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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210-903-3
625-58-1
Unst. Expl.
Details
203-722-6
109-95-5
Flam. Gas 1; Press. Gas; Acute Tox. 4
Details
203-291-4
105-37-3
Flam. Liq. 2
Details
EAPOXC
421-790-7
13014-29-4
Water-react. 1; Skin Corr. 1A
Details
ET 344 SP
412-540-8
22471-55-2
Skin Irrit. 2
Details
BETA-DAASE; BETA-DIMETHYLAMIMO ACRYLIC ACID ETHYLESTER
402-650-4
1117-37-9
Skin Sens. 1
Details
MCDPAE
406-580-5
52460-86-3
Skin Irrit. 2
Details
200-834-7
75-04-7
Flam. Gas 1; Press. Gas; Eye Irrit. 2; STOT SE 3
Details
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
Details
209-940-8
598-56-1
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
Details
200-815-3
74-85-1
Flam. Gas 1; Press. Gas; STOT SE 3
Details
219-732-9
2514-53-6
Skin Irrit. 2
Details
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
Details
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
Details
200-849-9
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
Details
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
R Toxic for reproduction (article 57c)
Details
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
Z-2
400-520-1
164907-74-8
Skin Corr. 1B; Acute Tox. 4
Details
205-793-9
151-56-4
Flam. Liq. 2; Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
Details
425-430-1
6746-94-7
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
Details
ETHOFENPROX; TREBON
407-980-2
80844-07-1
Lact.
Details
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
Details
253-855-9
38260-54-7
Acute Tox. 4
Details
227-561-6
5888-33-5
Skin Sens. 1A
Details
CINEOLE ALCOHOL
402-470-6
87172-89-2
Acute Tox. 4; Eye Dam. 1
Details
The extract oil boiling in the range of approximately 220°C to 265°C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.
284-901-6
84989-12-8
Carc. 1B; Muta. 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
The redistillate from the fractional distillation of dephenolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220°C to 230°C (428°F to 446°F). It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons.
295-329-1
91995-66-3
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
The aqueous extract produced by an acidic wash of alkali-washed carbolic oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.
292-622-6
90640-99-6
Carc. 1B; Muta. 1B
Details
The aqueous extract produced by an acidic wash of alkali-washed napthalene oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.
292-623-1
90641-00-2
Carc. 1B; Muta. 1B
Details
The extract produced by the acidic extraction of bases from crude coal tar aromatic oils, neutralization, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.
273-077-3
68937-63-3
Carc. 1B; Muta. 1B
Details
The extract from coal tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.
266-020-9
65996-86-3
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85°C-195°C (185°F-383°F).
309-868-8
101316-63-6
Carc. 1B; Muta. 1B
Details
An acid sludge by-product of the sulphuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.
298-725-2
93821-38-6
Carc. 1B; Muta. 1B
Details
The redistillate from the distillate, freed of tar acids and tar bases, from bituminous coal high temperature tar boiling in the approximate range of 90°C to 160°C (194°F to 320°F). It consists predominantly of benzene, toluene and xylenes.
295-323-9
91995-61-8
Carc. 1B; Muta. 1B
Details
The residue from toluene extraction of dried brown coal.
294-285-0
91697-23-3
Carc. 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
309-867-2
101316-62-5
Carc. 1B; Muta. 1B
Details
The oil resulting from the acid washing of alkali-washed carbolic oil to remove the minor amounts of basic compounds (tar bases). Composed primarily of indene, indan and alkylbenzenes.
292-624-7
90641-01-3
Carc. 1B; Muta. 1B
Details
The first fraction from the distillation of aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oil boiling substantially below 145°C (293°F). Composed primarily of C7 and C8 aliphatic and aromatic hydrocarbons.
292-625-2
90641-02-4
Carc. 1B; Muta. 1B
Details
The distillate from aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oils, having an approximate boiling range of 155°C to 180°C (311°F to 356°F). Composed primarily of indene, indan and trimethylbenzenes.
292-626-8
90641-03-5
Carc. 1B; Muta. 1B
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
The distillate from alkali-washed naphthalene oil having an approximate distillation range of 180°C to 220°C (356°F to 428°F). Composed primarily of naphthalene, alkylbenzenes, indene and indan.
292-627-3
90641-04-6
Carc. 1B; Muta. 1B
Details
The residue from the distillation of alkali-washed naphthalene oil having an approximate distillation range of 220°C to 300°C (428°F to 572°F). Composed primarily of naphthalene, alkylnaphthalenes and aromatic nitrogen bases.
292-628-9
90641-05-7
Carc. 1B; Muta. 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
The product obtained by treatment of coal tar oil alkaline extract with CO2 and CaO. Composed primarily of CaCO3, Ca(OH)2, Na2CO3 and other organic and inorganic impurities.
292-629-4
90641-06-8
Carc. 1B; Muta. 1B
Details
The residue obtained from chemical oil extracted after the removal of naphthalene by distillation composed primarily of two to four membered condensed ring aromatic hydrocarbons and aromatic nitrogen bases.
277-567-8
73665-18-6
Carc. 1B; Muta. 1B
Details
The residue obtained from coal tar oil by an alkaline wash such as aqueous sodium hydroxide after the removal of crude coal tar acids. Composed primarily of naphthalenes and aromatic nitrogen bases.
266-021-4
65996-87-4
Carc. 1B; Muta. 1B
Details

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