EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).

Last updated 11 listopada 2024. Database contains 4918 unique substances/entries.
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213-666-4
999-81-5
Acute Tox. 4
Details
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
Details
2,4-DICHLORO-3-ETHYL-6-NITROPHENOL
420-740-1
99817-36-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
Details
DBBT
402-210-1
99688-47-8
STOT RE 2; Skin Sens. 1
Details
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
Details
ECPA
427-630-2
99469-99-5
Eye Dam. 1
Details
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
Details
213-611-4
994-05-8
Flam. Liq. 2; Acute Tox. 4; STOT SE 3
Details
213-608-8
993-16-8
Repr. 2
Details
T001446
419-600-2
99199-90-3
Skin Sens. 1
Details
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
Details
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
Details
213-589-6
991-42-4
Acute Tox. 4
Details
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
Details
202-807-5
99-98-9
Acute Tox. 3
Details
202-805-4
99-97-8
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT RE 2
Details
202-796-7
99-87-6
Flam. Liq. 3; Acute Tox. 3; Asp. Tox. 1
Details
202-795-1
99-86-5
Flam. Liq. 3; Acute Tox. 4; Skin Sens. 1; Asp. Tox. 1
Details
202-776-8
99-65-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
Details
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
Details
202-759-5
99-49-0
Skin Sens. 1
Details
202-752-7
99-35-4
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
Details
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
Details
213-584-9
989-38-8
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
Details
619-377-3
98886-44-3
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
Details
KAYACEL YELLOW CG; NO.466 BZN
407-680-1
98809-11-1
Eye Dam. 1; Skin Sens. 1
Details
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
Details
426-110-2
98377-35-6
Skin Sens. 1
Details
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
Details
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
Details
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
Details
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
Details
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
Details
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
R Toxic for reproduction (article 57c)
Details
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
Details
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
Details
202-704-5
98-82-8
Flam. Liq. 3; Carc. 1B; Asp. Tox. 1; STOT SE 3
Details
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
Details
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
202-635-0
98-08-8
Flam. Liq. 2
Details
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
202-627-7
98-01-1
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
202-626-1
98-00-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3
Details
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
Details
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
Details
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
Details
308-290-3
97926-71-1
Carc. 1B
Details
308-289-8
97926-70-0
Carc. 1B
Details
308-287-7
97926-68-6
Carc. 1B
Details
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
Details
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
Details
308-208-6
97925-95-6
Repr. 1B
Details
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
Details
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
Details
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
Details
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
Details
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
Details
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
Details
308-133-9
97862-83-4
Carc. 1B
Details
308-132-3
97862-82-3
Carc. 1B
Details
308-131-8
97862-81-2
Carc. 1B
Details
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
Details
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
Details
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
Details
619-290-0
97780-06-8
Eye Irrit. 2
Details
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
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
Details
307-451-5
97659-46-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
307-202-0
97553-43-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
307-035-3
97488-96-5
Carc. 1B
Details
307-034-8
97488-95-4
Carc. 1B
Details
307-033-2
97488-94-3
Asp. Tox. 1
Details
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
Details
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
Details
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
Details
213-546-1
973-21-7
Acute Tox. 3
Details
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
Details
D,L-ESTER
411-040-7
97101-46-7
Acute Tox. 4; Skin Sens. 1
Details
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
Details
202-621-4
97-95-0
Acute Tox. 4
Details
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
Details
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
202-613-0
97-86-9
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Skin Sens. 1B
Details
202-607-8
97-77-8
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
202-605-7
97-74-5
Acute Tox. 4; Skin Sens. 1
Details
202-598-0
97-64-3
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
Details
202-597-5
97-63-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
C Carcinogenic (article 57a)
Details
202-590-7
97-54-1
Skin Sens. 1A
Details
202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
Details

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