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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
xylene
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
xylenol
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
xylidines with the exception of those specified elsewhere in this Annex; dimethyl anilines with the exception of those specified elsewhere in this Annex
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
xylylcarb (ISO); 3,4-dimethylphenyl N-methylcarbamate; 3,4-xylyl methylcarbamate; MPMC
219-364-9
2425-10-7
Acute Tox. 4
zinc bis(dibutyldithiocarbamate)
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
zinc bis(diethyldithiocarbamate)
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
zinc chloride
231-592-0
7646-85-7
Acute Tox. 4; Skin Corr. 1B
zinc powder — zinc dust (pyrophoric)
231-175-3
7440-66-6
Water-react. 1; Pyr. Sol. 1
zinc sulphate (anhydrous)
231-793-3
7733-02-0
Acute Tox. 4; Eye Dam. 1
zineb (ISO); zinc ethylenebis(dithiocarbamate) (polymeric)
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
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
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
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
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-trifluorotoluene; benzotrifluoride
202-635-0
98-08-8
Flam. Liq. 2
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-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-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol; C.I. Solvent Blue 4
229-851-8
6786-83-0
yes
α-bromotoluene; benzyl bromide
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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
ε-caprolactam
203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
6,7-dihydrodipyrido[1,2-α:2',1'- c]pyrazinediylium dihydroxide
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Absorption oils, bicyclo arom. and heterocyclic hydrocarbon fraction; Wash Oil Redistillate [A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260 °C to 290 °C (500°F to 554°F).]
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
Alkanes, C10-26, chloro
307-451-5
97659-46-6
yes
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene pyrolysis-derived; Pyrolysis Products [A complex combination of hydrocarbonsobtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numberspredominantly in the range of C20 through C28 and having a softening pointof 100°C to 220°C (212°F to 428°F) according to DIN 52025.]
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene-polypropylene pyrolysis-derived; Pyrolysis Products [A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100 °C to 220 °C (212°F to 428°F) according to DIN 52025.]
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polystyrene pyrolysis-derived; Pyrolysis Products [A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.]
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
chrysoidine compound with dibutylnaphthalene sulfonic acid; dibutylnaphthalenesulfonic acid, compound with 4-(phenylazo)benzene-1,3-diamine (1:1)
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Coal liquids, liq. solvent extn. [The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.]
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
Coal liquids, liq. solvent extn. soln. [The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydro-genated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.]
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
dimethylhexanoic acid nickelsalt
301-323-2
93983-68-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Distillates (coal tar), benzole fraction, BTX-rich; Light Oil Redistillate, low boiling [ residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75 °C to 200 °C (167 °F to 392 °F).]
A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C (167°F to 392°F).
309-984-9
101896-26-8
Carc. 1B; Muta. 1B
Distillates (coal tar), benzole fraction, distn. residues; Wash Oil [ complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300 °C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70 °C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.]
A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300°C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70°C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.
310-165-3
121620-46-0
Carc. 1B; Muta. 1B
Distillates (coal tar), light oils, neutral fraction; Light Oil Extract Residues, high boiling [A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135o C to 210o C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135°C to 210°C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.
309-971-8
101794-90-5
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, indole-methylnaphthalene fraction; Methylnaphthalene Oil [ distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235 °C to 255 °C (455 °F to 491 °F).]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235°C to 255°C (455°F to 491°F).
309-972-3
101794-91-6
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, methylnaphthalene fraction; Methylnaphthalene Oil [ distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225 °C to 255 °C (437°F to 491 °F).]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225°C to 255°C (437°F to 491°F).
309-985-4
101896-27-9
Carc. 1B; Muta. 1B
Distillates (coal tar), pitch; Heavy Anthracene Oil [The oil obtained from condensation of the vapors from the heat treatment of pitch.; Composed primarily of two-to four-ring aromatic compounds boiling in the range of 200 °C to greater than 400 °C (392 °F to greater than 752 °F).]
The oil obtained from condensation of the vapors from the heat treatment of pitch. Composed primarily of two- to four-ring aromatic compounds boiling in the range of 200°C to greater than 400°C (392°F to greater than 752°F).
309-855-7
101316-49-8
Carc. 1B
Distillates (coal), liq. solvent extn., primary [he liquid product of condensation of vapors emitted during the digestion of coal in a liquid solvent and boiling in the range of approximately 30 °C to 300 °C 86 °F to 572 °F).; Composed primarily of partly hydrogenated condensed-ring aromatic hydrocarbons, aromatic compounds containing nitrogen, oxygen and sulfur, and their alkyl derivatives having carbon numbers predominantly in the range of C4 through C14.]
The liquid product of condensation of vapors emitted during the digestion of coal in a liquid solvent and boiling in the range of approximately 30°C to 300°C (86°F to 572°F). Composed primarily of partly hydrogenated condensed-ring aromatic hydrocarbons, aromatic compounds containing nitrogen, oxygen and sulfur, and their alkyl derivatives having carbon numbers predominantly in the range of C4 through C14.
