, dry (non pyrophoric)
231-176-9
7440-67-7
Self-heat. 1
Zirconia Aluminosilicate Refractory Ceramic Fibres
936-037-2
-
yes
ziram (ISO); zinc bis dimethyldithiocarbamate
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
zineb (ISO); zinc ethylenebis(dithiocarbamate) (polymeric)
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
zinc-bis(4-(n-octyloxycarbonylamino)salicylate) dihydrate
417-130-2
1379689-21-0
Eye Dam. 1
zinc sulphate (hydrous) (mono-, hexa-and hepta hydrate)
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
zinc sulphate (anhydrous)
231-793-3
7733-02-0
Acute Tox. 4; Eye Dam. 1
zinc powder — zinc dust (pyrophoric)
231-175-3
7440-66-6
Water-react. 1; Pyr. Sol. 1
zinc hexacyanocobaltate(III), tertiary butyl alcohol/polypropylene glycol complex
425-240-7
-
Eye Dam. 1
zinc chromates including zinc potassium chromate
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Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
-
-
Carc. 1A; Acute Tox. 4; Skin Sens. 1
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