EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 srpnja 2024. Database contains 4821 unique substances/entries.
Filter the list
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232-589-7
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9001-22-3
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Resp. Sens. 1 |
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278-636-5
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77182-82-2
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Repr. 1B; Acute Tox. 4; STOT RE 2 |
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EW 400; GLUCOPROTAMIN
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403-950-8
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164907-72-6
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Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B |
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203-856-5
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111-30-8
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Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A |
yes |
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200-240-8
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55-63-0
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Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2 |
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200-240-8
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55-63-0
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Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2 |
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203-474-9
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107-22-2
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Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1 |
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206-058-5
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298-12-4
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Eye Dam. 1; Skin Sens. 1B |
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213-997-4
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1071-83-6
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Eye Dam. 1 |
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617-243-9
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81591-81-3
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Acute Tox. 4 |
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219-468-4
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2439-99-8
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Eye Dam. 1 |
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201-964-7
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90-05-1
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Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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GUANIDINIUMBENZOAT
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429-820-0
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26739-54-8
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Acute Tox. 4 |
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200-002-3
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50-01-1
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Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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620-427-1
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108173-90-6
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Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1 |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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TILCOM HTB
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411-740-2
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22411-22-9
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Eye Dam. 1; Skin Sens. 1 |
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600-130-3
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100784-20-1
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Repr. 1B |
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HALOXYFOP ETHOXYETHYL EST
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402-560-5
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87237-48-7
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Acute Tox. 4 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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-
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12035-71-1
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Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1 |
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B Bacteria and similar species |
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218-165-4
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2058-94-8
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yes |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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200-962-3
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76-44-8
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Carc. 2; Acute Tox. 3; STOT RE 2 |
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213-831-0
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1024-57-3
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Carc. 2; Acute Tox. 3; STOT RE 2 |
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206-803-4
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376-06-7
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yes |
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203-767-1
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110-43-0
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Flam. Liq. 3; Acute Tox. 4 |
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203-388-1
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106-35-4
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Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2 |
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204-608-9
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123-19-3
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Flam. Liq. 3; Acute Tox. 4 |
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205-563-8
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142-82-5
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3 |
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203-838-7
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111-14-8
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Skin Corr. 1B |
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245-737-0
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23560-59-0
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Acute Tox. 3 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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show/hide
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247-148-4
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25637-99-4
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Repr. 2; Lact. |
yes |
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204-129-5
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116-16-5
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Acute Tox. 4 |
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204-273-9
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118-74-1
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Carc. 1B; STOT RE 1 |
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201-029-3
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77-47-4
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Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B |
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show/hide
Platinate(2-), hexachloro-, (OC-6-11)-, dihydrogen, reaction products with tributylphosphine hydrochloride and N-(3-(trimethoxysilyl)propyl)-1,2-ethanediamine
EC / List no:
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| CAS no:
67924-25-8
Platinate(2-), hexachloro-, dihydrogen, (OC-6-11)-, reaction products with palladium
EC / List no:
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| CAS no:
68516-04-1
Platinate(2-), hexachloro-, (OC-6-11)-, dihydrogen, reaction products with 2,4,6,8-tetraethenyl-2,4,6,8-tetramethylcyclotetrasiloxane
EC / List no:
271-555-6
| CAS no:
68585-32-0
Dihydrogen hexachloroplatinate, compound with 1,1,3,3-tetramethyl-1,3-divinyldisiloxane
EC / List no:
258-092-5
| CAS no:
52672-74-9
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Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
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241-010-7
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16941-12-1
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Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1 |
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HEXACONAZOLE
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413-050-7
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79983-71-4
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Acute Tox. 4; Skin Sens. 1 |
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204-127-4
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116-15-4
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Press. Gas; Acute Tox. 4; STOT SE 3 |
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256-356-4
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48122-14-1
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Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
yes |
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260-566-1
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57110-29-9
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Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
yes |
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243-072-0
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19438-60-9
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Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
yes |
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AMINAZA TOLFAMATATE
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418-350-1
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-
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Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1 |
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247-094-1
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25550-51-0
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Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1 |
yes |
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DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
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405-160-9
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124537-30-0
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Acute Tox. 3; Skin Sens. 1 |
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235-921-9
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13048-33-4
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1 |
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212-485-8
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822-06-0
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Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1 |
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204-679-6
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124-09-4
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Acute Tox. 4; STOT SE 3; Skin Corr. 1B |
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211-653-8
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680-31-9
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Carc. 1B; Muta. 1B |
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203-852-3
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111-27-3
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Acute Tox. 4 |
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209-731-1
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591-78-6
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Flam. Liq. 3; Repr. 2; STOT RE 1; STOT SE 3 |
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203-523-4
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107-83-5
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3 |
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Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3 |
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247-143-7
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25637-27-8
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Acute Tox. 4 |
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PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
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417-250-5
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151436-99-6
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Eye Dam. 1; Skin Sens. 1 |
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BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
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405-280-1
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76508-02-6
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Eye Irrit. 2 |
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RED SF-PE 3534
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410-180-6
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157627-99-1
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Eye Dam. 1 |
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C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
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400-050-7
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85153-92-0
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Resp. Sens. 1; Skin Sens. 1 |
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BRUN REACTIF 45; BRUNO REATTIVO 45; C.I. REACTIVE BROWN 45; CIBACROM BROWN 1347; CIBACRON BROWN 1347; REACTIVE BRAUN 45
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401-650-1
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85665-96-9
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Skin Sens. 1 |
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NATRIUMMETAWOLFRAMAT
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412-770-9
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12141-67-2
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Acute Tox. 4; Eye Dam. 1 |
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257-074-4
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51235-04-2
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Acute Tox. 4; Eye Irrit. 2 |
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219-698-5
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2499-95-8
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1 |
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F Fungi |
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F Fungi |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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-
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-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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-
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-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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-
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-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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-
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-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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-
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-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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-
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-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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-
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-
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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206-114-9
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302-01-2
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Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1 |
yes |
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STABO-FIX
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405-030-1
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148434-03-1
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Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1 |
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616-584-0
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7803-57-8
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yes |
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HNF; HYDRAZINIUM NITROFORMATE
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414-850-9
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4682-01-3
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Expl. 1.1; Self-react. A; Carc. 1B; Acute Tox. 3; Skin Sens. 1 |
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204-563-5
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122-66-7
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Carc. 1B; Acute Tox. 4 |
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233-109-9
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10034-85-2
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Press. Gas; Skin Corr. 1A |
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233-109-9
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10034-85-2
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Skin Corr. 1B |
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233-113-0
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10035-10-6
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Skin Corr. 1B; STOT SE 3 |
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233-113-0
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10035-10-6
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Press. Gas; Skin Corr. 1A; STOT SE 3 |
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The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 120°C (158°F to 248°F).
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309-745-9
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100801-63-6
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Carc. 1B; Muta. 1B |
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The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70°C to 120°C (158°F to 248°F).
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309-748-5
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100801-65-8
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Carc. 1B; Muta. 1B |
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The oil obtained from the heat treatment of polystyrene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 210°C (158°F to 410°F).
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309-749-0
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100801-66-9
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Carc. 1B; Muta. 1B |
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