302-688-0
94114-52-0
Carc. 1B; Muta. 1B
Distillates (coal), solvent extn., hydrocracked [Distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30 °C to 300°C (86 °F to 572 °F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 through C14. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.]
Distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 300°C (86°F to 572°F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 through C14. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.
302-689-6
94114-53-1
Carc. 1B; Muta. 1B
Distillates (coal), solvent extn., hydrocracked hydrogenated middle [Distillate from the hydroge nation of hydrocracked middle distillate from coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180 °C to 280 °C (356 F to 536°F). Composed primarily of hydrogenated two-ring carbon compounds and their alkyl derivatives having carbon numbers predominantly in the range of C9 through C14.]
Distillate from the hydrogenation of hydrocracked middle distillate from coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 280°C (356°F to 536°F). Composed primarily of hydrogenated two- ring carbon compounds and their alkyl derivatives having carbon numbers predominantly in the range of C9 through C14.
302-693-8
94114-57-5
Carc. 1B; Muta. 1B
Distillates (coal), solvent extn., hydrocracked middle [Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180 °C to 300 °C (356°F to 572°F. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present.]
Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 300°C (356°F to 572°F. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present.
302-692-2
94114-56-4
Carc. 1B; Muta. 1B
Distillates (petroleum), C7-9, C8-rich, hydrodesulfurized dearomatized; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120 o C to 130 o C (248 °F to 266 °F).]
A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120°C to 130°C (248°F to 266°F).
309-862-5
101316-56-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), carbon-treated light paraffinic; Gasoil — unspecified [A complex combination of hydrocarbons obtained by the treatment of a petroleum oil fraction with activated charcoal for the removal of traces of polar constituents and impur ities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C28.]
A complex combination of hydrocarbons obtained by the treatment of a petroleum oil fraction with activated charcoal for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C28.
309-667-5
100683-97-4
Carc. 1B
Distillates (petroleum), catalytic cracked heavy tar light; Cracked kerosine [ complex combination of hydrocarbons obtained by distillation of catalytic cracking heavy tars. It consists predomi nantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100 °C to 250 °C (212 °F to 482 °F).]
A complex combination of hydrocarbons obtained by distillation of catalytic cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-938-8
101631-13-4
Asp. Tox. 1
Distillates (petroleum), heavy steam-cracked; Cracked gasoil [ complex combination of hydrocarbons obtained by distillation of steam cracking heavy residues. It consists predominantly of highly alkylated heavy aromatic hydrocarbons boiling in the range of approximately 250 °C to 400 °C (482 °F to 752 °F).]
A complex combination of hydrocarbons obtained by distillation of steam cracking heavy residues. It consists predominantly of highly alkylated heavy aromatic hydrocarbons boiling in the range of approximately 250°C to 400°C (482°F to 752°F).
309-939-3
101631-14-5
Carc. 1B
Distillates (petroleum), hydrocracked solvent-refined light; Baseoil — unspecified [ complex combination of hydrocarbons obtained by the solvent treatment of a distillate from hydrocracked petroleum distillates. It consists predomiantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370 °C to 450°C (698 °F to 842 °F.]
A complex combination of hydrocarbons obtained by the solvent treatment of a distillate from hydrocracked petroleum distillates. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).
307-010-7
97488-73-8
Carc. 1B
Distillates (petroleum), hydrodesulfurized full-range middle coker; Kerosine — unspecified [ complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized coker distillate. It consists predominantly of hydrocarbons having carbon; numbers predominantly in the range of C8 through C16 and boiling in the range of approximately 120 °C to 283 °C (248 °F to 541 °F).]
A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C16 and boiling in the range of approximately 120°C to 283°C (248°F to 541°F).
309-864-6
101316-58-9
Asp. Tox. 1
Distillates (petroleum), hydrodesulfurized full-range middle; Heavy Fuel oil [A complex combination of hydrocarbons obtained by treating a petroleum stock with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C25 and boiling in the range of approximately 150°C to 400°C (302 °F to 752 °F).]
A complex combination of hydrocarbons obtained by treating a petroleum stock with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C25 and boiling in the range of approximately 150°C to 400°C (302°F to 752°F).
309-863-0
101316-57-8
Carc. 1B
Distillates (petroleum), hydrodesulfurized middle coker; Cracked gasoil [ complex combination of hydrocarbons by fractionation from hydrodesulfurised coker distillate stocks. Is consists of hydrocarbons having carbon numbers predominantly in the range of C12 through C21 and boiling in the range of approximately 200 °C to 360 °C (392 °F to 680 °F).]
A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate stocks. It consists of hydrocarbons having carbon numbers predominantly in the range of C12 through C21 and boiling in the range of approximately 200°C to 360°C (392°F to 680°F).
309-865-1
101316-59-0
Carc. 1B
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Zobrazení 3 151 - 3 200 z 4 821 výsledků.

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