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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 30 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
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
carbon monoxide
211-128-3
630-08-0
Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1
chlordimeform (ISO); N2-(4-chloro-o-tolyl)-N1,N1-dimethylformamidine
228-200-5
6164-98-3
Carc. 2; Acute Tox. 4
chloroform; trichloromethane
200-663-8
67-66-3
Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
chrysoidine-p-dodecylbenzenesulfonate; dodecylbenzenesulfonic acid, compound with 4-(phenylazo)benzene-1,3-diamine (1:1)
264-409-8
63681-54-9
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
cis-1-(3-chloropropyl)-2,6-dimethyl-piperidin hydrochloride
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
Clarified oils (petroleum), catalytic cracked; Heavy Fuel oil [A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-064-6
64741-62-4
Carc. 1B
Clarified oils (petroleum), hydrodesulfurized catalytic cracked; Heavy Fuel oil [A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350 °C (662 °F). This stream is likely to contain 5 wt. % or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-782-0
68333-26-6
Carc. 1B
cobalt dimolybdenum nickel octaoxide
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
cobalt nickel gray periclase; C.I. Pigment Black 25; C.I. 77332
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
colchicine
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
colecalciferol; cholecalciferol; Vitamin D3
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
constitutional isomers of penta-O-allyl-β-D-fructofuranosyl-α-D-glucopyranoside; constitutional isomers of hexa-O-allyl-β-D-fructofuranosyl-α-D-glucopyranoside; constitutional isomers of hepta-O-allyl-β-D-fructofuransoyl-α-D-glucopyranoside
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Corynebacterium pseudotuberculosis
-
68583-16-4
B Bacteria and similar species
Creosote oil [ complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200 °C to 325 °C (392°F to 617°F).]
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
cycloheximide (ISO);4-{(2R)-2-[(1S,3S,5S)-3,5- dimethyl-2-oxocyclohexyl]-2- hydroxyethyl}piperidine-2,6- dione
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
cyclopentane-1,2,3,4-tetracarboxylic dianhydride
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; beta-cyfluthrin
269-855-7
68359-37-5
Acute Tox. 2; Acute Tox. 3
cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; beta-cyfluthrin
269-855-7
68359-37-5
Acute Tox. 2
cyprofuram (ISO); N-(3-chlorophenyl)-N-(tetrahydro-2-oxo-3-furyl)cyclopropanecarboxamide
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
D, L-(N,N-diethyl-2-hydroxy-2-phenylacetamide)
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
demephion-O (ISO); O, O-dimethyl O-2-methylthioethyl phosphorothioate
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
di-sec-butylamine
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
dibutyltin dichloride; (DBTC)
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
dichlorvos (ISO); 2,2-dichlorovinyl dimethyl phosphate
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
dicoumarol; 4,4'-dihydroxy-3,3'-methylenebis(2H-chromen-2-one)
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
dieldrin (ISO)
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
diethyl ether; ether
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
diethyl sulphate
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
diethylmercury
211-000-7
627-44-1
Acute Tox. 2; Acute Tox. 1; STOT RE 2
diethylmethylbenzenediamine
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
diisopentylphthalate
210-088-4
605-50-5
Repr. 1B
yes
diketene; diketen
211-617-1
674-82-8
Flam. Liq. 3; Acute Tox. 4
dimepiperate (ISO);S-(1-methyl-1-phenylethyl) piperidine-1-carbothioate
262-784-2
61432-55-1
Acute Tox. 4
dimethoate (ISO); O, O-dimethyl methylcarbamoylmethyl phosphorodithioate
200-480-3
60-51-5
Acute Tox. 4
dimethyl (2S)-2-hydroxysuccinate
432-310-0
617-55-0
Flam. Liq. 3; Eye Dam. 1; Skin Sens. 1
dimethyl carbonate
210-478-4
616-38-6
Flam. Liq. 2
dimethyl disulphide
210-871-0
624-92-0
Flam. Liq. 2; Acute Tox. 3; STOT SE 3; STOT SE 1; Eye Irrit. 2; Skin Sens. 1
dimethylnitrosoamine; N-nitrosodimethylamine
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
dinocton; reaction mass of isomers:; methyl 2-octyl-4,6-dinitrophenyl carbonate, methyl 4-octyl-2,6-dinitrophenyl carbonate
-
63919-26-6
Acute Tox. 4
dioxacarb (ISO); 2-(1,3-dioxolan-2-yl)phenyl N-methylcarbamate
230-253-4
6988-21-2
Acute Tox. 3
disodium metasilicate
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
Distillates (coal tar), upper; Heavy Anthracene Oil [The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.]
The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.
266-026-1
65996-91-0
Carc. 1B
Distillates (coal tar); Heavy Anthracene Oil [The distillate from coal tar having an approximate distil lationrange of 100°C to 450°C (212°F to 842°F). Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.]
The distillate from coal tar having an approximate distillation range of 100°C to 450°C (212°F to 842°F). Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.
266-027-7
65996-92-1
Carc. 1B
Distillates (coal-petroleum), condensed-ring arom; Distillates [The distillate from a mixture of coal and tar and aromatic petroleum streams having an approximate distillation range of 220 °C to 450 °C (428°F to 842°F). Composed primarily of 3-to 4-membered condensed ring aromatic hydrocarbons.]
The distillate from a mixture of coal tar and aromatic petroleum streams having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of 3- to 4-membered condensed ring aromatic hydrocarbons.
269-159-3
68188-48-7
Carc. 1B
Distillates (petroleum), acid-treated heavy naphthenic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-117-3
64742-18-3
Carc. 1A
Distillates (petroleum), acid-treated heavy paraffinic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons btained as a raffinate from a sulfuric acid process. It consists predomi nantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of a least 100 SUS at 100°F (19cSt at 40 °C).]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-119-4
64742-20-7
Carc. 1A
Distillates (petroleum), acid-treated light naphthenic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-118-9
64742-19-4
Carc. 1A
Distillates (petroleum), acid-treated light paraffinic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oi having aviscosity of less than 100 SUS at 100 °F (19cSt at 40°C).]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-121-5
64742-21-8
Carc. 1A
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