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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
disodium tetraborate, anhydrous
215-540-4
1330-43-4
Repr. 1B
yes
disodium tetrachloroplatinate
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
disodium {5-[(4'-((2,6-hydroxy3-((2-hydroxy-5-sulphophenyl)azo)phenyl)azo)(1,1'-biphenyl)-4-yl)azo]salicylato (4-)}cuprate(2-); CI Direct Brown 95
240-221-1
16071-86-6
Carc. 1B
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 (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), 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
Distillates (petroleum), intermediate paraffinic, carbon-treated; Gasoil — unspecified [A complex combination of hydrocarbons obtained by the treatment of petroleum with activated charcoal for the removal of trace polar consti tuents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.]
A complex combination of hydrocarbons obtained by the treatment of petroleum with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
309-668-0
100683-98-5
Carc. 1B
Distillates (petroleum), intermediate paraffinic, clay-treated; Gasoil — unspecified [A complex combination of hydrocarbons obtained by the treatment of petroleum with bleaching earth for the removal of trace polar constituents and impurities. It consists predomi nantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.]
A complex combination of hydrocarbons obtained by the treatment of petroleum with bleaching earth for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
309-669-6
100683-99-6
Carc. 1B
Distillates (petroleum), steam-cracked heavy tar light; Cracked kerosine [ complex combination of hydrocarbons obtained by distillation of steam 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).]
A complex combination of hydrocarbons obtained by distillation of steam 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).
309-940-9
101631-15-6
Asp. Tox. 1
Distillates (petroleum), thermal-cracked, alkylarom. hydrocarbon-rich; Cracked kerosine [ complex combination of hydrocarbons obtained by distillation of thermal-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.]
A complex combination of hydrocarbons obtained by distillation of thermal-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).
309-866-7
101316-61-4
Asp. Tox. 1
disul (ISO); 2-(2,4-dichlorophenoxy)ethyl hydrogensulphate; 2,4-DES
205-259-5
149-26-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
disulphur dichloride; sulfur monochloride
233-036-2
10025-67-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
divanadium pentaoxide; vanadium pentoxide
215-239-8
1314-62-1
Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3
dodecyl 3,4,5-trihydroxybenzoate
214-620-6
1166-52-5
Skin Sens. 1
dodecyl methacrylate
205-570-6
142-90-5
STOT SE 3
dodemorph (ISO); 4-cyclododecyl-2,6-dimethylmorpholine
216-474-9
1593-77-7
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
E-ethyl-4-oxo-4-phenylcrotonate
BAE; BENZOYLACRYLATE D'ETHYLE; BENZOYLACRYLATE D'ÉTHYLE (TRANS); BENZOYLACRYLIC ACID ETHYL ESTER; BENZOYLACRYLSÄURE ETHYLESTER
408-040-4
15121-89-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
edifenphos (ISO); O-ethyl S, S-diphenyl phosphorodithioate
241-178-1
17109-49-8
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
emamectin benzoate (ISO); (4''R)-4''-deoxy-4''-(methylamino) avermectin B1 benzoate
605-015-1
155569-91-8
Acute Tox. 3; STOT SE 1; STOT RE 1; Eye Dam. 1
endosulfan (ISO); 1,2,3,4,7,7-hexachloro-8,9,10-trinorborn-2-en-5,6-ylenedimethylene sulfite; 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-en-2,3-ylenedimethylene sulfite
204-079-4
115-29-7
Acute Tox. 2; Acute Tox. 4
endothal (ISO); 7-oxabicyclo(2,2,1)heptane-2,3-dicarboxylic acid
205-660-5
145-73-3
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
endothal-sodium (ISO); disodium 7-oxabicyclo(2,2,1)heptane-2,3-dicarboxylate
204-959-8
129-67-9
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
epoxiconazole (ISO); (2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane
406-850-2
133855-98-8
Carc. 2; Repr. 1B
erbon (ISO); 2-(2,4,5-trichlorophenoxy)ethyl2,2-dichloropropionate
-
136-25-4
Acute Tox. 4
erionite
620-440-2
12510-42-8
Carc. 1A
ethanediol; ethylene glycol
203-473-3
107-21-1
Acute Tox. 4
ethephon; 2-chloroethylphosphonic acid
240-718-3
16672-87-0
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C
ethidium bromide; 3,8-diamino-1-ethyl-6-phenylphenantridinium bromide
214-984-6
1239-45-8
Muta. 2; Acute Tox. 2; Acute Tox. 4
ethoate-methyl (ISO); ethylcarbamoylmethyl O,O-dimethyl phosphorodithioate
204-121-1
116-01-8
Acute Tox. 4
ethoprophos (ISO); ethyl-S,S-dipropyl phosphorodithioate
236-152-1
13194-48-4
Acute Tox. 2; Acute Tox. 1; Acute Tox. 3; Skin Sens. 1
ethyl (3-cyanomethyl-3,4-dihydro-4-oxophthalazin-1-yl)acetate
429-680-0
122665-86-5
Skin Sens. 1
ethyl (3R)-4-cyano-3-hydroxybutanoate
430-220-6
141942-85-0
Eye Irrit. 2
ethyl 1-(2,4-dichlorophenyl)-5-(trichloromethyl)-1H-1,2,4-triazole-3-carboxylate
HOE 70542
401-290-5
103112-35-2
Carc. 1B
ethyl 1-ethyl-6,7,8-trifluoro-1,4-dihydro-4-oxoquinoline-3-carboxylate
DM-8
405-880-3
100501-62-0
Skin Sens. 1
ethyl 2-(1-cyanocyclohexyl)acetate
GABAPENTINE ETHYL ESTER; PD 137016
415-970-4
133481-10-4
Acute Tox. 4; STOT RE 2
ethyl 2-(4-phenoxyphenyl)lactate
429-220-9
132584-17-9
Skin Sens. 1
ethyl 2-carboxy-3-(2-thienyl)propionate
SB-201999
415-680-8
143468-96-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
ethyl 6,8-dichlorooctanoate
6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
435-080-1
1070-64-0
Skin Sens. 1
ethyl 7-chloro-1-(2,4-difluorophenyl)-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylate
422-360-1
100491-29-0
Skin Sens. 1
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