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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
spirotetramat (ISO); (5s,8s)-3- (2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4,5]dec- 3-en-4-yl ethyl carbonate
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
solvent naphtha (petroleum), medium aliph.; Straight run kerosine [A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).]
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
265-191-7
64742-88-7
STOT RE 1; Asp. Tox. 1
Solvent naphtha (petroleum), light arom.; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135 °C to 210 °C (275°F to 410°F).]
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C (275°F to 410°F).
265-199-0
64742-95-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Solvent naphtha (petroleum), light arom., hydrotreated; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approxi mately 135 °C to 210 °C (275°F to 410°F).]
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C(275°F to 410°F).
270-988-8
68512-78-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Solvent naphtha (petroleum), light aliph.; Low boiling point naphtha [ complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 35o C to 160o C (95°F to 320°F).]
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 35°C to 160°C (95°F to 320°F).
265-192-2
64742-89-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Solvent naphtha (petroleum), hydrotreated light naphthenic; Low boiling point hydrogen treated naphtha [ complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approxi mately 73o C to 85o C (163 °F to 185 °F).]
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73°C to 85°C (163°F to 185°F).
295-529-9
92062-15-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Solvent naphtha (petroleum), hydrodesulfurized medium; Kerosine — unspecified [ complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175 °C to 220 °C (347 °F to 428 °F).]
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175°C to 220°C (347°F to 428°F).
309-884-5
101316-82-9
Asp. Tox. 1
Solvent naphtha (petroleum), hydrodesulfurized heavy arom.; Kerosine — unspecified [ complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180 °C to 240 °C (356 °F to 464 °F).]
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180°C to 240°C (356°F to 464°F).
309-882-4
101316-81-8
Asp. Tox. 1
Solvent naphtha (petroleum), hydrocracked heavy arom.; Cracked kerosine [ complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235 °C to 290 °C (455 °F to 554 °F).]
A complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235°C to 290°C (455°F to 554°F).
309-881-9
101316-80-7
Asp. Tox. 1
Solvent naphtha (petroleum), heavy arom.; Kerosine — unspecified [ complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 165 °C to 290 °C (330 °F to 554 °F).]
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 165°C to 290°C (330°F to 554°F).
265-198-5
64742-94-5
Asp. Tox. 1
Solvent naphtha (petroleum) heavy aliph.; Straight run kerosine [A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C11 through C16 and boiling in the range of approximately 190 °C to 290 °C (374 °F to 554 °F).]
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C11 through C16 and boiling in the range of approximately 190°C to 290°C (374°F to 554°F).
265-200-4
64742-96-7
Asp. Tox. 1
Solvent naphtha (coal); Light Oil Extract Residues, high boiling [The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130o C to 210o C (266oF to 410oF). Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.]
The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130°C to 210°C (266°F to 410°F) Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.
266-013-0
65996-79-4
Carc. 1B; Muta. 1B
Solvent naphtha (coal), xylene-styrene cut; Light Oil Redistillate, intermediate boiling
287-502-5
85536-20-5
Carc. 1B; Muta. 1B
Solvent naphtha (coal), light; Light Oil Redistillate, low boiling
287-498-5
85536-17-0
Carc. 1B; Muta. 1B
Solvent naphtha (coal), coumarone-styrene contg.; Light Oil Redistillate, intermediate boiling
287-500-4
85536-19-2
Carc. 1B; Muta. 1B
sodiumpentachlorophenolate
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
sodium, potassium, lithium 5-amino-3,6-bis(5-(4-chloro-6-(methyl-(2-methylaminoacetyl)amino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-4-hydroxynaphthalene-2,7-disulfonate
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
sodium selenite
233-267-9
10102-18-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
sodium salt of DNOC; sodium 4,6-dinitro-o-cresolate
219-007-7
2312-76-7
Acute Tox. 3; STOT RE 2
sodium salt of chloroacetic acid; sodium chloroacetate
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
sodium salt of 4-amino-3,6-bis[[5-[[4-chloro-6-[(2-methyl-4-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]azo]-5-hydroxy-2,7-naphthalenedisulfonic acid
435-350-7
141250-43-3
Eye Dam. 1
sodium polysulphides
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
Sodium peroxometaborate;sodium peroxometaborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium peroxometaborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
231-556-4
7632-04-4
yes
Sodium peroxometaborate;sodium peroxometaborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium peroxometaborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Sodium peroxometaborate;sodium peroxometaborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium peroxometaborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
-
-
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
-
-
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
sodium peroxide
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
sodium perchlorate
231-511-9
7601-89-0
Ox. Sol. 1; Acute Tox. 4
Sodium perborate; perboric acid, sodium salt;sodium perborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium perborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Sodium perborate; perboric acid, sodium salt;sodium perborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium perborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
239-172-9
15120-21-5
yes
Sodium perborate; perboric acid, sodium salt;sodium perborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium perborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
sodium nonadecafluorodecanoate
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes
sodium nitrite
231-555-9
7632-00-0
Ox. Sol. 3; Acute Tox. 3
sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]
274-357-8
70161-44-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
sodium methyl [(4-aminophenyl)sulphonyl]carbamate; sodium methyl (EZ)-sulfanilylcarbonimidate; asulam-sodium
218-953-8
2302-17-2
Skin Sens. 1
sodium methanolate; sodium methoxide
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
sodium metabisulphite
231-673-0
7681-57-4
Acute Tox. 4; Eye Dam. 1
sodium hypochlorite, solution... % Cl active
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1
sodium hydroxide; caustic soda
215-185-5
1310-73-2
Skin Corr. 1A
sodium hydrogensulphite ... %; sodium bisulphite . . . %
231-548-0
7631-90-5
Acute Tox. 4
sodium hydrogensulphate
231-665-7
7681-38-1
Eye Dam. 1
sodium hydride
231-587-3
7646-69-7
Water-react. 1
sodium fluoroacetate
200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
sodium fluoride
231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
sodium ethanolate; sodium ethoxide
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
sodium dithionite; sodium hydrosulphite
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
sodium dichromate
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
Sodium dichromate
616-541-6
7789-12-0
yes
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