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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
butyryl chloride
205-498-5
141-75-3
Flam. Liq. 2; Skin Corr. 1B
C,C'-azodi(formamide)
204-650-8
123-77-3
Resp. Sens. 1
yes
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
yes
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 2; Acute Tox. 4; Eye Dam. 1
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 1B; Acute Tox. 4; Eye Dam. 1
C.I. Disperse Yellow 3; N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]acetamide
220-600-8
2832-40-8
Carc. 2; Skin Sens. 1
C.I. Solvent Yellow 14; 1-phenylazo-2-naphthol
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
cadmium carbonate
208-168-9
513-78-0
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
cadmium chloride
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cadmium chloride (CdCl2), hydrate (2:5) EC / List no: 640-998-0 | CAS no: 7790-78-5
233-296-7
10108-64-2
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium cyanide
208-829-1
542-83-6
Acute Tox. 2; Acute Tox. 1; Carc. 2; STOT RE 2
cadmium diformate; cadmiumformate
224-729-0
4464-23-7
Acute Tox. 3; Carc. 2; STOT RE 2
cadmium fluoride
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium hydroxide; cadmium dihydroxide
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
cadmium iodide
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
cadmium nitrate; cadmium dinitrate
233-710-6
10325-94-7
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
cadmium oxide (non-pyrophoric)
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Monteponite (CdO) EC / List no: - | CAS no: 12139-21-8
215-146-2
1306-19-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
yes
Cadmium sulphate;cadmium sulphate
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Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
233-331-6
10124-36-4;31119-53-6
yes
Cadmium sulphate;cadmium sulphate
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Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
233-331-6
10124-36-4;31119-53-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
cadmium sulphide
215-147-8
1306-23-6
Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4
yes
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)
231-152-8
7440-43-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)
231-152-8
7440-43-9
Pyr. Sol. 1; Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)
231-152-8
7440-43-9
yes
cadmiumhexafluorosilicate(2-); cadmium fluorosilica
241-084-0
17010-21-8
Acute Tox. 3; Carc. 2; STOT RE 2
caffeine
200-362-1
58-08-2
Acute Tox. 4
calcium
231-179-5
7440-70-2
Water-react. 2
Calcium arsenate
231-904-5
7778-44-1
yes
calcium carbide
200-848-3
75-20-7
Water-react. 1
calcium chloride
233-140-8
10043-52-4
Eye Irrit. 2
calcium chromate
237-366-8
13765-19-0
Carc. 1B; Acute Tox. 4
calcium cyanamide
205-861-8
156-62-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1
calcium cyanide
209-740-0
592-01-8
Acute Tox. 2
calcium hydride
232-189-2
7789-78-8
Water-react. 1
calcium hypochlorite
231-908-7
7778-54-3
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1B
calcium phosphide; tricalcium diphosphide
215-142-0
1305-99-3
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1; Eye Dam. 1
calcium polysulphides
215-709-2
1344-81-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
calcium sulphide
243-873-5
20548-54-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
camphechlor (ISO); toxaphene
232-283-3
8001-35-2
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
captafol (ISO);1,2,3,6-tetrahydro-N-(1,1,2,2- tetrachloroethylthio)phthalimide
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
captan (ISO);1,2,3,6-tetrahydro-N-(trichloromethylthio)phthalimide
205-087-0
133-06-2
Carc. 2; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
carbadox (INN);methyl 3-(quinoxalin-2-ylmethylene)carbazate 1,4-dioxide; 2-(methoxycarbonylhydrazonomethyl) quinoxaline 1,4-dioxide
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
carbaryl (ISO); 1-naphthyl methylcarbamate
200-555-0
63-25-2
Carc. 2; Acute Tox. 4
carbendazim (ISO);methyl benzimidazol-2-ylcarbamate
234-232-0
10605-21-7
Muta. 1B; Repr. 1B; Skin Sens. 1
carbetamide (ISO); (R)-1-(ethylcarbamoyl) ethyl carbanilate; (2R)-1-(ethylamino)-1-oxopropan-2-yl phenylcarbamate
240-286-6
16118-49-3
Carc. 2; Repr. 1B; Acute Tox. 4
carbofuran (ISO); 2,3-dihydro-2,2-dimethylbenzofuran-7-yl N-methylcarbamate
216-353-0
1563-66-2
Acute Tox. 2
carbon disulphide
200-843-6
75-15-0
Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
carbon monoxide
211-128-3
630-08-0
Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1
carbon tetrachloride; tetrachloromethane
200-262-8
56-23-5
Carc. 2; Acute Tox. 3; STOT RE 1
carbonic acid, nickel salt
240-408-8
16337-84-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
carbophenothion (ISO); 4-chlorophenylthiomethyl O, O-diethyl phosphorodithioate
212-324-1
786-19-6
Acute Tox. 3
carbosulfan (ISO); 2,3-dihydro-2,2-dimethyl-7-benzofuryl [(dibutylamino)thio]methylcarbamate
259-565-9
55285-14-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
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