EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10
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 20 rujna 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained from catalytic hydrodesulfurization of vacuum gas oil and from which hydrogen sulfide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
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269-632-4
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68308-12-3
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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A complex combination of hydrocarbons obtained from the thermal cracking of vacuum residues. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
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270-815-6
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68478-34-2
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Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B |
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A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
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232-484-6
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8052-10-6
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Skin Sens. 1 |
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The fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distillation of low-temperature coal tar acids.
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284-896-0
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84989-07-1
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Carc. 1B; Muta. 1B |
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A complex combination of organic compounds obtained from brown coal gasification. Composed primarily of C6-10 hydroxy aromatic phenols and their homologs.
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295-536-7
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92062-22-1
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Carc. 1B; Muta. 1B |
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The reaction product obtained by neutralizing coal tar oil alkaline extract with an acidic solution, such as aqueous sulfuric acid, or gaseous carbon dioxide, to obtain the free acids. Composed primarily of tar acids such as phenol, cresols, and xylenols.
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266-019-3
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65996-85-2
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Carc. 1B; Muta. 1B |
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The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80°C (176°F). Composed primarily of polyalkylphenols, resin gums, and inorganic salts.
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271-418-0
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68555-24-8
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Carc. 1B; Muta. 1B |
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272-361-4
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68815-21-4
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Carc. 1B; Muta. 1B |
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A complex combination of organic compounds obtained from brown coal and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). It contains chiefly phenols and pyridine bases.
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295-540-9
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92062-26-5
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Carc. 1B; Muta. 1B |
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The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
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284-891-3
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84989-03-7
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Carc. 1B; Muta. 1B |
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The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
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284-892-9
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84989-04-8
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Carc. 1B; Muta. 1B |
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The fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225°C to 320°C (437°F to 608°F). Composed primarily of polyalkylphenols.
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284-893-4
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84989-05-9
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Carc. 1B; Muta. 1B |
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The residue from the distillation in the range of 235°C to 355°C (481°F to 697°F) of light carbolic oil.
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270-713-1
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68477-23-6
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Carc. 1B; Muta. 1B |
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The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
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284-895-5
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84989-06-0
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Carc. 1B; Muta. 1B |
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The distillation fraction boiling in the range of approximately 180°C to 200°C (356°F to 392°F) from the crude bases obtained by dephenolating and debasing the carbolated oil from the distillation of coal tar. It contains chiefly aniline, collidines, lutidines and toluidines.
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295-541-4
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92062-27-6
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Carc. 1B; Muta. 1B |
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The distillation fraction boiling in the range of approximately 181°C to 186°C (356°F to 367°F) from the crude bases obtained from the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of bituminous coal tar. It contains chiefly aniline and collidines.
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295-543-5
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92062-28-7
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Carc. 1B; Muta. 1B |
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The reaction product obtained by neutralizing coal tar base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.
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266-018-8
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65996-84-1
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Carc. 1B; Muta. 1B |
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The distillation residue remaining after the distillation of the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of coal tars. It contains chiefly aniline, collidines, quinoline and quinoline derivatives and toluidines.
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295-544-0
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92062-29-8
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Carc. 1B; Muta. 1B |
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293-766-2
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91082-52-9
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Carc. 1B; Muta. 1B |
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Pyridine bases boiling in the range of approximately 125°C to 160°C (257°F 320°F) obtained by distillation of neutralized acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.
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295-548-2
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92062-33-4
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Carc. 1B; Muta. 1B |
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274-560-1
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70321-67-4
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Carc. 1B; Muta. 1B |
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293-767-8
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91082-53-0
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Carc. 1B; Muta. 1B |
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271-020-7
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68513-87-1
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Carc. 1B; Muta. 1B |
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The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C (266°F to 410°F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.
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266-016-7
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65996-82-9
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Carc. 1B; Muta. 1B |
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Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
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295-535-1
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92062-20-9
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Carc. 1B |
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The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
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273-615-7
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68990-61-4
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Carc. 1B |
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The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
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266-024-0
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65996-89-6
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Carc. 1A |
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The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.
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266-025-6
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65996-90-9
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Carc. 1A |
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The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.
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293-764-1
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91082-50-7
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Carc. 1B |
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The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.
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232-361-7
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8007-45-2
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Carc. 1A |
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200-927-2
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76-03-9
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Skin Corr. 1A |
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211-479-2
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650-51-1
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STOT SE 3 |
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251-793-7
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34014-18-1
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Acute Tox. 4 |
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204-178-2
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117-18-0
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Acute Tox. 4; Skin Sens. 1 |
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236-813-4
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13494-80-9
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Repr. 1B; Lact. |
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231-193-1
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7446-07-3
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Repr. 1B; Lact. |
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203-495-3
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107-49-3
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Acute Tox. 1; Acute Tox. 2 |
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235-963-8
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13071-79-9
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Acute Tox. 1; Acute Tox. 2 |
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251-637-8
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33693-04-8
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Acute Tox. 4 |
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227-637-9
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5915-41-3
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Acute Tox. 4; STOT RE 2 |
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262-967-7
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61788-32-7
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VPVB very Persistent and very Bioaccumulative (article 57e) |
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262-967-7
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61788-32-7
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VPVB very Persistent and very Bioaccumulative (article 57e) |
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208-760-7
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540-88-5
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Flam. Liq. 2 |
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216-768-7
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1663-39-4
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Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1 |
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212-105-0
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762-75-4
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Flam. Liq. 2; Eye Irrit. 2; STOT SE 3 |
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200-915-7
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75-91-2
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Muta. 2 |
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216-653-1
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1634-04-4
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Flam. Liq. 2; Skin Irrit. 2 |
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208-757-0
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540-80-7
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Flam. Liq. 2; Acute Tox. 4 |
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222-389-8
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3457-61-2
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Org. Perox. E; Skin Irrit. 2 |
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235-541-3
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12267-73-1
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Repr. 1B |
R Toxic for reproduction (article 57c) |
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