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 24 lipnja 2024. Database contains 4917 unique substances/entries.
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2-NITROBENZYLIDENE METHYL ESTER; BAY O 2787
400-650-9
39562-27-1
Skin Sens. 1
Details
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
R Toxic for reproduction (article 57c)
Details
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
Details
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
Details
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
Details
Z-2
400-520-1
164907-74-8
Skin Corr. 1B; Acute Tox. 4
Details
BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046
400-510-7
85665-98-1
Eye Dam. 1; Skin Sens. 1
Details
C.I. DISPERSE BLUE 356
400-460-6
118578-14-6
Skin Sens. 1
Details
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
Details
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
Details
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
Details
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
Details
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
Details
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
Details
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
Details
C.I. REACTIVE RED 219
400-130-1
107231-51-6
Resp. Sens. 1
Details
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
Details
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
Details
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
Details
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
Details
AMARELO INDOSOL SF-2RL; INDOSOL GELB SF-2RL; INDOSOL YELLOW SF-2RL; JAUNE INDOSOL SF-2RL; JAUNE WK 1913; SOLAR GOLDEN YELLOW R; YELLOW WK 1913
400-010-9
81898-60-4
Skin Sens. 1
Details
The residue from low temperature coal tar oils after an alkaline wash, such as aqueous sodium hydroxide, to remove crude coal tar acids. Composed primarily of hydrocarbons and aromatic nitrogen bases.
310-191-5
122384-78-5
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons from the base-free fraction from the distillation of coal tar, boiling in the range of approximately 250°C to 280°C (482°F to 536°F). It consists predominantly of biphenyl and isomeric dimethylnaphthalenes.
310-189-4
122384-77-4
Carc. 1B
Details
Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240°C to 260°C (464°F to 500°F). Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.
310-171-6
122070-80-8
Carc. 1B; Muta. 1B
Details
A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiliing range of 225°C to 255°C (437°F to 491°F). Composed primarily of substituted dinuclear aromatic hydrocarbons.
310-170-0
122070-79-5
Carc. 1B; Muta. 1B
Details
Residue from the distillation of crude phenanthrene boiling in the approximate range of 340°C to 420°C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.
310-169-5
122070-78-4
Carc. 1B
Details
A complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallization process. It is composed primarily of naphthalene and alkyl naphthalenes.
310-167-4
121620-48-2
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.
310-166-9
121620-47-1
Carc. 1B; Muta. 1B
Details
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
Details
The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to 180°C (176°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
310-162-7
121575-60-8
Carc. 1B
Details
310-154-3
121158-58-5
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
310-154-3
121158-58-5
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
A complex combination of hydrocarbons obtained by the distillation of the products of steam cracking or similar processes after taking off the very light products resulting in a residue starting with hydrocarbons having carbon numbers greater than C5. It consists predominantly of aromatic hydrocarbons having carbon numbers greater than C5 and boiling above approximately 40°C (104°F).
310-057-6
102110-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of the products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers of C5 and dicyclopentadiene and boiling in the range of approximately 30°C to 170°C (86°F to 338°F).
310-013-6
102110-15-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly C5.
310-012-0
102110-14-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
309-987-5
101896-28-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
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
Details
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
Details
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 20°C to 130°C (68°F to 266°F).
309-976-5
101795-01-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140°C to 210°C (284°F to 410°F).
309-974-4
101794-97-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
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
Details
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
Details
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
Details
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
Details
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
Details
A complex combination of hydrocarbons obtained from a distillation process of crude petroleum. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
309-945-6
101631-20-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the distillation of petroleum and subsequent hydrotreatment. It consists predominantly of alkanes, cycloalkanes and alkylbenzenes having carbon numbers predominantly in the range of C12 through C16 and boiling in the range of approximately 230°C to 270°C (446°F to 518°F).
309-944-0
101631-19-0
Asp. Tox. 1
Details
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
Details
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
Details

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