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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 16 May 2024. Database contains 4821 unique substances/entries.
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213-666-4
999-81-5
Acute Tox. 4
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2,4-DICHLORO-3-ETHYL-6-NITROPHENOL
420-740-1
99817-36-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
DBBT
402-210-1
99688-47-8
STOT RE 2; Skin Sens. 1
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
ECPA
427-630-2
99469-99-5
Eye Dam. 1
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
213-611-4
994-05-8
Flam. Liq. 2; Acute Tox. 4; STOT SE 3
213-608-8
993-16-8
Repr. 2
T001446
419-600-2
99199-90-3
Skin Sens. 1
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
213-589-6
991-42-4
Acute Tox. 4
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
202-807-5
99-98-9
Acute Tox. 3
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
202-796-7
99-87-6
Flam. Liq. 3; Acute Tox. 3; Asp. Tox. 1
202-795-1
99-86-5
Flam. Liq. 3; Acute Tox. 4; Skin Sens. 1; Asp. Tox. 1
202-776-8
99-65-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
202-759-5
99-49-0
Skin Sens. 1
202-752-7
99-35-4
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
619-377-3
98886-44-3
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
KAYACEL YELLOW CG; NO.466 BZN
407-680-1
98809-11-1
Eye Dam. 1; Skin Sens. 1
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
426-110-2
98377-35-6
Skin Sens. 1
A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).
308-733-0
98219-64-8
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment and distillation of light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 35°C to 80°C (95°F to 176°F).
308-714-7
98219-47-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by the treatment and distillation of debenzenized light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 95°C to 200°C (203°F to 392°F).
308-713-1
98219-46-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
202-704-5
98-82-8
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
202-635-0
98-08-8
Flam. Liq. 2
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-627-7
98-01-1
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-626-1
98-00-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with silicic acid for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-298-7
97926-78-8
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with bentonite for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-297-1
97926-77-7
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of lignite carbonization tar with activated carbon for removal of trace constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-296-6
97926-76-6
Carc. 1B
308-290-3
97926-71-1
Carc. 1B
308-289-8
97926-70-0
Carc. 1B
308-287-7
97926-68-6
Carc. 1B
A complex combination of hydrocarbons obtained by catalytic dehydrosulfurization of thermal-cracked light vacuum petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C14 through C20 and boiling in the range of approximately 270°C to 370°C (518°F to 698°F).
308-278-8
97926-59-5
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of heavy naphthic solvent petroleum extract with bleaching earth. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C10 and boiling in the range of approximately 80°C to 180°C (175°F to 356°F).
308-261-5
97926-43-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
308-208-6
97925-95-6
Repr. 1B
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-158-5
97863-06-4
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-156-4
97863-05-3
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-155-9
97863-04-2
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-150-1
97862-98-1
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-149-6
97862-97-0
Carc. 1B
308-133-9
97862-83-4
Carc. 1B
308-132-3
97862-82-3
Carc. 1B
308-131-8
97862-81-2
Carc. 1B
A complex combination of hydrocarbons obtained from the redistillation of the effluents from the treatment of paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C27 and boiling in the range of approximately 330°C to 340°C (626°F to 644°F).
308-128-1
97862-78-7
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of Foots oil with silicic acid for removal of trace constituents and impurities. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-127-6
97862-77-6
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of Foots oil with activated carbon for the removal of trace constituents and impurities. It consists predominantly of saturated straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-126-0
97862-76-5
Carc. 1B
619-290-0
97780-06-8
Eye Irrit. 2
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 16cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C14 through C29 and boiling in the range of approximately 250°C to 425°C (482°F to 797°F).
307-760-5
97722-10-6
Carc. 1B
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 9.5cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C27 and boiling in the range of approximately 240°C to 400°C (464°F to 752°F).
307-758-4
97722-09-3
Carc. 1B
A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 2.2cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 through C17 and boiling in the range of approximately 200°C to 300°C (392°F to 572°F).
307-757-9
97722-08-2
Carc. 1B
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the catalytic hydrotreatment of a solvent deasphalted short residue having a viscosity of 8cSt at approximately 100°C (212°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C40 and boiling in the range of approximately 300°C to 500°C (592°F to 932°F).
307-755-8
97722-06-0
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction from a naphthenic distillate having a viscosity of 27cSt at 100°C (212°F). It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C26 through C55 and boiling in the range of approximately 395°C to 640°C (743°F to 1184°F).
307-753-7
97722-04-8
Carc. 1B
A complex combination of hydrocarbons obtained by solvent dewaxing of a distillation residue from a hydrocracked paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C20 and boiling in the range of approximately 360°C to 500°C (680°F to 932°F). It produces a finished oil having a viscosity of 4.5cSt at approximately 100°C (212°F).
307-662-2
97675-88-2
Carc. 2
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a solvent-deasphalted short residue with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C30 and boiling in the range of approximately 300°C to 400°C (572°F to 752°F). It produces a finished oil having a viscosity of 4cSt at approximately 100°C (212°F).
307-661-7
97675-87-1
Carc. 1B
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of heavy paraffins with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C20 and boiling in the range of approximately 230°C to 350°C (446°F to 662°F). It produces a finished oil having a viscosity of 2cSt at 100°C (212°F).
307-660-1
97675-86-0
Carc. 1B
A complex combination of hydrocarbons obtained as first runnings from the vacuum distillation of effluents from the treatment of a middle distillate with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C20 and boiling in the range of approximately 290°C to 350°C (554°F to 662°F). It produces a finished oil having a viscosity of 2cSt at 100°C (212°F).
307-659-6
97675-85-9
Carc. 1B
307-451-5
97659-46-6
yes
307-202-0
97553-43-0
yes
307-035-3
97488-96-5
Carc. 1B
307-034-8
97488-95-4
Carc. 1B
307-033-2
97488-94-3
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the treatment of a hydrogenated petroleum distillate with a solvent. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C19 through C40 and boiling in the range of approximately 390°C to 550°C (734°F to 1022°F).
307-011-2
97488-74-9
Carc. 1B
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
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
213-546-1
973-21-7
Acute Tox. 3
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
D,L-ESTER
411-040-7
97101-46-7
Acute Tox. 4; Skin Sens. 1
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
202-621-4
97-95-0
Acute Tox. 4
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-613-0
97-86-9
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Skin Sens. 1B
202-607-8
97-77-8
Acute Tox. 4; STOT RE 2; Skin Sens. 1
202-605-7
97-74-5
Acute Tox. 4; Skin Sens. 1
202-598-0
97-64-3
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
202-597-5
97-63-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
202-590-7
97-54-1
Skin Sens. 1A
202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
202-564-5
97-17-6
Acute Tox. 4

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